CIPHR Research Publications

Abstract

Importance: The COVID-19 pandemic led to reductions in primary care and cancer screening visits, which may delay detection of some cancers. The impact on incidence has not been fully quantified. We examined change in cancer incidence to determine how the COVID-19 pandemic may have altered the characteristics of cancers diagnosed among women.

Methods: This study included female patients aged ≥18 years and diagnosed with breast (n = 9489), colon (n = 958), pancreatic (n = 669), or uterine (n = 1991) cancer at three hospitals in North Carolina. Using interrupted time series, we compared incidence of cancers diagnosed between March 2020 and November 2020 (during pandemic) with cancers diagnosed between January 2016 and February 2020 (pre-pandemic).

Results: During the pandemic, incidence of breast and uterine cancers was significantly lower than expected compared to pre-pandemic (breast-18%, p = 0.03; uterine -20%, p = 0.05). Proportions of advanced pathologic stage and hormone receptor-negative breast cancers, and advanced clinical stage and large size uterine cancers were more prevalent during the pandemic. No significant changes in incidence were detected for pancreatic (-20%, p = 0.08) or colon (+14%, p = 0.30) cancers.

Conclusion and relevance: In women, the COVID-19 pandemic resulted in a significant reduction in the incidence of breast and uterine cancers, but not colon or pancreatic cancers. A change in the proportion of poor prognosis breast and uterine cancers suggests that some cancers that otherwise would have been diagnosed at an earlier stage will be detected in later years. Continued analysis of long-term trends is needed to understand the full impact of the pandemic on cancer incidence and outcomes.

Abstract

Purpose: Assessing factors associated with being up-to-date with colorectal cancer (CRC) screening is important for identifying populations for which targeted interventions may be needed.

Methods: This study used Medicare and private insurance claims data for residents of North Carolina to identify up-to-date status in the 10th year of continuous enrollment in the claims data and in available subsequent years. USPSTF guidelines were used to define up-to-date status for multiple recommended modalities. Area Health Resources Files provided geographic and health care service provider data at the county level. A generalized estimating equation logistic regression model was used to examine the association between individual- and county-level characteristics and being up-to-date with CRC screening.

Results: From 2012-2016, 75% of the sample (n = 274,660) age 59-75 was up-to-date. We identified several individual- (e.g., sex, age, insurance type, recent visit with a primary care provider, distance to nearest endoscopy facility, insurance type) and county-level (e.g., percentage of residents with a high school education, without insurance, and unemployed) predictors of being up-to-date. For example, individuals had higher odds of being up-to-date if they were age 73-75 as compared to age 59 [OR: 1.12 (1.09, 1.15)], and if living in counties with more primary care physicians [OR: 1.03 (1.01, 1.06)].

Conclusion: This study identified 12 individual- and county-level demographic characteristics related to being up-to-date with screening to inform how interventions may optimally be targeted.

Abstract

Background: Previous studies of hospital-based patients with metastatic melanoma suggest sociodemographic factors, including insurance type, may be associated with the receipt of systemic treatments.

Objectives: To examine whether insurance type is associated with the receipt of systemic treatment among patients with melanoma in a broad cohort of patients in North Carolina.

Methods: We conducted a retrospective cohort study between 2011 and 2017 of patients with stages III-IV melanoma using data from the North Carolina Central Cancer Registry linked to Medicare, Medicaid, and private health insurance claims across the state. The primary outcome was the receipt of any systemic treatment, and the secondary outcome was the receipt of immunotherapy.

Results: A total of 372 patients met the inclusion criteria. The average age was 68 years old (interquartile range: 56-76) and 61% were male. Within the cohort 48% had Medicare only, 29% had private insurance, 12% had both Medicare and Medicaid, and 11% had Medicaid only. A total of 186 (50%) patients received systemic treatment for melanoma, 125 (67%) of whom received immunotherapy. The use of systemic therapy, including immunotherapy, increased significantly over time. Having Medicaid-only insurance was independently associated with a 45% lower likelihood of receiving any systemic treatment [0.55 (95% CI: 0.35, 0.85)] and a 43% lower likelihood of receipt of immunotherapy [0.57 (95% CI: 0.34, 0.95)] compared with private insurance.

Conclusions: Stage III-IV melanoma patients with Medicaid-only insurance were less likely to receive systemic therapy or immunotherapy than patients with private insurance or Medicare insurance. This finding raises concerns about insurance-based disparities in treatment access.

Abstract

Purpose: Hospital visits for drug use-related bacterial and fungal infections have increased alongside overdose deaths. The incidence of mortality from these infections and the comparison to overdose mortality is not established.

Methods: This cohort study examined mortality outcomes among adults with drug use diagnoses who were insured by public and private plans during 2007 through 2018 in North Carolina. We examined bacterial and fungal infection-related mortality and overdose mortality using cumulative incidence functions.

Results: Among 131,522 people with drug use diagnoses, the median age was 45 years (interquartile range: 31-57), 58% were women and 65% had an opioid use disorder diagnosis. The one-year incidence of bacterial and fungal infection-associated mortality was progressively higher as age increased (35-49 years: 9 per 10,000 people, 50-64 years: 23 per 10,000, 65+ years: 50 per 10,000 people). Conversely, the one-year incidence of overdose mortality was markedly lower among older adults compared to those under the age of 65 (18-34 years: 34 deaths per 10,000 people; 35-49 years: 47 per 10,000; 50-64 years: 41 per 10,000; 65+ years: 9 per 10,000).

Conclusions: Bacterial and fungal infections and overdose were notable causes of death among adults with drug use diagnoses, and varied by age group.

Abstract

Background: Severe skin and soft tissue infections related to injection drug use have increased in concordance with a shift to heroin and illicitly manufactured fentanyl. Opioid agonist therapy medications (methadone and buprenorphine) may improve long-term outcomes by reducing injection drug use. We aimed to examine the association of medication use with mortality among people with opioid use-related skin or soft tissue infections.

Methods: An observational cohort study of Medicaid enrollees aged 18 years or older following their first documented medical encounters for opioid use-related skin or soft tissue infections during 2007-2018 in North Carolina. The exposure was documented medication use (methadone or buprenorphine claim) in the first 30 days following initial infection compared with no medication claim. Using Kaplan-Meier estimators, we examined the difference in 3-year incidence of mortality by medication use, weighted for year, age, comorbidities, and length of hospital stay.

Results: In this sample, there were 13,286 people with opioid use-related skin or soft tissue infections. The median age was 37 years, 68% were women, and 78% were white. In Kaplan-Meier curves for the total study population, 12 of every 100 patients died during the first 3 years. In weighted models, for every 100 people who used medications, there were four fewer deaths over 3 years (95% confidence interval = 2, 6).

Conclusion: In this study, people with opioid use-related skin and soft tissue infections had a high risk of mortality following their initial healthcare visit for infections. Methadone or buprenorphine use was associated with reductions in mortality.

Abstract

Purpose: Women face multiple barriers to fertility preservation after cancer diagnosis, but few studies have examined disparities in use of these services.

Methods: Women aged 15-39 years diagnosed with cancer during 2004-2015 were identified from the North Carolina Central Cancer Registry and linked to the Society for Assisted Reproductive Technology Clinic Outcomes Reporting System. Women who cryopreserved oocytes or embryos for fertility preservation (n = 96) were compared to women who received gonadotoxic treatment but did not use fertility preservation (n = 7964). Conditional logistic and log-binomial regression were used to estimate odds ratios (ORs) or prevalence ratios (PRs) and 95% confidence intervals (CIs).

Results: Few adolescent and young adult women with cancer in our study (1.2%) used fertility preservation. In multivariable regression, women less likely to use fertility preservation were older at diagnosis (ages 25-29 vs. 35-39: OR = 6.27, 95% CI: 3.35, 11.73); non-Hispanic Black (vs. non-Hispanic White: PR = 0.44, 95% CI: 0.24, 0.79); and parous at diagnosis (vs. nulliparous: PR = 0.24, 95% CI: 0.13, 0.45); or lived in census tracts that were non-urban (vs. urban: PR = 0.12, 95% CI: 0.04, 0.37) or of lower socioeconomic status (quintiles 1-3 vs. quintiles 4 and 5: PR = 0.39, 95% CI: 0.25, 0.61).

Conclusions: Women with cancer who were older, non-Hispanic Black, parous, or living in areas that were non-urban or of lower socioeconomic position were less likely to use fertility preservation.

Implications for cancer survivors: Clinical and policy interventions are needed to ensure equitable access to fertility services among women facing cancer treatment-related infertility.

Abstract

Purpose: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population.

Methods: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only).

Results: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients.

Conclusion: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.

Abstract

Background: Hepatocellular carcinoma (HCC) surveillance is underutilized, with <25% of individuals with cirrhosis receiving surveillance exams as recommended. The epidemiology of cirrhosis and HCC in the United States has also shifted in recent years, but little is known about recent trends in surveillance utilization. We characterized patterns of HCC surveillance by payer, cirrhosis etiology, and calendar year in insured individuals with cirrhosis.

Methods: We conducted a retrospective cohort study of individuals with cirrhosis using claims data from Medicare, Medicaid, and private insurance plans in North Carolina. We included individuals ≥ 18 years with a first occurrence of an ICD-9/10 code for cirrhosis between January 1, 2010, and June 30, 2018. The outcome was HCC surveillance by abdominal ultrasound, CT, or MRI. We estimated 1- and 2-year cumulative incidences for HCC surveillance and assessed longitudinal adherence to surveillance by computing the proportion of time covered (PTC).

Results: Among 46,052 individuals, 71% were enrolled through Medicare, 15% through Medicaid, and 14% through private insurance. The overall 1-year cumulative incidence of HCC surveillance was 49% and the 2-year cumulative incidence was 55%. For those with an initial screen in the first 6 months of their cirrhosis diagnosis, the median 2-year PTC was 67% (Q1, 38%; Q3, 100%).

Conclusions: HCC surveillance initiation after cirrhosis diagnosis remains low, though it has improved slightly over time, particularly among individuals with Medicaid.

Impact: This study provides insight into recent trends in HCC surveillance and highlights areas to target for future interventions, particularly among patients with nonviral etiologies.

Abstract

Purpose: Remote symptom monitoring (RSM) using electronic patient-reported outcomes enables patients with cancer to communicate symptoms between in-person visits. A better understanding of key RSM implementation outcomes is crucial to optimize efficiency and guide implementation efforts. This analysis evaluated the association between the severity of patient-reported symptom alerts and time to response by the health care team.

Methods: This secondary analysis included women with stage I-IV breast cancer who received care at a large academic medical center in the Southeastern United States (October 2020-September 2022). Symptom surveys with at least one severe symptom alert were categorized as severe. Response time was categorized as optimal if the alert was closed by a health care team member within 48 hours. Odds ratios (ORs), predicted probabilities, and 95% CIs were estimated using a patient-nested logistic regression model.

Results: Of 178 patients with breast cancer included in this analysis, 63% of patients identified as White and 85% of patients had a stage I-III or early-stage cancer. The median age at diagnosis was 55 years (IQR, 42-65). Of 1,087 surveys included, 36% reported at least one severe symptom alert and 77% had an optimal response time by the health care team. When compared with surveys that had no severe symptom alerts, surveys with at least one severe symptom alert had similar odds of having an optimal response time (OR, 0.97; 95% CI, 0.68 to 1.38). The results were similar when stratified by cancer stage.

Conclusion: Response times to symptom alerts were similar for alerts with at least one severe symptom compared with alerts with no severe symptoms. This suggests that alert management is being incorporated into routine workflows and not prioritized based on disease or symptom alert severity.

Abstract

Purpose: Cardiovascular disease (CVD) is a common cause of mortality among men with prostate cancer. However, receipt of preventive care and management of pre-existent CVD has not been well studied in prostate cancer survivors.

Methods: This study examined a prospective cohort of men newly diagnosed with localized prostate cancer between 2011 and 2013 throughout North Carolina linked to Medicare and private insurance claims and clinical data from the Veterans Affairs (VA). In patients without pre-existent CVD, the primary outcome was a composite measure of annual preventive care (blood glucose screening, cholesterol level testing, and ≥ 1 primary care provider visit). In patients with pre-existent CVD, the primary outcome was annual cardiologist visit; blood glucose, cholesterol level testing, and primary care visits were also assessed.

Results: Our sample comprised 492 patients successfully linked to insurance claims and/or VA data, among whom 103 (20.9%) had pre-existent CVD. Receipt of preventive care declined from 52.7% (95% confidence interval [CI], 47.7 to 57.6%) during the first year after prostate cancer diagnosis to 40.8% (95% CI: 33.7 to 48.4%) during the third year. Among patients with pre-existent CVD, only 23.4% (95% CI: 13.6 to 37.2%) visited a cardiologist in all 3 years. Black men were more likely than White men to visit a cardiologist the first year (risk ratio [RR] = 1.72, 95% CI: 1.10 to 2.71).

Conclusion: In a population-based cohort of prostate cancer survivors, receipt of CVD preventive care declined over time, and frequency of cardiologist-led management of pre-existent CVD was low.

Abstract

Purpose: Residents of communities facing social vulnerability (eg, poverty) have limited access to clinical trials, leaving them susceptible to experiencing poor health outcomes. We examined the association between North Carolina county-level social vulnerability and available multiple myeloma (MM) trials.

Methods: Using a novel data linkage between ClinicalTrials.gov, the 2019 American Community Survey, and the Centers for Disease Control and Prevention's Social Vulnerability Index, we investigated at the county level (1) availability of MM trial sites and (2) the relationship between Social Vulnerability Index and MM trial site availability using logistic regression.

Results: Between 2002 and 2021, 229 trials were registered across 462 nonunique trial sites in 34 counties. Nearly 50% of trial sites were in academic medical centers, 80% (n = 372) of all trials were industry-sponsored, 60% (n = 274) were early-phase, and 50% (n = 232) were for patients with relapsed or refractory MM. Counties with low as opposed to high poverty rates had six times greater odds of having ≥ 1 MM trial sites (odds ratio [OR], 5.60; 95% CI, 1.85 to 19.64; P = .004). Counties with the lowest percentage of Black Indigenous Persons of Color and non-native English speakers had 77% lower odds (OR, 0.23; 95% CI, 0.07 to 0.69; P = .011) of having ≥ 1 trial sites. The effect remained significant after accounting for the presence of five academic medical centers (n = 95; OR, 0.18; 95% CI, 0.05 to 0.6; P = .008) and adjustment for metropolitan, suburban, or rural status (OR, 0.25; 95% CI, 0.07 to 0.81; P = .025).

Conclusion: Counties with the lowest poverty rates had more MM trial sites, whereas those with the lowest percentage of Black Indigenous Persons of Color populations had fewer MM trial sites. Multilevel efforts are needed to improve the availability and access to trials for socially vulnerable populations.

Abstract

Background: Fertility preservation (FP) may be underused after cancer diagnosis because of uncertainty around delays to cancer treatment and subsequent reproductive success.

Methods: Women aged 15 to 39 years diagnosed with cancer between 2004 and 2015 were identified from the North Carolina Central Cancer Registry. Use of assisted reproductive technology (ART) after cancer diagnosis between 2004 and 2018 (including FP) was assessed through linkage to the Society for Assisted Reproductive Technology. Linear regression was used to examine time to cancer treatment among women who did (n = 95) or did not (n = 469) use FP. Modified Poisson regression was used to estimate risk ratios (RRs) and 95% CIs for pregnancy and birth based on timing of ART initiation relative to cancer treatment (n = 18 initiated before treatment for FP vs n = 26 initiated after treatment without FP).

Results: The median time to cancer treatment was 9 to 33 days longer among women who used FP compared with women who did not, matched on clinical factors. Women who initiated ART before cancer treatment may be more likely to have a live birth given pregnancy compared with women who initiated ART after cancer treatment (age-adjusted RR, 1.47; 95% CI, 0.98-2.23), though this may be affected by the more frequent use of gestational carriers in the former group (47% vs 20% of transfer cycles, respectively).

Conclusions: FP delayed gonadotoxic cancer treatment by up to 4.5 weeks, a delay that would not be expected to alter prognosis for many women. Further study of the use of gestational carriers in cancer populations is warranted to better understand its effect on reproductive outcomes.

Abstract

Purpose: Cancer is a major reason for concurrent prescription of opioids with other sedating medications-particularly benzodiazepines and gabapentinoids-yet population-based assessments of the extent and predictors of concurrent prescribing among clinically and demographically diverse patients with cancer are lacking.

Methods: We conducted a retrospective cohort study of patients with non-metastatic cancer using North Carolina cancer registry data linked with Medicare and private insurance claims (2013-2016). We used modified Poisson regression to assess associations of patient characteristic with adjusted relative risk (aRR) of new concurrent prescribing of opioids with benzodiazepines or gabapentinoids after diagnosis.

Results: Overall, 15% of patients were concurrently prescribed opioids with benzodiazepines or gabapentinoids. Characteristics independently associated with an increased risk of concurrent prescribing included cancer type (e.g., aRR cervical vs. colorectal cancer: 1.55, 95% CI: 1.12-2.14); prior use of opioids (aRR: 2.43, 95% CI:2.21-2.67), benzodiazepines (aRR: 4.08, 95% CI: 3.72-4.48), or gabapentinoids (3.82, 95% CI: 3.31-4.39), and premorbid mental health conditions, including substance use disorder (aRR: 1.27, 95% CI: 1.05-1.54). Black and Hispanic patients were less likely to experience concurrent prescribing (aRR, Black vs. White: 0.35, 95% CI: 0.15-0.83; aRR, Hispanic vs. White: 0.75, 95% CI: 0.66-0.85).

Conclusion: Approximately 1 in 7 patients with cancer was concurrently prescribed opioids with other sedating medications. Associations between patient characteristics and risk of concurrent prescribing highlight predictors of concurrent prescribing and suggest a rationale for systematic assessment of substance use history at diagnosis. Future research could explore inequitable pain and symptom management and investigate risk of adverse medication-related events.

Abstract

Introduction: There are multiple measures of area socioeconomic status (SES) and there is little evidence on the comparative performance of these measures. We hypothesized adding area SES measures improves model ability to predict guideline concordant care and overall survival compared to models with standard clinical and demographic data alone.

Materials and methods: We included patients with colorectal cancer from 2006 to 2015 from the North Carolina Cancer Registry merged with insurance claims data. The primary area SES study variables were the Social Deprivation Index, Distressed Communities Index, Area Deprivation Index, and Social Vulnerability Index. We used multivariable logistic modeling and Cox proportional hazards modeling to assess the adjusted association of each indicator, with guideline concordant care and overall survival, respectively. Model performance of the SES measures was compared to a base model using likelihood ratio testing and area under the curve (AUC) assessments to compare SES indicator models with each other.

Results: We found that the Area Deprivation Index, Social Vulnerability Index and Social Deprivation Index, but not Distressed Communities Index, were significantly associated with receiving guideline concordant care and significantly improved model fit over the base model on likelihood ratio testing. All models had similar AUCs. With respect to overall survival, we found that all indices were independently and significantly associated with survival and had significantly improved model fit over the base model on likelihood ratio testing. AUC analysis again showed all area SES measures had comparable performance for overall survival at 5 y.

Conclusions: This analysis demonstrates the importance of including these measures in risk adjustment models. However, of the commonly available measures, no one measure stood out as superior to others.

Abstract

Background: Studies evaluating the effects of cancer treatments are prone to immortal time bias that, if unaddressed, can lead to treatments appearing more beneficial than they are.

Methods: To demonstrate the impact of immortal time bias, we compared results across several analytic approaches (dichotomous exposure, dichotomous exposure excluding immortal time, time-varying exposure, landmark analysis, clone-censor-weight method), using surgical resection among women with metastatic breast cancer as an example. All adult women diagnosed with incident metastatic breast cancer from 2013-2016 in the National Cancer Database were included. To quantify immortal time bias, we also conducted a simulation study where the "true" relationship between surgical resection and mortality was known.

Results: 24,329 women (median age 61, IQR 51-71) were included, and 24% underwent surgical resection. The largest association between resection and mortality was observed when using a dichotomized exposure (HR=0.54, 95% CI=0.51-0.57), followed by dichotomous with exclusion of immortal time (HR=0.62, 95% CI=0.59-0.65). Results from the time-varying exposure, landmark, and clone-censor-weight method analyses were closer to the null (HRs=0.67-0.84). Results from the plasmode simulation found that the time-varying exposure, landmark, and clone-censor-weight method models all produced unbiased HRs (bias -0.003 to 0.016). Both standard dichotomous exposure (HR=0.84, bias -0.177) and dichotomous with exclusion of immortal time (HR=0.93, bias -0.074) produced meaningfully biased estimates.

Conclusions: Researchers should use time-varying exposures with a treatment assessment window or the clone-censor-weight method when immortal time is present.

Impact: Using methods that appropriately account for immortal time will improve evidence and decision-making from research using real-world data.

Abstract

BACKGROUND Our objectives were to evaluate geographic access to lung cancer treatment modalities in North Carolina and to characterize how practice patterns are changing over time. We hypothesized that rural patients would be less likely to undergo treatment compared to urban patients, with widening disparities over time.

METHODS We identified patients with Stage I non-small cell lung cancer (NSCLC) from 2006 to 2015 using the North Carolina Central Cancer Registry linked with Medicaid, Medicare, and private insurance claims. The primary outcome was first-course treatment: surgery, radiation, or no treatment. Calendar years were split into earlier (2006-2010) and later (2011-2015) periods. We estimated the adjusted odds ratio (OR) of rural/urban status and time period with 1) surgery and 2) any treatment (surgery or radiation) using multivariable logistic regression.

RESULTS Among 5504 patients, 3206 (58%) underwent surgery as initial therapy, 1309 (24%) received radiation as initial therapy, and 989 (18%) had no therapy. There were no rural-urban disparities in treatment patterns. For rural and urban patients, the odds of surgery decreased over time and the odds of radiation increased. We also found that only 48% of those receiving no treatment ever reached a surgeon or radiation oncologist.LIMITATIONS This was an insured, single-state population. Treatment preferences are unknown.

CONCLUSIONS Among all treated patients, whether urban or rural, there was increasing use of radiation and decreasing use of surgery over time. Many patients without treatment never had a consultation with a surgeon/radiation oncologist, and this is an actionable target for improving treatment access for early-stage NSCLC.

Abstract

Introduction: Studies find differences in tobacco retailer density according to neighborhood sociodemographic characteristics, raising issues of social justice, but not all research is consistent. This study examined associations between tobacco retailer density and neighborhood sociodemographic characteristics in the United States (US) at four timepoints (2000, 2007, 2012, 2017) and investigated if associations remained stable over time.

Methods: Data on tobacco retailers came from the National Establishment Time-Series Database. Adjusted log-linear models examined the relationship between retailer density and census tract sociodemographic characteristics (% non-Hispanic Black [Black], % Hispanic, % vacant housing units, median household income), controlling for percentage of youth, urbanicity and US region. To examine whether the relationship between density and sociodemographic characteristics changed over time, additional models were estimated with interaction terms between each sociodemographic characteristic and year.

Results: Tobacco retailer density ranged from 1.22-1.44 retailers/1,000 persons from 2000 to 2017. There were significant, positive relationships between tobacco retailer density and the percentage of Black (standardized exp(b)=1.05 (95% CI: 1.04, 1.07) and Hispanic (standardized exp(b)=1.06 (95% CI: 1.05, 1.08) residents and the percentage of vacant housing units (standardized exp(b)=1.08 (95% CI: 1.07, 1.10) in a census tract. Retailer density was negatively associated with income (standardized exp(b)=0.84 (95% CI: 0.82, 0.86). From 2000 to 2017, the relationship between retailer density and income and vacant housing units became weaker.

Conclusions: Despite the weakening of some associations, there are sociodemographic disparities in tobacco retailer density from 2000 to 2017, which research has shown may contribute to inequities in smoking.

