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N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10.

Abiraterone in metastatic prostate cancer without previous chemotherapy.

Collaborators (151)

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, 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 A, Kantoff PW, Carducci MA, Vogelzang NJ, Kelly WK, Auchus RJ, Meyers M, Rackoff W, Tran N, Yu M, Knoblauch R, Naini V, Matheny S, Maul S, Larsen J, Martin J, Wawda H, Goffredo D, Li J, Li S, Li B, Durve K, Morris MJ, Larson SM.

Erratum in

  • N Engl J Med. 2013 Feb 7;368(6):584.

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 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.).

PMID:
23228172
[PubMed - indexed for MEDLINE]
PMCID:
PMC3683570
Free PMC Article
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