PMID- 25683285
OWN - NLM
STAT- MEDLINE
DCOM- 20150622
LR  - 20211203
IS  - 1097-0045 (Electronic)
IS  - 0270-4137 (Print)
IS  - 0270-4137 (Linking)
VI  - 75
IP  - 8
DP  - 2015 Jun
TI  - Safety of enzalutamide in patients with metastatic castration-resistant prostate 
      cancer previously treated with docetaxel: expanded access in North America.
PG  - 836-44
LID - 10.1002/pros.22965 [doi]
AB  - 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.
CI  - (c) 2015 The Authors. The Prostate, published by Wiley Periodicals, Inc.
FAU - Joshua, Anthony M
AU  - Joshua AM
AD  - University Health Network/Princess Margaret Cancer Centre, Toronto, Ontario, 
      Canada.
FAU - Shore, Neal D
AU  - Shore ND
FAU - Saad, Fred
AU  - Saad F
FAU - Chi, Kim N
AU  - Chi KN
FAU - Olsson, Carl A
AU  - Olsson CA
FAU - Emmenegger, Urban
AU  - Emmenegger U
FAU - Scholz, Mark
AU  - Scholz M
FAU - Berry, William
AU  - Berry W
FAU - Mukherjee, Som D
AU  - Mukherjee SD
FAU - Winquist, Eric
AU  - Winquist E
FAU - Haas, Naomi B
AU  - Haas NB
FAU - Foley, Margaret A
AU  - Foley MA
FAU - Dmuchowski, Carl
AU  - Dmuchowski C
FAU - Perabo, Frank
AU  - Perabo F
FAU - Hirmand, Mohammad
AU  - Hirmand M
FAU - Hasabou, Nahla
AU  - Hasabou N
FAU - Rathkopf, Dana
AU  - Rathkopf D
CN  - Enzalutamide Expanded Access Study Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT01606982
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150214
PL  - United States
TA  - Prostate
JT  - The Prostate
JID - 8101368
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Benzamides)
RN  - 0 (Nitriles)
RN  - 0 (Taxoids)
RN  - 15H5577CQD (Docetaxel)
RN  - 2010-15-3 (Phenylthiohydantoin)
RN  - 93T0T9GKNU (enzalutamide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Benzamides
MH  - Docetaxel
MH  - Drug Resistance, Neoplasm/drug effects
MH  - Fatigue/chemically induced
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Nitriles
MH  - North America/epidemiology
MH  - Phenylthiohydantoin/adverse effects/*analogs & derivatives/therapeutic use
MH  - Prostatic Neoplasms, Castration-Resistant/*drug therapy/*epidemiology
MH  - Taxoids/adverse effects/*therapeutic use
MH  - Treatment Outcome
PMC - PMC5024054
OTO - NOTNLM
OT  - enzalutamide
OT  - expanded access program
OT  - metastatic castration-resistant prostate cancer
OT  - safety
OT  - treatment exposure
EDAT- 2015/02/17 06:00
MHDA- 2015/06/24 06:00
PMCR- 2016/09/15
CRDT- 2015/02/17 06:00
PHST- 2014/09/25 00:00 [received]
PHST- 2014/12/29 00:00 [accepted]
PHST- 2015/02/17 06:00 [entrez]
PHST- 2015/02/17 06:00 [pubmed]
PHST- 2015/06/24 06:00 [medline]
PHST- 2016/09/15 00:00 [pmc-release]
AID - PROS22965 [pii]
AID - 10.1002/pros.22965 [doi]
PST - ppublish
SO  - Prostate. 2015 Jun;75(8):836-44. doi: 10.1002/pros.22965. Epub 2015 Feb 14.