Premium
Safety of enzalutamide in patients with metastatic castration‐resistant prostate cancer previously treated with docetaxel: Expanded access in North America
Author(s) -
Joshua Anthony M.,
Shore Neal D.,
Saad Fred,
Chi Kim N.,
Olsson Carl A.,
Emmenegger Urban,
Scholz Mark,
Berry William,
Mukherjee Som D.,
Winquist Eric,
Haas Naomi B.,
Foley Margaret A.,
Dmuchowski Carl,
Perabo Frank,
Hirmand Mohammad,
Hasabou Nahla,
Rathkopf Dana
Publication year - 2015
Publication title -
the prostate
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.295
H-Index - 123
eISSN - 1097-0045
pISSN - 0270-4137
DOI - 10.1002/pros.22965
Subject(s) - enzalutamide , medicine , cabazitaxel , docetaxel , prostate cancer , adverse effect , oncology , population , discontinuation , expanded access , cancer , androgen deprivation therapy , androgen receptor , environmental health
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.