Abiraterone in metastatic prostate cancer without previous chemotherapy.
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Ryan Charles J, Smith Matthew R, de Bono Johann S, Molina Arturo, Logothetis Christopher J, de Souza Paul, Fizazi Karim, Mainwaring Paul, Piulats Josep M, Ng Siobhan, Carles Joan, Mulders Peter F A, Basch Ethan, Small Eric J, Saad Fred, Schrijvers Dirk, Van Poppel Hendrik, Mukherjee Som D, Suttmann Henrik, Gerritsen Winald R, Flaig Thomas W, George Daniel J, Yu Evan Y, Efstathiou Eleni, Pantuck Allan, Winquist Eric, Higano Celestia S, Taplin Mary-Ellen, Park Youn, Kheoh Thian, Griffin Thomas, Scher Howard I, Rathkopf Dana E, COU-AA-302 Investigators
Аннотация
METHODS: In this double-blind study, we randomly assigned 1088 patients to receive abiraterone acetate (1000 mg) plus prednisone (5 mg twice daily) or placebo plus prednisone. The coprimary end points were radiographic progression-free survival and overall survival.
RESULTS: The study was unblinded after a planned interim analysis that was performed after 43% of the expected deaths had occurred. The median radiographic progression-free survival was 16.5 months with abiraterone-prednisone and 8.3 months with prednisone alone (hazard ratio for abiraterone-prednisone vs. prednisone alone, 0.53; 95% confidence interval [CI], 0.45 to 0.62; P<0.001). Over a median follow-up period of 22.2 months, overall survival was improved with abiraterone-prednisone (median not reached, vs. 27.2 months for prednisone alone; hazard ratio, 0.75; 95% CI, 0.61 to 0.93; P=0.01) but did not cross the efficacy boundary. Abiraterone-prednisone showed superiority over prednisone alone with respect to time to initiation of cytotoxic chemotherapy, opiate use for cancer-related pain, prostate-specific antigen progression, and decline in performance status. Grade 3 or 4 mineralocorticoid-related adverse events and abnormalities on liver-function testing were more common with abiraterone-prednisone.
CONCLUSIONS: Abiraterone improved radiographic progression-free survival, showed a trend toward improved overall survival, and significantly delayed clinical decline and initiation of chemotherapy in patients with metastatic castration-resistant prostate cancer. (Funded by Janssen Research and Development, formerly Cougar Biotechnology; ClinicalTrials.gov number, NCT00887198.).