Implications: This study examines associations between tobacco retailer density and neighborhood sociodemographic characteristics in the United States at four time points from 2000 to 2017. Although some associations weakened, there are sociodemographic disparities in tobacco retailer density over the study period. Research suggests that sociodemographic disparities in retailer density may contribute to inequities in smoking. Findings from this study may help identify which communities should be prioritized for policy intervention and regulation.

Abstract

Purpose: To examine trends in the surgical treatment of breast cancer by age, rurality, and among Black women in a populous, racially diverse, state in the Southeastern United States of America.

Methods: We identified women diagnosed with localized or regional breast cancer between 2003 and 2016 in the North Carolina Central Cancer Registry (n = 86,776). Using Joinpoint regression we evaluated the average annual percentage change in proportion of women treated with mastectomy versus breast-conserving surgery overall, by age group, among Black women, and for women residing in rural areas.

Results: Overall, the rate of mastectomy usage in the population declined 2.5% per year between 2003 and 2016 (95% CI - 3.2, - 1.7). Over this same time interval, breast-conserving surgery increased by 1.6% per year (95% CI 0.9, 2.2). These temporal trends in surgery were also observed among Black women and rural residing women. Trends in surgery type varied by age group: mastectomy declined over time among women > 50 years, but not among women aged 18-49 at diagnosis.

Discussion: In contrast to national studies that reported increasing use of mastectomy, we found declining mastectomy rates in the early 2000s in a Southern US state with a racially and geographically diverse population. These decreasing trends were consistent among key subgroups affected by cancer inequities, including Black and White rural women.

Abstract

Introduction: Oral anti-neoplastic agents (OAAs) for metastatic renal cell carcinoma (mRCC) are associated with increased cancer-specific survival. However, racial disparities in survival persist and older adults have the lowest rates of cancer-specific survival. Research from other cancers demonstrates specialty access is associated with high-quality cancer care, but older adults receive cancer treatment less often than younger adults. We therefore examined whether patient, provider, and hospital characteristics were associated with OAA initiation, adherence, and cancer-specific survival after initiation and whether race, ethnicity, and/or age was associated with an increased likelihood of seeing a medical oncologist for diagnosis of mRCC.

Patients and methods: We used Surveillance, Epidemiology, and End Results (SEER)Medicare data to identify patients ≥65 years of age who were diagnosed with mRCC from 2007 to 2015 and enrolled in Medicare Part D. Insurance claims were used to identify receipt of OAAs within twelve months of metastatic diagnosis, calculate proportion of days covered, and to identify the primary cancer provider and hospital. We examined provider and hospital characteristics associated with OAA initiation, adherence, and all-cause mortality after OAA initiation.

Results: We identified 2792 patients who met inclusion criteria. Increased OAA initiation was associated with access to a medical oncologist. Patients were less likely to begin OAA treatment if their primary oncologic provider was a urologist (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.77). Provider/hospital characteristics were not associated with differences in OAA adherence or mortality. Patients who started sorafenib (odds ratio [OR] 0.50; 95% CI 0.29-0.86), were older (aged >81 OR 0.56; 95% CI 0.34-0.92), and those living in high poverty ZIP codes (OR 0.48; 95% CI 0.29-0.80) were less likely to adhere to OAA treatment. Furthermore, provider characteristics did not account for differences in mortality once an OAA was initiated. Last, only age > 81 years was statistically and clinically associated with a decreased relative risk of seeing a medical oncologist (risk ratio [RR] 0.87; CI 0.82-0.92).

Conclusion: Provider/hospital factors, specifically, being seen by a medical oncologist for mRCC diagnosis, are associated with OAA initiation. Older patients were less likely to see a medical oncologist; however, race and/or ethnicity was not associated with differences in seeing a medical oncologist. Patient factors are more critical to OAA adherence and mortality after OAA initiation than provider/hospital factors.

Abstract

Purpose: In an era of rapid expansion of FDA approvals for oral anticancer agents (OAAs), it is important to understand the factors associated with survival among real-world populations, which include groups not well-represented in pivotal clinical trials of OAAs, such as the elderly, racial minorities, and medically complex patients. Our objective was to evaluate patient- and provider-level characteristics' associations with mortality among a multi-payer cohort of metastatic renal cell carcinoma (mRCC) patients who initiated OAAs.

Methods: This retrospective cohort study was conducted using data from the North Carolina state cancer registry linked to multi-payer claims data for the years 2004 to 2015. Provider data were obtained from North Carolina Health Professions Data System and the National Plan & Provider Enumeration System. Included patients were individuals with mRCC who initiated an OAA and survived ≥90 days after beginning treatment. We estimated hazard ratios (HR) and corresponding 95% confidence limits (CL) using Cox hazard models for associations between patient demographics, patient clinical characteristics, provider-level factors, and 2-year all-cause mortality.

Results: The cohort included 207 patients with mRCC who received OAAs. In multivariable models, clinical variables such as frailty (HR: 1.36, 95% CL: 1.11-1.67) and de novo metastatic diagnosis (HR: 2.63, 95%CL: 1.67-4.16) were associated with higher all-cause mortality. Additionally, patients solely on Medicare had higher adjusted all-cause mortality compared with patients with any private insurance (HR: 2.35, 95% CL: 1.32-4.18). No provider-level covariates investigated were associated with all-cause mortality.

Conclusions: Within a real-world population of mRCC patients taking OAAs, survival differed based on patient characteristics. In an era of rapid expansion of FDA approvals for OAAs, these real-world data underscore the continued importance of access to high-quality care, particularly for medically complex patients with limited resources.

Abstract

Purpose: Surgery is an important part of early stage breast cancer treatment that affects overall survival. Many studies of surgical treatment of breast cancer rely on data sources that condition on continuous insurance coverage or treatment at specified facilities and thus under-sample populations especially affected by cancer care inequities including the uninsured and rural populations. Statewide cancer registries contain data on first course of cancer treatment for all patients diagnosed with cancer but the accuracy of these data are uncertain.

Methods: Patients diagnosed with stage I-III breast cancer between 2003 and 2016 were identified using the North Carolina Central Cancer Registry and linked to Medicaid, Medicare, and private insurance claims. We calculated the sensitivity, specificity, positive predictive value, negative predictive value, and Kappa statistics for receipt of surgery and type of surgery (breast conserving surgery or mastectomy) using the insurance claims as the presumed gold standard. Analyses were stratified by race, insurance type, and rurality.

Results: Of 26,819 patients who met eligibility criteria, 23,125 were identified as having surgery in both the claims and registry for a sensitivity of 97.9% (95% CI 97.8%, 98.1%). There was also strong agreement for surgery type between the cancer registry and the insurance claims (Kappa: 0.91). Registry treatment data validity was lower for Medicaid insured patients than for Medicare and commercially insured patients.

Conclusions: Cancer registry treatment data reliably identified receipt and type of breast cancer surgery. Cancer registries are an important source of data for understanding cancer care in underrepresented populations.

Abstract

Purpose: Availability of targeted oral anticancer agents (OAAs) has transformed care for patients with metastatic renal cell carcinoma (mRCC). Our objective was to identify patterns and predictors of OAA use within 12 months after mRCC was detected to understand real-world adoption of OAAs.

Methods: We used a novel, North Carolina cancer registry-linked multipayer claims data resource to examine patterns of use of five oral therapies among patients with mRCC diagnosed in 2006-2015, with claims through 2016. Patients were required to have 12 months of continuous enrollment before metastatic index date. Log-Poisson models estimated unadjusted and adjusted risk ratios (RRs) for associations between patient characteristics and OAA use. In sensitivity analyses, we used a competing risk framework to estimate adjusted risk differences in OAA use.

Results: Our population-based study of 713 patients demonstrated low (37%) OAA use during the first year after metastatic index date among both publicly and privately insured patients, with shifting patterns of use consistent with regulatory approvals over time. Compared with patients age 18-49 years, patients age 70-74 years were half likely to use OAAs (95% confidence limit [CL], 0.34 to 0.78) and patients age 80+ years were 71% less likely to use OAAs (95% CL, 0.17 to 0.50). Patients with two comorbidities (RR, 0.73; 95% CL, 0.55 to 0.98) and those with 3+ comorbidities (RR, 0.68; 95% CL, 0.50 to 0.91) were less likely to receive OAA than those without comorbidities. Patients with higher frailty also had lower OAA utilization (RR, 0.67; 95% CL, 0.52 to 0.85).

Conclusion: These findings suggest a need to better understand the system-level and provider-level drivers of OAA underuse, as well as OAA adherence and associated survival.

Abstract

Background: We conducted a mediation analysis of the provider team's role in changes to chronic condition medication adherence among cancer survivors.

Methods: We used a retrospective, longitudinal cohort design following Medicare beneficiaries from 18-months before through 24-months following cancer diagnosis. We included beneficiaries aged ≥66 years newly diagnosed with breast, colorectal, lung or prostate cancer and using medication for non-insulin anti-diabetics, statins, and/or anti-hypertensives and similar individuals without cancer from Surveillance, Epidemiology, and End Results-Medicare data, 2008-2014. Chronic condition medication adherence was defined as a proportion of days covered ≥ 80%. Provider team structure was measured using two factors capturing the number of providers seen and the historical amount of patient sharing among providers. Linear regressions relying on within-survivor variation were run separately for each cancer site, chronic condition, and follow-up period.

Results: The number of providers and patient sharing among providers increased after cancer diagnosis relative to the non-cancer control group. Changes in provider team complexity explained only small changes in medication adherence. Provider team effects were statistically insignificant in 13 of 17 analytic samples with significant changes in adherence. Statistically significant provider team effects were small in magnitude (<0.5 percentage points).

Conclusions: Increased complexity in the provider team associated with cancer diagnosis did not lead to meaningful reductions in medication adherence. Interventions aimed at improving chronic condition medication adherence should be targeted based on the type of cancer and chronic condition and focus on other provider, systemic, or patient factors.

Abstract

Background: No population-based studies have examined chronic opioid use among cancer survivors who are diverse with respect to diagnosis, age group, and insurance status.

Methods: We conducted a retrospective cohort study using North Carolina (NC) cancer registry data linked with claims from public and private insurance (2006-2016). We included adults with non-metastatic cancer who had no prior chronic opioid use (N = 38,366). We used modified Poisson regression to assess the adjusted relative risk of chronic opioid use in survivorship (>90-day continuous supply of opioids in the 13-24 months following diagnosis) associated with patient characteristics.

Results: Only 3.0% of cancer survivors in our cohort used opioids chronically in survivorship. Predictors included younger age (adjusted risk ratio [aRR], 50-59 vs 60-69 = 1.23, 95% confidence interval [CI] = 1.05-1.43), baseline depression (aRR = 1.22, 95% CI = 1.06-1.41) or substance use (aRR = 1.43, 95% CI = 1.15-1.78) and Medicaid (aRR vs Private = 1.93, 95% CI = 1.56-2.40). Survivors who used opioids intermittently (vs not at all) before diagnosis were twice as likely to use opioids chronically in early survivorship (aRR = 2.62, 95% CI = 2.28-3.02). Those who used opioids chronically (vs intermittently or not at all) during active treatment had a nearly 17-fold increased likelihood of chronic use in survivorship (aRR = 16.65, 95 CI = 14.30-19.40).

Conclusions: Younger and low-income survivors, those with baseline depression or substance use, and those who require chronic opioid therapy during treatment are at increased risk for chronic opioid use in survivorship. Our findings point to opportunities improve assessment of psychosocial histories and to engage patients in shared decision-making around long-term pain management, when chronic opioid therapy is required during treatment.

Abstract

Surgical excision is important for melanoma treatment. Delays in surgical excision after diagnosis of melanoma have been linked to decreased survival in hospital-based cohorts. This study was aimed at quantifying the association between the timeliness of surgical excision and overall survival in patients diagnosed with melanoma in hospital- and non-hospital-based settings, using a retrospective cohort study of patients with stage 0-III melanoma and using data linked between the North Carolina Central Cancer Registry to Medicare, Medicaid, and private health insurance plan claims across the state. We identified 6,496 patients diagnosed between 2004 and 2012 with follow-up through 2017. We categorized the time from diagnostic biopsy to surgical excision as < 6 weeks after diagnosis, 6 weeks to 90 days after diagnosis, and > 90 days after melanoma diagnosis. Multivariable Cox regression was used to estimate differences in survival probabilities. Five-year overall survival was lower for those with time to surgery over 90 days (78.6%) compared with those with less than 6 weeks (86%). This difference appeared greater for patients with Stage 1 melanoma. This study was retrospective, included one state, and could not assess melanoma specific mortality. Surgical timeliness may have an effect on overall survival in patients with melanoma. Timely surgery should be encouraged.

Abstract

Background: Improving oral anticancer agent (OAA) initiation and adherence is the important quality-of-care issues, particularly since one fourth of anticancer agents being developed will be administered orally. Our objective was to identify provider- and patient-level characteristics associated with OAA initiation and adherence among individuals with metastatic renal cell carcinoma (mRCC).

Methods: We used state cancer registry data linked to multi-payer claims data to identify patients with mRCC diagnosed in 2004-2015. Provider data were obtained from North Carolina Health Professions Data System and the National Plan & Provider Enumeration System. We estimated risk ratios (RRs) and corresponding 95% confidence limits (CLs) using modified Poisson regression to evaluate factors associated with OAA initiation and adherence.

Results: Among the 207 (out of 687) patients who initiated an OAA following mRCC diagnosis and survived 90 days, median proportion of days covered was 0.91. Patients with a modal provider specializing in hematology/medical oncology were much more likely to initiate OAAs than those seen by other specialties. Additionally, patients with a female provider were more likely to initiate OAAs than those with a male provider. Compared to patients treated by providers practicing in both urban and rural areas, patients with providers practicing solely in urban areas were more likely to initiate OAAs, after controlling for patient-level factors (RR = 1.37; 95% CL: 1.09-1.73). Medicare patients were less likely to be adherent than those with private insurance (RR = 0.61; 95% CL: 0.42-0.87).

Conclusions: Our results suggest that provider- and patient-level factors influence OAA initiation in patients with mRCC but only insurance type was associated with adherence.

Abstract

BACKGROUND:
Measuring care coordination in administrative data facilitates important research to improve care quality.

OBJECTIVE:
To compare shared patient networks constructed from administrative claims data across multiple payers.

DESIGN:
Social network analysis of pooled cross sections of physicians treating prevalent colorectal cancer patients between 2003 and 2013.

PARTICIPANTS:
Surgeons, medical oncologists, and radiation oncologists identified from North Carolina Central Cancer Registry data linked to Medicare claims (N = 1735) and private insurance claims (N = 1321).

MAIN MEASURES:
Provider-level measures included the number of patients treated, the number of providers with whom they share patients (by specialty), the extent of patient sharing with each specialty, and network centrality. Network-level measures included the number of providers and shared patients, the density of shared-patient relationships among providers, and the size and composition of clusters of providers with a high level of patient sharing.

RESULTS:
For 24.5% of providers, total patient volume rank differed by at least one quintile group between payers. Medicare claims missed 14.6% of all shared patient relationships between providers, but captured a greater number of patient-sharing relationships per provider compared with the private insurance database, even after controlling for the total number of patients (27.242 vs 26.044, p < 0.001). Providers in the private network shared a higher fraction of patients with other providers (0.226 vs 0.127, p < 0.001) compared to the Medicare network. Clustering coefficients for providers, weighted betweenness, and eigenvector centrality varied greatly across payers. Network differences led to some clusters of providers that existed in the combined network not being detected in Medicare alone.

CONCLUSION:
Many features of shared patient networks constructed from a single-payer database differed from similar networks constructed from other payers' data. Depending on a study's goals, shortcomings of single-payer networks should be considered when using claims data to draw conclusions about provider behavior.

Abstract

Background: Precision medicine in advanced non-small cell lung cancer (NSCLC) requires molecular biomarker testing in patients with nonsquamous and select patients with squamous histologies, and programmed death-ligand 1 (PD-L1) testing in both.

Research question: What are rates of molecular and PD-L1 biomarker testing in patients with advanced NSCLC in community practices, and do rates vary by sociodemographic factors? What is the prevalence of molecular biomarker mutations and PD-L1 expression levels?

Study design and methods: From 389 stage IV NSCLC pathology reports obtained through the University of North Carolina Lineberger Comprehensive Cancer Center's Rapid Case Ascertainment Program from 38 community hospitals across North Carolina, we abstracted demographics, histology, molecular biomarker testing and results, and PD-L1 testing and expression. We geocoded patient and hospital addresses to determine travel time, distance to care, and census block level contextual variables. We compared molecular biomarker and PD-L1 testing rates, the prevalence of molecular biomarkers, and PD-L1 expression levels by race and sex, using χ2 tests. We determined predictors of testing, using multivariable logistic regression and report adjusted ORs and 95%CI.

Results: Among patients with nonsquamous NSCLC, 64.4% were tested for molecular biomarkers, and among all NSCLC patients 53.2% were tested for PD-L1 expression. Differences in biomarker testing rates by sociodemographic factors were not statistically significant in univariate or adjusted analyses. Adjusted analyses showed that patients living in areas with higher household internet access were more likely to undergo PD-L1 testing (adjusted OR = 1.66, 95% CI, 1.02-2.71). Sociodemographic differences in molecular biomarker prevalence and PD-L1 expression levels were not statistically significant, except for human epidermal growth factor receptor 2 (HER2) mutations, which occurred in 16.7% of males vs 0% in females, P = .05.

Interpretation: Biomarker testing remains underused in NSCLC. Future work should include larger populations and evaluate hospital-specific testing protocols to identify and address barriers to guideline-recommended testing.

Abstract

There are associations between tobacco retailer density and smoking behaviors, but little is known about whether places with more tobacco retailers have more smoking-related health problems. Using cross-sectional data from 2014, we investigated the relationships between tobacco retailer density and chronic obstructive pulmonary disease (COPD) related outcomes in a sample of 1510 counties across the United States. Higher retailer density was associated with a 19% (IRR, 1.19; 95% CI, 1.12-1.27) higher COPD-related hospital discharge rate and 30% (IRR, 1.30; 95% CI 1.21-1.39) higher total COPD-related hospital costs per population. The tobacco retailer environment may be an important target for reducing smoking-related health burdens and costs.

Abstract

Background: Substantial racial and socioeconomic disparities in metastatic RCC (mRCC) have persisted following the introduction of targeted oral anticancer agents (OAAs). The relationship between patient characteristics and OAA access and costs that may underlie persistent disparities in mRCC outcomes have not been examined in a nationally representative patient population.

Methods: Retrospective SEER-Medicare analysis of patients diagnosed with mRCC between 2007-2015 over age 65 with Medicare part D prescription drug coverage. Associations between patient characteristics, OAA receipt, and associated costs were analyzed in the 12 months following mRCC diagnosis and adjusted to 2015 dollars.

Results: 2,792 patients met inclusion criteria, of which 32.4%received an OAA. Most patients received sunitinib (57%) or pazopanib (28%) as their first oral therapy. Receipt of OAA did not differ by race/ethnicity or socioeconomic indicators. Patients of advanced age (> 80 years), unmarried patients, and patients residing in the Southern US were less likely to receive OAAs. The mean inflation-adjusted 30-day cost to Medicare of a patient's first OAA prescription nearly doubled from $3864 in 2007 to $7482 in 2015, while patient out-of-pocket cost decreased from $2409 to $1477.

Conclusion: Race, ethnicity, and socioeconomic status were not associated with decreased OAA receipt in patients with mRCC; however, residing in the Southern United States was, as was marital status. Surprisingly, the cost to Medicare of an initial OAA prescription nearly doubled from 2007 to 2015, while patient out-of-pocket costs decreased substantially. Shifts in OAA costs may have significant economic implications in the era of personalized medicine.

Abstract

Background: This study projected the number of metastatic breast cancer (mBC) cases and costs (medical and productivity) attributable to mBC through 2030 among 3 age groups: younger (aged 18-44 years), midlife (aged 45-64 years), and older women (aged 65 years and older).

Methods: We developed a stock/flow model in which women enter the mBC population at initial diagnosis (de novo stage IV) or through progression of an earlier-stage cancer. Women exit the mBC population through death. Input parameters by age and phase of treatment came from the US Census, Surveillance, Epidemiology, and End Results and peer-reviewed literature.

Results: In 2030, we estimated there would be 246 194 prevalent cases of mBC, an increase of 54.8% from the 2015 estimate of 158 997. We estimated total costs (medical and productivity) of mBC across all age groups and phases of care were $63.4 billion (95% sensitivity range = $59.4-$67.4 billion) in 2015 and would increase to $152.4 billion (95% sensitivity range = $111.6-$220.4 billion) in 2030, an increase of 140%. Trends in estimated costs were higher for younger and midlife women than for older women.

Conclusions: The cost of mBC could increase substantially in the coming decade, especially among younger and midlife women. Although accounting for trends in incidence, progression, and survival, our model did not attempt to forecast structural changes such as technological innovations in breast cancer treatment and health-care delivery reforms. These findings can motivate early detection activities, direct value-driven mBC treatment, and provide a useful baseline against which to measure the effect of prevention and treatment efforts.

Abstract

Introduction: Tobacco product retailers provide access to tobacco products and exposure to tobacco marketing. Without a national tobacco retailer licensing system in the United States (U.S.), there are no estimates of national trends in tobacco retailer numbers and store type over time.

Methods: We developed a protocol to identify likely tobacco retailers across the U.S. between 2000-2017 using industry codes and retailer names in the annual National Establishment Time Series (NETS) database. We calculated annual counts of tobacco retailers in seven store type categories, and annual numbers of tobacco retailers that opened and closed.

Results: We estimate that there were 317,492 tobacco product retailers in 2000; the number grew to 412,536 in 2009 before falling to 356,074 in 2017, for a net 12% increase overall. Gas/convenience stores and grocery stores accounted for more than two thirds of all retailers. On average, new openings accounted for 8.0% of the total retailers, while 7.3% of retailers closed or stopped selling tobacco each year, with stronger market volatility following the Great Recession. Since 2011, there was a disproportionate reduction in tobacco-selling pharmacies, and an increase in both tobacco-specialty shops and tobacco-selling discount stores.

Conclusions: During two decades when smoking declined, tobacco retailer availability increased in the U.S. The economic climate, corporate and public policies, and new tobacco products may all contribute to trends in tobacco retailer availability. State and local jurisdictions considering tobacco retailer policies may find retailer trend information useful for forecasting or evaluating potential policy impacts.

Implications: This study provides historic data tracking tobacco retailers in the U.S. between 2000-2017, documenting trends that unfolded as the general economic market contracted and grew, with greater regulation of the tobacco retailer environment. These data provide a context for better understanding future changes in the tobacco retailer market. In addition, the protocol established in this study could be applied in any U.S.-based location without tobacco retailer licensing to allow identification of stores and tracking of trends.

Abstract

Purpose: Recent clinical trials support de-escalation of adjuvant radiation therapy following lumpectomy in some older women with low-risk HR+ breast cancers planning to take endocrine therapy. The adoption of these findings into clinical practice, and the effectiveness of de-escalated therapy in real-world populations, remain under investigation.

Materials and methods: We evaluated use of adjuvant radiation therapy and/or endocrine therapy among older women with T1-2 node-negative, HR+ breast cancer in the United States between 2007 and 2011. The study included patients from the Surveillance, Epidemiology and End Results-Medicare linked database and the North Carolina Cancer Information and Population Health Resource database.

Results: Radiation therapy was received by 65.5% of patients, with no decrease over time. Older women and those with T2 (compared to T1) tumors were less likely to receive radiation therapy. In propensity-adjusted analyses, both radiation therapy alone (HR 0.75, 95% CI 0.67-0.84) and radiation + endocrine therapy (HR 0.62, 95% CI 0.54-0.69) were associated with significantly lower recurrence risk compared to endocrine therapy alone. Non-adherence to endocrine therapy was common (37%) and similar across groups. With a median follow-up of 48 months (range 13-84), we were not able to detect an association of non-adherence with recurrence risk in endocrine therapy-containing treatment arms.

Conclusion: Most older women with stage I HR+ breast cancers continue to receive radiation, at higher rates than patients with node-negative stage II tumors. These findings suggest that while multiple evidence-based treatment options exist in these patients, improvements are needed to ensure that radiation therapy is applied equitably and rationally.

