Impact of comprehensive medication reviews on potentially inappropriate medication discontinuation in Medicare beneficiaries.

BACKGROUND: The use of potentially inappropriate medications (PIMs) is associated with increased risk of hospitalizations and emergency room visits and varies by racial and ethnic subgroups. Medicare's nationwide medication therapy management (MTM) program requires that Part D plans offer an annual comprehensive medication review (CMR) to all beneficiaries who qualify, and provides a platform to reduce PIM use. The objective of this study was to assess the impact of CMR on PIM discontinuation in Medicare beneficiaries and whether this differed by race or ethnicity. METHODS: Retrospective cohort study of community-dwelling Medicare Part D beneficiaries ≥66 years of age who were eligible for MTM from 2013 to 2019 based on 5% Medicare fee-for-service claims data linked to the 100% MTM data file. Among those using a PIM, MTM-eligible CMR recipients were matched to non-recipients via sequential stratification. The probability of PIM discontinuation was estimated using regression models that pooled yearly subcohorts accounting for within-beneficiary correlations. The most common PIMs that were discontinued after CMR were reported. RESULTS: We matched 24,368 CMR recipients to 24,368 CMR non-recipients during the observation period. Median age was 74-75, 35% were males, most were White beneficiaries (86%-87%), and the median number of PIMs was 1. In adjusted analyses, CMR receipt was positively associated with PIM discontinuation (adjusted relative risk [aRR]: 1.26, 95% CI: 1.20-1.32). There was no evidence of differential impact of CMR by race or ethnicity. The PIMs most commonly discontinued after CMR were glimepiride, zolpidem, digoxin, amitriptyline, and nitrofurantoin. CONCLUSIONS: Among Medicare beneficiaries who are using a PIM, CMR receipt was associated with PIM discontinuation, suggesting that greater CMR use could facilitate PIM reduction for all racial and ethnic groups.

Association of Patient-Reported Social Needs with Emergency Department Visits and Hospitalizations Among Federally Qualified Health Center Patients.

BACKGROUND: Health care systems are increasingly screening for unmet social needs. The association between patient-reported social needs and health care utilization is not well understood. OBJECTIVE: To investigate the association between patient-reported social needs, measured by the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), and inpatient and emergency department (ED) utilization. DESIGN: This cohort study analyzed merged 2017-2019 electronic health record (EHR) data across multiple health systems. PARTICIPANTS: Adult patients from a federally qualified health center (FQHC) in central North Carolina who completed PRAPARE as part of a primary care visit with behavioral health services. MAIN MEASURES: The count of up to 12 unmet social needs, aggregated as 0, 1, 2, or 3 + . Outcomes include the probability of an ED visit and hospitalization 12 months after PRAPARE assessment, modeled by logistic regressions controlling for age, sex, race, ethnicity, comorbidity burden, being uninsured, and prior utilization in the past 12 months. KEY RESULTS: The study population consisted of 1924 adults (38.7% male, 50.1% Black, 36.3% Hispanic, 55.9% unemployed, 68.2% of patients reported 1 + needs). Those with more needs were younger, more likely to be unemployed, and experienced greater comorbidity burden. 35.3% of patients had ED visit(s) and 36.3% had hospitalization(s) 1 year after PRAPARE assessment. In adjusted analysis, having 3 + needs was associated with a percentage point increase in the predicted probability of hospitalization (average marginal effect 0.06, SE 0.03, p < 0.05) compared with having 0 needs. Similarly, having 2 needs (0.07, SE 0.03, p < 0.05) or 3 + needs (0.06, SE 0.03, p < 0.05) was associated with increased probability of ED visits compared to 0 needs. CONCLUSIONS: Patient-reported social needs were common and associated with health care utilization patterns. Future research should identify interventions to address unmet social needs to improve health and avoid potentially preventable escalating medical intervention.

Health Care Access Dimensions and Racial Disparities in End-of-Life Care Quality among Patients with Ovarian Cancer.

