Safety of long-term (LT) treatment (tmt) of chemotherapy (chemo)-naïve metastatic castration-resistant prostate cancer (mCRPC) patients (pts) with abiraterone acetate plus prednisone (AA + P) for ≥ 4 years (yrs)

J. Carles, I. Davis, J. S. de Bono, K. Fizazi, W. Gerritsen, D. E. Rathkopf, C. J. Ryan, F. Saad, T. Steuber, G. Wilding, Y. C. Park, R. Charnas, P. De Porre, H. Van Poppel

Research output: Contribution to journalMeeting Abstractpeer-review


Background: Low-toxicity therapies for LT tmt of mCRPC pts is an unmet need. The final analysis of the COU-AA-302 study (302) (median follow-up: 4.1 yrs) showed that AA + P significantly improves overall survival (OS) and has a favorable safety profile in chemo-naïve mCRPC pts. We assessed the LT safety of AA + P in pts treated for ≥ 4 and < 4 yrs in 302. Methods: 302 was an international phase 3, double-blind study of chemo-naïve mCRPC pts randomized 1:1 to AA 1000 mg + P 5 mg po BID (n = 546) vs placebo + P (n = 542). A post hoc analysis of adverse events (AEs) and an efficacy analysis were performed for pts with ≥ 4 (n = 41) and < 4 (n = 501) yrs of tmt with AA + P. Results: Baseline characteristics were similar for the ≥ 4 and < 4 yrs groups, with the exception of median age (67 and 71 yrs) and time from androgen deprivation to first AA + P dose (56 and 39 months [mos]), respectively. Median tmt duration was 50 mos in the ≥ 4 yrs group and 13 mos in the < 4 yrs group. The frequency of any grade and grade 3/4 AEs was similar for the ≥ 4 and < 4 yrs groups. The most common AEs were fatigue, diarrhea, arthralgia, back pain, and edema peripheral. The majority were grade 1/2 (Table). No pts in the ≥ 4 yrs group had an AE leading to tmt discontinuation, and 50 pts in the < 4 yrs group discontinued due to AEs. No pt in the ≥ 4 yrs group had died at the time of analysis. As expected, median time to prostate-specific antigen (PSA) progression was longer (47 vs 9 mos) and PSA response rate was greater (98% vs 66%) in the ≥ 4 vs < 4 yrs groups, respectively. Conclusions: 41 of 546 pts continued LT AA + P (≥ 4 yrs), and no new safety signals were associated with prolonged treatment with AA + P. Pts on LT AA + P may progress but have excellent survival and manageable toxicity.
Original languageEnglish
Pages (from-to)vi251
Number of pages1
JournalAnnals of Oncology
Issue numberSuppl. 6
Publication statusPublished - 1 Oct 2016
EventESMO Congress (ESMO) 2016 - Bella Center, Copenhagen, Denmark
Duration: 7 Oct 201611 Oct 2016
Conference number: 41st (Conference Website) (Abstract Book of the 41st ESMO Congress (ESMO 2016), 7-11 October 2016, Copenhagen, Denmark Published in the Annals of Oncology 1 October 2016, Volume 27, Supplement 6)

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