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J Clin Oncol. 2016 Jun 20;34(18):2098-106. doi: 10.1200/JCO.2015.64.9285. Epub 2016 Jan 25.

Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial.

Author information

1
David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA. david.penson@vanderbilt.edu.
2
David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.

Abstract

PURPOSE:

Enzalutamide, a potent oral androgen receptor inhibitor, improves survival in men with metastatic castration-resistant prostate cancer (CRPC) before and after chemotherapy. Bicalutamide, a nonsteroidal antiandrogen, is widely used to treat men with nonmetastatic or metastatic CRPC. The efficacy and safety of these drugs were compared in this randomized, double-blind, phase II study of men with CRPC.

PATIENTS AND METHODS:

A total of 396 men with nonmetastatic (n = 139) or metastatic (n = 257) CRPC were randomly assigned to enzalutamide 160 mg per day (n = 198) or bicalutamide 50 mg per day (n = 198). Androgen deprivation therapy was continued in both arms. The primary end point was progression-free survival (PFS).

RESULTS:

Enzalutamide reduced the risk of progression or death by 76% compared with bicalutamide (hazard ratio [HR], 0.24; 95% CI, 0.18 to 0.32; P < .001). Median PFS was 19.4 months with enzalutamide versus 5.7 months with bicalutamide. Enzalutamide resulted in significant improvements in all key secondary end points: time to prostate-specific antigen progression (HR, 0.19; 95% CI, 0.14 to 0.26; P < .001); proportion of patients with a ≥ 50% prostate-specific antigen response (81% v 31%; P < .001); and radiographic PFS in metastatic patients (HR, 0.32; 95% CI, 0.21 to 0.50; P < .001). Beneficial effects with enzalutamide were observed in both nonmetastatic and metastatic subgroups. The observed adverse event profile was consistent with that from phase III enzalutamide trials.

CONCLUSION:

Enzalutamide significantly reduced risk of prostate cancer progression or death compared with bicalutamide in patients with nonmetastatic or metastatic CRPC.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01664923.

PMID:
26811535
DOI:
10.1200/JCO.2015.64.9285
[Indexed for MEDLINE]

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