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; Boyce, A; Costello, A; Davis, I; Ganju, V; Horvath, L; Lynch, R; Marx, G; Parnis, F; Shapiro, J; Singhal, N; Slancar, M; Van Hazel, G; Wong, S; Yip, D; Carpentier, P; Luyten, D; Rottey, S; Van Aelst, F; Cheng, T; Chin, J; Ellard, S; Fradet, Y; Gleave, M; Joshua, A; Klotz, L; Martins, H; North, S; Abdel-Hamid, S; Colombel, M; Fléchon, A; Haillot, O; Joly, F; Oudard, S; Priou, F; Raymond, E; Albers, P; Boegemann, M; Gleissner, J; Gschwend, J; Hammerer, P; Heidenreich, A; Kuczyk, M; Miller, K; Oetzel, R; Roigas, J; Steuber, T; Stöckle, M; Wirth, M; Papandreou, C; Bracarda, S; Marcello, T; Sternberg, C; Bangma, C; de Reijke, T; Arija, J Arranz; Bellmunt, J; Lopez, R; Lopez-Brea, M; Bjartell, A; Damber, J; Haggman, M; Hellstrom, M; Seke, M; Brown, J; Chowdhury, S; Elliott, T; Harland, S; Innes, H; James, N; Jones, R; Mazhar, D; Paez, E; Protheroe, A; Staffurth, J; Ahmann, F; Andriole, G; Arrowsmith, E; Assikis, V; Baron, A; Berry, W; Bubley, G; Carney, J; Chu, L; Cosgriff, T; Denmeade, S; Deshpande, H; Duchene, D; Ferrari, A; Frenkel, E; Gabrail, N; Garcia, J; George, D; Gomella, L; Goodman, O; Gore, I; Gullo, J; Hainsworth, J; Hamid, O; Hutson, T; King, D; Koh, H; Koletsky, A; Kudrik, F; Lara, P; Lyons, R; Maranchie, J; Modiano, M; Nieva, J; Nordquist, L; Pinski, J; Poiesz, B; Polikoff, J; Quinn, D; Redfern, C; Riggs, S; Ryan, C; Saleh, M; Sartor, A; Scholz, M; Shore, N; Srinivas, S; Vaishampaya, U; Vieweg, J; Vira, M; Vogelzang, N; Wilding, G; Wong, Y; Belldegrun, Arie; Kantoff, Philip W; Carducci, Michael A; Vogelzang, Nicholas J; Kelly, William K; Auchus, Richard J; Meyers, Michael; Rackoff, Wayne; Tran, NamPhuong; Yu, Margaret; Knoblauch, Roland; Naini, Vahid; Matheny, Shannon; Maul, Scott; Larsen, Julie; Martin, Jason; Wawda, Haneefa; Goffredo, David; Li, Jinhui; Li, Susan; Li, Baoqing; Durve, Ketan; Morris, Michael J; Larson, Steven M «
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; Kh... »
Abiraterone in metastatic prostate cancer without previous chemotherapy.
Abiraterone acetate, an androgen biosynthesis inhibitor, improves overall survival in patients with metastatic castration-resistant prostate cancer after chemotherapy. We evaluated this agent in patients who had not received previous chemotherapy.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.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.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.).