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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.

DC FieldValueLanguage
dc.contributor.author정병하-
dc.contributor.author최영득-
dc.date.accessioned2017-02-27T08:10:28Z-
dc.date.available2017-02-27T08:10:28Z-
dc.date.issued2016-
dc.identifier.issn2466-0493-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/147102-
dc.description.abstractPURPOSE: 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.-
dc.description.statementOfResponsibilityopen-
dc.format.extent174~183-
dc.languageEnglish-
dc.publisherKorean Urological Association-
dc.relation.isPartOfINVESTIGATIVE AND CLINICAL UROLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdenocarcinoma/blood-
dc.subject.MESHAdenocarcinoma/diagnostic imaging-
dc.subject.MESHAdenocarcinoma/drug therapy-
dc.subject.MESHAdenocarcinoma/secondary*-
dc.subject.MESHAdministration, Oral-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHAntineoplastic Agents, Hormonal/adverse effects-
dc.subject.MESHAntineoplastic Agents, Hormonal/blood-
dc.subject.MESHAntineoplastic Agents, Hormonal/therapeutic use*-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols/therapeutic use-
dc.subject.MESHDisease Progression-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHHumans-
dc.subject.MESHKallikreins/blood-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHPhenylthiohydantoin/adverse effects-
dc.subject.MESHPhenylthiohydantoin/analogs & derivatives*-
dc.subject.MESHPhenylthiohydantoin/blood-
dc.subject.MESHPhenylthiohydantoin/therapeutic use-
dc.subject.MESHProstate-Specific Antigen/blood-
dc.subject.MESHProstatic Neoplasms, Castration-Resistant/blood-
dc.subject.MESHProstatic Neoplasms, Castration-Resistant/diagnostic imaging-
dc.subject.MESHProstatic Neoplasms, Castration-Resistant/drug therapy*-
dc.subject.MESHRadiography-
dc.subject.MESHSurvival Analysis-
dc.subject.MESHTreatment Outcome-
dc.titleThe PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients.-
dc.typeArticle-
dc.publisher.locationKorea-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Urology-
dc.contributor.googleauthorChoung-Soo Kim-
dc.contributor.googleauthorAd Theeuwes-
dc.contributor.googleauthorDong Deuk Kwon-
dc.contributor.googleauthorYoung Deuk Choi-
dc.contributor.googleauthorByung Ha Chung-
dc.contributor.googleauthorHyun Moo Lee-
dc.contributor.googleauthorKang Hyun Lee-
dc.contributor.googleauthorSang Eun Lee-
dc.identifier.doi10.4111/icu.2016.57.3.174-
dc.contributor.localIdA03607-
dc.contributor.localIdA04111-
dc.relation.journalcodeJ01185-
dc.identifier.eissn2466-054X-
dc.relation.journalsince2016~-
dc.identifier.pmid27195316-
dc.relation.journalbefore~2015 Korean Journal of Urology-
dc.subject.keywordAntineoplastic agents-
dc.subject.keywordCastration-resistant prostatic neoplasms-
dc.subject.keywordDisease-free survival-
dc.subject.keywordMDV 3100-
dc.subject.keywordRepublic of Korea-
dc.contributor.alternativeNameChung, Byung Ha-
dc.contributor.alternativeNameChoi, Young Deuk-
dc.contributor.affiliatedAuthorChung, Byung Ha-
dc.contributor.affiliatedAuthorChoi, Young Deuk-
dc.citation.volume57-
dc.citation.number3-
dc.citation.startPage174-
dc.citation.endPage183-
dc.identifier.bibliographicCitationINVESTIGATIVE AND CLINICAL UROLOGY, Vol.57(3) : 174-183, 2016-
dc.date.modified2017-02-24-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers

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