Abiraterone in metastatic prostate cancer without previous chemotherapy

Charles J. Ryan, Matthew R. Smith, Johann S. De Bono, Arturo Molina, Christopher J. Logothetis, Paul De Souza, Karim Fizazi, Paul Mainwaring, Josep M. Piulats, Siobhan Ng, Joan Carles, Peter F A Mulders, Ethan Basch, Eric J. Small, Fred Saad, Dirk Schrijvers, Hendrik Van Poppel, Som D. Mukherjee, Henrik Suttmann, Winald R. GerritsenThomas W. Flaig, Daniel J. George, Evan Y. Yu, Eleni Efstathiou, Allan Pantuck, Eric Winquist, Celestia S. Higano, Mary Ellen Taplin, Youn Park, Thian Kheoh, Thomas Griffin, Howard I. Scher, Dana E. Rathkopf

Research output: Contribution to journalArticle

Abstract

Background: 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. 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 progressionfree 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

Original languageEnglish (US)
Pages (from-to)138-148
Number of pages11
JournalNew England Journal of Medicine
Volume368
Issue number2
DOIs
StatePublished - Jan 10 2013
Externally publishedYes

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Prednisone
Prostatic Neoplasms
Drug Therapy
Survival
Castration
Proxy
Double-Blind Method
Androgens
Disease-Free Survival
abiraterone
Placebos
Confidence Intervals

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Ryan, C. J., Smith, M. R., De Bono, J. S., Molina, A., Logothetis, C. J., De Souza, P., ... Rathkopf, D. E. (2013). Abiraterone in metastatic prostate cancer without previous chemotherapy. New England Journal of Medicine, 368(2), 138-148. https://doi.org/10.1056/NEJMoa1209096

Abiraterone in metastatic prostate cancer without previous chemotherapy. / 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.

In: New England Journal of Medicine, Vol. 368, No. 2, 10.01.2013, p. 138-148.

Research output: Contribution to journalArticle

Ryan, CJ, Smith, MR, De Bono, JS, Molina, A, Logothetis, CJ, De Souza, P, Fizazi, K, Mainwaring, P, Piulats, JM, Ng, S, Carles, J, Mulders, PFA, Basch, E, Small, EJ, Saad, F, Schrijvers, D, Van Poppel, H, Mukherjee, SD, Suttmann, H, Gerritsen, WR, Flaig, TW, George, DJ, Yu, EY, Efstathiou, E, Pantuck, A, Winquist, E, Higano, CS, Taplin, ME, Park, Y, Kheoh, T, Griffin, T, Scher, HI & Rathkopf, DE 2013, 'Abiraterone in metastatic prostate cancer without previous chemotherapy', New England Journal of Medicine, vol. 368, no. 2, pp. 138-148. https://doi.org/10.1056/NEJMoa1209096
Ryan CJ, Smith MR, De Bono JS, Molina A, Logothetis CJ, De Souza P et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. New England Journal of Medicine. 2013 Jan 10;368(2):138-148. https://doi.org/10.1056/NEJMoa1209096
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. / Abiraterone in metastatic prostate cancer without previous chemotherapy. In: New England Journal of Medicine. 2013 ; Vol. 368, No. 2. pp. 138-148.
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AU - Fizazi, Karim

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AU - Yu, Evan Y.

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