Area Vulnerability and Disparities in Therapy for Patients With Metastatic Renal Cell Carcinoma.

Importance: Area-level measures of sociodemographic disadvantage may be associated with racial and ethnic disparities with respect to receipt of treatment for metastatic renal cell carcinoma (mRCC) but have not been investigated previously, to our knowledge. Objective: To assess the association between area-level measures of social vulnerability and racial and ethnic disparities in the treatment of US Medicare beneficiaries with mRCC from 2015 through 2019. Design, Setting, and Participants: This retrospective cohort study included Medicare beneficiaries older than 65 years who were diagnosed with mRCC from January 2015 through December 2019 and were enrolled in fee-for-service Medicare Parts A, B, and D from 1 year before through 1 year after presumed diagnosis or until death. Data were analyzed from November 22, 2022, through January 26, 2024. Exposures: Five different county-level measures of disadvantage and 4 zip code-level measures of vulnerability or deprivation and segregation were used to dichotomize whether an individual resided in the most vulnerable quartile according to each metric. Patient-level factors included age, race and ethnicity, sex, diagnosis year, comorbidities, frailty, Medicare and Medicaid dual enrollment eligibility, and Medicare Part D low-income subsidy (LIS). Main Outcomes and Measures: The main outcomes were receipt and type of systemic therapy (oral anticancer agent or immunotherapy from 2 months before to 1 year after diagnosis of mRCC) as a function of patient and area-level characteristics. Multivariable regression analyses were used to adjust for patient factors, and odds ratios (ORs) from logistic regression and relative risk ratios (RRRs) from multinomial logistic regression are reported. Results: The sample included 15 407 patients (mean [SD] age, 75.6 [6.8] years), of whom 9360 (60.8%) were men; 6931 (45.0%), older than 75 years; 93 (0.6%), American Indian or Alaska Native; 257 (1.7%), Asian or Pacific Islander; 757 (4.9%), Hispanic; 1017 (6.6%), non-Hispanic Black; 12 966 (84.2%), non-Hispanic White; 121 (0.8%), other; and 196 (1.3%), unknown. Overall, 8317 patients (54.0%) received some type of systemic therapy. After adjusting for individual factors, no county or zip code-level measures of social vulnerability, deprivation, or segregation were associated with disparities in treatment. In contrast, patient-level factors, including female sex (OR, 0.78; 95% CI, 0.73-0.84) and LIS (OR, 0.48; 95% CI, 0.36-0.65), were associated with lack of treatment, with particularly limited access to immunotherapy for patients with LIS (RRR, 0.25; 95% CI, 0.14-0.43). Associations between individual-level factors and treatment in multivariable analysis were not mediated by the addition of area-level metrics. Disparities by race and ethnicity were consistently and only observed within the most vulnerable areas, as indicated by the top quartile of each vulnerability deprivation index. Conclusions and Relevance: In this cohort study of older Medicare patients diagnosed with mRCC, individual-level demographics, including race and ethnicity, sex, and income, were associated with receipt of systemic therapy, whereas area-level measures were not. However, individual-level racial and ethnic disparities were largely limited to socially vulnerable areas, suggesting that efforts to improve racial and ethnic disparities may be most effective when targeted to socially vulnerable areas.

Trends in new and persistent opioid use in older adults with and without cancer.

BACKGROUND: The impact of ongoing efforts to decrease opioid use on patients with cancer remains undefined. Our objective was to determine trends in new and additional opioid use in patients with and without cancer. METHODS: This retrospective cohort study used data from Surveillance, Epidemiology, and End Results program-Medicare for opioid-naive patients with solid tumor malignancies diagnosed from 2012 through 2017 and a random sample of patients without cancer. We identified 238 470 eligible patients with cancer and further focused on 4 clinical strata: patients without cancer, patients with metastatic cancer, patients with nonmetastatic cancer treated with surgery alone ("surgery alone"), and patients with nonmetastatic cancer treated with surgery plus chemotherapy or radiation therapy ("surgery+"). We identified new, early additional, and long-term additional opioid use and calculated the change in predicted probability of these outcomes from 2012 to 2017. RESULTS: New opioid use was higher in patients with cancer (46.4%) than in those without (6.9%) (P < .001). From 2012 to 2017, the predicted probability of new opioid use was more stable in the cancer strata (relative declines: 0.1% surgery alone; 2.4% surgery+; 8.8% metastatic cancer), than in the noncancer stratum (20.0%) (P < .001 for each cancer to noncancer comparison). Early additional use declined among surgery patients (‒14.9% and ‒17.5% for surgery alone and surgery+, respectively) but was stable among patients with metastatic disease (‒2.8%, P = .50). CONCLUSIONS: Opioid prescribing declined over time at a slower rate in patients with cancer than in patients without cancer. Our study suggests important but tempered effects of the changing opioid climate on patients with cancer.

