Investigating racial differences in treatment responses through analysis of real-world data (RWD).

Abstract

e18141 Background: Clinical trials remain the most reliable means to evaluate drug efficacy and safety for evidence-based cancer care. However, there is a significant racial disparity among participants in clinical trials. For example, only 1-3% of the participants in registration trials of immune checkpoint inhibitors (CPIs) in advanced non-small cell lung cancers (aNSCLCs) were Black. RWD data enable assessment of whether clinical trial results can be generalized to broader populations. Methods: We analyzed clinical records of > 145,000 cancer patients treated at Mount Sinai hospitals. Therapeutic agents approved by FDA in recent years were assessed for responses across various race groups. Time to treatment discontinuation (TTD) was used as a surrogate clinical endpoint for outcomes. Results: Overall we did not observe significant differences in TTD among different race groups for the following drugs and indications we examined: palbociclib in metastatic breast cancer (mBC), EGFR tyrosine kinase inhibitors in aNSCLC, EGFR antibody cetuximab and panitumumab in metastatic colorectal cancer with wild type KRAS, abiraterone in metastatic castration-resistant prostate cancer (mCRPC), enzalutamide in mCRPC, sorafenib in unresectable hepatocellular carcinoma (HCC), CPIs in metastatic melanoma. For example, the median TTD of palbociclib in combination with fulvestrant or letrozole in post-menopausal women with HR+HER2- mBC was 181, 261, and 160 days in White (n = 114), Black (n = 55), other (n = 48) race groups, respectively (P = 0.61, log-rank test). Among patients with unresectable HCC treated with sorafenib, the median TTD was 64, 49, and 67 days in the White (n = 201), Black (n = 127) and other (n = 243) race groups, respectively (P = 0.70). However, when CPIs in aNSCLC were examined, we observed a significantly longer TTD in the Black group (median TTD not reached; n = 77) compare to the non-Black group (169 days, 95% CI 133-331; n = 211), P = 0.0049, median follow up 194 days. Conclusions: RWD showed there are no apparent differences of treatment response in various race groups for most new therapeutic agents. Preliminary results of CPIs in aNSCLC suggested a favorable response in the Black than the non-Black population.