This study investigated the association between health care access (HCA) dimensions and racial disparities in end-of-life (EOL) care quality among non-Hispanic Black (NHB), non-Hispanic White (NHW), and Hispanic patients with ovarian cancer. This retrospective cohort study used the Surveillance, Epidemiology, and End Results-linked Medicare data for women diagnosed with ovarian cancer from 2008 to 2015, ages 65 years and older. Health care affordability, accessibility, and availability measures were assessed at the census tract or regional levels, and associations between these measures and quality of EOL care were examined using multivariable-adjusted regression models, as appropriate. The final sample included 4,646 women [mean age (SD), 77.5 (7.0) years]; 87.4% NHW, 6.9% NHB, and 5.7% Hispanic. In the multivariable-adjusted models, affordability was associated with a decreased risk of intensive care unit stay [adjusted relative risk (aRR) 0.90, 95% confidence interval (CI): 0.83-0.98] and in-hospital death (aRR 0.91, 95% CI: 0.84-0.98). After adjustment for HCA dimensions, NHB patients had lower-quality EOL care compared with NHW patients, defined as: increased risk of hospitalization in the last 30 days of life (aRR 1.16, 95% CI: 1.03-1.30), no hospice care (aRR 1.23, 95% CI: 1.04-1.44), in-hospital death (aRR 1.27, 95% CI: 1.03-1.57), and higher counts of poor-quality EOL care outcomes (count ratio:1.19, 95% CI: 1.04-1.36). HCA dimensions were strong predictors of EOL care quality; however, racial disparities persisted, suggesting that additional drivers of these disparities remain to be identified. SIGNIFICANCE: Among patients with ovarian cancer, Black patients had lower-quality EOL care, even after adjusting for three structural barriers to HCA, namely affordability, availability, and accessibility. This suggests an important need to investigate the roles of yet unexplored barriers to HCA such as accommodation and acceptability, as drivers of poor-quality EOL care among Black patients with ovarian cancer.

Characteristics, healthcare utilization, and outcomes of patients with HER2-low breast cancer.

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.

Tumor-Associated and Systemic Autoimmunity in Pre-Clinical Breast Cancer among Post-Menopausal Women.

Autoantibodies to tumor-associated antigens (anti-TAA) are potential biomarkers for breast cancer, but their relationship systemic autoimmunity as ascertained though antinuclear antibodies (ANA) is unknown and warrants consideration given the common occurrence of autoimmunity and autoimmune diseases among women. The relationship between anti-TAAs and ANA among women who were later diagnosed with breast cancer and others who remained cancer free in the Women's Health Initiative cohort. The study sample included 145 post-menopausal women with baseline ANA data. A total of 37 ANA-positive women who developed breast cancer (i.e., cases; mean time to diagnosis 6.8 years [SE 3.9]) were matched to a random sample of 36 ANA-negative cases by age and time to diagnosis. An age-matched control sample was selected including 35 ANA-positive and 37 ANA-negative women who did not develop breast cancer (i.e., controls; follow-up time ~13 years [SE 3]). Baseline sera were assessed for Immunoglobulin G (IgG) antibodies, measured by custom microarray for 171 breast and other cancer-associated TAA. We used linear regression to estimate cross-sectional associations of ANA with log-transformed anti-TAA among cases and controls. Most anti-TAA did not vary by ANA status. Two anti-TAA were elevated in ANA-positive compared to ANA-negative cases: anti-PGM3 (p = 0.004) and anti-TTN (p = 0.005, especially in cases up to 7 years before diagnosis, p = 0.002). Anti-TAA antibodies were not generally related to ANA, a common marker of systemic autoimmunity. Associations of ANA with particular antigens inducing autoimmunity prior to breast cancer warrant further investigation.

Association of educational attainment with cancer mortality in a national cohort study of black and white adults: A mediation analysis.

