GU Cancers Symposium 2013 - Exploratory analysis of the visceral disease patient subset in COU-AA-301, a phase 3 study of abiraterone acetate in metastatic castration-resistant prostate cancer, by Oscar B. Goodman Jr., MD, PhD, et al. - Poster

ORLANDO, FL, USA (UroToday.com) - Visceral disease (VD) associated with liver metastases is a negative prognostic factor in patients with metastatic castration-resistant prostate cancer (mCRPC) as demonstrated in the TAX327 and CALGB 90401 phase 3 studies. In the CALGB trial, poor outcomes were seen in mCRPC patients with liver metastases, in whom median overall survival (OS) was significantly shorter compared with patients without liver metastases (14.4 vs 22.6 months; p = 0.019).

Abiraterone acetate (AA), a selective androgen biosynthesis inhibitor, blocks the action of CYP17, thereby inhibiting adrenal and intratumoral androgen synthesis. In the phase 3 COU-AA-301 trial, AA + prednisone (P) significantly improved OS, with a survival benefit of 4.6 months over placebo + P (hazard ratio [HR] = 0.74) in patients with mCRPC previously treated with docetaxel. These data led to the approval of AA + P for the treatment of patients with mCRPC in more than 60 countries globally. The indication was recently expanded to include mCRPC patients without prior chemotherapy.

The objective of this post hoc exploratory analysis was to determine whether clinical benefit of AA + P on OS and other clinical outcomes in post-docetaxel mCRPC patients is maintained in those with VD (liver or lung, but not nodal-only metastases)....Click here to enlarge and view the poster.

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Presented by Oscar B. Goodman Jr.,1 Thomas W. Flaig,2 Arturo Molina,3 Peter F.A. Mulders,4 Henrik Suttmann,5 Jinhui Li,6 Thian Kheoh,3 Johann S. de Bono,7 and Howard I. Scher8 at the 2013 Genitourinary Cancers Symposium - February 14 - 16, 2013 - Rosen Shingle Creek - Orlando, Florida USA

1Comprehensive Cancer Centers of Nevada, Las Vegas, NV; 2University of Colorado Cancer Center, Aurora, CO; 3Janssen Research & Development, Los Angeles, CA; 4Radboud University Medical Centre, Nijmegen, The Netherlands; 5Urologikum Hamburg, Hamburg, Germany; 6Janssen Research & Development, Raritan, NJ; 7Institute of Cancer Research and Royal Marsden Hospital, Sutton, United Kingdom; 8Memorial Sloan-Kettering Cancer Center and Weill-Cornell Medical College, New York, NY


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