EURURO Vol. 71 No. 4

656 692

Prostate Cancer
Subsequent Chemotherapy and Treatment Patterns After
Abiraterone Acetate in Patients with Metastatic Castration-
resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302
Johann S. de Bono Matthew R. Smith Fred Saad Dana E. Rathkopf Peter F.A. Mulders
Eric J. Small Neal D. Shore Karim Fizazi Peter De Porre Thian Kheoh Jinhui Li
Mary B. Todd Charles J. Ryan Thomas W. Flaig
a The Institute of Cancer Research and The Royal Marsden Hospital, Sutton, UK; b Harvard Medical School and Massachusetts General Hospital, Boston, MA,
USA; c Centre Hospitalier University of Montre´al, Montre´al, Que´bec, Canada; d Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College,
New York, NY, USA; e Radboud University Medical Centre, Nijmegen, The Netherlands; f Helen Diller Family Comprehensive Cancer Center, University of
California San Francisco, San Francisco, CA, USA; g Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC, USA; hInstitut Gustave
Roussy, University of Paris Sud, Villejuif, France; iJanssen Research & Development, Beerse, Belgium; j Janssen Research & Development, San Diego, CA, USA;
k Johnson & Johnson Medical China, Shanghai, China; l Janssen Global Services, Raritan, NJ, USA; m University of Colorado Cancer Center, Aurora, CO, USA
available at
journal homepage:
Article info
Article history:
Accepted June 21, 2016
Associate Editor:
James Catto
Keywords:
Abiraterone acetate
Docetaxel
Elderly
Metastatic castration-resistant
prostate cancer
Subsequent therapy
Treatment patterns
Abstract
Background: Treatment patterns for metastatic castration-resistant prostate cancer
(mCRPC) have changed substantially in the last few years. In trial COU-AA-302
(chemotherapy-naı¨ve men with mCRPC), abiraterone acetate plus prednisone (AA)
significantly improved radiographic progression-free survival and overall survival
(OS) when compared to placebo plus prednisone (P).
Objective: This post hoc analysis investigated clinical responses to docetaxel as first
subsequent therapy (FST) among patients who progressed following protocol-specified
treatment with AA, and characterized subsequent treatment patterns among older
( 75 yr) and younger (<75 yr) patient subgroups.
Design, setting, and participants: Data were collected at the final OS analysis (96% of
expected death events). Subsequent therapy data were prospectively collected, while
response and discontinuation data were collected retrospectively following discontinu-
ation of the study drug.
Intervention: At the discretion of the investigator, 67% (365/546) of patients from the
AA arm received subsequent treatment with one or more agents approved for mCRPC.
Outcome measurements and statistical analysis: Efficacy analysis was performed for
patients for whom baseline and at least one post-baseline prostate-specific antigen
(PSA) values were available.
Results and limitations: Baseline and at least one post-baseline PSA values were
available for 100 AA patients who received docetaxel as FST. While acknowledging
the limitations of post hoc analyses, 40% (40/100) of these patients had an unconfirmed
50% PSA decline with first subsequent docetaxel therapy, and 27% (27/100) had a
confirmed 50% PSA decline. The median docetaxel treatment duration among these
100 patients was 4.2 mo. Docetaxel was the most common FST among older and younger
patients from each treatment arm. However, 43% (79/185) of older patients who
progressed on AA received no subsequent therapy for mCRPC, compared with 17%
(60/361) of younger patients.
* Corresponding author. Tel. +44-208-7224029; Fax: +44 208 6427979.
E-mail address: (J.S. de Bono).
0302-2838/# 2016 European Association of Urology. Published by Elsevier B.V. This is an open access article under the CC
BY-NC-ND license ).