Disparities in immune and targeted therapy utilization for older US patients with metastatic renal cell carcinoma.

Disparities in metastatic renal cell carcinoma (mRCC) outcomes persist in the era of oral anticancer agents (OAAs) and immunotherapies (IOs). We examined variation in the utilization of mRCC systemic therapies among US Medicare beneficiaries from 2015 to 2019. Logistic regression models evaluated the association between therapy receipt and demographic covariates including patient race, ethnicity, and sex. In total, 15 407 patients met study criteria. After multivariable adjustment, non-Hispanic Black race and ethnicity was associated with reduced IO (adjusted relative risk ratio [aRRR] = 0.76, 95% confidence interval [CI] = 0.61 to 0.95; P = .015) and OAA receipt (aRRR = 0.76, 95% CI = 0.64 to 0.90; P = .002) compared with non-Hispanic White race and ethnicity. Female sex was associated with reduced IO (aRRR = 0.73, 95% CI = 0.66 to 0.81; P < .001) and OAA receipt (aRRR = 0.74, 95% CI = 0.68 to 0.81; P < .001) compared with male sex. Thus, disparities by race, ethnicity, and sex were observed in mRCC systemic therapy utilization for Medicare beneficiaries from 2015 to 2019.

Genetic testing in privately insured women with surgically treated breast cancer.

PURPOSE: Rates of BRCA1 and BRCA2 prevalence among women with breast cancer vary by age, hormone receptor status, and family history. Recommendations for genetic testing have varied between overlapping guidelines, payor coverage policies, and have evolved over time, resulting in unclear implications for adoption into routine breast cancer care. METHODS: Using a large, private insurer database, we examined rates of BRCA1/BRCA2 genetic testing in women with newly diagnosed invasive breast cancer undergoing surgery from 2015 through 2019. RESULTS: Testing increased among women 50 years or older from 26 to 38%, remained stable at 66% in both 2015 and 2019 in the under 50 population, and was slightly decreased in women under age 45 years. CONCLUSION: Among privately insured patients with breast cancer, rates are increasing in older women, but appear persistently underused in younger women.

End-of-Life Care for Patients With Metastatic Renal Cell Carcinoma in the Era of Oral Anticancer Therapy.

PURPOSE: New therapies including oral anticancer agents (OAAs) have improved outcomes for patients with metastatic renal cell carcinoma (mRCC). However, little is known about the quality of end-of-life (EOL) care and systemic therapy use at EOL in patients receiving OAAs or with mRCC. METHODS: We retrospectively analyzed EOL care for decedents with mRCC in two parallel cohorts: (1) patients (RCC diagnosed 2004-2015) from the University of North Carolina's Cancer Information and Population Health Resource (CIPHR) and (2) patients (diagnosed 2007-2015) from SEER-Medicare. We assessed hospice use in the last 30 days of life and existing measures of poor-quality EOL care: systemic therapy, hospital admission, intensive care unit admission, and > 1 ED visit in the last 30 days of life; hospice initiation in the last 3 days of life; and in-hospital death. Associations between OAA use, patient and provider characteristics, and EOL care were examined using multivariable logistic regression. RESULTS: We identified 410 decedents in the CIPHR cohort (53.4% received OAA) and 1,508 in SEER-Medicare (43.5% received OAA). Prior OAA use was associated with increased systemic therapy in the last 30 days of life in both cohorts (CIPHR: 26.5% v 11.0%; P < .001; SEER-Medicare: 23.4% v 11.7%; P < .001), increased in-hospital death in CIPHR, and increased hospice in the last 30 days in SEER-Medicare. Older patients were less likely to receive systemic therapy or be admitted in the last 30 days or die in hospital. CONCLUSION: Patients with mRCC who received OAAs and younger patients experienced more aggressive EOL care, suggesting opportunities to optimize high-quality EOL care in these groups.

