No new safety concerns were identified with longer treatment with abiraterone acetate than in a previous study. Grade 3/4 adverse events for the abiraterone acetate arm vs placebo arm were hypertension, 3.9% vs 3.0%; hypokalemia 2.4% vs 1.9%; elevated ALT, 5.4% vs 0.8%; elevated AST, 3.0% vs 0.9%, and fatigue, 2% vs 2%.
The investigators concluded that abiraterone acetate plus prednisone produced a statistically significant improvement in rPFS and a strong trend for increased OS at this interim analysis. In this study, time to all landmarks—PSA progression, tumor/bone progression, chemotherapy, pain, ECOG PS decline, and death—favored abiraterone acetate.
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