Safety of enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: expanded access in North America.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Joshua, AM; Shore, ND; Saad, F; Chi, KN; Olsson, CA; Emmenegger, U; Scholz, M; Berry, W; Mukherjee, SD; Winquist, E; Haas, NB; Foley, MA; Dmuchowski, C; Perabo, F; Hirmand, M; Hasabou, N; Rathkopf, D; Enzalutamide Expanded Access Study Investigators,

Published Date

  • June 2015

Published In

Volume / Issue

  • 75 / 8

Start / End Page

  • 836 - 844

PubMed ID

  • 25683285

Pubmed Central ID

  • PMC5024054

Electronic International Standard Serial Number (EISSN)

  • 1097-0045

Digital Object Identifier (DOI)

  • 10.1002/pros.22965


  • eng

Conference Location

  • United States