Racial and Ethnic Variation in COVID-19 Vaccination Uptake Among Medicare Beneficiaries with Cancer History.

BACKGROUND: The purpose of this study was to estimate COVID-19 vaccination rate among Medicare beneficiaries with cancer history and determine whether COVID-19 vaccine uptake is higher among non-Hispanic White beneficiaries compared with racially and ethnically minoritized beneficiaries. METHODS: We used US representative, cross-sectional data from the Medicare Current Beneficiary Survey COVID-19 Winter 2021 Rapid Response Community Supplement Survey. A total of 1,863 respondents with self-reported cancer history (other than skin cancer) were included. The outcome was self-reported receipt of at least one coronavirus vaccine dose since vaccines became available. The key independent variable of interest was self-reported race and ethnicity. We applied sample weights to account for the survey design and provide population estimates to 9.6 million beneficiaries with cancer history. Weighted descriptive statistics and multivariable logistic regression analyses were conducted. RESULTS: During the first 4 months of vaccine availability, 69.6% of beneficiaries received at least one vaccine dose of which 65.4% had two vaccine doses. A larger proportion of non-Hispanic White beneficiaries (71.9%) had at least one vaccine dose compared with non-Hispanic Black (60.4%) and Hispanic (57.4%) beneficiaries. An estimated 30.4% of beneficiaries were still unvaccinated, that represents approximately 2.9 million unvaccinated beneficiaries with cancer history. Hispanic beneficiaries were 42% (OR: 0.58; 95% CI: 0.33-0.99; p = .048) less likely to be vaccinated compared with non-Hispanic White beneficiaries. CONCLUSIONS: Results indicate racial and ethnic differences in vaccine uptake among Medicare beneficiaries with cancer history. Effective strategies are needed to help increase vaccine confidence and uptake among adults with cancer history.

Concurrent prescribing of opioids with other sedating medications after cancer diagnosis: a population-level analysis.

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.

Oral Anticancer Agent (OAA) Adherence and Survival in Elderly Patients With Metastatic Renal Cell Carcinoma (mRCC).

OBJECTIVE: To examine real-world adherence to oral anticancer agents (OAAs) and its association with outcomes among Medicare beneficiaries with metastatic renal cell carcinoma (mRCC). METHODS: SEER-Medicare retrospective cohort study of patients with metastatic renal cell carcinoma (mRCC) who received an OAA between 2007 and 2015. We examined A) adherence and B) overall and disease-specific 2-year survival landmarked at 3 months after OAA initiation. Adherence was assessed by calculating the proportion of days covered (PDC) within 3 months of OAA initiation, with adherent use being defined as PDC > 80%. RESULTS: A total of 905 patients met study criteria, of whom 445 patients (49.2%) were categorized as adherent to initial OAA treatment. Adjusting for clinical and demographic factors revealed decreased odds of adherence associated with living within an impoverished neighborhood (OR 0.49, CI 0.0.33 - 0.74) and out-of-pocket costs > $200 (OR 0.68, CI 0.47-.98). Adherence was associated with improved 2-year survival in univariate analysis (logrank test, P = .01) and a non-significant trend toward an association with decreased all-cause (HR 0.87, CI 0.72 - 1.05) and RCC-specific survival (HR 0.84, CI 0.69 - 1.03) in multivariable analysis. CONCLUSION: Local poverty levels and high out-of-pocket costs are associated with poor initial adherence to OAA therapy in Medicare beneficiaries with mRCC, which in turn, suggests a trend toward poor overall and disease-specific survival. Efforts to improve outcomes in the broader mRCC population should incorporate OAA adherence and economic factors.

