Abiraterone Acetate Significantly Improved Overall Survival for Patients with Metastatic Advanced Prostate Cancer
(Results observed in patients treated with abiraterone acetate plus prednisone/prednisolone whose disease progressed after docetaxel-based chemotherapy)
Patients who received abiraterone acetate and low-dose prednisone/prednisolone also showed significant improvements in secondary study endpoints when compared to the prednisone/prednisolone plus placebo group: time to PSA progression (TTPP) [median 10.2 months for abiraterone acetate vs. 6.6 months for placebo, HR=0.58 (95 percent CI: 0.46, 0.73); p<0.0001] and an increase in radiographic progression-free survival (rPFS) [median 5.6 months for abiraterone acetate vs. 3.6 months for placebo, HR=0.67 (95 percent CI: 0.58, 0.78); p<0.0001]. Total PSA response, defined as greater than or equal to a 50 percent decrease from baseline, was achieved in 38 percent of patients treated with abiraterone acetate vs. 10 percent in the prednisone/prednisolone plus placebo group [p<0.0001].
Patients in the abiraterone acetate group experienced more mineralocorticoid-related adverse events than those in the prednisone/prednisolone plus placebo group. The most frequent adverse events were fluid retention (30.5 percent vs. 22.3 percent) and hypokalemia (17.1 percent vs. 8.4 percent). Grade 3/4 hypokalemia and hypertension were more frequent in the abiraterone acetate arm than in the placebo arm (3.8 percent vs. 0.8 percent and 1.3 percent vs. 0.3 percent, respectively). Liver function test abnormalities were observed in 10.4 percent of abiraterone acetate treated patients compared to 8.1 percent in the prednisone/prednisolone plus placebo group. Cardiac disorders were observed in 12.5 percent of abiraterone acetate patients vs. 9.4 percent of patients who received placebo. Mechanism-based adverse events were amenable to medical management and distinct from adverse events commonly associated with cytotoxic chemotherapy.
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