Safety of enzalutamide in patients with metastatic castration‐resistant prostate cancer previously treated with docetaxel: Expanded access in North America Academic Article uri icon

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  • 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.


  • Joshua, Anthony M
  • Shore, Neal D
  • Saad, Fred
  • Chi, Kim N
  • Olsson, Carl A
  • Emmenegger, Urban
  • Scholz, Mark
  • Berry, William
  • Mukherjee, Som
  • Winquist, Eric
  • Haas, Naomi B
  • Foley, Margaret A
  • Dmuchowski, Carl
  • Perabo, Frank
  • Hirmand, Mohammad
  • Hasabou, Nahla
  • Rathkopf, Dana

publication date

  • June 2015

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