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Introduction: The therapeutic landscape in relapsed/refractory multiple myeloma (RRMM) has changed rapidly, with twenty-two drug approvals since 2012. We characterized population-level trends in RRMM therapy selection, survival and cost outcomes associated with RRMM treatment over time., Materials and Methods: Our cohort included adults diagnosed with multiple myeloma (MM) in the SEER-Medicare database from 2007-2017 who received at least one antimyeloma agent. MM-directed therapies and lines of therapy were identified. Changes in 2LT regimens over time were described. Trends in overall survival from 2LT initiation over time were analyzed using a Cox proportional hazards model adjusting for factors associated with survival in MM. Trends in mean inflation-adjusted cost per 12 months of 2LT were analyzed using JoinPoint analysis., Results: A total of 9,822 patients met eligibility criteria, of whom 5,866 (59.7%) received 2LT. By 2018, 46% of 2LT regimens contained at least one agent approved in 2012 or later. Year of 2LT initiation was associated with improved overall survival (HR 0.78 per 5 years, 95% CI 0.74-0.84) after adjustment. Costs associated with 2LT increased over the study period, and the rate of cost increase increased significantly after 2012 (0.89%/year vs. 9.9%/year, P < .001), with higher total costs for regimens containing newer novel agents (mean $224,193 vs. $189,381, P < .001) CONCLUSION: Overall survival after initiation of 2LT has improved, however this has been accompanied by significant increases in costs of RRMM treatment, particularly for patients receiving newer novel agents. These findings provide useful context for existing and future drug approvals in RRMM., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Introduction: Contemporary testis cancer management requires fastidious adherence to clinical guidelines and care principles, especially for those pursuing active surveillance (AS). However, real-world testis cancer care remains largely undescribed. Accordingly, we sought to assess the rigor of evaluation and monitoring among men with testis cancer., Patients and Methods: Using North Carolina Central Cancer Registry data linked to insurance claims, we selected adult males diagnosed with primary testis cancer from 2003 to 2013. After identifying demographics, care setting, histology, stage, and index management, we evaluated the receipt of tumor markers, imaging, and clinic visits during initial evaluation and subsequent monitoring with respect to contemporaneous clinical guidelines. Care patterns were compared using chi-squared testing and multivariable logistic regression., Results: Of 2526 men with primary testis cancer, we assembled a cohort of 487 with seminoma (59.3%) or nonseminoma (40.7%), losing most to a lack of insurance or continuous coverage. The cohort was predominantly white (92.4%) and had stage I disease (87.9%). Overall, 18.9% had complete tumor markers, staging imaging, and visits with 2 relevant specialists as recommended during their initial evaluation. For subsequent monitoring, 17.5% of patients with seminoma on active surveillance met minimal thresholds for recommended testing and follow-up during the first year vs. 21.9% and 34.9% of patients with seminoma treated with adjuvant radiation and chemotherapy, respectively. For nonseminoma, 10.1% of men on active surveillance met the minimal thresholds for recommended monitoring compared with 60.4% and 62.0% of those treated with surgery and chemotherapy, respectively. Recommended monitoring also differed by academic vs. community setting and receipt of recommended evaluation (P < .05)., Conclusions: From real-world data, the evaluation and monitoring of patients with testis cancer appears substandard. Ongoing data and quality gaps highlight potential challenges with generating real-world evidence and ensuring adequate surveillance in this population., Competing Interests: Disclosures The authors have no financial disclosures or conflicts of interest to report., (Copyright © 2022 Elsevier Inc. All rights reserved.)

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., Competing Interests: Declaration of Competing Interest SBW received unrelated grant funding to her institution from Pfizer. JR is currently employed by Mathematica, Inc.; his work on this manuscript was done as an employee of UNC Chapel Hill., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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., Competing Interests: Declaration of Competing Interest Dr. Meyer is currently employed by Roche, Inc. in a non-development role; Dr. Meng is founder and owner of the contract research company Element Stat Inc.; Jason Rotter is currently employed by Mathematica, Inc. Their work on this manuscript was done as employees of UNC Chapel Hill. The other authors have no current or past conflicts of interest to report., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

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., Competing Interests: Declarations of Competing Interest None., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

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., (Copyright © 2019 Elsevier Ltd. All rights reserved.)