Abstract

Surgical health services researchers are increasingly utilizing observational data to assess associations between treatments and outcomes, especially since some procedures are unable to be evaluated through randomized controlled trials. However, the results of many of these studies may be affected by the presence of immortal-time bias, which exists when treatment does not occur on Day 0 of the study. This bias can result in researchers overestimating a treatment benefit, or even observe a treatment benefit when none exists. In this paper, we describe what immortal-time bias is, the challenges it presents, and how to recognize and address it using the real-world example of surgical resection of the primary tumor for stage IV breast cancer throughout. In our example, we guide researchers and illustrate how the early studies, which did not account for immortal-time bias, suggested a protective benefit of surgery, and how these results were supplanted by more recent studies through identifying and addressing immortal-time bias in their design and analyses.

Abstract

Introduction: Greater availability of tobacco product retailers in an area may be associated with smoking behaviors, and the majority of people who smoke purchase their cigarettes at gas stations and convenience stores. This cross-sectional study investigates the associations of overall tobacco retailer density and gas/convenience density with adult smoking behaviors.

Methods: This study built a list of tobacco retailers in 2014 and calculated the county-level number of retailers per 1,000 people. Individual-level smoking behavior data were drawn from the 2014-2015 Tobacco Use Supplement for a sample of adults (n=88,850) residing in metropolitan counties across the U.S. General estimating equation models were fit to investigate the associations between retailer density and cigarette smoking behaviors (smoking status, quit attempt, quit length). Analyses were conducted in 2020.

Results: A greater number of tobacco retailers (AOR=1.63, 95% CI=1.35, 1.96) and gas stations and convenience stores (AOR=3.29, 95% CI=2.39, 4.52) per 1,000 people were each associated with a higher odds of a respondent smoking every day than the odds of a respondent not smoking. In addition, both measures were associated with a higher odds of a respondent being an every-day than being a some-day smoker. Associations for gas/convenience density were similar in models that additionally controlled for other tobacco retailers (excluding gas/convenience). Study results did not support associations between retailer density and cessation.

Conclusions: Tobacco retailer density, especially gas/convenience density, is correlated with daily smoking, the most harmful tobacco use behavior. Calculating tobacco retailer density using gas/convenience stores may be a feasible proxy for overall tobacco retailer density.

Abstract

Purpose: To evaluate the cost-effectiveness of endocrine therapy (ET), radiation therapy (XRT), and combination ET + XRT as post-surgical treatment for older women with early-stage breast cancer from the societal perspective.

Methods: We constructed a Markov state-transition model consisting of three mutually exclusive health-states: Disease-Free, Recurrence, or Death. Osteoporotic fracture, radiation-induced breast fibrosis, and radiation pneumonitis were modeled as treatment-related adverse events (AEs). Cancer registry-linked-Medicare data were used to assess probability of recurrence and total costs, after propensity adjustment to account for treatment selection, among women aged >65 years diagnosed with estrogen receptor positive or progesterone receptor positive (ER+/PR+) breast cancer receiving ET, XRT, or ET + XRT in 2007-2011. Following randomized controlled trials, overall survival was assumed equivalent, but locoregional recurrence varied. Indirect costs and health-state utilities were literature-driven and varied in sensitivity analyses. Costs and outcomes were discounted at 3% annually.

Results: In a cohort of 10,000 women over ten years, we estimated 1620 total recurrences in the ET-only group, 1296 in the XRT-only group, and 1076 with ET + XRT. Compared to ET-only, the base-case incremental cost-effectiveness ratio (ICER) was $10,826 per quality-adjusted life-year (QALY)-gained for XRT-only and $26,834/QALY-gained for ET + XRT. Similarities in cost and effectiveness between treatments led to highly sensitive results. We also present clinically-relevant patient preference scenarios for recurrence risk-averse patients and near-term AE risk-averse patients.

Conclusions: The cost-effectiveness of regimens including ET and/or XRT in older women with early-stage breast cancer is sensitive to small differences in costs, as well as risk of, and utilities associated with, locoregional recurrence, suggesting that patient preferences concerning treatment benefits and risks should be considered by physicians.

Abstract

Background: In the United States, >45,000 adolescent and young adult (AYA) women are diagnosed with cancer annually. Reproductive issues are critically important to AYA cancer survivors, but insufficient information is available to address their concerns. The AYA Horizon Study was initiated to contribute high-quality, contemporary evidence on reproductive outcomes for female cancer survivors in the United States.

Methods: The study cohort includes women diagnosed with lymphoma, breast, melanoma, thyroid, or gynecologic cancer (the five most common cancers among women ages 15-39 years) at three study sites: the state of North Carolina and the Kaiser Permanente health systems in Northern and Southern California. Detailed information on cancer treatment, fertility procedures, and pregnancy (e.g., miscarriage, live birth) and birth (e.g., birth weight, gestational length) outcomes are leveraged from state cancer registries, health system databases and administrative insurance claims, national data on assisted reproductive technology procedures, vital records, and survey data.

Results: We identified a cohort of 11,072 female AYA cancer survivors that includes >1,200 African American women, >1,400 Asian women, >1,600 Medicaid enrollees, and >2,500 Hispanic women using existing data sources. Active response to the survey component was low overall (N = 1,679), and notably lower among minority groups compared with non-Hispanic white women.

Conclusions: Passive data collection through linkage reduces participant burden and prevents systematic cohort attrition or potential selection biases that can occur with active participation requirements.

Abstract

Objective: To determine whether patient-reported health status, more so than comorbidity, influences treatment in men with localized prostate cancer.

Methods: Using Surveillance, Epidemiology, and End Results data linked with Medicare claims and CAHPS surveys, we identified men aged 65-84 diagnosed with localized prostate cancer from 2004 to 2013 and ascertained their National Cancer Institute (NCI) comorbidity score and patient-reported health status. Adjusting for demographics and cancer risk, we examined the relationship between these measures and treatment for the overall cohort, low-risk men aged 65-74, intermediate/high-risk men aged 65-74, and men aged 75-84.

Results: Among 2724 men, 43.0% rated their overall health as Excellent/Very Good, while 62.7% had a comorbidity score of 0. Beyond age and cancer risk, patient-reported health status was significantly associated with treatment. Compared to men reporting Excellent/Very Good health, men in Poor/Fair health less often received treatment (odds ratio [OR] 0.71, 95% confidence interval [CI] 0.56-0.90). Younger men with intermediate/high-risk cancer in Good (OR 0.60, 95% CI 0.41-0.88) or Fair/Poor (OR 0.49, 95% CI 0.30-0.79) health less often underwent prostatectomy vs radiation compared to men in Excellent/Very Good health. In contrast, men with NCI comorbidity score of 1 more often received treatment (OR 1.37, 95% CI 1.11-1.70) compared to men with NCI comorbidity score of 0.

Conclusion: Patient-reported health status drives treatment for prostate cancer in an appropriate direction whereas comorbidity has an inconsistent relationship. Greater understanding of this interplay between subjective and empiric assessments may facilitate more shared decision-making in prostate cancer care.

Abstract

Purpose: Life expectancy has become a core consideration in prostate cancer care. While multiple prediction tools exist to support decision-making, their discriminative ability remains modest, which hamper usage and utility. We examined whether combining patient-reported and claims-based health measures into prediction models improves performance.

Methods: Using SEER-CAHPS, we identified men ≥65 years old diagnosed with prostate cancer from 2004-2013 and extracted four types of data: demographics, cancer information, claims-based health measures, and patient-reported health measures. Next, we compared the performance of five nested competing risk regression models for other-cause mortality. Additionally, we assessed whether adding new health measures to established prediction models improved discriminative ability.

Results: Among 3,240 cases, 246 (7.6%) died of prostate cancer while 631 (19.5%) died of other causes. The National Cancer Institute Comorbidity Index score was associated but weakly correlated with patient-reported overall health (p<0.001, r=0.21). For predicting other-cause mortality, the 10-year Area Under the Receiver Operating Characteristic Curve improved from 0.721 (demographics only) to 0.755 with cancer information and to 0.777 and 0.812 when adding claims-based and patient-reported health measures, respectively. The full model generated the highest value of 0.820. Models based on existing tools also improved in their performance with the incorporation of new data types as predictor variables (p<0.001).

Conclusion: Prediction models for life expectancy that combine patient-reported and claims-based health measures outperform models that incorporate these measures separately. Given the modest degree of improvement, however, the implementation of life expectancy tools should balance model performance with data availability and fidelity.

Abstract

Importance: The US Food and Drug Administration (FDA) is required to communicate the risks of tobacco constituents to the public. Few studies have addressed how FDA media campaigns can effectively communicate about cigarette smoke constituents.

Objective: To examine whether messages about cigarette smoke constituents are effective in reducing smoking intentions and behaviors among adults who smoke.

Design, setting, and participants: This randomized clinical trial enrolled participants who were aged between 18 and 65 years, were English speakers, were living in the United States, and who smoked at least 100 cigarettes during their lifetime and now smoked every day or some days. Participants received daily messages via email for 15 days. Participants were randomized to 1 of 2 message conditions or a control group and reported their previous-day smoking behaviors daily. Follow-up surveys were conducted on days 16 and 32. Data were collected from June 2017 to April 2018 and analyzed from April to September 2018.

Interventions: The 3 groups were (1) constituent plus engagement messages (eg, "Cigarette smoke contains arsenic. This causes heart damage.") that included the FDA as the source and engagement text (eg, "Within 3 months of quitting, your heart and lungs work better. Ready to be tobacco free? You can quit. For free nicotine replacement, call 1-800-QUIT-NOW"); (2) constituent-only messages that did not list the FDA as the source or include engagement text; and (3) a control condition with messages about littering cigarette butts.

Main outcomes and measures: The primary outcome was the change in quit intentions (range, 1-4, with higher scores indicating stronger intentions) from pretest to day 16. Secondary outcome measures included daily smoking behaviors and quit attempts.

Results: A total of 789 participants (mean [SD] age, 43.4 [12.9] years; 483 [61.2%] women; 578 [73.3%] White; 717 [90.9%] non-Hispanic) were included in the study. The mean (SD) quit intention score was 2.5 (0.9) at pretest. Mean (SE) change in quit intention score from pretest to day 16 was 0.19 (0.07) points higher in the constituent plus engagement condition than in the control condition (P = .005) and 0.23 (0.07) points higher in the constituent-only condition compared with the control condition (P = .001). Participant reports of cigarettes smoked, forgone, and butted out were similar across study conditions at baseline and did not differ significantly at days 16 and 32 across study conditions. Viewing more messages was associated with an estimated decrease of 0.15 (SE, 0.01) cigarettes smoked per day per message viewed overall across conditions.

Conclusions and relevance: To our knowledge, this is the first longitudinal test of cigarette constituent campaign messages in a national sample of adults who currently smoke. Messages about cigarette smoke constituents, with or without engagement text and source information, increased participants' intentions to quit, lending support to FDA efforts to educate consumers about such constituents.

Abstract

Objectives: A cancer diagnosis can influence medication adherence for chronic conditions by shifting care priorities or reinforcing disease prevention. This study describes changes in adherence to medications for treating three common chronic conditions - diabetes, hyperlipidemia, and hypertension - among older adults newly diagnosed with non-metastatic breast, colorectal, lung, or prostate cancer.

Methods: We identified Medicare beneficiaries aged ≥66 years newly diagnosed with cancer and using medication for at least one chronic condition, and similar cohorts of matched individuals without cancer. To assess medication adherence, proportion of days covered (PDC) was measured in six-month windows starting six-months before through 24 months following cancer diagnosis or matched index date. Generalized estimating equations were used to estimate difference-in-differences (DID) comparing changes in PDCs across cohorts using the pre-diagnosis window as the referent. Analyses were run separately for each cancer type-chronic condition combination.

Results: Across cancer types and non-cancer cohorts, adherence was highest for anti-hypertensives (90-92%) and lowest for statins (77-79%). In older adults with colorectal and lung cancer, adherence to anti-diabetics and statins declined post-diagnosis compared with the matched non-cancer cohorts, with estimates ranging from a DID of -2 to -4%. In older adults with breast and prostate cancer cohorts, changes in adherence for all medications were similar to non-cancer cohorts.

Conclusion: Our findings highlight variation in medication adherence by cancer type and chronic condition. As many older adults with early stage cancer eventually die from non-cancer causes, it is imperative that cancer survivorship interventions emphasize medication adherence for other chronic conditions.

Abstract

Background: The importance of addressing adverse financial effects of cancer among adolescents and young adults (AYAs) is paramount as survival improves. In the current study, the authors examined whether cancer-related employment disruption was associated with financial hardship among female AYA cancer survivors in North Carolina and California.

Methods: AYA cancer survivors identified through the North Carolina Central Cancer Registry and the Kaiser Permanente Northern/Southern California tumor registries responded to an online survey. Disrupted employment was defined as reducing hours, taking temporary leave, or stopping work completely because of cancer. Financial hardship was defined as material conditions or psychological distress related to cancer. Descriptive statistics and chi-square tests were used to characterize the invited sample and survey respondents. Marginal structural binomial regression models were used to estimate prevalence differences (PDs) and 95% confidence intervals (95% CIs).

Results: Among 1328 women employed at the time of their diagnosis, women were a median age of 34 years at the time of diagnosis and 7 years from diagnosis at the time of the survey and approximately 32% experienced employment disruption. A substantial percentage reported financial hardship related to material conditions (27%) or psychological distress (50%). In adjusted analyses, women with disrupted employment had a 17% higher burden of material conditions (95% CI, 10%-23%) and an 8% higher burden of psychological distress (95% CI, 1%-16%) compared with those without disruption.

Conclusions: Financial hardship related to employment disruption among female AYA cancer survivors can be substantial. Interventions to promote job maintenance and transition back to the workforce after treatment, as well as improved workplace accommodations and benefits, present an opportunity to improve cancer survivorship.

Abstract

Background/objectives: A claims-based model predicting 5-year mortality (Lund-Lewis) was developed in a 2008 cohort of North Carolina (NC) Medicare beneficiaries and included indicators of comorbid conditions, frailty, disability, and functional impairment. The objective of this study was to validate the Lund-Lewis model externally within a nationwide sample of Medicare beneficiaries.

Design: Retrospective validation study.

Setting: U.S. Medicare population.

Participants: From a random sample of Medicare beneficiaries, we created four annual cohorts from 2008 to 2011 of individuals aged 66 and older with an office visit in that year. The annual cohorts ranged from 1.13 to 1.18 million beneficiaries.

Measurements: The outcome was 5-year all-cause mortality. We assessed clinical indicators in the 12 months before the qualifying office visit and estimated predicted 5-year mortality for each beneficiary in the nationwide sample by applying estimates derived in the original NC cohort. Model performance was assessed by quantifying discrimination, calibration, and reclassification metrics compared with a model fit on a comorbidity score.

Results: Across the annual cohorts, 5-year mortality ranged from 24.4% to 25.5%. The model had strong discrimination (C-statistics ranged across cohorts from .823 to .826). Reclassification measures showed improvement over a comorbidity score model for beneficiaries who died but reduced performance among beneficiaries who survived. The calibration slope ranged from .83 to .86; the model generally predicted a higher risk than observed.

Conclusion: The Lund-Lewis model showed strong and consistent discrimination in a national U.S. Medicare sample, although calibration indicated slight overfitting. Future work should investigate methods for improving model calibration and evaluating performance within specific disease settings.

Abstract

Background: Approximately 40% of patients with cancer also have another chronic medical condition. Patient-centered medical homes (PCMHs) have improved outcomes among patients with multiple chronic comorbidities. The authors first evaluated the impact of a cancer diagnosis on chronic medication adherence among patients with Medicaid coverage and, second, whether PCMHs influenced outcomes among patients with cancer.

Methods: Using linked 2004 to 2010 North Carolina cancer registry and claims data, the authors included Medicaid enrollees who were diagnosed with breast, colorectal, or lung cancer who had hyperlipidemia, hypertension, and/or diabetes mellitus. Using difference-in-difference methods, the authors examined adherence to chronic disease medications as measured by the change in the percentage of days covered over time among patients with and without cancer. The authors then further evaluated whether PCMH enrollment modified the observed differences between those patients with and without cancer using a differences-in-differences-in-differences approach. The authors examined changes in health care expenditures and use as secondary outcomes.

Results: Patients newly diagnosed with cancer who had hyperlipidemia experienced a 7-percentage point to 11-percentage point decrease in the percentage of days covered compared with patients without cancer. Patients with cancer also experienced significant increases in medical expenditures and hospitalizations compared with noncancer controls. Changes in medication adherence over time between patients with and without cancer were not determined to be statistically significantly different by PCMH status. Some PCMH patients with cancer experienced smaller increases in expenditures (diabetes) and emergency department use (hyperlipidemia) but larger increases in their inpatient hospitalization rates (hypertension) compared with non-PCMH patients with cancer relative to patients without cancer.

Conclusions: PCMHs were not found to be associated with improvements in chronic disease medication adherence, but were associated with lower costs and emergency department visits among some low-income patients with cancer.

Abstract

Introduction: Minimum floor price laws (MFPLs) are an emerging tobacco control policy that sets a minimum price below which a specific tobacco product cannot be sold. MFPLs target cheaper products and may disproportionately impact consumers choosing low price brands or using discounts to reduce prices. We developed a static microsimulation model for California, USA to project short-term effects of different MFPL options for a 20-stick pack of cigarettes on adult smoking behaviors.

Methods: We simulated 300,000 individuals defined by race/ethnicity, sex, age, and poverty status. Smoking behaviors and cigarette prices were assigned based on demographic distributions in the 2014-2016 California Behavioral Risk Factor Surveillance System. We drew 100 random samples (n=30,000), weighted to state-level California demographic characteristics. We simulated six MFPL options and modeled impacts on smoking prevalence and cigarette consumption, in general, and separately for those in households below or above 250% of the federal poverty level (FPL), assuming a price elasticity of -0.4.

Results: Predicted changes in prices, prevalence, and consumption increased exponentially as the floor price increased from $7.00 to $9.50. Assuming 15% policy avoidance, projected increases in average cigarette prices ranged from $0.19 to $1.61. Decreases in smoking prevalence ranged from 0.05 to 0.43 percentage points, and decreases in average monthly cigarette consumption ranged from 1.4 to 12.3 cigarettes. Projected prices increased, and prevalence and consumption decreased, more among individuals in households below 250% FPL.

Conclusions: MFPLs are a promising tobacco control strategy with the potential to reduce socioeconomic disparities in cigarette smoking prevalence and consumption.

Abstract

Purpose: We estimated average medical costs due to metastatic breast cancer (mBC) among younger (aged 18-44), midlife (aged 45-64), and older women (aged 65 and older) by phase of care: initial, continuing, and terminal.

Methods: We used 2003-2014 North Carolina cancer registry data linked with administrative claims from public and private payers. We developed a claims-based algorithm to identify breast cancer patients who progressed to metastatic disease. We matched breast cancer patients (mBC and earlier stage) to non-cancer patients on age group, county of residence, and insurance plan. Outcomes were average monthly medical expenditures and expected medical expenditures by phase. We used regression to estimate excess costs attributed to mBC as the difference in mean payments between patients with mBC (N = 4806) and patients with each earlier-stage breast cancer (stage 1, stage 2, stage 3, and unknown stage; N = 21,772) and non-cancer controls (N = 109,631) by treatment phase and age group.

Results: Adjusted monthly costs for women with mBC were significantly higher than for women with earlier-stage breast cancer and non-cancer controls for all age groups and treatment phases except the initial treatment among women with stage 3 breast cancer at diagnosis. The largest expected total costs were for women aged 18-44 with mBC during the continuing phase ($209,961 95% Confidence Interval $165,736-254,186).

Conclusions: We found substantial excess costs for mBC among younger women and during the continuing and terminal phases of survivorship. It is important to assess whether this care is high value for these women.

Abstract

We examine whether county-level tobacco retailer density and adult smoking prevalence are positively associated in the United States and determine whether associations differ in metropolitan vs. nonmetropolitan counties. We merged a list of likely tobacco retailers from the 2012 National Establishment Time-Series with smoking prevalence data from the Behavioral Risk Factor Surveillance System for 2828 US counties, as well as state tobacco policy information and county-level demographic data for the same year. We modeled adult smoking prevalence as a function of tobacco retailer density, accounting for clustering of counties within states. Average density in US counties was 1.25 retailers per 1000 people (range = 0.3-4.5). Smoking prevalence was 0.86 percentage points higher in the most retailer-dense counties, compared to the least. This association, however, was only significant for metropolitan counties. Metropolitan counties in the highest tobacco retailer density quartile had smoking prevalence levels that were 1.9 percentage points higher than metropolitan counties in the lowest density quartile. Research should examine whether policies limiting the quantity, type and location of tobacco retailers could reduce smoking prevalence.

Abstract

Purpose: Clinical trial enrollment is low among adolescents and young adults (AYAs) with cancer and may contribute to inferior survival gains in recent years in this population compared with other age groups. We investigated clinical trial participation among AYA women with cancer, and examined whether patients discussed clinical trial participation with their doctor and reasons for nonparticipation.

Methods: Women with a diagnosis of breast cancer, thyroid cancer, melanoma, lymphoma, or gynecologic cancer at ages 15-39 years during 2004-2016 were identified from the North Carolina Central Cancer Registry and the Kaiser Permanente Southern California health system. During 2018-2019, a total of 1264 eligible women completed an online survey (response = 13%), which examined survivorship issues among AYAs.

Results: Overall, 5% of participants reported that they had participated in a clinical trial. Most women reported that they had not discussed clinical trial participation with a medical provider (76%) and that they did not know whether a relevant trial was available for their cancer (73%). Among those who knew that a trial was available but did not participate, the most commonly reported reasons for nonparticipation included concerns about side effects of the treatment in the trial and concerns that the treatment had not been sufficiently tested.

Conclusion: Only a small proportion of AYA women with cancer in our cohort reported discussing a clinical trial with a provider or knowing whether a relevant trial was available. Our findings point to opportunities to improve patient/provider communication to increase clinical trial enrollment among AYAs with cancer.

Abstract

BACKGROUND:
Population-based cancer registries collect information on first course of treatment that may be utilized in research on cancer care quality, yet few studies have investigated the validity of this information. We examined the accuracy and completeness of registry-based treatment information in a cohort of adolescent and young adult women.

METHODS:
Women diagnosed with breast cancer, lymphoma, thyroid cancer, cervical/uterine cancer or ovarian cancer at ages 15-39 during 2003-2014 were identified using data from the North Carolina Central Cancer Registry (CCR) (N = 2342). CCR data were linked to Medicaid and private insurance claims data, and claims were reviewed for the 12 months following diagnosis to identify cancer treatments received. Using claims data as the gold standard, we calculated the sensitivity and positive predictive value (PPV) of CCR data for receipt of chemotherapy, radiation and hormone therapy. We also compared dates of treatment initiation between the two data sources.

RESULTS:
For all cancer types combined, the sensitivity of the CCR data was high for chemotherapy (86%) and moderate for radiation (74%). PPVs were 82% and 83% for chemotherapy and radiation, respectively. Both the sensitivity (67%) and PPV (70%) were lower for hormone therapy for breast cancer. For all three treatment types, dates of initiation in the registry and the claims differed by ≤30 days for most women.

CONCLUSIONS:
In this cohort of young women, population-based cancer registry data on chemotherapy receipt was reasonably accurate and complete in comparison with insurance claims. Radiation and hormone therapy appeared to be less complete.

Abstract

Background: Academic physicians, such as those affiliated with National Cancer Institute (NCI)–designated Comprehensive Cancer Centers, may have different practice patterns regarding the use of high‐cost cancer drugs than nonacademic physicians.

