Abiraterone in metastatic castration-resistant prostate cancer: Efficacy and safety in unselected patients

Abstract Background Abiraterone acetate (AA), an androgen biosynthesis inhibitor, is now a standard of care for men with metastatic, castration-sensitive and castration-resistant prostate cancer (mCRPC). Data exploring real-world toxicity and outcomes are scarce. Methods Retrospective study on unselected patients with mCRPC on AA plus steroids. Results 93 patients were included in the study. Median duration of treatment by AA was 7.5 months (95% CI 5.7–12) among the 58 patients pretreated with chemotherapy, versus 12.7 months ( 95% CI 8.2–35.9) among the 33 chemo-naive patients. Median survivals would reach 13.4 months (95% CI 10.2–19.1) and 36.4 months (95% CI 24.7–41.5) respectively. Rates of hypokalemia, peripheral edema, hypertension, cardiac failure, and overall survival assessments in patients with and without prior chemotherapy were similar to that previously reported in phase 3 randomized trials. The median survival time without adverse event of special interest was 7.5 months for hypokalemia and hypertension, and 5.3 months for liver-function test abnormalities (it was not reached for cardiac disorders). Conclusion Our findings provide further evidence for the survival benefits of AA with a low frequency of additional adverse events among unselected patients. In patients who have not developed hypokalemia or a transaminase increase within 7.5 and 5.3 months respectively, a lighter systematic monitoring may be considered.