Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill (UNC-CH), Chapel Hill, NC; Lineberger Comprehensive Cancer Center (LCCC), UNC-CH, Chapel Hill, NC, USA.
Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale School of Medicine, New Haven, CT, USA; Department of Chronic Disease Epidemiology, Yale School of Medicine, Yale School of Public Health, New Haven, CT, USA.
Clin Genitourin Cancer. 2022 Oct;20(5):e396-e405. doi: 10.1016/j.clgc.2022.04.010. Epub 2022 Apr 25.
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.
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.
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.
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.
在 FDA 批准口服抗癌药物（OAAs）迅速增加的时代，了解与真实世界人群生存相关的因素非常重要，这些因素包括在 OAAs 的关键性临床试验中代表性不足的群体，如老年人、少数民族和医疗复杂的患者。我们的目的是评估患者和提供者层面特征与接受 OAAs 治疗的转移性肾细胞癌（mRCC）患者死亡率之间的关系。
这项回顾性队列研究使用了 2004 年至 2015 年北卡罗来纳州癌症登记处与多付款人索赔数据链接的数据。提供者数据来自北卡罗来纳州卫生专业人员数据系统和国家计划和提供者登记系统。纳入的患者为接受 OAAs 治疗且在开始治疗后至少存活 90 天的 mRCC 患者。我们使用 Cox 风险模型估计了患者人口统计学、患者临床特征、提供者层面特征与 2 年全因死亡率之间的风险比（HR）和相应的 95%置信区间（CL）。
该队列包括 207 名接受 OAAs 治疗的 mRCC 患者。在多变量模型中，临床变量如衰弱（HR：1.36，95%CL：1.11-1.67）和初诊转移性疾病（HR：2.63，95%CL：1.67-4.16）与更高的全因死亡率相关。此外，与任何私人保险的患者相比，仅接受医疗保险的患者调整后的全因死亡率更高（HR：2.35，95%CL：1.32-4.18）。未发现调查的提供者层面协变量与全因死亡率相关。
在接受 OAAs 治疗的 mRCC 患者的真实世界人群中，生存情况因患者特征而异。在 FDA 批准 OAAs 迅速增加的时代，这些真实世界的数据强调了获得高质量护理的持续重要性，特别是对于资源有限的医疗复杂患者。
