Loriot, Y., Fizazi, K., de Bono, J. S., Forer, D., Hirmand, M., Scher, H. I. (2017) Enzalutamide in Castration-Resistant Prostate Cancer Patients With Visceral Disease in the Liver and/or Lung: Outcomes From the Randomized Controlled Phase 3 AFFIRM Trial. Cancer, 123 (2). pp. 253-262. ISSN 0008-543X

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Abstract

BACKGROUND: Patients with metastatic castration-resistant prostate cancer (mCRPC) and visceral metastases have a worse prognosis than those with nonvisceral metastases. Treatment with the androgen receptor inhibitor enzalutamide in the phase 3 AFFIRM trial led to significant improvements in outcomes for patients with mCRPC. For the current report, the authors analyzed the efficacy of enzalutamide among patients from the AFFIRM trial who had visceral disease. METHODS: Patients who had liver and/or lung metastases at baseline were selected for prespecified overall survival (OS) and exploratory post hoc analyses, including prostate-specific antigen (PSA) response and the time to PSA and radiographic progression. RESULTS: In patients who had liver metastases (n=92), enzalutamide was associated with a lower risk of radiographic progression (hazard ratio [HR], 0.645; 95% confidence interval [CI], 0.413-1.008), improved 12-month OS (37.7% vs 20.6%) and radiographic progression-free survival (rPFS) (11.6% vs 3.0%) rates, and higher PSA response rates (35.1% vs 4.8%) compared with placebo. Enzalutamide-treated patients who had lung metastases (n=104) had improved median OS (HR, 0.848; 95% CI, 0.510-1.410), a substantially reduced risk of radiographic progression (HR, 0.386; 95% CI, 0.259-0.577), improved 12-month OS (65.1% vs 55.3%) and rPFS (30.9% vs 8.2%) rates, increased time to PSA progression (HR, 0.358; 95% CI, 0.204-0.627), and a better PSA response rate (52.1% vs 4.9%) compared with those who received placebo. No increase in treatment-related adverse events was observed for the visceral metastases cohort compared with the nonvisceral metastases cohort. CONCLUSIONS: Across multiple endpoints, patients who have visceral metastases have better outcomes with enzalutamide than with placebo. (C) 2016 American Cancer Society.

Item Type:	Article
Authors (ICR Faculty only):	De Bono, Johann
All Authors:	Loriot, Y., Fizazi, K., de Bono, J. S., Forer, D., Hirmand, M., Scher, H. I.
Additional Information:	ISI Document Delivery No.: EL6GU Times Cited: 0 Cited Reference Count: 30 Loriot, Yohann Fizazi, Karim de Bono, Johann S. Forer, David Hirmand, Mohammad Scher, Howard I. Medivation, Inc.; Astellas Pharma, Inc. This study was funded by Medivation, Inc., and Astellas Pharma, Inc., the co-developers of enzalutamide. Medical writing and editorial support were provided by Sara-Jane Rutherford, Tim Lohret, PhD, Joshua Safran, and Shannon Davis of Infusion Communications (Haddam, CT), based on detailed discussions and feedback from all authors, and was funded by Medivation, Inc., and Astellas Pharma, Inc. 0 WILEY-BLACKWELL HOBOKEN CANCER-AM CANCER SOC
Uncontrolled Keywords:	enzalutamide liver lung metastatic castration-resistant prostate cancer visceral metastasis 1ST-LINE CHEMOTHERAPY PLUS PREDNISONE DOUBLE-BLIND SURVIVAL DOCETAXEL CABAZITAXEL MEN RECOMMENDATIONS MITOXANTRONE GUIDELINE
Research teams:	ICR divisions > Cancer Therapeutics > Cancer Biomarkers ICR divisions > Clinical Studies > Cancer Biomarkers ICR divisions > Clinical Studies > Prostate Cancer Targeted Therapy Group
Depositing User:	Barry Jenkins
Date Deposited:	25 Apr 2017 13:03
Last Modified:	18 May 2017 15:27
URI:	http://publications.icr.ac.uk/id/eprint/15775

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