Representation of age, race and ethnicity in real-world evidence (RWE), randomized clinical trial (RCT), and Surveillance, Epidemiology, and End Results (SEER) cancer patient registry data in advanced renal cell carcinoma (aRCC).

Abstract

e18672 Background: Representation of key demographic characteristics in real-world settings and clinical trial environments is medically necessary to address evidentiary gaps and disparities in clinical outcomes among patients with advanced renal cell carcinoma (aRCC). We characterized age, race, and ethnicity in patients with aRCC in real-world evidence (RWE), corresponding randomized controlled trials (RCTs), and Surveillance, Epidemiology, and End Results (SEER) data during contemporaneous periods spanning 2017-2022. Methods: Demographic characteristics were assessed from one RWE chart review study, two RCTs (Checkmate 214 and Keynote 426), and a SEER cohort based on RCT/RWE eligibility criteria and compared across data sources using 2-sided chi-square or t-tests. Results: Age, race and ethnicity were collected for 4,821 patients (RWE: n = 635, 13.2%; RCT: Checkmate 214 n = 1,096 and Keynote 426 n = 861, 40.6% across both RCTs; SEER: n = 2,229, 46.2%). RCT participants were younger at metastatic diagnosis (60.9 vs 65.1 years) and at 1L therapy initiation (60.9 vs 65.7 years) compared to patients in RWE and SEER, respectively (both p < 0.0001). Black patients accounted for 17.2% in RWE, 1.6% in RCT, and 4.8% in SEER data, and Asian patients accounted for 6.3% in RWE, 11.8% in RCT, and 6.0% in SEER data. Hispanic representation was significantly higher in RWE studies than RCT studies, (15.0% vs 3.4%), P< .001. A significantly greater proportion of white patients was observed in RCTs than RWE (84.5% vs 71.7%) and greater representation of non-Hispanic white patients was observed in SEER vs RWE (67.5% vs 60.3%), P< .001 (Table 1). Conclusions: This study describes existing disparities in representation of age, race, and ethnicity among patients with aRCC in research. RCTs had lower representation of older, Black, and Hispanic patients with aRCC compared to SEER and RWE studies. Despite limitations including sparse data available among Hispanics in RCTs, RWE studies can provide greater visibility to traditionally medically underrepresented patients with aRCC. [Table: see text]