Materials and Methods: For this cohort study, we linked cancer registry, administrative, and demographic data for patients with newly diagnosed cancer in North Carolina from 2004 to 2011. We selected cancer types with multiple U.S. Food and Drug Administration–approved, National Comprehensive Cancer Network–recommended treatment options and large differences in reimbursement between higher‐priced and lower‐priced options (stage IV colorectal, stage IV lung, and stage II–IV head‐and‐neck cancers). We assessed whether provider's practice setting—NCI‐designated Comprehensive Cancer Center (“NCI”) versus other location (“non‐NCI”)—was associated with use of higher‐cost treatment options. We used inverse probability of exposure weighting to control for patient characteristics.

Results: Of 800 eligible patients, 79.6% were treated in non‐NCI settings. Patients treated in non‐NCI settings were more likely to receive high‐cost treatment than patients treated in NCI settings (36.0% vs. 23.2%), with an unadjusted prevalence difference of 12.7% (95% confidence interval [CI], 5.1%–20.0%). After controlling for potential confounding factors, non‐NCI patients remained more likely to receive high‐cost treatment, although the strength of association was attenuated (adjusted prevalence difference, 9.6%; 95% CI −0.1%–18.7%). Exploratory analyses suggested potential heterogeneity across cancer type and insurance status.

Conclusion: Use of higher‐cost cancer treatments may be more common in non‐NCI than NCI settings. This may reflect differential implementation of clinical evidence, local practice variation, or possibly a response to the reimbursement incentives presented by chemotherapy billing.

Abstract

BACKGROUND:
Population-based studies suggest that patients with multiple myeloma (MM) have better outcomes when treated at high-volume facilities, but the relative contribution of provider expertise and hospital resources to improved outcomes is unknown. This study explored how treating facility, individual provider volume, and patient-sharing between MM specialists and community providers influenced outcomes for patients with MM.

PATIENTS AND METHODS:
A state cancer registry linked to public and private insurance claims was used to identify a cohort of patients diagnosed with MM in 2006 through 2012. Three multivariable Cox models were used to examine how the following factors impacted overall survival: (1) evaluation at an NCI-designated Comprehensive Cancer Center (NCICCC), (2) the primary oncologist's volume of patients with MM, and (3) patient-sharing between MM specialists and community oncologists.

RESULTS:
A total of 1,029 patients diagnosed with MM in 2006 through 2012 were identified. Patients who were not evaluated at an NCICCC had an increased risk of mortality compared with those evaluated at an NCICCC (hazard ratio [HR], 1.50; 95% CI, 1.21-1.86; P<.001). Compared with patients treated by NCICCC MM specialists, those treated by both low-volume community providers (HR, 1.47; 95% CI, 1.14-1.90; P<.01) and high-volume community providers (HR, 1.29; 95% CI, 1.04-1.61; P<.05) had a higher risk of mortality. No difference in mortality was seen between patients treated by NCICCC MM specialists and those treated by the highest-volume community oncologists in the ninth and tenth deciles (HR, 1.08; 95% CI, 0.84-1.37; P=.5591). Patients treated by community oncologists had a higher risk of mortality regardless of patient-sharing compared with patients treated by MM specialists (eg, community oncologist with a history of sharing vs NCICCC MM specialist: HR, 1.49; 95% CI, 1.10-2.02; P<.05).

CONCLUSIONS:
Findings of this study add to the accumulating evidence showing that patients with MM benefit from care at high-volume facilities, and suggest that similar outcomes can be achieved by the highest-volume providers in the community.

Abstract

PURPOSE
The association between geriatric assessment (GA)-identified impairments and long-term health care use in older cancer survivors remains unknown. Our objective was to evaluate whether a GA performed at cancer diagnosis was predictive of hospitalizations and long-term care (LTC) use in older adult cancer survivors.

METHODS
Older adults with GA performed between 3 months before through 6 months after diagnosis were included (N = 125). Patients with Medicare Parts A and B coverage and no managed care were identified. Hospitalizations and LTC use (skilled nursing or assisted living) were assessed up to 5 years postdiagnosis. GA risk measures were evaluated in separate Poisson models estimating the relative risk (RR) for hospital and LTC visits, adjusting for age and Charlson comorbidity score.

RESULTS
The mean age of patients was 74 years, and the majority were female (80%) and white (90%). Breast cancer (64%) and early-stage disease (stages 0 to III, 77%) were common. Prefrail/frail status (RR, 2.5; P < .001), instrumental activities of daily living impairment (RR, 5.47; P < .001), and limitations in climbing stairs (RR, 2.94; P < .001) were associated with increased hospitalizations. Prefrail/frail status (RR, 1.86; P < .007), instrumental activities of daily living impairment (RR, 4.58; P < .001), presence of falls (RR, 6.73; P < .001), prolonged Timed Up and Go (RR, 5.45; P < .001), and limitations in climbing stairs (RR, 1.89; P < .005) were associated with LTC use.

CONCLUSION
GA-identified impairments were associated with increased hospitalizations and LTC use among older adults with cancer. GA-focused interventions should be targeted toward high-risk patients to reduce long-term adverse health care use in this vulnerable population.

Abstract

PURPOSE:
De-implementation of low-value services among patients with limited life expectancy is challenging. Robust mortality prediction models using routinely collected health care data can enhance health care stakeholders' ability to identify populations with limited life expectancy. We developed and validated a claims-based prediction model for 5-year mortality using regularized regression methods.

METHODS:
Medicare beneficiaries age 66 or older with an office visit and at least 12 months of pre-visit continuous Medicare A/B enrollment were identified in 2008. Five-year mortality was assessed through 2013. Secondary outcomes included 30-, 90-, and 180-day and 1-year mortality. Claims-based predictors, including comorbidities and indicators of disability, frailty, and functional impairment, were selected using regularized logistic regression, applying the least absolute shrinkage and selection operator (LASSO) in a random 80% training sample. Model performance was assessed and compared with the Gagne comorbidity score in the 20% validation sample.

RESULTS:
Overall, 183 204 (24%) individuals died. In addition to demographics, 161 indicators of comorbidity and function were included in the final model. In the validation sample, the c-statistic was 0.825 (0.823-0.828). Median-predicted probability of 5-year mortality was 14%; almost 4% of the cohort had a predicted probability greater than 80%. Compared with the Gagne score, the LASSO model led to improved 5-year mortality classification (net reclassification index = 9.9%; integrated discrimination index = 5.2%).

CONCLUSIONS:
Our claims-based model predicting 5-year mortality showed excellent discrimination and calibration, similar to the Gagne score model, but resulted in improved mortality classification. Regularized regression is a feasible approach for developing prediction tools that could enhance health care research and evaluation of care quality.

Abstract

BACKGROUND:
While rural cancer patients encounter substantial barriers to care, they more often report receiving timely care than urban patients. We examined whether geographic distance, a contributor to urban-rural health disparities, differentially influences treatment initiation and completion among insured urban and rural cervical cancer patients.

METHODS:
We identified women diagnosed with cervical cancer from 2004-2013 from a statewide cancer registry linked to multi-payer, insurance claims. Primary outcomes were initiation of guideline-concordant care within 6 weeks of diagnosis and, among stage IB2-IVA cancer patients, completion of concurrent chemoradiotherapy (CCRT) in 56 days. We estimated risk ratios using modified Poisson regressions, stratified by urban/rural status, to examine the association between distance and treatment timing (initiation or completion).

RESULTS:
Among 999 stage IA-IVA patients, 48% initiated guideline-concordant care within 6 weeks of diagnosis, and 37% of 492 stage IB2-IVA cancer patients completed CCRT in 56 days. In urban areas, stage IA-IVA patients who lived ≥15 miles from the nearest treatment facility were less likely to initiate timely treatment compared to those <5 miles (RR:0.72, 95% CI:0.54-0.95). Among IB2-IVA stage cancer patients, rural women residing >15 miles from the nearest radiation facility were more likely to complete CCRT in 56 days (RR:2.49, 95% CI:1.12-5.51).

CONCLUSIONS:
Geographic distance differentially influences the initiation and completion of treatment among urban and rural cervical cancer patients.

IMPACT:
Distance was an access barrier for insured cervical cancer patients in urban areas whereas rural patients may require more intensive outreach, support, and resources, even among those living closer to treatment.

Abstract

PURPOSE
A recent study using national data from 2000 to 2009 identified colorectal cancer (CRC) mortality “hotspots” in 11 counties of North Carolina (NC). In this study, we used more recent, state-specific data to investigate the county-level determinants of geographic variation in NC through a geospatial analytic approach.

METHOD
Using NC CRC mortality data from 2003 to 2013, we first conducted clustering analysis to confirm spatial dependence. Spatial economic models were then used to incorporate spatial structure to estimate the association between determinants and CRC mortality. We included county-level data on socio-demographic characteristics, access and quality of healthcare, behavioral risk factors (CRC screening, obesity, and cigarette smoking), and urbanicity. Due to correlation among screening, obesity and quality of healthcare, we combined these factors to form a cumulative risk group variable in the analysis.

RESULTS
We confirmed the existence of spatial dependence and identified clusters of elevated CRC mortality rates in NC counties. Using a spatial lag model, we found significant interaction effect between CRC risk groups and socioeconomic deprivation. Higher CRC mortality rates were also associated with rural counties with large towns compared to urban counties.

CONCLUSION
Our findings depicted a spatial diffusion process of CRC mortality rates across NC counties, demonstrated intertwined effects between SES deprivation and behavioral risks in shaping CRC mortality at area-level, and identified counties with high CRC mortality that were also deprived in multiple factors. These results suggest interventions to reduce geographic variation in CRC mortality should develop multifaceted strategies and work through shared resources in neighboring areas.

Abstract

PURPOSE:
The goal of this systematic review is to provide an update to the review by Pouwels et al. by conducting a systematic review and an assessment of the reporting quality of the economic analyses conducted since 2014.

METHODS:
This systematic review identified published articles focused on metastatic breast cancer treatment using the Medline/PubMed and Scopus databases and the following search criteria: (((cost effectiveness[MeSH Terms]) OR (cost effectiveness) OR (cost-effectiveness) OR (cost utility) OR (cost-utility) OR (economic evaluation)) AND (("metastatic breast cancer") OR ("advanced breast cancer"))). The reporting quality of the included articles was evaluated using the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist.

RESULTS:
Of the 256 identified articles, 67 of the articles were published after October 2014 when the prior systematic review stopped its assessment (Pouwels et al. in Breast Cancer Res Treat 165:485-498, 2017). From the 67 articles, we narrowed down to include 17 original health economic analyses specific to metastatic or advanced breast cancer. These articles were diverse with respect to methods employed and interventions included.

CONCLUSION:
Although each of the articles contributed their own analytic strengths and limitations, the overall quality of the studies was moderate. The review demonstrated that the vast majority of the reported incremental cost-effectiveness ratios exceeded the typically employed willingness to pay thresholds used in each country of analysis. Only three of the reviewed articles studied chemotherapies rather than treatments targeting either HER2 or hormone receptors, demonstrating a gap in the literature.

Abstract

BACKGROUND:
Our aim was to evaluate the prognostic impact of three inflammatory markers - neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR) and lymphocyte monocyte ratio (LMR) - on overall survival (OS) in older adults with cancer.

MATERIALS AND METHODS:
Our sample includes 144 patients age ≥ 65 years with solid tumor cancer who completed a cancer-specific Geriatric Assessment (GA) from 2010 to 2014 and had pretreatment CBC with differential. NLR was dichotomized a previously reported cut-off value of 3.5, while PLR and LMR were dichotomized at the median. Cox proportional hazards models evaluated whether NLR, PLR and LMR were predictive of OS independent of covariates including a recently developed 3-item GA-derived prognostic scale consisting of (1) "limitation in walking several blocks", (2) "limitation in shopping", and (3) "≥ 5% unintentional weight loss in 6 months".

RESULTS:
Median age was 72 years, 53% had breast cancer, 27% had stage 4 cancer, 14% had Karnofsky Performance Status (KPS) < 80, 11% received less intensive than standard treatment for stage, and 39% had NLR > 3.5. In univariable analysis, higher NLR and PLR and lower LMR were significantly associated with worse OS. NLR remained a significant predictor of OS (HR = 2.16, 95% CI; 1.10-4.25, p = .025) after adjusting for cancer type, stage, age, KPS, treatment intensity, and the GA-derived prognostic scale.

CONCLUSION:
NLR > 3.5 is predictive of poorer OS in older adults with cancer, independent of traditional prognostic factors and the GA-derived prognostic scale.

Abstract

OBJECTIVE:
Urban-rural health disparities are often attributed to the longer distances rural patients travel to receive care. However, a recent study suggests that distance to care may affect urban and rural cancer patients differentially. We examined whether this urban-rural paradox exists among patients with cervical cancer.

METHODS:
We identified individuals diagnosed with cervical cancer from 2004 to 2013 using a statewide cancer registry linked to multi-payer, insurance claims. Our primary outcome was receipt of guideline-concordant care: surgery for stages IA1-IB1; external beam radiation therapy (EBRT), concomitant chemotherapy, and brachytherapy for stages IB2-IVA. We estimated risk ratios (RR) using modified Poisson regressions, stratified by urban/rural location, to examine the association between distance to nearest facility and receipt of treatment.

RESULTS:
62% of 999 cervical cancer patients received guideline-concordant care. The association between distance and receipt of care differed by type of treatment. In urban areas, cancer patients who lived ≥15 miles from the nearest surgical facility were less likely to receive primary surgical management compared to those <5 miles from the nearest surgical facility (RR: 0.77, 95% CI: 0.60-0.98). In rural areas, patients living ≥15 miles from the nearest brachytherapy facility were more likely to receive treatment compared to those <5 miles from the nearest brachytherapy facility (RR: 1.71, 95% CI: 1.14-2.58). Distance was not associated with the receipt of chemotherapy or EBRT.

CONCLUSIONS:
Among cervical cancer patients, there is evidence supporting the urban-rural paradox, i.e., geographic distance to cancer care facilities is not consistently associated with treatment receipt in expected or consistent ways. Healthcare systems must consider the diverse and differential barriers encountered by urban and rural residents to improve access to high quality cancer care.

Abstract

Objective: A geriatric assessment (GA) assesses functional age of older patients with cancer and is a well-established tool predictive of toxicity and survival. The objective of this study was to investigate the prognostic value of individual GA items.

Materials and methods: 546 patients with cancer ≥ 65 years completed GA from 2009 to 2014 and were followed for survival status for a median of 3.7 years. The GA consisted of function, nutrition, comorbidity, cognition, psychological state, and social activity/support domains. GA items with p < 0.05 in univariable analyses for overall survival (OS) were entered into multivariable stepwise selection procedure using a Cox proportional hazards model. A prognostic scale was constructed with significant GA items retained in the final model.

Results: Median age was 72 years, 49% had breast cancer, and 42% had stage 3-4 cancer. Three GA items were significant prognostic factors, independent of traditional factors (cancer type, stage, age, and Karnofsky Performance Status): (1) "limitation in walking several blocks", (2) "limitation in shopping", and (3) "≥ 5% unintentional weight loss in 6 months". A three-item prognostic scale was constructed with these items. In comparison with score 0 (no positive items), hazard ratios for OS were 1.85 for score 1, 2.97 for score 2, and 8.67 for score 3. This translated to 2-year estimated survivals of 85%, 67%, 51% and 17% for scores of 0, 1, 2 and 3, respectively.

Conclusions: This three-item scale was a strong independent predictor of survival. If externally validated, this could be a streamlined tool with broader applicability.

Abstract

PURPOSE:
Regionalization of care and travel distance may result in unintended consequences for complex surgery such as cystectomy. Our objective was to evaluate effect of differential distance on cystectomy receipt among patients with muscle-invasive bladder cancer (MIBC) and investigate the association between travel distance and cystectomy outcomes such as readmission.

METHODS:
Using a linked data resource combining the NC Central Cancer Registry with claims data from Medicare, Medicaid, and private insurance plans, we included 736 patients with MIBC and 1,082 who underwent cystectomy. To evaluate access, differential distance was calculated as the difference between the nearest urologist and nearest cystectomy provider. To assess outcomes, logistic regression was used to evaluate rehospitalization and major complications, and Cox proportional hazards model for survival analysis.

RESULTS:
To evaluate access and outcomes, 736 patients with MIBC and 1,082 patients undergoing cystectomy were evaluated, respectively. Overall, 29% (211 of 736) with MIBC underwent cystectomy. Differential distance was not a predictor of cystectomy receipt (odds ratio = 1.0; 95% CI: 1.00, 1.01). Among patients undergoing cystectomy, travel distance from cystectomy provider was not a significant predictor of 30- or 31 to 90day readmissions (odds ratio = 1.0; 95% CI: 1.00, 1.00) although patients who lived further from their cystectomy provider were more likely to be readmitted to a nonindex hospital (P<0.001) when controlling for other factors. Although travel distance did not have a significant effect on overall survival, patients readmitted between 31 to 90days had worse overall survival (P<0.0001).

CONCLUSIONS:
The additional distance needed to reach a cystectomy provider did not predict receipt of surgery for MIBC. Furthermore, travel distance from cystectomy provider was not a significant predictor for subsequent readmission after cystectomy and did not affect overall survival.

Abstract

OBJECTIVES:
To estimate the association between provider and team experience and adherence to guidelines, survival, and utilization among colorectal cancer patients in North Carolina.

SUBJECTS:
The analysis cohort included 7295 patients diagnosed with incident stage II/III colorectal cancer between 2004 and 2013 who received surgery.

METHODS:
Primary outcomes included adherence to guidelines: consultation with a medical oncologist (stage III), receipt of adjuvant chemotherapy (stage III), and receipt of surveillance colonoscopy posttreatment. Secondary outcomes included 5-year overall survival, number of surveillance radiology studies, any unplanned hospitalization, and any emergency department visit. The primary predictors were measures of provider volume and patient sharing across surgeons and medical oncologists. Regression analyses adjusted for patient and provider characteristics.

RESULTS:
Patients whose surgeons shared >40% of their colorectal cancer patients in the previous year with a medical oncologist were (1) more likely to have had a consultation with a medical oncologist [marginal effect (ME)=13.3 percentage points, P-value<0.001], (2) less likely to receive a surveillance colonoscopy within 12 months (ME=3.5 percentage points, P-value=0.049), and (3) received more radiology studies (ME=0.254 studies, P-value=0.029). Patients whose surgeon and medical oncologist shared >20% of their colorectal cancer patients with each other in the previous year had a higher likelihood of receiving adjuvant chemotherapy (ME=11.5 percentage points, P-value<0.001) and surveillance colonoscopy within 12 months (ME=6.7 percentage points, P-value=0.030) and within 18 months (ME=6.2 percentage points, P-value=0.054).

CONCLUSIONS:
Our study shows that team experience is associated with patients' quality of care, survival, and utilization.

Abstract

Background: Our ability to optimize the care of older adults with cancer and comorbid illnesses is insufficient because most clinical trials lack systematic measurement. The primary purpose of this study was to evaluate the association between patient-reported comorbidity and all-cause mortality using various comorbidity scoring algorithms.

Materials and methods: The Carolina Senior Registry was linked with the North Carolina Central Cancer Registry to obtain mortality data. Comorbidity was assessed using the patient-reported Older Americans Resources and Services Questionnaire subscale that assesses 13 specific conditions and the degree to which each impairs activities. Multivariable Cox proportional hazard regression models were used to evaluate the association between comorbidities and all-cause mortality.

Results: The study sample included 539 patients; the median age was 72 years, 72% were female, and 47% had breast cancer. Overall, 92% reported ≥1 comorbid condition, with a mean of 2.7 conditions (range 0-10), with arthritis and hypertension the most common (52% and 50%, respectively). Approximately 60% reported a functional limitation related to comorbidity. After adjusting for time from diagnosis to geriatric assessment, age, cancer type, and stage, the risk of death increased by 5% for each unit increase in comorbidity burden score (adjusted hazard ratio [HR] = 1.05, 95% confidence interval [CI]: 1.01-1.10) and 12% for each comorbid condition impacting function (HR = 1.12, 95% CI: 1.02-1.23).

Conclusion: Comorbid conditions in older adults with cancer are highly prevalent and associated with all-cause mortality, particularly those conditions that impair function. Routine comorbidity assessment should be included in clinical trials and can be measured via a simple one-page patient-reported questionnaire.

Implications for practice: In order to optimize and personalize the care of older adults with cancer, systematic measurement of comorbidities is necessary in both clinical trials and routine practice. Patient-reported comorbid conditions in older adults with cancer are highly prevalent and are associated with increased risk of all-cause mortality, particularly for those conditions that impair function. Comorbidity can be systematically measured via a one-page patient-reported questionnaire and should be incorporated into future clinical trials and considered for use in oncology clinics to aid in assessing older adults with cancer.

Abstract

BACKGROUND:
Gene expression profiling (GEP) has been rapidly adopted for early breast cancer and can aid in chemotherapy decision making. Study results regarding racial disparities in testing are conflicting, and may reflect different care settings. To the authors' knowledge, data regarding the influence of provider factors on testing are scarce.

METHODS:
The authors used a statewide, multipayer, insurance claims database linked to cancer registry records to examine the impact of race and provider characteristics on GEP uptake in a cohort of patients newly diagnosed with breast cancer between 2005 and 2012. Incidence proportion models were used to examine the adjusted likelihood of testing. Models were stratified by lymph node status (N0 vs N1).

RESULTS:
Among 11,958 eligible patients, 23% of black and 26% of non-Hispanic white patients received GEP. Among patients with N0 disease, black individuals were 16% less likely to receive testing after adjustment for clinical factors and the provider's specialty and volume of patients with breast cancer (95% confidence interval, 0.77-0.93). Adjustment for provider characteristics did not attenuate the effect of race on testing. Patients of middle-volume providers were more likely to be tested compared with those with either high-volume or low-volume providers, whereas patients seeing a medical oncologist were more likely to be tested compared with those whose only providers were from surgical specialties.

CONCLUSIONS:
Provider volume and specialty were found to be significant predictors of GEP use, but did not explain racial disparities in testing. Further research concerning the key contributors to lagging test use among black women is needed to optimize the equitable use of GEPs and support personalized treatment decision making for all patients.

Abstract

Importance:
Timely receipt of treatment for cancer is an important aspect of health care quality. It is unknown how delays of surgery for melanoma vary by insurance type.

Objective:
To analyze factors associated with delays between diagnosis and surgery for melanoma in patients with Medicare, Medicaid, or private insurance.

Design, Setting, and Participants:
Retrospective cohort study of patients who received a diagnosis of melanoma between 2004 and 2011 in North Carolina using data from the North Carolina Cancer Registry linked to administrative claims from Medicare, Medicaid, and private insurance. Inclusion criteria were incident patients with a diagnosis of melanoma stage 0 to III and with continuous insurance enrollment from at least 1 month prior to the month of diagnosis to 12 months after diagnosis of melanoma.

Main Outcomes and Measures:
Surgical delay, defined as definitive surgical excision occurring more than 6 weeks after melanoma diagnosis. Generalized linear models with log link, Poisson distributions, and robust standard errors were used to estimate adjusted risk ratios (RRs) to model risk of delay in definitive surgery.

Results:
A total of 7629 patients were included (4210 [55%] female; mean [SD] age, 64 [15] years), 48% (n = 3631) Medicare, 48% (n = 3667) privately insured, and 4% (n = 331) Medicaid patients. Privately insured patients were least likely to experience a delay in definitive surgery, followed by Medicare and Medicaid patients (519 [14%], 609 [17%], and 79 [24%], respectively; P < .001). After demographic adjustment, the risk of surgical delay was significantly increased in patients with Medicaid compared with private insurance (RR, 1.36; 95% CI, 1.09-1.70). Delays were more likely in nonwhite patients (RR, 1.38; 95% CI, 1.02-1.87). Surgical delays were less likely if the physician performing the surgery (RR, 0.82; 95% CI, 0.72-0.93) or the diagnosing clinician (RR, 0.81; 95% CI, 0.71-0.93) was a dermatologist as compared with a nondermatologist.

Conclusion and Relevance:
Surgical treatment delays were common but were less prevalent in patients diagnosed or surgically treated by a dermatologist. Medicaid patients experienced the most surgical delays. A reduction in delays in melanoma surgery could be achieved through better access to specialty care and cross-disciplinary coordination.