Association between cognitive impairment and oral anticancer agent use in older patients with metastatic renal cell carcinoma.

BACKGROUND: Kidney cancer is the fastest-growing cancer diagnosis in the developed world. About 16% of new cases are stage IV, which has a low five-year survival rate. Many patients with metastatic renal cell carcinoma (mRCC) are older and may have mild cognitive impairment or dementia (MCI/D). Given prior reports of patients with dementia initiating less cancer therapy and the importance of oral anticancer agents (OAAs) in mRCC treatment, we investigated the prevalence of preexisting MCI/D in patients with mRCC and their OAA use. METHODS: SEER-Medicare patients were analyzed who were ≥65 years, diagnosed with mRCC between 2007 and 2015, and had Medicare part D coverage. Patterns and predictors of (a) OAA utilization within the 12 months following mRCC diagnosis and (b) adherence (percent of days covered [PDC] ≥ 80%) during the first 90 days following treatment initiation were assessed. RESULTS: Of the 2792 eligible patients, 268 had preexisting MCI/D, and 907 initiated OAA treatment within 12 months of mRCC diagnosis. Patients with preexisting MCI/D were less likely to begin an OAA than those without MCI/D (fully-adjusted HR 0.53, 95% CI 0.38-0.76). Among OAA initiators, a preexisting MCI/D diagnosis did not alter the likelihood that a person would be adherent (adjusted RR 0.84, 95% CI 0.55-1.28). CONCLUSIONS: Patients with preexisting MCI/D were half as likely to start an OAA during the year following mRCC diagnosis than patients without comorbid MCI/D. The 90-day adherence of OAA initiators was not significantly different between those with and without preexisting MCI/D. In light of this, clinicians should assess mRCC patients for cognitive impairment and take steps to optimize OAA utilization by those with MCI/D.

Patient- And Provider-Level Predictors of Survival Among Patients With Metastatic Renal Cell Carcinoma Initiating Oral Anticancer Agents.

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.

Patient, provider, and hospital factors associated with oral anti-neoplastic agent initiation and adherence in older patients with metastatic renal cell carcinoma.

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.

Evaluation of mild cognitive impairment and dementia in patients with metastatic renal cell carcinoma.

BACKGROUND: Dementia and cancer are both more common in adults as they age. As new cancer treatments become more popular, it is important to consider how these treatments might affect older patients. This study evaluates metastatic renal cell carcinoma (mRCC) as a risk factor for older adults developing mild cognitive impairment or dementia (MCI/D) and the impact of mRCC-directed therapies on the development of MCI/D. METHODS: We identified patients diagnosed with mRCC in a Surveillance, Epidemiology, and End Results (SEER)-Medicare dataset from 2007 to 2015 and matched them to non-cancer controls. Exclusion criteria included age < 65 years at mRCC diagnosis and diagnosis of MCI/D within the year preceding mRCC diagnosis. The main outcome was time to incident MCI/D within one year of mRCC diagnosis for cases or cohort entry for non-cancer controls. Cox proportional hazards models were used to measure associations between mRCC and incident MCI/D as well as associations of oral anticancer agent (OAA) use with MCI/D development within the mRCC group. RESULTS: Patients with mRCC (n = 2533) were matched to non-cancer controls (n = 7027). mRCC (hazard ratio [HR] 8.52, p < .001), being older (HR 1.05 per 1-year age increase, p < .001), and identifying as Black (HR 1.92, p = .047) were predictive of developing MCI/D. In addition, neither those initiating treatment with OAAs nor those who underwent nephrectomy were more likely to develop MCI/D. CONCLUSIONS: Patients with mRCC were more likely to develop MCI/D than those without mRCC. The medical and surgical therapies evaluated were not associated with increased incidence of MCI/D. The increased incidence of MCI/D in older adults with mRCC may be the result of the pathology itself or risk factors common to the two disease processes.

Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial.

BACKGROUND: As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists. METHODS/DESIGN: The Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36). Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers. DISCUSSION: As the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale. TRIAL REGISTRATION: This study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020.

