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The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients.

Authors
 Choung-Soo Kim  ;  Ad Theeuwes  ;  Dong Deuk Kwon  ;  Young Deuk Choi  ;  Byung Ha Chung  ;  Hyun Moo Lee  ;  Kang Hyun Lee  ;  Sang Eun Lee 
Citation
 Investigative and Clinical Urology, Vol.57(3) : 174-183, 2016 
Journal Title
 Investigative and Clinical Urology 
ISSN
 2466-0493 
Issue Date
2016
MeSH
Adenocarcinoma/blood ; Adenocarcinoma/diagnostic imaging ; Adenocarcinoma/drug therapy ; Adenocarcinoma/secondary* ; Administration, Oral ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents, Hormonal/adverse effects ; Antineoplastic Agents, Hormonal/blood ; Antineoplastic Agents, Hormonal/therapeutic use* ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Disease Progression ; Double-Blind Method ; Humans ; Kallikreins/blood ; Male ; Middle Aged ; Phenylthiohydantoin/adverse effects ; Phenylthiohydantoin/analogs & derivatives* ; Phenylthiohydantoin/blood ; Phenylthiohydantoin/therapeutic use ; Prostate-Specific Antigen/blood ; Prostatic Neoplasms, Castration-Resistant/blood ; Prostatic Neoplasms, Castration-Resistant/diagnostic imaging ; Prostatic Neoplasms, Castration-Resistant/drug therapy* ; Radiography ; Survival Analysis ; Treatment Outcome
Keywords
Antineoplastic agents ; Castration-resistant prostatic neoplasms ; Disease-free survival ; MDV 3100 ; Republic of Korea
Abstract
PURPOSE: This post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial. MATERIALS AND METHODS: Asymptomatic or mildly symptomatic chemotherapy-naive men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS). Secondary end points included investigator-assessed rPFS, time to initiation of chemotherapy, time to prostate-specific antigen (PSA) progression, PSA response (≥50% decline), and time to skeletal-related event. RESULTS: Of 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). Hazard ratios (95% confidence interval) for enzalutamide versus placebo were 0.23 (0.02-2.24) for centrally assessed rPFS, 0.77 (0.28-2.15) for OS, 0.21 (0.08-0.51) for time to chemotherapy, and 0.31 (0.17-0.56) for time to PSA progression. A PSA response was observed in 70.0% of enzalutamide-treated and 10.5% of placebo-treated Korean patients. Adverse events of grade ≥3 occurred in 33% of enzalutamide-treated and 11% of placebo-treated Korean patients, with median treatment durations of 13.0 and 5.1 months, respectively. At 13 weeks, the plasma concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90% confidence interval, 0.97-1.10). CONCLUSIONS: In Korean patients, treatment effects and safety of enzalutamide were consistent with those observed in the overall PREVAIL study population.
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DOI
10.4111/icu.2016.57.3.174
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers
Yonsei Authors
정병하(Chung, Byung Ha) ORCID logo https://orcid.org/0000-0001-9817-3660
최영득(Choi, Young Deuk) ORCID logo https://orcid.org/0000-0002-8545-5797
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/147102
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