Background: Low educational attainment is associated with excess cancer mortality. However, the mechanisms driving this association remain unknown. Methods: Using data from the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, we evaluated the associations of participant and parental/caregiver education with cancer mortality using Cox proportional hazards models, adjusting for socio-demographic characteristics and health conditions. We used principal components analysis to generate indices of measures representing the social determinants of health (SDOH) and health behaviors. We used structural equation modeling to determine if the association between educational attainment and cancer mortality was mediated by these domains. Results: Among 30,177 REGARDS participants included in this analysis, 3798 (12.6%) had less than a high school degree. In fully adjusted models, those without a high school education experienced about 50% greater risk of death than high school graduates and higher (White participants HR: 1.47; 95% CI: 1.23, 1.76 and Black HR: 1.54; 95% CI: 1.33, 1.79). There was evidence of a modest mediation effect for the association between education and cancer mortality by the SDOH domain score (White total effect HR: 1.25; 95% CI: 1.18, 1.33, indirect effect HR: 1.04; 95% CI: 1.03, 1.05, direct effect HR: 1.21; 95% CI: 1.14, 1.28 and Black total effect HR: 1.24; 95% CI: 1.18, 1.29, indirect effect HR: 1.04; 95% CI: 1.03, 1.05, direct effect HR: 1.19; 95% CI: 1.14, 1.24). There was no evidence of mediation by the health behaviors score. No significant associations were found for female caregiver/mother's or male caregiver/father's education (N = 13,209). Conclusions: In conclusion, participant education was strongly associated with cancer mortality, and this association was partially mediated by the SDOH domain score.

Association of racial residential segregation with all-cause and cancer-specific mortality in the reasons for geographic and racial differences in stroke (REGARDS) cohort study.

•Increased racial residential segregation increased the risk of all-cause mortality among White participants.•Higher interaction lowered the risk of all-cause mortality among White participants.•Higher isolation lowered the risk of cancer mortality among Black participants.

Factors Associated With Receipt of Molecular Testing and its Impact on Time to Initial Systemic Therapy in Metastatic Non-Small Cell Lung Cancer.

BACKGROUND: Despite recommendations for molecular testing irrespective of patient characteristics, differences exist in receipt of molecular testing for oncogenic drivers amongst metastatic non-small cell lung cancer (mNSCLC) patients. Exploration into these differences and their effects on treatment is needed to identify opportunities for improvement. PATIENTS AND METHODS: We conducted a retrospective cohort study of adult patients diagnosed with mNSCLC between 2011 and 2018 using PCORnet's Rapid Cycle Research Project dataset (n = 3600). Log-binomial, Cox proportional hazards (PH), and time-varying Cox regression models were used to ascertain whether molecular testing was received, and time from diagnosis to molecular testing and/or initial systemic treatment in the context of patient age, sex, race/ethnicity, and multiple comorbidities status. RESULTS: The majority of patients in this cohort were ≤ 65 years of age (median [25th, 75th]: 64 [57, 71]), male (54.3%), non-Hispanic white individuals (81.6%), with > 2 comorbidities in addition to mNSCLC (54.1%). About half the cohort received molecular testing (49.9%). Patients who received molecular testing had a 59% higher probability of initial systemic treatment than patients who were yet to receive testing. Multiple comorbidity status was positively associated with receipt of molecular testing (RR, 1.27; 95% CI 1.08, 1.49). CONCLUSION: Receipt of molecular testing in academic centers was associated with earlier initiation of systemic treatment. This finding underscores the need to increase molecular testing rates amongst mNSCLC patients during a clinically relevant period. Further studies to validate these findings in community centers are warranted.

Health-care access dimensions and ovarian cancer survival: SEER-Medicare analysis of the ORCHiD study.

