BACKGROUND - Prostate cancer disproportionately affects older men. Because age affects treatment decisions, it is important to understand the efficacy and tolerability of therapies for advanced prostate cancer in elderly men.
This analysis describes efficacy and safety outcomes in men aged ≥75 years who received enzalutamide, an androgen receptor inhibitor, in the phase III PREVAIL trial.
PATIENTS AND METHODS - PREVAIL was a randomised, double-blind, multinational study of oral enzalutamide 160 mg/day (N=872) versus placebo (N=845) in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Overall survival (OS) and radiographic progression-free survival (rPFS) were coprimary endpoints. Subgroup analysis of men aged ≥75 years ("elderly") and men aged
RESULTS - Among 609 elderly patients (35%) who participated in PREVAIL, median treatment duration was 16. 6 and 5. 0 months in the enzalutamide and placebo arms, respectively. In the elderly subgroup, OS was greater with enzalutamide than with placebo (32. 4 months [95% CI 27. 7-not yet reached] versus 25. 1 months [95% CI 22. 6-28. 0]; hazard ratio [HR]=0. 61 [95% CI 0. 47-0. 79]; P=0. 0001), as was rPFS (not yet reached [95% CI 12. 3-not yet reached] versus 3. 7 months [95% CI 3. 6-5. 3]; HR=0. 17 [95% CI 0. 12-0. 24]; P
CONCLUSIONS - Elderly men benefited from treatment with enzalutamide in terms of OS and rPFS. Enzalutamide was well tolerated in the elderly subgroup and those aged
CLINICAL TRIAL IDENTIFIER - NCT01212991, ClinicalTrials. gov.
Annals of oncology : official journal of the European Society for Medical Oncology / ESMO. 2015 Nov 16 [Epub ahead of print]
J N Graff, G Baciarello, A J Armstrong, C S Higano, P Iversen, T W Flaig, D Forer, T Parli, D Phung, B Tombal, T M Beer, C N Sternberg
Division of Hematology & Medical Oncology, Knight Cancer Institute, Oregon Health & Science University Division of Oncology, Portland VA Medical Center, Portland, OR, USA. , Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy. , Divisions of Medical Oncology and Urology, Duke University Medical Center and the Duke Cancer Institute, Durham, NC, USA. , Division of Medical Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA. , Copenhagen Prostate Cancer Center, Rigshospitalet, University of Copenhagen, Denmark. , University of Colorado Cancer Center, Aurora, CO, USA. , Medivation, Inc. , San Francisco, CA, USA. , Medivation, Inc. , San Francisco, CA, USA. , Astellas Pharma Global Development, Inc. , Leiden, The Netherlands. , Department of Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium. , Division of Hematology & Medical Oncology, Knight Cancer Institute, Oregon Health & Science University. , Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy.