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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)

Date

09 Oct 2016

Session

Poster display

Presenters

Joan Carles

Citation

Annals of Oncology (2016) 27 (6): 243-265. 10.1093/annonc/mdw372

Authors

J. Carles1, I. Davis2, J.S. de Bono3, K. Fizazi4, W. Gerritsen5, D.E. Rathkopf6, C.J. Ryan7, F. Saad8, T. Steuber9, G. Wilding10, Y.C. Park11, R. Charnas12, P. De Porre13, H. Van Poppel14

Author affiliations

  • 1 Oncologia, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 2 Medicine, Monash University Eastern Health Clinical School, 3128 - Box Hill/AU
  • 3 Division Of Cancer Therapeutics/clinical Studies, The Institute of Cancer Research and The Royal Marsden Hospital, SW3 6JJ - London/GB
  • 4 Department Of Cancer Medicine, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 5 Department Of Medical Oncology, Radboud University Medical Centre Nijmegen, 6500 HB - Nijmegen/NL
  • 6 Oncology And Internal Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York/US
  • 7 Medicine, Hematology/oncology, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco/US
  • 8 Surgery, University of Montréal, Montreal/CA
  • 9 Medicine, Martini-Clini, University Hospital Hamburg-Eppendorf, Hamburg/DE
  • 10 Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston/US
  • 11 Biostats Oncology, Janssen Research & Development, Raritan/US
  • 12 Wc Oncology, Janssen Research & Development, Los Angeles/US
  • 13 Clinical Oncology, Janssen Research and Development, Beerse/BE
  • 14 Department Of Urology, University Hospitals of KU Leuven, 3000 - Leuven/BE
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Resources

Abstract 2516

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 

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 

Results

Baseline characteristics were similar for the ≥ 4 and 

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.

Clinical trial identification

Clinicaltrials.gov NCT00887198

Legal entity responsible for the study

This study was sponsored by Janssen Research & Development

(formerly Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology)

Funding

This study was sponsored by Janssen Research & Development

(formerly Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology).

Disclosure

J. Carles: Consulting or Advisory Role - Amgen, Astellas, Bayer, BMS, Johnson & Johnson, and Pfizer.

I. Davis: Research Funding - Astellas and Exelixis; Patents, Royalties, other Intellectual Property - Ludwig Institute for Cancer Research.

J.S. de Bono: Honoraria - Johnson & Johnson; Consulting or Advisory Role - Johnson & Johnson; Research Funding - Johnson & Johnson.

K. Fizazi: Consulting or Advisory Role - Astellas Pharma, Bayer, Curevac, Dendreon, Ipsen, Janssen Oncology, Novartis, Orion Pharma, Sanofi, and Takeda; Travel, Accommodations, Expenses - Amgen; Honoraria - Astellas Pharma, Janssen, Sanofi, and Takeda.

D.E. Rathkopf: Consulting or Advisory Role - Janssen Oncology; Research Funding - Celgene, Ferring, Janssen Oncology, Medivation, Millennium, Novartis, and Takeda.

C.J. Ryan: Honoraria - Janssen; Travel, Accommodations, Expenses - Janssen.

F. Saad: Consulting or Advisory Role - Abbvie, Amgen, Astellas Pharma, Bavarian Nordic, Janssen Oncology, Millennium, Novartis, and Sanofi; Honoraria - Abbvie, Amgen, Astellas Pharma, Bayer, Janssen Oncology, Novartis, and Sanofi.

T. Steuber: Honoraria - Amgen, Astellas Pharma, and Janssen; Consulting or Advisory Role - Amgen, Astellas Pharma, and Janssen; Travel, Accommodations, Expenses - Amgen, Astellas Pharma, and Janssen.

Y.C. Park, R. Charnas, P. De Porre: Employee of Janssen Research & Development and holds stock in Johnson & Johnson.

All other authors have declared no conflicts of interest.

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