Abstract

Abstract Objective: To validate the 17-gene Oncotype DX Genomic Prostate Score (GPS) biopsy-based gene expression assay as a predictor of adverse pathology (AP: Pathologic Gleason score ≥4+3, presence of any Gleason 5, and/or ≥pT3) in African American (AA) men. Methods: Between February 2009 and September 2014, AA and European American (EA) men with very low, low, and intermediate risk prostate cancer (PCa) enrolled in a multi-institutional prospective study of vitamin D impacts of biopsy outcomes. The subset who proceeded to immediate radical prostatectomy (RP) after biopsy with available biopsy tumor blocks was included in a comparative effectiveness analysis of GPS on biopsy and its association with surgical AP on RP using logistic regression and receiver operating characteristic curves. Multiplicative interactions tested for differential prediction of GPS accuracy by race (AA vs. EA). Results: Overall, 102 AA and 76 EA men elected RP, out of which 51 (47.2%) had AP. GPS result was a significant predictor of AP (odds ratio per 20 GPS units [OR/20 units] in AA: 4.78; 95% CI 1.8-12.5, P =0.001; and EA: 4.41; 95% CI 1.6-11.9, P =0.003) in univariable analysis. On multivariate analysis, there was a significant interaction between GPS and race (P=0.01). On race stratified binary logistic regression, AP remained significant after adjustment for NCCN risk group in both AA and EA men (OR/20 units in AA: 3.29; 95% CI 1.2-9.1, P =0.02; and EA: 4.24; 95% CI 1.4-12.6, P =0.01). Area under the curves for AP using GPS/20 units was 0.719 for AAs vs. 0.745 for EAs (P=0.39). Conclusion: In this AA validation study, the Oncotype Dx PCa assay was confirmed as an independent predictor of AP at prostatectomy in AA and EA men with similar predictive accuracy, though there was evidence of effect modification by race. Citation Format: Samuel Carbunaru, Virgilia Marcias, Peter Gann, Roohollah Sharifi, Ximing Yang, Michael Dixon, Chase Gorbein, Borko Jovanovic, Andre Kajdacsy-Balla, Adam B. Murphy. Oncotype DX assay has similar predictive accuracy for adverse pathology at radical prostatectomy in African American and European American men [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr A067.

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