Charles J. Ryan, M.D., Matthew R. Smith, M.D., Ph.D., Johann S. de Bono, M.B., Ch.B., Ph.D., Arturo Molina, M.D., Christopher J. Logothetis, M.D., Paul.

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Presentation transcript:

Charles J. Ryan, M.D., Matthew R. Smith, M.D., Ph.D., Johann S. de Bono, M.B., Ch.B., Ph.D., Arturo Molina, M.D., Christopher J. Logothetis, M.D., Paul de Souza, M.B., Ph.D., Karim Fizazi, M.D., Ph.D., Paul Mainwaring, M.D., Josep M. Piulats, M.D., Ph.D., Siobhan Ng, M.D., Joan Carles, M.D., Peter F.A. Mulders, M.D., Ph.D., Ethan Basch, M.D., Eric J. Small, M.D., Fred Saad, M.D., Dirk Schrijvers, M.D., Ph.D., Hendrik Van Poppel, M.D., Ph.D., Som D. Mukherjee, M.D., Henrik Suttmann, M.D., Winald R. Gerritsen, M.D., Ph.D., Thomas W. Flaig, M.D., Daniel J. George, M.D., Evan Y. Yu, M.D., Eleni Efstathiou, M.D., Ph.D., Allan Pantuck, M.D., Eric Winquist, M.D., Celestia S. Higano, M.D., Mary-Ellen Taplin, M.D., Youn Park, Ph.D., Thian Kheoh, Ph.D., Thomas Griffin, M.D., Howard I. Scher, M.D., and Dana E. Rathkopf, M.D., for the COU-AA-302 Investigators NEJM Jan 2013 Vol 368 : R2 Lee Tae-In/ Prof. Jeong Jae-Heon

 Metastatic castration-resistant prostate cancer causes approximately 258,400 deaths annualy worldwide  Docetaxel chemotherapy and sipuleucel-T immunotherapy  Abiraterone acetate  Abiraterone acetate is a first-in-class inhibitor of cytochrome P-450c17, a critical enzyme in extragonadal and testicular androgen synthesis

 Phase 1 and 2 studies in patients who have not received chemotherapy have shown a durable responses, suggesting that the benefits of abiraterone may be optimal in this patient group  In this randomised Phase 3 study, authors evaluate the effects of abiraterone plus prednisone

 Randomly assigned 1088 patients  Abiraterone + prednisone : 546 patients  Placebo + prednisone : 542 patients  Age of 18 years or older  Metastatic, histologically or cytologically confirmed adenocarcinoma of the prostate  PSA progression  Radiographic progression with / without PSA  Ongoing androgen deprivation  ECOG status 0 or 1

 Multinational, double-blind, placebo-controlled Abiraterone prednisone Placebo prednisone VS

 The coprimary efficacy end points were radiographic progression-free survival and overall survival  The prespecified secondary end points were times to opiate use, to initiation of chemotherapy, to a decline in ECOG status, and to PSA progression

 Efficacy assessments included sequential radiographic imaging to assess radiograhpic progression-free survival and measurement of PSA levels

 In patients with metastatic castration- resistant prostate cancer, Abiraterone Abiraterone improved radiographic progression-free survival, overall survival, and significantly delayed clinical decline and initiation of chemotherapy