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

Author:

Penson David F.1,Armstrong Andrew J.1,Concepcion Raoul1,Agarwal Neeraj1,Olsson Carl1,Karsh Lawrence1,Dunshee Curtis1,Wang Fong1,Wu Kenneth1,Krivoshik Andrew1,Phung De1,Higano Celestia S.1

Affiliation:

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;...

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

Reference28 articles.

1. National Comprehensive Cancer Network: Clinical Practice Guidelines for Prostate Cancer 2015 http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf

2. Current Management of Castrate-Resistant Prostate Cancer

3. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy

4. Enzalutamide in Metastatic Prostate Cancer before Chemotherapy

5. Abiraterone and Increased Survival in Metastatic Prostate Cancer

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