Abstract

BACKGROUND:
Younger women (aged 18-44 years) diagnosed with breast cancer often face more aggressive tumors, higher treatment intensity, and lower survival rates than older women. In this study, we estimated incident breast cancer costs by stage at diagnosis and by race for younger women enrolled in Medicaid.

METHODS:
We analyzed cancer registry data linked to Medicaid claims in North Carolina from 2003 to 2008. We used Surveillance, Epidemiology, and End Results (SEER) Summary 2000 definitions for cancer stage. We split breast cancer patients into two cohorts: a younger and older group aged 18-44 and 45-64 years, respectively. We conducted a many-to-one match between patients with and without breast cancer using age, county, race, and Charlson Comorbidity Index. We calculated mean excess total cost of care between breast cancer and non-breast cancer patients.

RESULTS:
At diagnosis, younger women had a higher proportion of regional cancers than older women (49 vs. 42%) and lower proportions of localized cancers (44 vs. 50%) and distant cancers (7 vs. 9%). The excess costs of breast cancer (all stages) for younger and older women at 6 months after diagnosis were $37,114 [95% confidence interval (CI) = $35,769-38,459] and $28,026 (95% CI = $27,223-28,829), respectively. In the 6 months after diagnosis, the estimated excess cost was significantly higher to treat localized and regional cancer among younger women than among older women. There were no statistically significant differences in excess costs of breast cancer by race, but differences in treatment modality were present among younger Medicaid beneficiaries.

CONCLUSIONS:
Younger breast cancer patients not only had a higher prevalence of late-stage cancer than older women, but also had higher within-stage excess costs.

Abstract

Purpose:
The combination of chemotherapy and trastuzumab is the standard of care for adjuvant treatment of human epidermal growth factor receptor 2-positive breast cancer. Two regimens have been widely adopted in the United States: doxorubicin, cyclophosphamide, paclitaxel, and trastuzumab (ACTH) and docetaxel, carboplatin, and trastuzumab (TCH). No head-to-head comparison of these regimens has been conducted in a clinical trial, and existing trial data have limited generalizability to older patients.

Methods:
We used SEER-Medicare data from 2005 to 2013 to compare outcomes of ACTH versus TCH among patients age older than 65 years. Propensity score matching was used to balance cohort characteristics between treatment arms. Outcomes included toxicity-related hospitalization, survival, and trastuzumab completion. Data from 1,077 patients receiving ACTH or TCH were analyzed, and the propensity-matched subsample included 416 women.

Results:
There was a significant shift toward TCH over time, with 88% of patients receiving ACTH in 2005 compared with 15% by 2011. Among propensity score-matched patients, we found no difference between regimens in health care use overall or for chemotherapy-related adverse events (ACTH, 34% v TCH, 36.5%; P = .46). Patients receiving TCH were significantly more likely to complete trastuzumab (89% v 77%; P = .001). There was no difference in 5-year breast cancer-specific survival (ACTH, 92% v TCH, 96%; hazard ratio, 2.08; 95% CI, 0.90 to 4.82) or overall survival.

Conclusion:
Among a matched sample of older patients, ACTH compared with TCH was not associated with a higher rate of serious adverse events or hospitalizations, but it was associated with less completion of adjuvant trastuzumab. We did not detect a difference in 5-year survival outcomes for ACTH compared with TCH. In the context of limited evidence in older patients, selection between these two regimens on the basis of concerns about differential toxicity or efficacy may not be appropriate.

Abstract

Older adults (aged 65 years and older) diagnosed with cancer account for most cancer-related morbidity and mortality in the United States but are often underrepresented on clinical trials. Recent attention from a variety of professional, research, regulatory, and patient advocacy groups has centered on data linkage and data sharing as a means to capture patient information and outcomes outside of clinical trials to accelerate progress in the fight against cancer. The development of a more robust observational research data infrastructure would help to address gaps in the evidence base regarding optimal approaches to treating cancer among the growing and complex population of older adults. To demonstrate the feasibility of building such a resource, we linked information from a sample of older adults with cancer in North Carolina using three distinct, but complementary, data sources: (a) the Carolina Senior Registry, (b) the North Carolina Central Cancer Registry, and (c) North Carolina fee-for-service Medicare claims data. A description of the linkage process, metrics, and characteristics of the final cohort is reported. This study highlights the potential for data linkage to improve the characterization of health status among older adults with cancer and the possibility to conduct passive follow-up for outcomes of interest over time. Extensions of these linkage efforts in partnership with other institutions will enhance our ability to generate evidence that can inform the management of older adults with cancer.

Abstract

Background:
An objective measure is needed to identify frail older adults with cancer who are at increased risk for poor health outcomes. The primary objective of this study was to develop a frailty index from a cancer-specific geriatric assessment (GA) and evaluate its ability to predict all-cause mortality among older adults with cancer.

Patients and Methods:
Using a unique and novel data set that brings together GA data with cancer-specific and long-term mortality data, we developed the Carolina Frailty Index (CFI) from a cancer-specific GA based on the principles of deficit accumulation. CFI scores (range, 0-1) were categorized as robust (0-0.2), pre-frail (0.2-0.35), and frail (>0.35). The primary outcome for evaluating predictive validity was all-cause mortality. The Kaplan-Meier method and log-rank tests were used to compare survival between frailty groups, and Cox proportional hazards regression models were used to evaluate associations.

Results:
In our sample of 546 older adults with cancer, the median age was 72 years, 72% were women, 85% were white, and 47% had a breast cancer diagnosis. Overall, 58% of patients were robust, 24% were pre-frail, and 18% were frail. The estimated 5-year survival rate was 72% in robust patients, 58% in pre-frail patients, and 34% in frail patients (log-rank test, P<.0001). Frail patients had more than a 2-fold increased risk of all-cause mortality compared with robust patients (adjusted hazard ratio, 2.36; 95% CI, 1.51-3.68).

Conclusions:
The CFI was predictive of all-cause mortality in older adults with cancer, a finding that was independent of age, sex, cancer type and stage, and number of medical comorbidities. The CFI has the potential to become a tool that oncologists can use to objectively identify frailty in older adults with cancer.

Abstract

PURPOSE:
Younger women (under age 45 years) diagnosed with breast cancer often face more aggressive tumors, higher treatment intensity, lower survival rates, and greater financial hardship. The purpose of this study was to estimate breast cancer costs by stage at diagnosis during the first 18 months of treatment for privately insured younger women.

METHODS:
We analyzed North Carolina cancer registry data linked to claims data from private insurers from 2003 to 2010. Breast cancer patients were split into two cohorts: a younger and older group aged 21-44 and 45-64 years, respectively. We conducted a cohort study and matched women with and without breast cancer using age, ZIP, and Charlson Comorbidity Index. We calculated mean excess costs between breast cancer and non-breast cancer patients at 6, 12, and 18 months.

RESULTS:
For younger women, AJCC 6th edition stage II cancer was the most common at diagnosis (40%), followed by stage I (34%). On the other hand, older women had more stage I (46%) cancer followed by stage II (34%). The excess costs for younger and older women at 12 months were $97,486 (95% confidence interval [CI] $93,631-101,341) and $75,737 (95% CI $73,962-77,512), respectively. Younger breast cancer patients had both a higher prevalence of later-stage disease and higher within-stage costs.

CONCLUSIONS:
The study reports high costs of treatment for both younger and older women than a non-cancer comparison group; however, the estimated excess cost was significantly higher for younger women. The financial implications of breast cancer treatment costs for younger women need to be explored in future studies.

Abstract

BACKGROUND:
Systematic coding systems are used to define clinically meaningful outcomes when leveraging administrative claims data for research. How and when these codes are applied within a research study can have implications for the study validity and their specificity can vary significantly depending on treatment received.

SUBJECTS:
Data are from the Surveillance, Epidemiology, and End Results-Medicare linked dataset.

STUDY DESIGN:
We use propensity score methods in a retrospective cohort of prostate cancer patients first examined in a recently published radiation oncology comparative effectiveness study.

RESULTS:
With the narrowly defined outcome definition, the toxicity event outcome rate ratio was 0.88 per 100 person-years (95% confidence interval, 0.71-1.08). With the broadly defined outcome, the rate ratio was comparable, with 0.89 per 100 person-years (95% confidence interval, 0.76-1.04), although individual event rates were doubled. Some evidence of surveillance bias was suggested by a higher rate of endoscopic procedures the first year of follow-up in patients who received proton therapy compared with those receiving intensity-modulated radiation treatment (11.15 vs. 8.90, respectively).

CONCLUSIONS:
This study demonstrates the risk of introducing bias through subjective application of procedure codes. Careful consideration is required when using procedure codes to define outcomes in administrative data.

Abstract

INTRODUCTION:
Hepatocellular carcinoma (HCC) is a poor-prognosis cancer with a high symptom burden. Multidisciplinary HCC care is complex and unique in cancer medicine. We sought to determine whether the distinct process affects hospice use and how hospice affects end-of-life acute care utilization.

PATIENTS AND METHODS:
Patients dying after HCC diagnosed from 2004 to 2011 were identified within SEER-Medicare. Hospice use and associated factors were described using logistic regression. Coarse exact and propensity score matching created groups of hospice and nonhospice comparators balanced on clinical characteristics. Health care use from first hospice claim to death and the matched duration in the nonhospice group were compared.

RESULTS:
Of 7,992 decedent patients with HCC, 63% used hospice before death, with a median duration of 18 days (interquartile range, 5-51 days). Initial treatment with surgery and ablation (odds ratio [OR], 0.63; 95% CI, 0.53 to 0.74) or chemoembolization/radioembolization (OR, 0.71; 95% CI, 0.62 to 0.80) was associated with decreased odds of subsequent hospice use compared with untreated patients. Hospice use was more likely in those consulting hematology/oncology (OR, 1.33; 95% CI, 1.13 to 1.56) but not in those consulting gastroenterology (OR, 0.79; 95% CI, 0.65 to 0.95). Hospice patients had lower rates of hospitalization (7.9% v 47.8%; risk ratio [RR], 0.16; 95% CI, 0.14 to 0.19), intensive care unit stay (2.8% v 25.3%; RR, 0.11; 95% CI, 0.09 to 0.14), and in-hospital death (3.5% v 58.4%; RR, 0.06; 95% CI, 0.05 to 0.07).

CONCLUSION:
Processes of care influence which patients with HCC are referred to hospice. Hospice use has a marked effect on acute care use at the end of life in patients with HCC. Efforts to incorporate cancer-focused palliative care might improve the quality of end-of-life care in HCC.

Abstract

We examined the associations between frailty and inflammatory markers, in particular neutrophil lymphocyte ratio (NLR), in elderly cancer patients. We conducted cross-sectional analyses of data derived from the Carolina Seniors Registry (CSR), a database of geriatric assessments (GA) in older adults (≧65 years) with cancer. We included patients in the CSR who had a GA and complete blood count test before initiation of therapy. The primary outcome was frailty, determined using the 36-item Carolina Frailty Index (CFI). In our sample of 133 patients, the median age was 74, and 54% were robust, 22% were pre-frail, and 24% were frail. There was a significant positive correlation between CFI and NLR (r = 0.22, p = 0.025). In multivariable analysis, patients in the top tertile of NLR had an odds ratio of 3.8 (95% CI = 1.1-12.8) for frail/pre-frail status, adjusting for age, sex, race, education level, marital status, cancer type and stage. In bivariable analyses, higher NLR was associated with lower instrumental activity of daily living (IADL) score (p = 0.040) and prolonged timed up and go (p = 0.016). This study suggests an association between frailty and inflammation in older adults with cancer.

Abstract

Importance:
Patients diagnosed with localized prostate cancer have to decide among treatment strategies that may differ in their likelihood of adverse effects.

Objective:
To compare quality of life (QOL) after radical prostatectomy, external beam radiotherapy, and brachytherapy vs active surveillance.

Design, Setting, and Participants:
Population-based prospective cohort of 1141 men (57% participation among eligible men) with newly diagnosed prostate cancer were enrolled from January 2011 through June 2013 in collaboration with the North Carolina Central Cancer Registry. Median time from diagnosis to enrollment was 5 weeks, and all men were enrolled with written informed consent prior to treatment. Final follow-up date for current analysis was September 9, 2015.

Exposures:
Treatment with radical prostatectomy, external beam radiotherapy, brachytherapy, or active surveillance.

Main Outcomes and Measures:
Quality of life using the validated instrument Prostate Cancer Symptom Indices was assessed at baseline (pretreatment) and 3, 12, and 24 months after treatment. The instrument contains 4 domains-sexual dysfunction, urinary obstruction and irritation, urinary incontinence, and bowel problems-each scored from 0 (no dysfunction) to 100 (maximum dysfunction). Propensity-weighted mean domain scores were compared between each treatment group vs active surveillance at each time point.

Results:
Of 1141 enrolled men, 314 pursued active surveillance (27.5%), 469 radical prostatectomy (41.1%), 249 external beam radiotherapy (21.8%), and 109 brachytherapy (9.6%). After propensity weighting, median age was 66 to 67 years across groups, and 77% to 80% of participants were white. Across groups, propensity-weighted mean baseline scores were 41.8 to 46.4 for sexual dysfunction, 20.8 to 22.8 for urinary obstruction and irritation, 9.7 to 10.5 for urinary incontinence, and 5.7 to 6.1 for bowel problems. Compared with active surveillance, mean sexual dysfunction scores worsened by 3 months for patients who received radical prostatectomy (36.2 [95% CI, 30.4-42.0]), external beam radiotherapy (13.9 [95% CI, 6.7-21.2]), and brachytherapy (17.1 [95% CI, 7.8-26.6]). Compared with active surveillance at 3 months, worsened urinary incontinence was associated with radical prostatectomy (33.6 [95% CI, 27.8-39.2]); acute worsening of urinary obstruction and irritation with external beam radiotherapy (11.7 [95% CI, 8.7-14.8]) and brachytherapy (20.5 [95% CI, 15.1-25.9]); and worsened bowel symptoms with external beam radiotherapy (4.9 [95% CI, 2.4-7.4]). By 24 months, mean scores between treatment groups vs active surveillance were not significantly different in most domains.

Conclusions and Relevance:
In this cohort of men with localized prostate cancer, each treatment strategy was associated with distinct patterns of adverse effects over 2 years. These findings can be used to promote treatment decisions that incorporate individual preferences.

Abstract

INTRODUCTION:
Colorectal cancer (CRC) screening rates are suboptimal, particularly among the uninsured and the under-insured and among rural and African American populations. Little guidance is available for state-level decision makers to use to prioritize investment in evidence-based interventions to improve their population's health. The objective of this study was to demonstrate use of a simulation model that incorporates synthetic census data and claims-based statistical models to project screening behavior in North Carolina.

METHODS:
We used individual-based modeling to simulate and compare intervention costs and results under 4 evidence-based and stakeholder-informed intervention scenarios for a 10-year intervention window, from January 1, 2014, through December 31, 2023. We compared the proportion of people living in North Carolina who were aged 50 to 75 years at some point during the window (that is, age-eligible for screening) who were up to date with CRC screening recommendations across intervention scenarios, both overall and among groups with documented disparities in receipt of screening.

RESULTS:
We estimated that the costs of the 4 intervention scenarios considered would range from $1.6 million to $3.75 million. Our model showed that mailed reminders for Medicaid enrollees, mass media campaigns targeting African Americans, and colonoscopy vouchers for the uninsured reduced disparities in receipt of screening by 2023, but produced only small increases in overall screening rates (0.2-0.5 percentage-point increases in the percentage of age-eligible adults who were up to date with CRC screening recommendations). Increased screenings ranged from 41,709 additional life-years up to date with screening for the voucher intervention to 145,821 for the mass media intervention. Reminders mailed to Medicaid enrollees and the mass media campaign for African Americans were the most cost-effective interventions, with costs per additional life-year up to date with screening of $25 or less. The intervention expanding the number of endoscopy facilities cost more than the other 3 interventions and was less effective in increasing CRC screening.

CONCLUSION:
Cost-effective CRC screening interventions targeting observed disparities are available, but substantial investment (more than $3.75 million) and additional approaches beyond those considered here are required to realize greater increases population-wide.

Abstract

Understanding multilevel predictors of colorectal cancer (CRC) screening test modality can help inform screening program design and implementation. We used North Carolina Medicare, Medicaid, and private, commercially available, health plan insurance claims data from 2003 to 2008 to ascertain CRC test modality among people who received CRC screening around their 50th birthday, when guidelines recommend that screening should commence for normal risk individuals. We ascertained receipt of colonoscopy, fecal occult blood test (FOBT) and fecal immunochemical test (FIT) from billing codes. Person-level and county-level contextual variables were included in multilevel random intercepts models to understand predictors of CRC test modality, stratified by insurance type. Of 12,570 publicly-insured persons turning 50 during the study period who received CRC testing, 57% received colonoscopy, whereas 43% received FOBT/FIT, with significant regional variation. In multivariable models, females with public insurance had lower odds of colonoscopy than males (odds ratio [OR] = 0.68; p < 0.05). Of 56,151 privately-insured persons turning 50 years old who received CRC testing, 42% received colonoscopy, whereas 58% received FOBT/FIT, with significant regional variation. In multivariable models, females with private insurance had lower odds of colonoscopy than males (OR = 0.43; p < 0.05). People living 10-15 miles away from endoscopy facilities also had lower odds of colonoscopy than those living within 5 miles (OR = 0.91; p < 0.05). Both colonoscopy and FOBT/FIT are widely used in North Carolina among insured persons newly age-eligible for screening. The high level of FOBT/FIT use among privately insured persons and women suggests that renewed emphasis on FOBT/FIT as a viable screening alternative to colonoscopy may be important.

Abstract

BACKGROUND:
Population-based studies have demonstrated survival disparities related to socioeconomic factors for patients with acute myeloid leukemia (AML). The objective of the current study was to determine whether the local health care infrastructure, represented by Area Health Education Centers (AHEC) region, or treating center experience, represented by National Cancer Institute Comprehensive Cancer Center (NCICCC) designation, were associated with outcomes among patients with AML in North Carolina.

METHODS:
Patients who were diagnosed with AML from 2003 to 2009 were identified using the University of North Carolina Lineberger Integrated Cancer Information and Surveillance System, a database linking insurance claims to the North Carolina Cancer Registry. A Cox proportional-hazards model was used to explore survival based on AHEC region. A subset of patients who received inpatient chemotherapy was examined to evaluate the impact of treatment at an NCICCC.

RESULTS:
Nine hundred patients were identified in the study period, 553 of whom received inpatient chemotherapy therapy within 30 days of diagnosis. Almost one-half of these patients (n = 294) received chemotherapy at a non-NCICCC. Among the patients who received intensive inpatient therapy, residence in 3 of 9 AHEC regions was associated with a higher risk of mortality (hazard ratio: range, 1.97-4.03; P < .01) at 1 year in multivariate analysis. Treatment at a non-NCICCC was not associated with an increased risk of mortality at 1 year (hazard ratio, 1.25; 95% confidence interval, 0.95-1.65).

CONCLUSIONS:
Survival among patients with AML in North Carolina varies according to geographic region. Further examination of local practice and referral patterns may inform strategies to improve AML outcomes across the state.

Abstract

BACKGROUND:
High-volume center surgery and gynecologic oncology care are associated with improved outcomes for women with uterine cancer. Referral patterns, from biopsy through to chemotherapy, may have patients interacting with high-volume centers for all, a portion, or none of their care. The relative frequency, the underlying factors that contribute to referral, and the potential impact of these referral patterns on treatment outcomes are unknown.

OBJECTIVE:
We sought to analyze the referral patterns and subsequent impact of care sites on treatment for women with high- and low-risk uterine cancer.

STUDY DESIGN:
This is a population-based retrospective cohort study of uterine cancer cases from 2004 through 2009 in North Carolina. Using state cancer registry files linked to Medicare, Medicaid, and private payer insurance claims, we analyzed referral and treatment patterns by annual surgical volume (high ≥12/y). We examined clinical and demographic factors associated with referral and used modified Poisson regression to evaluate risk of referral, lymphadenectomy, and chemotherapy. Stratified Kaplan-Meier plots and Cox proportional hazard models were used to examine survival.

RESULTS:
A total of 2053 women were analyzed, including 34% (n = 677) with grade 3 histology. Of 1630 (80%) women with preoperative biopsies, referral patterns (biopsy to surgery) were: low volume to high volume (n = 652, 40%), followed by high volume to high volume (n = 605, 37%), then low volume to low volume (n = 318, 20%), and the rare high volume to low volume (n = 50, 3%). Women retained in low-volume centers after biopsy were older, were less likely to have private insurance, and had more comorbidities. High-risk histology (aRR, 1.14; 95% confidence interval, 1.04-1.25) was positively associated with referral, while Medicaid insurance was negatively associated with referral (aRR, 0.64; 95% confidence interval, 0.42-0.96). Most women (74%, n = 1557) had surgery at high-volume centers. Lymphadenectomy was less likely at low-volume centers (aRR, 0.71; 95% confidence interval, 0.64-0.77). Similarly, for high-risk patients, the relationship between low-volume center surgery and subsequent chemotherapy was aRR, 0.71 (95% confidence interval, 0.48-1.02). Of 290 women who received chemotherapy, the referral patterns (surgery to chemotherapy) were: high volume-all (high volume to high volume), high volume-hybrid (high volume to low volume, or low volume to high volume), and high volume-none (low volume to low volume). In all, 36% (n = 104/290) received chemotherapy at a low-volume center, the majority (68%, n = 71/104) of whom were referred from high-volume centers after surgery. Crude, unadjusted mortality risk of chemotherapy recipients differed by referral pattern (surgery to chemotherapy): high volume-all patients (hazard ratio, 1.0; referent), followed by high volume-hybrid (hazard ratio, 1.33; 95% confidence interval, 0.93-1.91) then high volume-none patients (RR, 1.95; 95% confidence interval, 1.24-3.08).

CONCLUSION:
Most women with uterine cancer treated at high-volume centers arrive through referral, which is affected by age and type of insurance, in addition to histology. For high-risk women who require chemotherapy, survival may be related to the extent of treatment received at high-volume centers.

Abstract

BACKGROUND:
Phase III trials show sorafenib improves survival in advanced hepatocellular carcinoma (HCC). Because of narrow trial eligibility, results may not be generalizable to a broader HCC population. We sought to evaluate the effectiveness of initial sorafenib versus no treatment among Medicare beneficiaries with advanced HCC.

MATERIALS AND METHODS:
Patients with advanced HCC diagnosed from 2008 to 2011 were identified from the Surveillance, Epidemiology, and End Results-Medicare database. Eligible patients received initial sorafenib or no therapy and were covered by Medicare parts A, B, and D. Sorafenib use and outcomes were described in this population. Using a propensity score (PS)-matched sample, we compared the effectiveness of sorafenib versus no treatment by Cox proportional hazards and binomial regression, using a landmark requiring all patients to survive ≥60 days after diagnosis.

RESULTS:
Of 1,532 patients, 27% received initial sorafenib. Median duration of sorafenib use was 60 days (interquartile range [IQR], 30-107 days), and median survival from first prescription was 3 months (IQR, 1-8 months). In the PS-matched cohort, median survival was 3 months from the 60-day landmark in sorafenib-treated (n = 223) and 2 months in untreated (n = 223) patients (adjusted hazard ratio, 0.95 [95% confidence interval (CI), 0.78-1.16]). Sorafenib was associated with a nonsignificant reduction in mortality at 3 months (44% versus 51%; adjusted risk ratio, 0.88 [95% CI, 0.72-1.07]), but no reduction thereafter.

CONCLUSION:
Survival after sorafenib initiation in newly diagnosed Medicare beneficiaries with HCC is exceptionally short, suggesting trial results are not generalizable to all HCC patients. The downsides of sorafenib use-high drug-related symptom burden and high drug cost-must be considered in light of this minimal benefit.

