Safety of enzalutamide in patients with metastatic castration‐resistant prostate cancer previously treated with docetaxel: Expanded access in North America |
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| Authors: | Anthony M. Joshua Neal D. Shore Fred Saad Kim N. Chi Carl A. Olsson Urban Emmenegger Mark Scholz William Berry Som D. Mukherjee Eric Winquist Naomi B. Haas Margaret A. Foley Carl Dmuchowski Frank Perabo Mohammad Hirmand Nahla Hasabou Dana Rathkopf for The Enzalutamide Expanded Access Study Investigators |
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| Affiliation: | 1. University Health Network/Princess Margaret Cancer Centre, Toronto, Ontario, Canada;2. Carolina Urologic Research Center, Myrtle Beach, South Carolina;3. University of Montreal Hospital Research Centre (CRCHUM), Montreal, Quebec, Canada;4. British Columbia Cancer Agency‐Vancouver Cancer Centre, Vancouver, British Columbia, Canada;5. Columbia University Medical Center and Integrated Medical Professionals, New York, New York;6. Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada;7. Prostate Oncology Specialists Inc., Marina del Rey, California;8. US Oncology Inc, Cancer Centers of North Carolina, Raleigh, North Carolina;9. Juravinski Cancer Centre, Hamilton, Ontario, Canada;10. Western University‐London Health Sciences Centre, London, Ontario, Canada;11. Abramson Cancer Center, Philadelphia, Pennsylvania;12. Astellas Pharma Global Development, Northbrook, Illinois;13. Medivation Inc., San Francisco, California;14. Memorial Sloan Kettering Cancer Center, New York, New York |
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| Abstract: | BACKGROUND The open‐label, single‐arm enzalutamide expanded access program (EAP) in the United States and Canada evaluated the safety of enzalutamide in patients with metastatic castration‐resistant prostate cancer (mCRPC) who had previously received docetaxel. METHODS Patients (n = 507) received enzalutamide 160 mg/day until disease progression, intolerable adverse events (AEs), or commercial availability occurred. AEs and other safety variables were assessed on day 1, weeks 4 and 12, and every 12 weeks thereafter. Data following transition to commercial drug were not collected. RESULTS Median age was 71 years (range 43–97); 426 patients (83.9%) had a baseline ECOG score of ≤1. In addition to docetaxel, the majority of patients had received prior prostate cancer treatments such as abiraterone (76.1%) or cabazitaxel (28.6%). Median study treatment duration was 2.6 months (range 0.03–9.07). The most frequently reported reasons for discontinuation were commercial availability of enzalutamide (46.7%) and progressive disease (33.7%). A total of 88.2% of patients experienced AEs; 45.4% experienced AEs with a maximum grade of 1 or 2. Fatigue (39.1%), nausea (22.7%), and anorexia (14.8%) were the most commonly reported AEs. Seizure was reported in four patients (0.8%). The most commonly reported event leading to death was progression of metastatic prostate cancer (7.7%). CONCLUSION In this heavily pretreated EAP population with progressive mCRPC, enzalutamide was well tolerated and the safety profile was consistent with that of the AFFIRM trial. Prostate 75: 836–844, 2015. © 2015 The Authors. The Prostate, published by Wiley Periodicals, Inc. |
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| Keywords: | enzalutamide metastatic castration‐resistant prostate cancer expanded access program safety treatment exposure |
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