BACKGROUND: Racial and ethnic disparities in ovarian cancer (OC) survival are well-documented. However, few studies have investigated how health-care access (HCA) contributes to these disparities. METHODS: To evaluate the influence of HCA on OC mortality, we analyzed 2008-2015 Surveillance, Epidemiology, and End Results-Medicare data. Multivariable Cox proportional hazards regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for the association between HCA dimensions (affordability, availability, accessibility) and OC-specific and all-cause mortality, adjusting for patient characteristics and treatment receipt. RESULTS: The study cohort included 7590 OC patients: 454 (6.0%) Hispanic, 501 (6.6%) Non-Hispanic (NH) Black, and 6635 (87.4%) NH White. Higher affordability (HR = 0.90, 95% CI = 0.87 to 0.94), availability (HR = 0.95, 95% CI = 0.92 to 0.99), and accessibility scores (HR = 0.93, 95% CI = 0.87 to 0.99) were associated with lower risk of OC mortality after adjusting for demographic and clinical factors. Racial disparities were observed after additional adjustment for these HCA dimensions: NH Black patients experienced a 26% higher risk of OC mortality compared with NH White patients (HR = 1.26, 95% CI = 1.11 to 1.43) and a 45% higher risk among patients who survived at least 12 months (HR = 1.45, 95% CI = 1.16 to 1.81). CONCLUSIONS: HCA dimensions are statistically significantly associated with mortality after OC and explain some, but not all, of the observed racial disparity in survival of patients with OC. Although equalizing access to quality health care remains critical, research on other HCA dimensions is needed to determine additional factors contributing to disparate OC outcomes by race and ethnicity and advance the field toward health equity.

Factor Analysis of Health Care Access With Ovarian Cancer Surgery and Gynecologic Oncologist Consultation.

Importance: Poor health care access (HCA) is associated with racial and ethnic disparities in ovarian cancer (OC) survival. Objective: To generate composite scores representing health care affordability, availability, and accessibility via factor analysis and to evaluate the association between each score and key indicators of guideline-adherent care. Design, Setting, and Participants: This retrospective cohort study used data from patients with OC diagnosed between 2008 and 2015 in the Surveillance, Epidemiology, and End Results (SEER) Medicare database. The SEER Medicare database uses cancer registry data and linked Medicare claims from 12 US states. Included patients were Hispanic, non-Hispanic Black, and non-Hispanic White individuals aged 65 years or older diagnosed from 2008 to 2015 with first or second primary OC of any histologic type (International Classification of Diseases for Oncology, 3rd Edition [ICD-O-3] code C569). Data were analyzed from June 2020 to June 2022. Exposures: The SEER-Medicare data set was linked with publicly available data sets to obtain 35 variables representing health care affordability, availability, and accessibility. A composite score was created for each dimension using confirmatory factor analysis followed by a promax (oblique) rotation on multiple component variables. Main Outcomes and Measures: The main outcomes were consultation with a gynecologic oncologist for OC and receipt of OC-related surgery in the 2 months prior to or 6 months after diagnosis. Results: The cohort included 8987 patients, with a mean (SD) age of 76.8 (7.3) years and 612 Black patients (6.8%), 553 Hispanic patients (6.2%), and 7822 White patients (87.0%). Black patients (adjusted odds ratio [aOR], 0.75; 95% CI, 0.62-0.91) and Hispanic patients (aOR, 0.81; 95% CI, 0.67-0.99) were less likely to consult a gynecologic oncologist compared with White patients, and Black patients were less likely to receive surgery after adjusting for demographic and clinical characteristics (aOR, 0.76; 95% CI, 0.62-0.94). HCA availability and affordability were each associated with gynecologic oncologist consultation (availability: aOR, 1.16; 95% CI, 1.09-1.24; affordability: aOR, 1.13; 95% CI, 1.07-1.20), while affordability was associated with receipt of OC surgery (aOR, 1.08; 95% CI, 1.01-1.15). In models mutually adjusted for availability, affordability, and accessibility, Black patients remained less likely to consult a gynecologic oncologist (aOR, 0.80; 95% CI, 0.66-0.97) and receive surgery (aOR, 0.80; 95% CI, 0.65-0.99). Conclusions and Relevance: In this cohort study of Hispanic, non-Hispanic Black, and non-Hispanic White patients with OC, HCA affordability and availability were significantly associated with receiving surgery and consulting a gynecologic oncologist. However, these dimensions did not fully explain racial and ethnic disparities.