IMPLICATIONS FOR PRACTICE:
The findings of a median survival of only 3 months in Medicare beneficiaries with HCC prescribed sorafenib as first-line therapy highlight the questionable value of sorafenib in this population. Patients should be cautioned that outside of the narrow confines of randomized trials, their life expectancy may be very short, and any benefit of sorafenib is likely to be quite small. Given that sorafenib causes considerable adverse effects and offers no symptom palliation, supportive care should be discussed as a reasonable alternative to sorafenib, particularly for patients who have a poor performance status or advanced cirrhosis.

Abstract

Intensity-modulated radiation therapy (IMRT), an innovative treatment option for prostate cancer, has rapidly diffused over the past decade. To inform our understanding of racial disparities in prostate cancer treatment and outcomes, this study compared diffusion of IMRT in African American (AA) and Caucasian American (CA) prostate cancer patients during the early years of IMRT diffusion using the Surveillance, Epidemiology and End Results (SEER)-Medicare linked database. A retrospective cohort of 947 AA and 10,028 CA patients diagnosed with localized prostate cancer from 2002 through 2006, who were treated with either IMRT or non-IMRT as primary treatment within 1 year of diagnoses was constructed. Logistic regression was used to examine potential differences in diffusion of IMRT in AA and CA patients, while adjusting for socioeconomic and clinical covariates. A significantly smaller proportion of AA compared with CA patients received IMRT for localized prostate cancer (45% vs. 53%, p < .0001). Racial differences were apparent in multivariable analysis though did not achieve statistical significance, as time and factors associated with race (socioeconomic, geographic, and tumor related factors) explained the preponderance of variance in use of IMRT. Further research examining improved access to innovative cancer treatment and technologies is essential to reducing racial disparities in cancer care.

Abstract

BACKGROUND:
The burden of readmissions after major cancer surgery is high. Prior work suggests that one-third of readmitted patients are readmitted to a different hospital than where the surgery was performed. The impact of this location of readmission needs to be more thoroughly understood.

METHODS:
This retrospective cohort study was performed on Surveillance, Epidemiology, and End Results (SEER)-Medicare patients with bladder, esophagus, lung, or pancreas cancer diagnosed from 2001 to 2007 who underwent extirpative surgery and were readmitted within 90 days. Readmission location was classified as 'index' if readmission was at the hospital where surgery was performed, or 'different' if readmission was elsewhere. Outcomes including complications, reoperations, in-hospital mortality, 90-day mortality, and 90-day total costs were compared based on the location of readmission using a propensity score inverse probability treatment weight analysis.

RESULTS:
Overall, 7903 (28 %) patients were readmitted within 90 days of index hospitalization. Thirty-three percent were readmitted to a different hospital (bladder 30 %, esophagus 34 %, lung 34 %, pancreas 34 %). Ninety-day mortality and total costs of care were not significantly different between the readmission location groups (all p > 0.05); however, substantial differences in the types of patients, and timing of and reasons for readmission were observed between the two groups.

CONCLUSIONS:
Patients readmitted to different hospitals after major cancer surgery are a different group of patients than those readmitted to the index hospital. Accounting for this, we did not find significant differences in short-term clinical outcomes or costs of care based on readmission location; however, differences in long-term outcomes were observed that should be further explored in future studies.

Abstract

BACKGROUND:
The psychosocial benefits of postmastectomy breast reconstruction are well established; however, health care barriers persist. The authors evaluated statewide patient population to further identify obstacles to reconstruction.

METHODS:
A linked data set combining the North Carolina Central Cancer Registry with administrative claims from Medicare, Medicaid, and private insurance plans identified women diagnosed with breast cancer from 2003 to 2006. For inclusion in the study, women must have had a mastectomy within 6 months of diagnosis and had continuous insurance enrollment at least 2 years postoperatively (n = 5381). Multivariable logistic regression was used to model odds of reconstruction.

RESULTS:
Approximately 20 percent underwent reconstruction (n = 1130). Distance to a plastic surgeon-10 to 20 miles (OR, 0.78) and greater than 20 miles (OR, 0.73; p < 0.05)-was significantly predictive of no reconstruction, independent of other well-known disparities, including age, race, rural location, and lower household income. Women with government-funded health care, such as Medicare (OR, 0.58) and Medicaid (OR, 0.24; p < 0.001), were also significantly less likely to undergo reconstruction. Consistent with previous study, advanced cancer stage and receipt of radiation therapy decreased the likelihood of reconstruction. Furthermore, when the authors compared immediate to delayed reconstruction, rural location, chemotherapy, and radiation therapy were significantly predictive of delay.

CONCLUSIONS:
This is the first population-based study to demonstrate distance to care and insurance plan as significant predictors of receipt of reconstruction. Additional research is needed to understand health care barriers and to determine whether distance to a plastic surgeon can be ameliorated by outreach programs.

CLINICAL QUESTION/LEVEL OF EVIDENCE:
Risk, III.

Abstract

Introduction: Large amounts of health data generated by a wide range of health care applications across a variety of systems have the potential to offer valuable insight into populations and health care systems, but robust and secure computing and analytic systems are required to leverage this information.

Framework: We discuss our experiences deploying a Secure Data Analysis Platform (SeDAP), and provide a framework to plan, build and deploy a virtual desktop infrastructure (VDI) to enable innovation, collaboration and operate within academic funding structures. It outlines 6 core components: Security, Ease of Access, Performance, Cost, Tools, and Training.

Conclusion: A platform like SeDAP is not simply successful through technical excellence and performance. Its adoption is dependent on a collaborative environment where researchers and users plan and evaluate the requirements of all aspects.

Abstract

PURPOSE:
Trastuzumab is a key component of adjuvant therapy for stage I to III human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The rates and patterns of trastuzumab use have never been described in a population-based sample. The recent addition of HER2 information to the SEER-Medicare database offers an opportunity to examine patterns of trastuzumab use and to evaluate possible disparities in receipt of trastuzumab.

METHODS:
We examined a national cohort of Medicare beneficiaries with incident stage I to III HER2-positive breast cancer diagnosed in 2010 and 2011 (n = 1,362). We used insurance claims data to track any use of trastuzumab in the 12 months after diagnosis as well as to identify chemotherapy drugs used in partnership with trastuzumab. We used modified Poisson regression analysis to evaluate the independent effect of race on likelihood of receiving trastuzumab by controlling for clinical need, comorbidity, and community-level socioeconomic status.

RESULTS:
Overall, 50% of white women and 40% of black women received some trastuzumab therapy. Among women with stage III disease, 74% of whites and 56% of blacks received trastuzumab. After adjustment for tumor characteristics, poverty, and comorbidity, black women were 25% less likely to receive trastuzumab within 1 year of diagnosis than white women (risk ratio, 0.745; 95% CI, 0.60 to 0.93).

CONCLUSION:
Approxemately one half of patients 65 years of age and older with stage I to III breast cancer do not receive trastuzumab-based therapy, which includes many with locally advanced disease. Significant racial disparities exist in the receipt of this highly effective therapy. Further research that identifies barriers to use and increases uptake of trastuzumab could potentially improve recurrence and survival outcomes in this population, particularly among minority women.

Abstract

PURPOSE:
Many low-income patients enroll in Medicaid at the time of cancer diagnosis, which improves survival outcomes. Medicaid enrollment before cancer diagnosis may confer additional benefits. Our objective was to compare stage at diagnosis and overall mortality between women with and without Medicaid enrollment before gynecologic cancer diagnosis.

METHODS AND MATERIALS:
Women younger than 65 years with a gynecologic cancer (2003 to 2008) were identified through the North Carolina Central Cancer Registry and linked to state Medicaid enrollment files. Those with and without Medicaid enrollment within 6 months before diagnosis were identified. Propensity matching was used to balance the exposure groups. Stage at diagnosis was evaluated by using logistic regression, and all-cause mortality was assessed with Cox proportional hazard models.

RESULTS:
Of 564 women, one half (n = 282) had prediagnosis Medicaid enrollment. Disease sites included the cervix (44%), uterus (25%), ovary (26%), and vulva/vagina (5%). More than one half (51%) of cancers were advanced stage. Women without prediagnosis Medicaid had an increased odds of advanced-stage disease (hazard ratio, 1.46; 95% CI, 1.03 to 2.05). Crude survival outcomes differed significantly between the groups; however, when adjusted for stage at diagnosis, lack of prediagnosis Medicaid coverage had a hazard ratio of 1.19 (95% CI, 0.92 to 1.53).

CONCLUSION:
Medicaid enrollment before gynecologic cancer diagnosis is associated with an earlier stage at presentation. Given the existence of a cervical cancer screening program in North Carolina and lack of Medicaid expansion, these data suggest that screening programs alone are not sufficient to counteract the delay in diagnosis that is common for uninsured individuals.

Abstract

PURPOSE:
The Centers for Medicare and Medicaid Services recently initiated small reimbursement adjustments to improve the value of care delivered under fee-for-service. To estimate the degree to which reimbursement influences physician decision making, we examined utilization of gonadotropin-releasing hormone (GnRH) agonists among urologists as Part B drug reimbursement varied in a fee-for-service environment.

METHODS:
We analyzed treatment patterns of urologists treating 15,128 men included in SEER-linked Medicare claims who were diagnosed with localized prostate cancer between January 1, 2000, and December 31, 2003. We calculated a reimbursement generosity index to measure differences in GnRH agonist reimbursement among regional Medicare carriers and over time. We used multilevel analysis to control for patient and provider characteristics.

RESULTS:
Among urologists treating early-stage and lower grade prostate cancer, variation in reimbursement was not associated with overuse of GnRH agonists from 2000 to 2003, a period of guideline stability (odds ratio, 1.00; 95% CI, 0.99 to 1.00).

CONCLUSION:
Small differences in androgen-deprivation therapy reimbursement generosity were not associated with differential use. Fee-for-service reimbursement changes currently being implemented to improve quality in fee-for-service Medicare may not affect patterns of cancer care.

Abstract

Large and high-dimensional real-world datasets are being gathered across a wide range of application disciplines to enable data-driven decision making. Interactive data visualization can play a critical role in allowing domain experts to select and analyze data from these large collections. However, there is a critical mismatch between the very large number of dimensions in complex real-world datasets and the much smaller number of dimensions that can be concurrently visualized using modern techniques. This gap in dimensionality can result in high levels of selection bias that go unnoticed by users. The bias can in turn threaten the very validity of any subsequent insights. In this paper, we present Adaptive Contextualization (AC), a novel approach to interactive visual data selection that is specifically designed to combat the invisible introduction of selection bias. Our approach (1) monitors and models a user's visual data selection activity, (2) computes metrics over that model to quantify the amount of selection bias after each step, (3) visualizes the metric results, and (4) provides interactive tools that help users assess and avoid bias-related problems. We also share results from a user study which demonstrate the effectiveness of our technique.

Abstract

BACKGROUND:
Clinical trials provide access to innovative, high-quality cancer treatment. Simultaneously, broad access helps to ensure that trials include heterogeneous patient populations, which improves the generalizability of findings and the development of interventions that are effective for diverse populations. We provide updated data describing enrollment into cancer treatment trials in North Carolina.

METHODS:
For the period 1996-2009, person-level data regarding cancer clinical trial enrollment and cancer incidence were obtained from the North Carolina Central Cancer Registry and the National Cancer Institute (NCI). Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for race, sex, and year for each county, Area Health Education Center region, and the state overall. Enrollment rates for common cancers are presented.

RESULTS:
From 1996 to 2009, North Carolina NCI treatment trial enrollment rates were 2.4% and 2.2% for white patients and minority patients, respectively. From 2007 to 2009, rates were 3.8% for white women, 3.5% for minority women, 1.3% for white men, and 1.0% for minority men; there was greater enrollment among more urban populations (2.4%) than among the most rural populations (1.5%).

LIMITATIONS:
This study is limited to NCI-sponsored treatment trials in North Carolina. Policies governing collection of original data necessitate a delay in data availability.

CONCLUSIONS:
Effort is needed to ensure trial access and enrollment among all North Carolina populations. Specifically, we identified racial and sex disparities, particularly for certain cancers (eg, breast cancer). Programs in North Carolina and across the nation can use the methods we employed to assess their success in broadening clinical trial enrollment to include diverse populations.

Abstract

BACKGROUND:
The patient-centered medical home (PCMH) is increasingly being implemented in an effort to improve and coordinate primary care, but its effect on health care utilization among breast cancer patients remains unclear. The objective of this study was to examine health care utilization and expenditures as a function of PCMH enrollment among breast cancer patients in North Carolina's Medicaid program.

METHODS:
North Carolina Medicaid claims linked to North Carolina Central Cancer Registry records (2003-2007) were used to examine monthly patterns of health care use and expenditures. Controlling for a selection bias for time-invariant characteristics, fixed effects regression models analyzed associations between PCMH enrollment and utilization of outpatient, inpatient, and emergency department (ED) services and Medicaid expenditures during the 15 months after the diagnosis of breast cancer.

RESULTS:
Among 758 breast cancer patients, 381 (50%) were enrolled in a PCMH at some time in the 15 months after diagnosis. After controlling for individual fixed effects, PCMH enrollment was significantly associated with greater outpatient service use, but there was no difference in the probability of inpatient hospitalizations or ED visits. Enrollment in a PCMH was associated with increased average expenditures of $429 per month during the first 15 months.

CONCLUSIONS:
Greater outpatient care utilization and increased average expenditures among breast cancer patients enrolled in a PCMH may suggest that these women have improved access to primary and specialty care. Expanding PCMHs may change patterns of service utilization for Medicaid breast cancer patients but may not be associated with lower costs.

Abstract

BACKGROUND:
Oxaliplatin was rapidly adopted for treatment of stage III colon cancer after FDA approval in November 2004, thus providing an opportunity to use calendar time as an instrumental variable in nonexperimental comparative effectiveness research. Assuming instrument validity, instrumental variable analyses account for unmeasured confounding and are particularly valuable in sub-populations of unresolved effectiveness, such as older individuals.

METHODS:
We examined stage III colon cancer patients ages 65+ years initiating chemotherapy between 2003 and 2008 using US population-based cancer registry data linked with Medicare claims (N = 3,660). Risk differences for all-cause mortality were derived from Kaplan-Meier survival curves. We examined instrumental variable strength and compared risk differences with propensity score estimates.

RESULTS:
Calendar time greatly affected oxaliplatin receipt. The calendar time instrument compared patients treated from January 2003 through September 2004 (N = 1,449) with those treated from March 2005 through May 2007 (N = 1,432), resulting in 54% compliance. The 1-, 2-, and 3-year local average treatment effect of the risk differences per 100 patients in the "compliers" (95% confidence intervals) were -4.6 (-8.2, -0.44), -6.3 (-12, -0.16), and -9.2 (-15, -2.5), respectively. Corresponding propensity score-matched results were -1.9 (-4.0, 0.2), -3.4 (-6.2, -0.05), and -4.3 (-7.5, -0.96).

CONCLUSIONS:
Instrumental variable and propensity score analyses both indicate better survival among patients treated with oxaliplatin. As these results are based on different populations and assumptions, the instrumental variable analysis adds to evidence of oxaliplatin's effectiveness in older adults, who bear the greatest burden of colon cancer yet were underrepresented in clinical trials. In nonexperimental comparative effectiveness research of rapidly emerging therapies, the potential to use calendar time as an instrumental variable is worth consideration.

Abstract

BACKGROUND:
Optimal administration of transarterial chemoembolization (TACE), the standard approach for intermediate-stage hepatocellular carcinoma (HCC), requires clinical and technical expertise. We sought to evaluate whether TACE retains its effectiveness when administered across a broad range of health care settings. Furthermore, as the use of yttrium(90) (Y(90)) radioembolization has been increasing, we explored the comparative effectiveness of Y(90) as an alternative to TACE.

METHODS:
Patients with HCC diagnosed from 2004 through 2009 treated initially with TACE or Y(90) were identified from the SEER-Medicare linkage. Key covariates included prediagnosis α-fetoprotein (AFP) screening, complications of cirrhosis, and tumor extent. Effect of treatment, patient, and health care system factors on overall survival (OS) was evaluated using multivariable Cox proportional hazards. Stratified OS estimates are provided. Propensity score (PS) weighting was used to compare effectiveness of Y(90) with TACE.

RESULTS:
Of 1528 patients who underwent intra-arterial embolization, 577 received concurrent chemotherapy (eg, TACE). Median OS was 21 months (95% CI, 18-23) following TACE and 9 months (95% CI, 1-41) following Y(90). Refined survival estimates stratified by stage, AFP screening, and liver comorbidity are presented. The 90-day mortality rate after TACE was 21% to 25% in patients with extrahepatic spread or vascular invasion. In the PS-weighted analysis, Y(90) was associated with inferior survival, with an adjusted hazard ratio of 1.39 (95% CI, 1.02-1.90).

CONCLUSIONS:
The effectiveness of TACE is generalizable to Medicare patients receiving care in a variety of treatment settings. However, early posttreatment mortality is high in patients with advanced disease. We found no evidence of improved outcomes with Y(90) compared with TACE. Survival estimates from this large cohort can be used to provide prognostic information to patients considering palliative TACE.

Abstract

BACKGROUND
Adults aged ≥65 years who are dually enrolled in Medicare and Medicaid are an at-risk group in health care. However, to the best of the authors' knowledge, the outcomes of women with gynecologic cancers in this population are unknown.

METHODS
The current study was a population-based cohort study of North Carolina state cancer registry cases of uterine, ovarian, cervical, and vulvar/vaginal cancers (2003-2009), with linked enrollment in Medicare and state Medicaid. Outcomes of all-cause mortality and stage of disease at the time of diagnosis were analyzed as a function of enrollment status using multivariate analysis and survival curves.

RESULTS
Of 4522 women aged ≥65 years (3702 of whom were enrolled in Medicare [82%] and 820 of whom were dually enrolled [18%]), there were 2286 cases of uterine (51%), 1587 cases of ovarian (35%), 302 cases of cervical (7%), and 347 cases of vulvar/vaginal (8%) cancers. Dual enrollees had increased all-cause mortality overall (adjusted hazard ratio [aHR], 1.34; 95% confidence interval [95% CI], 1.19-1.49), and within each cancer site (uterine: aHR, 1.22 [95% CI, 1.02-1.47]; ovarian: aHR, 1.25 [95% CI, 1.05-1.49]; cervical: aHR, 1.34 [95% CI, 0.96-1.87]; and vulvar/vaginal: aHR, 1.93 [95% CI, 1.36-2.72]). Increased odds of advanced-stage disease at the time of diagnosis among dual enrollees was only present in patients with uterine cancer (adjusted odds ratio, 1.38; 95% CI, 1.06-1.79). Stratified survival curves demonstrated the strongest disparities among women with early-stage uterine and early-stage vulvar/vaginal cancers.

CONCLUSIONS
Women aged ≥65 years who were dually enrolled in Medicare and Medicaid were found to have an overall 34% increase in all-cause mortality after diagnosis with a gynecologic cancer compared with the non-dually enrolled Medicare population. Women with early-stage uterine and vulvar/vaginal cancers appeared to have the most disparate outcomes. Because these malignancies are generally curable, they have the most potential for benefit from targeted interventions.

Abstract

BACKGROUND: Medicare reimbursement cuts have been associated with declining gonadotropin-releasing hormone (GnRH) agonist overuse in localized prostate cancer. Medical school affiliation and foreign training have been associated with persistent overuse. However, physician-level prescribing changes and the practice type of persistent overusers have not been examined. We sought to describe physician-level changes in GnRH agonist overuse and test the association of time in practice and solo practice type with GnRH agonist overuse.

METHODS: We matched American Medical Association physician data for 2138 urologists to Surveillance, Epidemiology and End Result-Medicare data for 12,943 men diagnosed with early-stage and lower-grade adenocarcinoma of the prostate between 2000 and 2007. We conducted a population-based, retrospective study using multilevel modeling to control for patient and provider characteristics.

RESULTS: Three distinct patterns of GnRH agonist overuse were observed. Urologists' time in practice was not associated with GnRH agonist overuse (odds ratio (OR) 0.89; 95% confidence interval (CI): 0.75-1.05). However, solo practice type (OR 1.65; 95% CI: 1.34-2.02), medical school affiliation (OR 0.65; 95% CI: 0.55-0.77) and patient race were. Compared with non-Hispanic whites, non-Hispanic blacks (OR 1.76; 95% CI: 1.37-2.27), Hispanics (OR 1.41; 95% CI: 1.12-1.79) and men of 'other' race (OR 1.44; 95% CI: 1.04-1.99) had greater odds of receiving unnecessary GnRH agonists.

CONCLUSIONS: GnRH agonist overuse remains high among some urologists who may be professionally isolated and difficult to reach. These urologists treat more vulnerable populations, which may contribute to health disparities in prostate cancer treatment quality. Nonetheless, these findings provide guidance to develop interventions to address overuse in prostate cancer.

Abstract

Big data on real-world patients and practices are essential for answering questions regarding treatment effectiveness and long-term outcomes.

Abstract

Objectives
We examined associations between local health department (LHD) spending, staffing, and services and community health outcomes in North Carolina.

Methods
We analyzed LHD investments and community mortality in North Carolina from 2005 through 2010. We obtained LHD spending, staffing, and services data from the National Association of City and County Health Officials 2005 and 2008 profile surveys. Five mortality rates were constructed using Centers for Disease Control and Prevention mortality files, North Carolina vital statistics data, and census data for LHD service jurisdictions: heart disease, cancer, diabetes, pneumonia and influenza, and infant mortality.

Results
Spending, staffing, and services varied widely by location and over time in the 85 North Carolina LHDs. A 1% increase in full-time-equivalent staffing (per 1000 population) was associated with decrease of 0.01 infant deaths per 1000 live births (P < .05). Provision of women and children's services was associated with a reduction of 1 to 2 infant deaths per 1000 live births (P < .05).

Conclusions
Our findings, in the context of other studies, provide support for investment in local public health services to improve community health.

Abstract

BACKGROUND:
Provider-based research networks such as the National Cancer Institute's Community Clinical Oncology Program (CCOP) have been shown to facilitate the translation of evidence-based cancer care into clinical practice. This study compared the utilization of laparoscopy and partial nephrectomy among patients with early-stage kidney cancer according to their exposure to CCOP-affiliated providers.

METHODS:
With linked Surveillance, Epidemiology, and End Results-Medicare data, patients with T1aN0M0 kidney cancer who had been treated with nephrectomy from 2000 to 2007 were identified. For each patient, the receipt of care from a CCOP physician or hospital and treatment with laparoscopy or partial nephrectomy were determined. Adjusted for patient characteristics (eg, age, sex, and marital status) and other organizational features (eg, community hospital and National Cancer Institute-designated cancer center), multivariate logistic regression was used to estimate the association between each surgical innovation and CCOP affiliation.

RESULTS:
During the study interval, 1578 patients (26.8%) were treated by a provider with a CCOP affiliation. Trends in the utilization of laparoscopy and partial nephrectomy remained similar between affiliated and nonaffiliated providers (P ≥ .05). With adjustments for patient characteristics, organizational features, and clustering, no association was noted between CCOP affiliation and the use of laparoscopy (odds ratio [OR], 1.11; 95% confidence interval [CI], 0.81-1.53) or partial nephrectomy (OR, 1.04; 95% CI, 0.82-1.32) despite the more frequent receipt of these treatments in academic settings (P < .05).

CONCLUSIONS:
At a population level, patients treated by providers affiliated with CCOP were no more likely to receive at least 1 of 2 surgical innovations for treatment of their kidney cancer, indicating perhaps a more limited scope to provider-based research networks as they pertain to translational efforts in cancer care. Cancer 2014. © 2014 American Cancer Society.

Abstract

PURPOSE:
Travel distances to care have increased substantially with centralization of complex cancer procedures at high-volume centers. We hypothesize that longer travel distances are associated with higher rates of postoperative readmission and poorer outcomes.

METHODS:
SEER-Medicare patients with bladder, lung, pancreas, or esophagus cancer who were diagnosed in 2001 to 2007 and underwent extirpative surgery were included. Readmission rates and survival were calculated using Kaplan-Meier functions. Multivariable negative binomial models were used to examine factors associated with readmission.

