Overall survival from PANTHER: A multicenter trial of apalutamide, abiraterone acetate plus prednisone in Black and White patients with metastatic castration-resistant prostate cancer (mCRPC)
Abstract
5072 Background: ACIS was an international phase III trial comparing apalutamide (A) plus abiraterone acetate and prednisone (AAP) to AAP in patients (pts) with mCRPC. Recognizing that lack of diversity in clinical trials is a major challenge to real-world translation of outcomes, we purposely designed to PANTHER to oversample Black pts compared to our catchment area demographics to estimate clinical outcomes among Black and White pts with mCRPC, accrued in parallel, single arm cohorts and treated with A+AAP. Here we report the long term radiographic progression-free survival (rPFS) and overall survival (OS) for both cohorts. Methods: This parallel cohort multicenter study treated androgen receptor pathway inhibitor naïve mCRPC pts with oral apalutamide (240 mg/d), abiraterone (1000 mg/d) and prednisone (10 mg/d) (AAAP) continuously until disease progression, unacceptable toxicity or 2 years, at which point patients were switched to standard of care. The primary endpoint is rPFS; secondary endpoints were to estimate (OS) and best PSA response among Black and White pts, separately. The target number of rPFS events was 26 per group. Exploratory endpoints included safety and correlative biomarkers of outcome by race and ancestry. Results: Between July 2017 and January 2021, we enrolled 43 Black and 50 White pts from 8 sites. Key baseline prognostic factors for the Black and White cohorts, respectively included: Gleason score 8-10 (56%; 56%), KPS 70-80% (26%; 18%), median age…
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Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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