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.

Healthcare Access Domains Mediate Racial Disparities in Ovarian Cancer Treatment Quality in a US Patient Cohort: A Structural Equation Modelling Analysis.

BACKGROUND: Ovarian cancer survival disparities have persisted for decades, driven by lack of access to quality treatment. We conducted structural equation modeling (SEM) to define latent variables representing three healthcare access (HCA) domains: affordability, availability, and accessibility, and evaluated the direct and indirect associations between race and ovarian cancer treatment mediated through the HCA domains. METHODS: Patients with ovarian cancer ages 65 years or older diagnosed between 2008 and 2015 were identified from the SEER-Medicare dataset. Generalized SEM was used to estimate latent variables representing HCA domains by race in relation to two measures of ovarian cancer-treatment quality: gynecologic oncology consultation and receipt of any ovarian cancer surgery. RESULTS: A total of 8,987 patients with ovarian cancer were included in the analysis; 7% were Black. The affordability [Ω: 0.876; average variance extracted (AVE) = 0.689], availability (Ω: 0.848; AVE = 0.636), and accessibility (Ω: 0.798; AVE = 0.634) latent variables showed high composite reliability in SEM analysis. Black patients had lower affordability and availability, but higher accessibility compared with non-Black patients. In fully adjusted models, there was no direct effect observed between Black race to receipt of surgery [ß: -0.044; 95% confidence interval (CI), -0.264 to 0.149]; however, there was an inverse total effect (ß: -0.243; 95% CI, -0.079 to -0.011) that was driven by HCA affordability (ß: -0.025; 95% CI, -0.036 to -0.013), as well as pathways that included availability and consultation with a gynecologist oncologist. CONCLUSIONS: Racial differences in ovarian cancer treatment appear to be driven by latent variables representing healthcare affordability, availability, and accessibility. IMPACT: Strategies to mitigate disparities in multiple HCA domains will be transformative in advancing equity in cancer treatment.

Development and Psychometric Evaluation of Healthcare Access Measures among Women with Ovarian Cancer.

Several proposed theoretical frameworks have defined the complex nature of healthcare access (HCA) [...].

Healthcare Access Dimensions and Guideline-Concordant Ovarian Cancer Treatment: SEER-Medicare Analysis of the ORCHiD Study.

BACKGROUND: Racial disparities exist in receipt of guideline-concordant treatment of ovarian cancer (OC). However, few studies have evaluated how various dimensions of healthcare access (HCA) contribute to these disparities. METHODS: We analyzed data from non-Hispanic (NH)-Black, Hispanic, and NH-White patients with OC diagnosed in 2008 to 2015 from the SEER-Medicare database and defined HCA dimensions as affordability, availability, and accessibility, measured as aggregate scores created with factor analysis. Receipt of guideline-concordant OC surgery and chemotherapy was defined based on the NCCN Guidelines for Ovarian Cancer. Multivariable-adjusted modified Poisson regression models were used to assess the relative risk (RR) for guideline-concordant treatment in relation to HCA. RESULTS: The study cohort included 5,632 patients: 6% NH-Black, 6% Hispanic, and 88% NH-White. Only 23.8% of NH-White patients received guideline-concordant surgery and the full cycles of chemotherapy versus 14.2% of NH-Black patients. Higher affordability (RR, 1.05; 95% CI, 1.01-1.08) and availability (RR, 1.06; 95% CI, 1.02-1.10) were associated with receipt of guideline-concordant surgery, whereas higher affordability was associated with initiation of systemic therapy (hazard ratio, 1.09; 95% CI, 1.05-1.13). After adjusting for all 3 HCA scores and demographic and clinical characteristics, NH-Black patients remained less likely than NH-White patients to initiate systemic therapy (hazard ratio, 0.86; 95% CI, 0.75-0.99). CONCLUSIONS: Multiple HCA dimensions predict receipt of guideline-concordant treatment but do not fully explain racial disparities among patients with OC. Acceptability and accommodation are 2 additional HCA dimensions which may be critical to addressing these disparities.