RESULTS:
Four thousand nine hundred forty cystectomies, 1,573 esophagectomies, 20,362 lung resections, and 2,844 pancreatectomies were included. Thirty- and 90-day readmission rates ranged from 13% to 29% and 23% to 43%, respectively, based on tumor type. Predictors of readmission were discharge to somewhere other than home, longer length of stay, comorbidities, higher stage at diagnosis, and longer travel distance (P < .001 for each). Patients who lived farther from the index hospital also had increased emergency room visits and were more likely to be readmitted to a hospital other than the index hospital (P < .001). Of readmitted patients, 31.9% were readmitted more than once. Long-term survival was worse and costs of care higher for patients who were readmitted (P < .001 for all).

CONCLUSION:
The burden of readmissions after major cancer surgery is high, resulting in substantially poorer patient outcomes and higher costs. Risk of readmission was most strongly associated with length of stay and discharge destination. Travel distance also has an impact on patterns of readmission. Interventions targeted at higher risk individuals could potentially decrease the population burden of readmissions after major cancer surgery.

Abstract

Purpose
A significant proportion of renal masses removed for suspected malignancy are histologically benign, with probabilities inversely proportional to lesion size. The number of preoperatively misclassified benign renal masses (BRM) undergoing nephrectomy is currently unknown. Given the increasing incidence and decreasing average size of renal cell carcinoma (RCC), this burden is likely increasing. The purpose of this study is to estimate the population-level burden of surgically removed, preoperatively misclassified BRM in the US.

Materials and Methods
A systematic review of the literature was conducted for studies reporting pathology of renal masses removed for suspected RCC based on pre-operative imaging through July 1, 2014. We excluded studies not reporting benign pathology, not stratified by size, and in which pathology was based on biopsy. SEER data were queried for incidence of surgically removed RCC in 2000-2009.

Results
19 studies reporting tumor pathology based on size met criteria for review. The pooled estimates of the proportion of benign histology in our primary analysis (US studies only, 1 cm increments) were 40.4%, 20.9%, 19.6%, 17.2%, 9.2%, and 6.4% for <1, 1-2, 2-3, 3-4, 4-7, and > 7 cm tumors, respectively. The estimated number of surgically resected BRM in the US from 2000 to 2009 increased by 82%, from 3098 to 5624.

Conclusions
These estimates suggest that the population-level burden of preoperatively misclassified BRM is substantial and increasing rapidly, paralleling increases in surgically resected small RCCs. This study illustrates an important and previously unstudied dimension of overtreatment, not directly quantified in contemporary surveillance data.

Abstract

BACKGROUND:
African American (AA) patients with colon cancer (CC) experience worse outcomes than whites partly due to differential treatment. The National Cancer Institute's Community Clinical Oncology Program (CCOP), a provider-based research network, adopts and diffuses innovative CC treatments quickly. The authors hypothesized that CCOP participation would lessen racial differences in the receipt of oxaliplatin, an innovative treatment for CC, among patients with stage III CC in the community.

METHODS:
Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, the authors performed a population-based retrospective cohort study of AA and white individuals aged ≥66 years who were diagnosed with AJCC stage III CC from 2003 through 2005. Generalized estimating equations were used to calculate the odds of receiving an oxaliplatin-containing regimen. Predicted probabilities of oxaliplatin receipt for race-CCOP combinations were calculated. The absolute difference in oxaliplatin receipt between races was estimated using the interaction contrast ratio.

RESULTS:
Of 2971 included individuals, 36% received oxaliplatin, 29.5% were CCOP-affiliated, and 7.6% were AA. On multivariate analysis, early diffusion of oxaliplatin was not found to be associated with race or CCOP participation. The probability of receiving oxaliplatin for AAs participating in a CCOP (0.46) was nearly double that of AAs who were not participating in a CCOP (0.25; P <.05). For white individuals, the probabilities of receiving oxaliplatin did not differ by CCOP participation. For oxaliplatin receipt, the joint effects assessment suggested a greater benefit of CCOP participation among AAs (interaction contrast ratio, 1.7).

CONCLUSIONS:
Among older patients with stage III CC, there is a differential impact of race on oxaliplatin receipt depending on CCOP participation. AAs treated by CCOPs were more likely to receive oxaliplatin than AAs treated elsewhere. Provider-based research networks may facilitate early access to innovative treatment for AAs with stage III CC. Cancer 2015;121:93-101. © 2014 American Cancer Society.

Abstract

PURPOSE:
Hormone receptor-positive (HR+) cancers account for most breast cancer diagnoses and deaths. Among survivors with HR + breast cancers, endocrine therapy (ET) reduces 5-year risk of recurrence by up to 40 %. Observational studies in Medicare- and privately-insured survivors suggest underutilization of ET. We sought to characterize ET use in a low-income Medicaid-insured population in North Carolina.

METHODS:
Medicaid claims data were matched to state cancer registry records for survivors aging 18-64 diagnosed with stage 0-II HR + breast cancer from 2003 to 2007, eligible for ET, and enrolled in Medicaid for at least 12 of 15 months post-diagnosis. We used multivariable logistic regression to model receipt of any ET medication during 15 months post-diagnosis controlling for age, race, tumor characteristics, receipt of other treatments, comorbidity, residence, reason for Medicaid eligibility, involvement in the Breast and Cervical Cancer Control Program (BCCCP), and diagnosis year.

RESULTS:
Of 222 women meeting the inclusion criteria, only 50 % filled a prescription for ET. Involvement in the BCCCP and earlier year of diagnoses were associated with significantly higher odds of initiating guideline-recommended ET (adjusted odds ratio [AOR] for the BCCCP 3.76, 95 % confidence interval [CI] 1.67-8.48; AOR for 2004 relative to 2007 2.80, 95 % CI 1.03-7.62; AOR for 2005 relative to 2007 2.11, 95 % CI 0.92-4.85).

CONCLUSIONS:
Results suggest substantial underutilization of ET in this population. Interventions are needed to improve timely receipt of ET and to better support survivors taking ET.

IMPLICATIONS FOR CANCER SURVIVORS:
Low-income survivors should be counseled on the importance of ET and offered support services to promote initiation and long-term adherence.

Abstract

Occupational therapy may significantly improve cancer survivors' ability to participate in activities, thereby improving quality of life. Little is known, however, about the use of occupational therapy services by adults with cancer. The objective of this study was to understand what shapes patterns of occupational therapy use to help improve service delivery. We examined older (age >65 yr) adults diagnosed with breast, prostate, lung, or melanoma (skin) cancer between 2004 and 2007 (N = 27,131) using North Carolina Central Cancer Registry data linked to Medicare billing claims. Survivors who used occupational therapy within 1 yr before their cancer diagnosis were more likely to use occupational therapy after diagnosis but also experienced the highest levels of comorbidities. Survivors with Stage 4 cancers or lung cancer were less likely to use occupational therapy. These findings suggest possible disparities in utilization of occupational therapy by older adults with cancer.

Abstract

Health registries greatly enhance health services research, especially when linked with other data sources such as administrative claims. Recently, concerns about patient privacy and data security have produced policies such as the
Health Insurance Portability and Accountability Act (HIPAA) that reduce the availability of sensitive identifying information. In this context, the development of effective record linkage approaches for varying scenarios of data availability is critical. This report presents a conceptual framework and instructional information that scientifically describe the strengths and limitations of different approaches to record linkage of registries to other data sources.

(Prepared by the University
of North Carolina at Chapel Hill under Contract No. 290-2010-000141.) AHRQ Publication No.
14-EHC033-EF. Rockville, MD: Agency for Healthcare Research and Quality; September 2014.
www.effectivehealthcare.ahrq.gov/reports/final.cfm

Abstract

The Integrated Cancer Information and Surveillance System (ICISS) facilitates population-based cancer research by developing extensive information technology systems that can link and manage large data sets. Taking an interdisciplinary 'team science' approach, ICISS has developed data, systems, and methods that allow researchers to better leverage the power of big data to improve population health.

Abstract

BACKGROUND:
Distance to oncology service providers and rurality may affect receipt of guideline-recommended radiation therapy (RT), but the extent to which these factors affect the care of Medicare-insured patients is unknown.

METHODS:
Using cancer registry data linked to Medicare claims from the Integrated Cancer Information and Surveillance System (ICISS), we identified all women aged 65 years or older who were diagnosed with stage I, II, or III breast cancer from 2003 through 2005, who had Medicare claims through 2006, and who were clinically eligible for RT. We geocoded the address of each RT service provider's practice location and calculated the travel distance from each patient's residential address to the nearest RT provider. We used ZIP codes to classify each patient's residence as rural or urban according to rural- urban commuting area codes. We used generalized estimating equations models with county-level clustering and interaction terms between distance categories and rural-urban status to estimate the effect of distance to care and rural-urban status on receipt of RT.

RESULTS:
In urban areas, increasing distance to the nearest RT provider was associated with a lower likelihood of receiving RT (odds ratio [OR] = 0.54; 95% confidence interval [CI], 0.30-0.97) for those living more than 20 miles from the nearest RT provider compared with those living less than 10 miles away. In rural areas, those living within 10-20 miles of the nearest RT provider were more likely to receive RT than those living less than 10 miles away (OR = 1.73; 95% CI, 1.08-2.76).

LIMITATIONS:
Results may not be generalizable to areas outside North Carolina or to non-Medicare populations.

CONCLUSION:
Coordinated outreach programs targeted differently to rural and urban patients may be necessary to improve the quality of oncology care.

Abstract

Despite its demonstrated effectiveness, colorectal cancer (CRC) testing is suboptimal, particularly in vulnerable populations such as those who are publicly insured. Prior studies provide an incomplete picture of the importance of the intersection of multilevel factors affecting CRC testing across heterogeneous geographic regions where vulnerable populations live. We examined CRC testing across regions of North Carolina by using population-based Medicare and Medicaid claims data from disabled individuals who turned 50 years of age during 2003-2008. We estimated multilevel models to examine predictors of CRC testing, including distance to the nearest endoscopy facility, county-level endoscopy procedural rates, and demographic and community contextual factors. Less than 50% of eligible individuals had evidence of CRC testing; men, African-Americans, Medicaid beneficiaries, and those living furthest away from endoscopy facilities had significantly lower odds of CRC testing, with significant regional variation. These results can help prioritize intervention strategies to improve CRC testing among publicly insured, disabled populations.

Abstract

BACKGROUND:

Chemotherapy-related health care utilization by breast cancer patients can be expensive for payers and patients. This study evaluated the patient-centered medical home program Community Care of North Carolina (CCNC) in terms of its potential to reduce health care utilization associated with chemotherapy-related adverse events (AEs).

METHODS:
Early-stage breast cancer cases diagnosed during the 5-year period 2003-2007 were identified in the North Carolina Central Cancer Registry; these cases were then linked to North Carolina Medicaid claims data. We measured health care utilization associated with chemotherapy-related AEs by setting (inpatient, outpatient, or emergency department) during a 15-month postdiagnosis follow-up period. Descriptive and multivariate analyses were performed to examine associations between CCNC enrollment and health care utilization associated with chemotherapy-related AEs.

RESULTS:
A large proportion of breast cancer patients had at least 1 health care visit associated with a chemotherapy-related AE (n = 412 [72.3%]). The mean numbers of AE-related visits occurring in inpatient, outpatient, and emergency department settings were 0.30 (standard deviation [SD] = 0.83), 6.92 (SD = 10.94), and 0.46 (SD = 1.26), respectively. CCNC enrollment was associated with significantly fewer inpatient admissions (marginal effect, -0.1421; 95% confidence interval, -0.280 to -0.004).

LIMITATIONS:
In this observational study, we were unable to draw conclusions about the causality of these associations.

CONCLUSIONS:
Patients enrolled in CCNC had fewer inpatient health care visits associated with chemotherapy-related AEs. Future research should continue to explore the extent to which patient-centered medical homes can monitor and help manage the effects of cancer treatments.

Abstract

Endocrine therapy (ET) is the cornerstone of adjuvant therapy for hormone-receptor positive (HR+) breast cancer. The survival gap between African-American (AA) and white women with breast cancer is most pronounced in HR+ subtypes, and could be related to differences in ET use. The relationship between race and initiation of ET is not well defined. We investigated patterns of ET initiation by race in a diverse cohort of women covered by commercial health insurance. We identified 2,640 women with incident HR+ breast cancer in the North Carolina Central Cancer Registry whose records linked to commercial insurance claims using the Integrated Cancer Information and Surveillance System (ICISS) database. The sample included women age <65 years diagnosed with stage I-III HR+ cancers between 2004 and 2009. We used multivariate Poisson regression to examine the effect of race on likelihood of initiating ET. 14 % of women did not initiate ET within 12 months of diagnosis. AA women were 17 % less likely to initiate ET than whites (aRR 0.83, 95 % CI 0.74-0.93). When analyzed by subset, racial disparities persisted among women who received chemotherapy (aHR 0.67, 95 % CI 0.56-0.80) but not among women who did not receive chemotherapy (aHR 0.96, 95 % CI 0.76-1.21). AA women in our sample were less likely to initiate ET than whites, and this disparity was concentrated among chemotherapy-treated women. ET under-utilization may contribute to the racial survival gap in HR+ breast cancer, and represents an opportunity for intervention to reduce breast cancer disparities.

Abstract

PURPOSE:
The purpose of this study was to compare chemoradiation therapy (CRT) with radiation therapy (RT) only in an older patient population with head and neck squamous cell carcinoma (HNSCC).

METHODS AND MATERIALS:
Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database (1992-2007), we identified a retrospective cohort of nonmetastatic HNSCC patients and divided them into treatment groups. Comparisons were made between CRT and RT cohorts. Propensity scores for CRT were estimated from covariates associated with receipt of treatment using multivariable logistic regression. Standardized mortality ratio weights (SMRW) were created from the propensity scores and used to balance groups on measured confounders. Multivariable and SMR-weighted Cox proportional hazard models were used to estimate the hazard ratio (HR) of death for receipt of CRT versus RT among the whole group and for separate patient and tumor categories.

RESULTS:
The final cohort of 10,599 patients was 68% male and 89% white. Median age was 74 years. Seventy-four percent were treated with RT, 26% were treated with CRT. Median follow-up points for CRT and RT survivors were 4.6 and 6.3 years, respectively. On multivariable analysis, HR for death with CRT was 1.13 (95% confidence interval [CI]: 1.07-1.20; P<.01). Using the SMRW model, the HR for death with CRT was 1.08 (95% CI: 1.02-1.15; P=.01).

CONCLUSIONS:
Although the addition of chemotherapy to radiation has proven efficacious in many randomized controlled trials, it may be less effective in an older patient population treated outside of a controlled trial setting.

Abstract

OBJECTIVE:
This study characterizes the surgical oncology workforce as a baseline for future workforce projections.

BACKGROUND:
Measuring the capacity of the surgical oncology workforce is difficult due to the wide variety of surgeons who contribute to surgical cancer care. We hypothesize that the bulk of surgical oncology care is provided by general surgeons.

METHODS:
Using Medicare claims data linked to the North Carolina Central Cancer Registry, all patients 65 years or older who had a diagnosis of incident cancer of the bladder, breast, colon/rectum, esophagus, gallbladder, kidney, liver, lung, skin (melanoma-only), ovary, pancreas, prostate, small bowel, stomach, or uterus in 2005 and who underwent an extirpative procedure for cancer were identified. The proportion of procedures performed by different types of providers was examined.

RESULTS:
A total of 7759 patients underwent 16,734 extirpative surgical procedures. Excluding procedures for gynecologic/urologic malignancies, the proportion of procedures performed by general surgeons and surgical oncologists was 48% and 12%, respectively. Patients treated by general surgeons were more likely to be older, female, minority, and from areas of high poverty. For each tumor type, travel distances were shorter for patients treated by general surgeons than those treated by specialists.

CONCLUSIONS:
Workforce projections must account for the significant overlap in the scope of services delivered by providers of different specialties and for the large contribution of general surgeons to cancer care. Efforts to improve the quality of cancer care need to move beyond centralization and focus on educating the surgeons who are providing the bulk of oncology care.

Abstract

Comparative effectiveness research (CER) is a broad category of outcomes research encompassing many different methods employed by researchers and clinicians from numerous disciplines. The goal of cancer-focused CER is to generate new knowledge to assist cancer stakeholders in making informed decisions that will improve health care and outcomes of both individuals and populations. There are numerous CER methods that may be used to examine specific questions, including randomized controlled trials, observational studies, systematic literature reviews, and decision sciences modeling. Each has its strengths and weaknesses. To both inform and serve as a reference for readers of this issue of Seminars in Radiation Oncology as well as the broader oncology community, we describe CER and several of the more commonly used approaches and analytical methods.

Abstract

Existing evidence suggests that preoperative breast magnetic resonance imaging (MRI) might not improve surgical outcomes in the general breast cancer population. To determine if patients differentially benefit from breast MRI, we examined surgical outcomes-initial mastectomy, reoperation, and final mastectomy rates-among patients grouped by histologic type. We identified women diagnosed with early-stage breast cancer from 2004 to 2007 in the SEER-Medicare dataset. We classified patients as having invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC), mixed ductal/lobular carcinoma (IDLC) or other histologic type. Medicare claims were used to identify breast MRI and definitive surgeries during the initial surgical treatment episode. We used propensity score methods to account for the differential likelihood of exposure to MRI. Of the 20,332 patients who met our inclusion criteria for this study, 12.2 % had a preoperative breast MRI. Patients with ILC as compared to other histologic groups were most likely to receive MRI [OR 2.32; 95 % CI (2.02-2.67)]. In the propensity score-adjusted analyses, breast MRI was associated with an increased likelihood of an initial mastectomy for all patients and among all histologic subgroups. Among patients with ILC, having a breast MRI was associated with lower odds of a reoperation [OR 0.59; 95 % CI (0.40-0.86)], and an equal likelihood of a final mastectomy compared to similar patients without a breast MRI. Overall and among patients with IDC and IDLC, breast MRI was not significantly associated with a likelihood of a reoperation but was associated with greater odds of a final mastectomy. Our study provides evidence in support of the targeted use of preoperative breast MRI among patients with ILC to improve surgical planning; it does not provide evidence for the routine use of breast MRI among all newly diagnosed breast cancer patients or among patients with IDC.

Abstract

BACKGROUND
Bladder cancer is notable for a striking heterogeneity of disease-specific risks. Among the approximately 75% of incident cases found to be superficial to the muscularis propria at the time of presentation (non–muscle-invasive bladder cancer), the risk of progression to the lethal phenotype of muscle-invasive disease is strongly associated with stage and grade of disease. Given the suggestion of an increasing percentage of low-risk cases in hospital-based registry data in recent years, the authors hypothesized that population-based data may reveal changes in the stage distribution of early-stage cases.

METHODS
Surveillance, Epidemiology, and End Results (SEER) data were used to examine trends for the stage-specific incidence of bladder cancer between 1988 and 2006, adjusted for age, race, and sex, using Joinpoint and nonparametric tests.

RESULTS
The adjusted incidence rate of papillary noninvasive (Ta) predominantly low grade (77%) disease was found to increase from 5.52 to 9.09 per 100,000 population (P < .0001), with an average annual percentage change of +3.3. Over the same period, concomitant, albeit smaller, decreases were observed for flat in situ (Tis) and lamina propria-invasive (T1) disease (2.57 to 1.19 and 6.65 to 4.61 per 100,000 population [both P < .0001]; average annual percent change of −5.0 and −1.6, respectively). The trend was most dramatic among patients in the oldest age strata, suggesting a previously unappreciated cohort phenomenon.

CONCLUSIONS
The findings of the current study should motivate further epidemiological investigations of differential associations of genetic and environmental factors with different bladder cancer phenotypes as well as further scrutiny of clinical practice guideline recommendations for the growing subgroup of predominantly older patients with lower-risk disease.

Abstract

In the United States, renal cell carcinoma (RCC) has rapidly increased in incidence for over two decades. The most common histologic subtypes of RCC, clear cell, papillary, and chromophobe have distinct genetic and clinical characteristics; however, epidemiologic features of these subtypes have not been well characterized, particularly regarding any associations between race, disease subtypes, and recent incidence trends. Using data from the Surveillance, Epidemiology, and End Results (SEER) Program, we examined differences in the age-adjusted incidence rates and trends of RCC subtypes, including analysis focusing on racial differences. Incidence rates increased over time (2001–2009) for all three subtypes. However, the proportion of white cases with clear cell histology was higher than among blacks (50% vs. 31%, respectively), whereas black cases were more likely than white cases to have papillary RCC (23% vs. 9%, respectively). Moreover, papillary RCC incidence increased more rapidly for blacks than whites (P < 0.01) over this period. We also observed that increased incidence of papillary histology among blacks is not limited to the smallest size strata. We observed racial differences in proportionate incidence of RCC subtypes, which appear to be increasing over time; this novel finding motivates further etiologic, clinical, molecular, and genetic studies.

Abstract

BACKGROUND:
Prostate-specific antigen (PSA) testing is recommended every 6 to 12 months for the first 5 years following radical prostatectomy as a means to detect potential disease recurrence. Despite substantial research on factors affecting treatment decisions, recurrence, and mortality, little is known about whether men receive guideline-concordant surveillance testing or whether receipt varies by year of diagnosis, time since treatment, or other individual characteristics.

METHODS:
Surveillance testing following radical prostatectomy among elderly men was examined using Surveillance, Epidemiology, and End Results cancer registry data linked to Medicare claims. Multivariate logistic regression was used to examine the effect of demographic, tumor, and county-level characteristics on the odds of receiving surveillance testing within a given 1-year period following treatment.

RESULTS:
Overall, receipt of surveillance testing was high, with 96% of men receiving at least one test the first year after treatment and approximately 80% receiving at least one test in the fifth year after treatment. Odds of not receiving a test declined with time since treatment. Nonmarried men, men with less-advanced disease, and non-Hispanic blacks and Hispanics had higher odds of not receiving a surveillance test. Year of diagnosis did not affect the receipt of surveillance tests.

CONCLUSIONS:
Most men receive guideline-concordant surveillance PSA testing after prostatectomy, although evidence of a racial disparity between non-Hispanic whites and some minority groups exists. The decline in surveillance over time suggests the need for well-designed long-term surveillance plans following radical prostatectomy. Cancer 2013. © 2013 American Cancer Society.

Abstract

Background: Practice-based research networks (PBRNs) are promising for accelerating not only research, but also dissemination of research-based evidence into broader community practice. Sentinel lymph node biopsy (SLNB) is an innovation in breast cancer care associated with equivalent survival and lower morbidity, as compared with standard axillary lymph node dissection. We examined the diffusion of SLNB into practice and whether affiliation with the Community Clinical Oncology Program (CCOP), a cancer-focused PBRN, was associated with more rapid uptake of SLNB.

Research Design: Surveillance Epidemiology and End Results-Medicare data were used to study women diagnosed with stage I or II breast cancer in the years 2000–2005 and undergoing breast-conserving surgery with axillary staging (n=6226). The primary outcome was undergoing SLNB. CCOP affiliation of the surgical physician was ascertained from NCI records. Multivariable generalized linear modeling with generalized estimating equations was used to measure association between CCOP exposure and undergoing SLNB, controlling for potential confounders.

Results: Women treated by a CCOP physician had significantly higher odds of receiving SLNB compared with women treated by a non-CCOP physician (OR 2.68; 95% CI, 1.35–5.34). The magnitude of this association was larger than that observed among patients treated by physicians operating in medical school–affiliated hospitals (OR 1.76; 95% CI, 1.30–2.39).

Conclusions: Women treated by CCOP-affiliated physicians were more likely to undergo SLNB irrespective of the hospital’s medical school affiliation, suggesting that the CCOP PBRN may play a role in the rapid adoption of research-based innovation in community practice.

Abstract

PURPOSE:
Nonexperimental studies of treatment effectiveness provide an important complement to randomized trials by including heterogeneous populations. Propensity scores (PSs) are common in these studies but may not adequately capture changes in channeling experienced by innovative treatments. We use calendar time-specific (CTS) PSs to examine the effect of oxaliplatin during dissemination from off-label to widespread use.