Real-World Utilization of Oral Anticancer Agents and Related Costs in Older Adults with Metastatic Renal Cell Carcinoma in the United States.

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.

Analysis of Sociodemographic, Clinical, and Genomic Factors Associated With Breast Cancer Mortality in the Linked Surveillance, Epidemiology, and End Results and Medicare Database.

Importance: Understanding interactions among health service, sociodemographic, clinical, and genomic factors in breast cancer disparities research has been limited by a disconnect between health services and basic biological approaches. Objective: To describe the first linkage of Surveillance, Epidemiology, and End Results (SEER)-Medicare data to physical tumor samples and to investigate the interaction among screening detection, socioeconomic status, tumor stage, tumor biology, and breast cancer outcomes within a single context. Design, Setting, and Participants: This population-based cohort study used tumor specimen blocks from a subset of women aged 66 to 75 years with newly diagnosed nonmetastatic, estrogen receptor-positive invasive breast cancer from January 1, 1993, to December 31, 2007. Specimens were obtained from the Iowa and Hawaii SEER Residual Tissue Repositories (RTRs) and linked with Medicare claims data and survival assessed through December 31, 2015. Data were analyzed from August 1, 2018, to July 25, 2021. Exposures: Screening- vs symptom-based detection of tumors was assessed using validated claims-based algorithms. Demographic factors and zip code-based educational attainment and poverty socioeconomic characteristics were obtained via SEER. Main Outcomes and Measures: Molecular subtyping and exploratory genomic analyses were completed using the NanoString Breast Cancer 360 gene expression panel containing the 50-gene signature classifier. Factors associated with overall and breast cancer-specific (BCS) survival were analyzed using Cox proportional hazards regression models combining sociodemographic, clinical, and genomic data. Results: SEER-Medicare data were available for 3522 women (mean [SD] age, 70.9 [2.6] years; 3049 [86.6%] White), of whom 1555 (44.2%) were diagnosed by screening mammogram. In the SEER-Medicare cohort, factors associated with increased BCS mortality included symptomatic detection (hazard ratio [HR], 1.49 [95% CI, 1.16-1.91]), advanced disease stage (HR for stage III, 2.33 [95% CI, 1.41-3.85]), and high-grade disease (HR, 1.85 [95% CI, 1.46-2.34]). The molecular cohort of 130 cases with luminal A/B cancer further revealed increased all-cause mortality associated with genomic upregulation of transforming growth factor ß activation and p53 dysregulation (eg, p53 dysregulation: HR, 2.15 [95% CI, 1.20-3.86]) and decreased mortality associated with androgen receptor, macrophage, cytotoxicity, and Treg signaling (eg, androgen receptor signaling: HR, 0.23 [95% CI, 0.12-0.45]). Symptomatic detection (HR, 2.49 [95% CI, 1.19-5.20]) and zip codes with low levels of educational attainment (HR, 5.17 [95% CI, 2.12-12.60]) remained associated with mortality after adjusting for all clinical and demographic factors. Conclusions and Relevance: Linkage of SEER-Medicare data to physical tumor specimens may elucidate associations among biology, health care access, and disparities in breast cancer outcomes. The findings of this study suggest that screening detection and socioeconomic status are associated with survival in patients with locally advanced, estrogen receptor-positive tumors, even after incorporating clinical and genomic factors.

Real-world systemic therapy utilization in Medicare patients with locally advanced or metastatic urothelial carcinoma diagnosed between 2008 and 2012.

