Abstract
BackgroundImmune-checkpoint-inhibitors (ICIs) have become the cornerstone of metastatic renal-cell-carcinoma (mRCC) therapy. However, data are limited regarding clinical outcomes by race. In this study, we compared the real-world outcomes between African American (AA) and Caucasian mRCC patients treated with ICIs.MethodsWe performed a retrospective study of 198 patients with mRCC who received ICI at the Emory Winship Cancer Institute from 2015-2020. Clinical outcomes were measured by overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) defined as a complete or partial response maintained for at least 6 months per response evaluation criteria in solid tumors version 1.1. Univariate and multivariable analyses were carried out for OS and PFS by Cox proportional-hazard model and ORR by logistical-regression model. Descriptive statistics compared rates of immune-related adverse events (irAEs) and non-clear-cell-RCC (nccRCC) histology were assessed using Chi-square test.ResultsOur cohort was comprised of 38 AA and 160 Caucasian patients. Most were diagnosed with clear-cell-RCC (ccRCC) (78%) and more than half received (57%) PD-1/PD-L1 monotherapy. Most patients were intermediate or poor-risk groups (83%). Comparing to Caucasians, our AA cohort contained more females and nccRCC cases. Kaplan-Meier method showed AAs had no statistically different median OS (17 vs 25 months, p=0.368) and PFS (3.1 vs 4.4 months, p=0.068) relative to Caucasian patients. On multivariable analysis, AA patients had significantly shorter PFS (HR=1.52, 95% CI: 1.01-2.3, p=0.045), similar ORR (OR=1.04, 95% CI: 0.42-2.57, p=0.936) and comparable OS (HR=1.09, 95% CI: 0.61-1.95, p=0.778) relative to Caucasians.ConclusionsOur real-world analysis of ICI-treated mRCC patients showed that AAs experienced shorter PFS but similar OS relative to Caucasians. This similarity in survival outcomes is reassuring for the use of ICI amongst real-world patient populations, however, the difference in treatment response is poorly represented in early outcomes data from clinical trials. Thus, the literature requires larger prospective studies to validate these findings.
Highlights
Immune checkpoint inhibitors (ICIs) are a major treatment option for metastatic renal cell carcinoma
Clinical outcomes were measured by overall survival (OS), progression-free survival (PFS), and overall response rate (ORR)
Our cohort was comprised of 38 AA (19%) and 160 Caucasian (81%) patients (Table 1)
Summary
Immune checkpoint inhibitors (ICIs) are a major treatment option for metastatic renal cell carcinoma (mRCC). ICI monotherapy and combination therapies have displayed improved efficacy and favorable toxicity profiles for mRCC patients relative to the older regimens [3,4,5]. Patients of racial and ethnic minorities were underrepresented in the ICI clinical trials that led to the regulatory approval of these agents in several tumor types, including mRCC [6]. Only 5 AA patients were enrolled in the 821 patient CHECKMATE-025 trial comparing nivolumab to everolimus in mRCC patients receiving prior standard of care treatment [7]. Immune-checkpoint-inhibitors (ICIs) have become the cornerstone of metastatic renal-cell-carcinoma (mRCC) therapy. We compared the real-world outcomes between African American (AA) and Caucasian mRCC patients treated with ICIs
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