Race, Affordability and Utilization of Supportive Care in Ovarian Cancer Patients.

OBJECTIVE: Lack of access to supportive care (SC) among cancer patients have been well documented. However, the role of affordability in this disparity among ovarian cancer (OC) patients remain poorly understood. METHODS: Patients with OC between 2008 and 2015 were identified from the SEER-Medicare dataset. Racial disparities in utilization of SC medications within the six months of OC diagnosis among patients with Medicare Part D coverage was examined. Multivariable log-binomial regression models were used to examine the associations of race, affordability and SC medications after adjusting for clinical covariates among all patients and separately among patients with advanced-stage disease. RESULTS: The study cohort included 3697 patients: 86% non-Hispanic White (NHW), 6% non-Hispanic Black (NHB), and 8% Hispanic. In adjusted models, NHB and Hispanic patients were less likely to receive antidepressants compared to NHW patients (NHB: aOR 0.46; 95% CI 0.33-0.63 and Hispanic: aOR 0.79; 95% CI 0.63-0.99). This association persisted for NHB patients with advanced-stage disease (aOR 0.42; 95% CI 0.28-0.62). Patients dual enrolled in Medicaid were more likely to receive antidepressants (overall: aOR 1.34; 95% CI 1.17-1.53 and advanced-stage: aOR 1.29; 95% CI 1.10-1.52). However, patients residing in areas with higher vs. lower proportions of lower educated adults (overall: aOR 0.82; 95% CI 0.70-0.97 and advanced-stage: aOR 0.82; 95% CI 0.68-0.99) were less likely to receive antidepressants. CONCLUSION: Black OC patients and those living in lower educated areas were less likely to receive antidepressants as SC. Given the importance of post-primary treatment quality of life for cancer patients, interventions are needed to enhance equitable access to SC.

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.

Associations of Healthcare Affordability, Availability, and Accessibility with Quality Treatment Metrics in Patients with Ovarian Cancer.

BACKGROUND: Differential access to quality care is associated with racial disparities in ovarian cancer survival. Few studies have examined the association of multiple healthcare access (HCA) dimensions with racial disparities in quality treatment metrics, that is, primary debulking surgery performed by a gynecologic oncologist and initiation of guideline-recommended systemic therapy. METHODS: We analyzed data for patients with ovarian cancer diagnosed from 2008 to 2015 in the Surveillance, Epidemiology, and End Results-Medicare database. We defined HCA dimensions as affordability, availability, and accessibility. Modified Poisson regressions with sandwich error estimation were used to estimate the relative risk (RR) for quality treatment. RESULTS: The study cohort was 7% NH-Black, 6% Hispanic, and 87% NH-White. Overall, 29% of patients received surgery and 68% initiated systemic therapy. After adjusting for clinical variables, NH-Black patients were less likely to receive surgery [RR, 0.83; 95% confidence interval (CI), 0.70-0.98]; the observed association was attenuated after adjusting for healthcare affordability, accessibility, and availability (RR, 0.91; 95% CI, 0.77-1.08). Dual enrollment in Medicaid and Medicare compared with Medicare only was associated with lower likelihood of receiving surgery (RR, 0.86; 95% CI, 0.76-0.97) and systemic therapy (RR, 0.94; 95% CI, 0.92-0.97). Receiving treatment at a facility in the highest quartile of ovarian cancer surgical volume was associated with higher likelihood of surgery (RR, 1.12; 95% CI, 1.04-1.21). CONCLUSIONS: Racial differences were observed in ovarian cancer treatment quality and were partly explained by multiple HCA dimensions. IMPACT: Strategies to mitigate racial disparities in ovarian cancer treatment quality must focus on multiple HCA dimensions. Additional dimensions, acceptability and accommodation, may also be key to addressing disparities.

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.