Response to androgen signaling (AS)-directed therapy after treatment with abiraterone acetate (AA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Post hoc analysis of study COU-AA-302.

Authors

null

Matthew R. Smith

Harvard Medical School and Massachusetts General Hospital, Boston, MA

Matthew R. Smith , Shannon Matheny , Fred Saad , Dana E. Rathkopf , Peter F.A. Mulders , Johann Sebastian De Bono , Eric Jay Small , Neal D. Shore , Karim Fizazi , Thian San Kheoh , Jinhui Li , Mary Beth Todd , Thomas W. Griffin , Margaret K. Yu , Charles J. Ryan

Organizations

Harvard Medical School and Massachusetts General Hospital, Boston, MA, Janssen Research & Development, LLC, Los Angeles, CA, University of Montréal, Montréal, QC, Canada, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands, The Institue of Cancer Research, The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC, Institut Gustave Roussy, University of Paris Sud, Villejuif, France, Janssen Research & Development, LLC, Raritan, NJ, Janssen Global Services, Raritan, NJ

Research Funding

Pharmaceutical/Biotech Company

Background: In study COU-AA-302 of men with mCRPC and no prior chemotherapy, AA plus prednisone (hereafter AA) significantly increased radiographic progression-free survival. There is limited information about response to subsequent AS-directed therapies following AA. In this post hoc analysis of pts who received AA during study COU-AA-302, we evaluated clinical response to subsequent AA or enzalutamide (ENZ). Methods: In COU-AA-302, 546 pts were randomized and received AA. Subsequent response and discontinuation data from 88 pts receiving AS-directed therapy after study were collected retrospectively, source verified, and entered into the database. Median time to prostate-specific antigen (PSA) progression with 95% confidence intervals was estimated using the Kaplan-Meier method. Results: As of May 2013, following AA on study, 55 pts received subsequent AA and 33 received subsequent ENZ. 69% (38/55) of pts in the AA then AA group and 67% (22/33) pts in the AA then ENZ group received intervening chemotherapy. Baseline patient characteristics were similar across both groups and to the overall COU-AA-302 population. Median (range) exposure to subsequent therapy was 4 (1-20) months for AA and 5 (1-12) months for ENZ. Response to subsequent AA or ENZ is summarized in the Table. Conclusions: In this post hoc analysis, pts previously treated with AA experienced modest clinical response on subsequent treatment with either AA or ENZ. These data support further studies of subsequent AS-targeted drugs following treatment with AA for mCRPC. Clinical trial information: NCT00887198.

AA then AA AA then ENZ
n 55 33
Median time to PSA progression on subsequent
therapy, months
3.9 (2.6, NE) 2.8 (1.8, NE)
Positive response during subsequent
therapya [n (%)]
27 (49) 22 (67)
Clinical symptoms 10 (18) 4 (12)
CT/MRI/bone scans 1 (2) 1 (3)
PSA values 24 (44) 22 (67)
Other 0 1 (3)
Reason for discontinuation during subsequent
therapya [n (%)]
Radiographic progression 10 (18) 5 (15)
Clinical progression 17 (31) 9 (27)
PSA progression 28 (51) 13 (39)
Adverse event 3 (6) 0
Therapy ongoing 6 (11) 11 (33)
Other 14 (26) 6 (18)

a More than one reason allowed.

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Abstract Details

Meeting

2014 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session A: Prostate Cancer

Track

Prostate Cancer

Sub Track

Prostate Cancer

Clinical Trial Registration Number

NCT00887198

Citation

J Clin Oncol 32, 2014 (suppl 4; abstr 21)

DOI

10.1200/jco.2014.32.4_suppl.21

Abstract #

21

Poster Bd #

B5

Abstract Disclosures