METHODS:
Stage III colon cancer patients aged 65+ years initiating chemotherapy between 2003 and 2006 were examined using cancer registry data linked with Medicare claims. Two PS approaches for receipt of oxaliplatin versus 5-flourouricil were constructed using logistic models with key components of age, sex, substage, grade, census-level income, and comorbidities: (i) a conventional, year-adjusted PS and (ii) a CTS PS constructed and matched separately within 1-year intervals, then combined. We compared PS-matched hazard ratios (HRs) for mortality using Cox models.

RESULTS:
Oxaliplatin use increased significantly; 8% (n = 86) of patients received it in the first time period versus 52% (n = 386) in the last. Channeling by comorbidities, income, and age appeared to change over time. The CTS PS improved covariate balance within calendar time strata and yielded an attenuated estimated benefit of oxaliplatin (HR = 0.75) compared with the conventional PS (HR = 0.69).

CONCLUSION:
In settings where prescribing patterns have changed and calendar time acts as a confounder, a CTS PS can characterize changes in treatment choices and estimating separate PSs within specific calendar time periods may result in enhanced confounding control. To increase validity of comparative effectiveness research, researchers should carefully consider drug lifecycles and effects of innovative treatment dissemination over time. Copyright © 2013 John Wiley & Sons, Ltd.

Abstract

There is growing evidence in the literature that older patients may not benefit from more intensive therapy for head and neck squamous cell carcinoma (HNSCC). A growing number of patients with HNSCC are age 65years or older; however, much of the evidence base informing treatment decisions is based on substantially younger and healthier clinical trial populations. The purpose of this study was to assess the patterns of care of older HNSCC patients to better understand how age is associated with treatment decisions.
Methods

Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database (1992–2007), we identified patients with non-metastatic HNSCC (n=10,867) and categorized them by treatment: surgery vs. non-surgery and chemoradiotherapy (CRT) vs. radiotherapy (RT). Multivariate logistic regression models were used to identify variables associated with the receipt of surgery and CRT.
Results

Increasing age w\as associated with decreased odds of receiving CRT (OR=0.94; 95% CI 0.93–0.94) but not surgery (OR 1.00; 95% CI 0.99–1.00). Co-morbidity and race were not associated with receipt of either surgery or CRT. Utilization of CRT increased while surgery decreased between 1992 and 2007.
Conclusion

Age may influence the receipt of CRT for older HNSCC patients. There has been an increasing trend in the receipt of CRT and a decrease in primary surgery.

Abstract

IMPORTANCE Comparative effectiveness research of prostate cancer therapies is needed because of the development and rapid clinical adoption of newer and costlier treatments without proven clinical benefit. Radiotherapy is indicated after prostatectomy in select patients who have adverse pathologic features and in those with recurrent disease.

OBJECTIVES To examine the patterns of use of intensity-modulated radiotherapy (IMRT), a newer, more expensive technology that may reduce radiation dose to adjacent organs compared with the older conformal radiotherapy (CRT) in the postprostatectomy setting, and to compare disease control and morbidity outcomes of these treatments.

DESIGN AND SETTING Data from the Surveillance, Epidemiology, and End Results-Medicare-linked database were used to identify patients with a diagnosis of prostate cancer who had received radiotherapy within 3 years after prostatectomy.

PARTICIPANTS Patients who received IMRT or CRT.

MAIN OUTCOMES AND MEASURES The outcomes of 457 IMRT and 557 CRT patients who received radiotherapy between 2002 and 2007 were compared using their claims through 2009. We used propensity score methods to balance baseline characteristics and estimate adjusted incidence rate ratios (RRs) and their 95% CIs for measured outcomes.

RESULTS Use of IMRT increased from zero in 2000 to 82.1% in 2009. Men who received IMRT vs CRT showed no significant difference in rates of long-term gastrointestinal morbidity (RR, 0.95; 95% CI, 0.66-1.37), urinary nonincontinent morbidity (0.93; 0.66-1.33), urinary incontinence (0.98; 0.71-1.35), or erectile dysfunction (0.85; 0.61-1.19). There was no significant difference in subsequent treatment for recurrent disease (RR, 1.31; 95% CI, 0.90-1.92).

CONCLUSIONS AND RELEVANCE Postprostatectomy IMRT and CRT achieved similar morbidity and cancer control outcomes. The potential clinical benefit of IMRT in this setting is unclear. Given that IMRT is more expensive, its use for postprostatectomy radiotherapy may not be cost-effective compared with CRT, although formal analysis is needed.

Abstract

The effectiveness of stem cell mobilization with G-CSF in lymphoma patients is suboptimal. We reviewed our institutional experience using chemomobilization with etoposide (VP-16; 375 mg/m(2) on days +1 and +2) and G-CSF (5 μg/kg twice daily from day +3 through the final day of collection) in 159 patients with lymphoma. This approach resulted in successful mobilization (>2 × 10(6) CD34+ cells collected) in 94% of patients (83% within 4 apheresis sessions). Fifty-seven percent of patients yielded at least 5 × 10(6) cells in 2 days and were defined as good mobilizers. The regimen was safe with a low rate of rehospitalization. Average costs were $14 923 for good mobilizers and $27 044 for poor mobilizers (P<0.05). Using our data, we performed a 'break-even' analysis that demonstrated that adding two doses of Plerixafor to predicted poor mobilizers at the time of first CD34+ cell count would achieve cost neutrality if the frequency of good mobilizers were to increase by 21%, while the frequency of good mobilizers would need to increase by 25% if three doses of Plerixafor were used. We conclude that chemomobilization with etoposide and G-CSF in patients with lymphoma is effective, with future opportunities for cost-neutral improvement using novel agents.Bone Marrow Transplantation advance online publication, 19 November 2012; doi:10.1038/bmt.2012.216.

Abstract

Background: Community Care of North Carolina (CCNC) initiated an innovative medical home program in the 1990s to improve primary care in Medicaid-insured populations. CCNC has been successful in improving asthma, diabetes, and cardiovascular outcomes but has not been evaluated in the context of cancer care. We explored whether CCNC enrollment was associated with guideline-concordant follow-up care among breast cancer survivors.

Methods: Using state cancer registry records matched to Medicaid claims, we identified women aged from 18 to 64 who were diagnosed with stage 0, I, II, or unstaged breast cancer from 2003 to 2007 and tracked their monthly CCNC enrollment. Using published American Society for Clinical Oncology guidelines to define our outcomes, we employed multivariate logistic regressions to examine the correlation of receipt of mammogram and at least 2 physical examinations/history-taking visits within observational windows consistent with the guidelines.

Results: Of the 840 women, approximately half were enrolled into the CCNC for some time during the study period. Between 40% and 85% received follow-up mammogram in accordance with guidelines, with significant variation by CCNC status, and 95% of women received at least 2 physical examinations/history-taking visits. In multivariate models, increasing months of CCNC enrollment was significantly positively associated with receipt of follow-up mammogram but not with physical examinations/history-taking visits.

Conclusions: Results suggest that CCNC enrollment is associated with guideline-concordant follow-up care for Medicaid-insured survivors. Given the growing population of cancer survivors and increased emphasis on primary care medical homes, future studies should explore what factors are associated with medical home participation and whether similar findings are observed with extended follow-up.

Abstract

OBJECTIVES:
Randomized controlled trials remain the gold standard for evaluating cancer intervention efficacy. Randomized trials are not always feasible, practical, or timely and often don't adequately reflect patient heterogeneity and real-world clinical practice. Comparative effectiveness research can leverage secondary data to help fill knowledge gaps randomized trials leave unaddressed; however, comparative effectiveness research also faces shortcomings. The goal of this project was to develop a new model and inform an evolving framework articulating cancer comparative effectiveness research data needs.

STUDY DESIGN AND SETTING:
We examined prevalent models and conducted semi-structured discussions with 76 clinicians and comparative effectiveness research researchers affiliated with the Agency for Healthcare Research and Quality's cancer comparative effectiveness research programs.

RESULTS:
A new model was iteratively developed and presents cancer comparative effectiveness research and important measures in a patient-centered, longitudinal chronic care model better reflecting contemporary cancer care in the context of the cancer care continuum, rather than a single-episode, acute-care perspective.

CONCLUSION:
Immediately relevant for federally funded comparative effectiveness research programs, the model informs an evolving framework articulating cancer comparative effectiveness research data needs, including evolutionary enhancements to registries and epidemiologic research data systems. We discuss elements of contemporary clinical practice, methodology improvements, and related needs affecting comparative effectiveness research's ability to yield findings clinicians, policy makers, and stakeholders can confidently act on.

Abstract

PURPOSE:
To perform a cost comparison of three approaches to partial nephrectomy (PN): Open (OPN), hand-assisted laparoscopic (HALPN), and robot-assisted (RAPN).

PATIENTS AND METHODS:
We retrospectively evaluated cost and clinical data from patients undergoing OPN, HALPN, and RAPN from 2007 to 2010 (n=89). Baseline demographic data, patient comorbidities, R.E.N.A.L. nephrometry score, and perioperative outcomes were assessed. Costs and subcosts from the operating room (OR) and hospital were evaluated using nonparametric statistical analyses.

RESULTS:
Patient demographics and tumor characteristics were similar between HALPN and RAPN, while OPN patients had more comorbidities and more difficult-to-resect tumors. Thus, HALPN and RAPN were directly compared, while OPNs were excluded from the analysis. No difference was found in overall costs between HALPN and RAPN ($13,560 vs $13,439, P=0.29). OR costs were higher for RAPN ($7276 vs $5708, P=0.0001) because of the higher robotic capital and reusable equipment costs that outweighed higher disposable costs in the HALPN group. OR time-related costs were similar between groups. RAPN patients had a shorter length of stay (LOS), which decreased postoperative hospital costs ($4371 vs $5984, P=0.002).

CONCLUSIONS:
No difference in overall cost was found between RAPN and HALPN. Robot allocation, OR equipment use, and LOS are important determinants of total cost. Further study regarding recovery and quality of life may reveal added benefits to minimally invasive approaches and increase use of nephron-sparing surgery.

Abstract

BACKGROUND:
Provider-based research networks (PBRNs)--collaborative research partnerships between academic centers and community-based practitioners--are a promising model for accelerating the translation of research into practice; however, empirical evidence of accelerated translation is limited. Oxaliplatin in adjuvant combination chemotherapy is an innovation with clinical trial-proven survival benefit compared with prior therapies. The goal of this study is to examine the diffusion of oxaliplatin into community practice, and whether affiliation with the National Cancer Institute's (NCI's) Community Clinical Oncology Program (CCOP)--a nationwide cancer-focused PBRN--is associated with accelerated innovation adoption.

DESIGN, SETTING, AND PARTICIPANTS:
This retrospective observational study used linked Surveillance, Epidemiology, and End Results-Medicare and NCI CCOP data to examine Medicare participants with stage III colon cancer initiating treatment in 2003 through 2006, the years surrounding oxaliplatin's Food and Drug Administration approval. A fixed-effects analysis examined chemotherapy use among patients treated outside academic centers at CCOP-affiliated practices compared with non-CCOP practices. Two-group modeling controlled for multiple levels of clustering, year of chemotherapy initiation, tumor characteristics, patient age, race, comorbidity, Medicaid dual-eligibility status, and education.

RESULTS:
Of 4055 community patients, 35% received 5-fluoruracil, 20% received oxaliplatin, 7% received another chemotherapy, and 38% received no chemotherapy. Twenty-five percent of CCOP patients received oxaliplatin, compared with 19% of non-CCOP patients. In multivariable analysis, CCOP exposure was associated with higher odds of receiving guideline-concordant treatment in general, and oxaliplatin specifically.

CONCLUSIONS:
These findings contribute to a growing set of evidence linking PBRNs with a greater probability of receiving treatment innovations and high-quality cancer care, with implications for clinical and research policy.

Abstract

BACKGROUND:
The Institute of Medicine (IOM) has recommended that each person with cancer should have access to clinical trials, which have been associated with improving care quality and disparities. With no effective enrollment monitoring system, patterns of trial enrollment remain unclear.

PURPOSE:
We developed a population-based, statewide system designed to facilitate monitoring of cancer trial enrollment and targeting of future interventions to improve it.

METHODS:
Person-level cancer incidence data from the North Carolina Central Cancer Registry (NCCCR), person-level treatment trial accrual data from the National Cancer Institute (NCI), and county-level Area Resource Files (ARF) measures for 12 years, 1996-2007, were studied. Deidentified person-level data necessitated county-level analysis. Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for each race, gender, year, and county combination. Multivariable analysis examined factors associated with trial accrual. Sensitivity analyses examined spurious fluctuations and temporal discordance of incidence and enrollment.

RESULTS:
The NCI treatment trial enrollment rate was 2.39% for whites and 2.20% for minorities from 1996 to 2007, and 2.88% and 2.47%, respectively, from 2005 to 2007. Numerous counties had no minority enrollment. The 2005-2007 enrollment rates for white and minority females was 4.04% and 3.59%, respectively, and for white and minority males was 1.74% and 1.36%, respectively. Counties with a medical school or NCI Community Clinical Oncology Program (CCOP)-affiliated practice had higher trial enrollment.

LIMITATIONS:
We examined NCI trial accrual only - industry-sponsored and investigator-initiated trials were excluded; however, studies comprise the majority of all clinical trial participants. Delays in data availability may hinder the immediacy of population-based analyses.

CONCLUSIONS:
Model stability and consistency suggest that this system is effective for population-based enrollment surveillance. For North Carolina, it suggests a worsening disparity in minority trial enrollment, though our analyses elucidate targets for intervention. Regional enrollment variation suggests the importance of access to clinical research networks and infrastructure. Substantial gender differences merit further examination.

Abstract

BACKGROUND:
African Americans in the United States have higher rates of colon cancer mortality than other races. This study examines the use of oxaliplatin, a novel chemotherapeutic agent approved in 2004, among African American and Caucasian American patients with stage III colon cancer to determine whether differential receipt or differential effectiveness of the drug may explain the racial disparity in colon cancer mortality.

METHODS:
The authors conducted a population-based retrospective cohort study of stage III colon cancer patients aged 65 years and older treated from 2004 through 2006 who initiated chemotherapy within 90 days of surgical resection (N = 1162) using Surveillance, Epidemiology and End Results-Medicare data. Patients receiving oxaliplatin (n = 477) were compared with those receiving 5-fluorouracil without oxaliplatin (n = 685). The authors estimated prevalence ratios and hazard ratios (HRs) using multivariate binomial regression and Cox models to evaluate racial differences in oxaliplatin receipt and survival.

RESULTS:
African Americans were as likely as Caucasian Americans to receive oxaliplatin (40.5 vs 41.1%; prevalence ratio, 0.90; 95% confidence interval [CI], 0.71-1.13). Oxaliplatin was associated with lower mortality compared with 5-fluorouracil (HR, 0.76; 95% CI, 0.58-1.00). This benefit appeared stronger among African Americans (HR, 0.31; 95% CI, 0.09-1.05) than Caucasian Americans (HR, 0.80; 95% CI, 0.60-1.06).

CONCLUSIONS:
In Medicare-insured patients receiving chemotherapy, the authors observed no meaningful racial disparities in receipt of oxaliplatin and, among those receiving it, potentially better survival among African Americans. Differential receipt and effectiveness of oxaliplatin-containing regimens does not appear to contribute to the previously documented racial disparities in colon cancer survival. Understanding reasons for potentially enhanced effectiveness among African Americans may inform efforts to resolve racial disparities in colon cancer outcomes.

Abstract

PURPOSE:
To characterize overall receipt and timeliness of radiation therapy (RT) following breast-conserving surgery among Medicaid-insured patients.

METHOD:
State cancer registry data linked with Medicaid claims from 2003 to 2009 were analyzed. Multivariate logistic and Cox proportional hazards regressions were employed.

RESULTS:
Overall, 81% of patients received guideline-recommended RT. Significant variation in timing of RT initiation was documented. Having fewer comorbitidies and receiving chemotherapy were correlated with higher odds of RT initiation within 1 year.

CONCLUSION:
Although RT use in Medicaid-insured women appears to have improved since earlier studies, documented delays in RT are troublesome and warrant further investigation.

Abstract

Comparative effectiveness research (CER) can efficiently and rapidly generate new scientific evidence and address knowledge gaps, reduce clinical uncertainty, and guide health care choices. Much of the potential in CER is driven by the application of novel methods to analyze existing data. Despite its potential, several challenges must be identified and overcome so that CER may be improved, accelerated, and expeditiously implemented into the broad spectrum of cancer care and clinical practice. To identify and characterize the challenges to cancer CER, the authors reviewed the literature and conducted semistructured interviews with 41 cancer CER researchers at the Agency for Healthcare Research and Quality's Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Cancer CER Consortium. Several data sets for cancer CER were identified and differentiated into an ontology of 8 categories and were characterized in terms of strengths, weaknesses, and utility. Several themes emerged during the development of this ontology and discussions with CER researchers. Dominant among them was accelerating cancer CER and promoting the acceptance of findings, which will necessitate transcending disciplinary silos to incorporate diverse perspectives and expertise. Multidisciplinary collaboration is required, including those with expertise in nonexperimental data, statistics, outcomes research, clinical trials, epidemiology, generalist and specialty medicine, survivorship, informatics, data, and methods, among others. Recommendations highlight the systematic, collaborative identification of critical measures; application of more rigorous study design and sampling methods; policy-level resolution of issues in data ownership, governance, access, and cost; and development and application of consistent standards for data security, privacy, and confidentiality.

Abstract

CONTEXT:
There has been rapid adoption of newer radiation treatments such as intensity-modulated radiation therapy (IMRT) and proton therapy despite greater cost and limited demonstrated benefit compared with previous technologies.

OBJECTIVE:
To determine the comparative morbidity and disease control of IMRT, proton therapy, and conformal radiation therapy for primary prostate cancer treatment.

DESIGN, SETTING, AND PATIENTS:
Population-based study using Surveillance, Epidemiology, and End Results-Medicare-linked data from 2000 through 2009 for patients with nonmetastatic prostate cancer.

MAIN OUTCOME MEASURES:
Rates of gastrointestinal and urinary morbidity, erectile dysfunction, hip fractures, and additional cancer therapy.

RESULTS:
Use of IMRT vs conformal radiation therapy increased from 0.15% in 2000 to 95.9% in 2008. In propensity score-adjusted analyses (N = 12,976), men who received IMRT vs conformal radiation therapy were less likely to receive a diagnosis of gastrointestinal morbidities (absolute risk, 13.4 vs 14.7 per 100 person-years; relative risk [RR], 0.91; 95% CI, 0.86-0.96) and hip fractures (absolute risk, 0.8 vs 1.0 per 100 person-years; RR, 0.78; 95% CI, 0.65-0.93) but more likely to receive a diagnosis of erectile dysfunction (absolute risk, 5.9 vs 5.3 per 100 person-years; RR, 1.12; 95% CI, 1.03-1.20). Intensity-modulated radiation therapy patients were less likely to receive additional cancer therapy (absolute risk, 2.5 vs 3.1 per 100 person-years; RR, 0.81; 95% CI, 0.73-0.89). In a propensity score-matched comparison between IMRT and proton therapy (n = 1368), IMRT patients had a lower rate of gastrointestinal morbidity (absolute risk, 12.2 vs 17.8 per 100 person-years; RR, 0.66; 95% CI, 0.55-0.79). There were no significant differences in rates of other morbidities or additional therapies between IMRT and proton therapy.

CONCLUSIONS:
Among patients with nonmetastatic prostate cancer, the use of IMRT compared with conformal radiation therapy was associated with less gastrointestinal morbidity and fewer hip fractures but more erectile dysfunction; IMRT compared with proton therapy was associated with less gastrointestinal morbidity.

Abstract

PURPOSE:
We examined whether an increased distance to a urologist is associated with a delayed diagnosis of prostate cancer among black and white patients, as manifested by higher risk disease at diagnosis.

MATERIALS AND METHODS:
North Carolina Central Cancer Registry data were linked to Medicare claims for patients with incident prostate cancer diagnosed in 2004 to 2005. Straight-line distances were calculated from the patient home to the nearest urologist. Race stratified multivariate ordinal logistic regression was used to examine the association between distance to a urologist and prostate cancer risk group (low, intermediate, high or very high/metastasis) at diagnosis for black and white patients while accounting for age, comorbidity, marital status and diagnosis year. An overall model was then used to examine the distance × race interaction effect.

RESULTS:
Included in analysis were 1,720 white and 531 black men. In the overall cohort the high risk cancer rate increased monotonically with distance to a urologist, including 40% for 0 to 10, 45% for 11 to 20 and 57% for greater than 20 miles. Correspondingly the low risk cancer rate decreased with longer distance. On race stratified multivariate analysis longer distance was associated with higher risk prostate cancer for white and black patients (p = 0.04 and <0.01, respectively) but the effect was larger in the latter group. The distance × race interaction term was significant in the overall model (p = 0.03).

CONCLUSIONS:
Longer distance to a urologist may disproportionally impact black patients. Decreasing modifiable barriers to health care access, such as distance to care, may decrease racial disparities in prostate cancer.

Abstract

To evaluate differences in use of sentinel lymph node biopsy (SLNB) by age and race in Medicare recipients with early-stage breast cancer, we examined Surveillance, Epidemiology and End Results—Medicare linked data for women undergoing breast conserving surgery for stage I or II breast cancer, including axillary staging, between January 2000 and December 2002. Multivariable generalized linear modeling with generalized estimating equations was used to identify predictors of receiving SLNB versus standard axillary lymph node dissection as the primary axillary staging modality. Women were significantly less likely to receive SLNB as their primary staging procedure if they were African American (OR 0.65), greater than 80 years of age (OR 0.71 vs. age <70), or dually eligible for Medicare and Medicaid (OR 0.61). Tumor characteristics, including well-differentiated histology and stage I disease, were associated with increased likelihood of SLNB, but estrogen receptor status was not a significant predictor. Women treated at an institution affiliated with an NCI cooperative research group had significantly greater likelihood of receiving SLNB (OR 2.31). Likelihood of receiving SLNB increased for women diagnosed in 2001 and 2002 compared with 2000. Significant disparities exist in receipt of SLNB in the Medicare population, with African Americans, the elderly, and economically disadvantaged patients being less likely to receive this innovative and morbidity-sparing procedure. These findings continue a previously observed pattern of reduced access to state of the art breast cancer care among underserved populations.

Abstract

INTRODUCTION:
The National Institutes of Health (NIH) sees provider-based research networks and other organizational linkages between academic researchers and community practitioners as promising vehicles for accelerating the translation of research into practice. This study examines whether organizational research affiliations and teaching affiliations are associated with accelerated diffusion of sentinel lymph node biopsy (SLNB), an innovation in the treatment of early-stage breast cancer.

METHODS:
Surveillance Epidemiology and End Results-Medicare data were used to examine the diffusion of SLNB for treatment of early-stage breast cancer among women aged 65 years and older diagnosed between 2000 and 2002, shortly after Medicare approved and began reimbursing for the procedure.

RESULTS:
In this population, patients treated at an organization affiliated with a research network--the American College of Surgeons Oncology Group (ACOSOG) or other National Cancer Institute (NCI) cooperative groups--were more likely to receive the innovative treatment (SLNB) than patients treated at unaffiliated organizations (odds ratio: 2.70, 95% confidence interval: 1.77-4.12; odds ratio: 1.84, 95% confidence interval: 1.26-2.69, respectively). Neither hospital teaching status nor surgical volume was significantly associated with differences in SLNB use.

DISCUSSION:
Patients who receive cancer treatment at organizations affiliated with cancer research networks have an enhanced probability of receiving SLNB, an innovative procedure that offers the promise of improved patient outcomes. Study findings support the NIH Roadmap and programs such as the NCI's Community Clinical Oncology Program, as they seek to accelerate the translation of research into practice by simultaneously accelerating and broadening cancer research in the community.