PURPOSE: Treatment of advanced urothelial carcinoma (UC) remains a challenging clinical entity occurring predominantly in older patients with limited treatment options. However, real-world treatment patterns, differential cancer center access, and association with outcomes is lacking in nationally representative clinical practice and will provide context for emerging therapies. MATERIALS AND METHODS: We used SEER-Medicare data to identify patients with locally advanced or metastatic UC of the bladder or upper urinary tract diagnosed between 2008 and 2012. We characterized utilization systemic therapy, including first- and second-line chemotherapy. Patients receiving neoadjuvant chemotherapy were excluded; results were stratified by academic versus non-academic setting. RESULTS: 3569 patients met study criteria; 48% received some form of chemotherapy within 2 years of diagnosis. Of these, one-third subsequently received second-line chemotherapy. The majority received a regimen including ≥2 agents. Gemcitabine alone or in combination with platinum was the most common first- and second-line treatment. Similar patterns of first- and second-line chemotherapy were observed between patients treated in academic and non-academic centers. Sensitivity analyses of trial-similar patients demonstrated increased utilization (69%). Receipt of platinum doublet as 1st line therapy was less likely in older patients and those with renal disease, and more likely for grade IV disease. CONCLUSIONS: Roughly half of all Medicare patients with locally advanced/metastatic UC receive systemic therapy regardless of access to academic cancer centers and despite poor oncologic outcomes. Cytotoxic, gemcitabine-based doublet chemotherapy remains the most common treatment. A substantial population of older patients exists for whom alternative, non-cytotoxic, treatment options may be of benefit.

Rapid rise in the cost of targeted cancer therapies for Medicare patients with solid tumors from 2006 to 2015.

BACKGROUND: Inflation-adjusted cancer costs in the United States have increased 40% in the last decade, leading to increasing financial burden on both payers and patients. Patients under 65 show substantial increases in utilization of expensive targeted therapy anticancer agents; however, patients aged 65+ account for the majority of new malignancies. Utilization and cost trends for these emerging agents have not been examined in detail in the Medicare population. PATIENTS AND METHODS: Retrospective prevalent cohort analysis of patients 65+ with any stage of invasive lung, breast, colorectal, or prostate cancer, receiving systemic therapy drawn from the United States Medicare 5% fee-for-service sample claims (2005-2015). Yearly trends in utilization and associated costs were modeled with adjustment for inflation, demographics, and comorbidities. RESULTS: Among Medicare beneficiaries with fee-for-service and Part D enrollment who were receiving some type of systemic anticancer therapy, there were 9230 patients with colorectal, 32,738 patients with breast, and 16,278 patients with lung cancers identified from 2006 to 2015, and 19,295 patients with prostate cancer from 2009 to 2015. The share of cancer costs to Medicare attributable to targeted therapies, increased dramatically for prostate cancer (1.7% to 19.4%), lung cancer (6.7% to 19.4%), colorectal cancer (11.7% to 22.2%), and breast cancer (15.8% to 25.5%). Although the proportion of patients receiving targeted therapies remained stable, mean per-patient cancer costs increased dramatically from 2006 to 2015 for patients with lung or prostate cancer receiving targeted therapy and for patients with breast cancer receiving non-hormonal targeted therapies. Targeted agents for these cancers showed substantial inflation-adjusted price growth over this time period.

Association of 21-Gene Assay (OncotypeDX) Testing and Receipt of Chemotherapy in the Medicare Breast Cancer Patient Population Following Initial Adoption.

BACKGROUND: Our objective was to investigate why early studies regarding adoption of the 21-gene recurrence score (RS) assay did not show an initial reduction in the number of patients with breast cancer receiving real-world chemotherapy. MATERIALS AND METHODS: We addressed 2 sources of confounding suspected in previous studies: (1) the early time frame during the initial adoption phase of the RS assay, and (2) suspected selective, increased administration to patients more likely to have been chemotherapy candidates. To address selective use during initial adoption, we used updated SEER-Medicare data from 2004 and 2011. To address individual selection bias, we examined whether RS test utilization was negatively associated with rates of local chemotherapy use assessed at the hospital referral region level using conventional ordinary least squares and instrumental variable approaches to adjust for selection bias. RESULTS: A total of 26,009 patients met inclusion criteria. Assay use was associated with a decrease in absolute percentage use of chemotherapy of 4.5% (95% confidence interval [CI], 3.2%-5.7%), which was even more pronounced in sensitivity analyses limited to later study years (2008-2011), with a decrease of 6.8% (95% CI, 5.3%-8.3%). Instrumental variable models yielded similar point estimates but were insufficiently powered to draw conclusions. CONCLUSION: Receipt of the 21-gene assay was associated with decreased utilization of chemotherapy by 2008.