Apalutamide for metastatic castration-sensitive prostate cancer:final analysis of the Asian subpopulation in the TITAN trial
作者机构：Gangnam Severance HospitalYonsei University College of MedicineSeoul 06273South Korea Sun Yat-Sen Memorial HospitalSun Yat-Sen UniversityGuangzhou 510123China Yokohama City University Medical CenterMinami-kuYokohamaKanagwa 232-0024Japan Severance HospitalYonsei University College of MedicineSeoul 03722South Korea Tongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China Toho University Sakura Medical CenterChiba 285-0841Japan Chonnam National University Hospital and Medical SchoolGwangju 61469South Korea Department of UrologyThe First Affiliated Hospital of Xi’an Jiaotong UniversityXi’an 710061China Prostate Cancer CenterNational Cancer CenterGoyang 10408South Korea Janssen Research and DevelopmentSpring HousePA 19002USA Ludwig Maximilians UniversityMunich 80539Germany Janssen Research and DevelopmentRaritanNJ 08869USA Janssen Medical AffairsAsia PacificSingapore 118222Singapore Guy’s and St Thomas’NHS Foundation TrustLondon SE14YBUK University of Utah Huntsman Cancer InstituteSalt Lake CityUT 84112USA Fudan University Shanghai Cancer CenterShanghai 200032China Vancouver Prostate CentreUniversity of British ColumbiaVancouverBritish Columbia V6H 3Z6Canada Kindai UniversityFaculty of MedicineOsaka-Sayama 589-8511Japan
出 版 物：《Asian Journal of Andrology》 (亚洲男性学杂志（英文版）)
年 卷 期：2023年第25卷第6期
页 面：653-661页
核心收录：
学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学]
基 金：The study was funded by Janssen Pharmaceutical Ltd.Writing assistance was provided by Katherine A Lyseng-Williamson and Kerry Dechant ISMPP CMPP^(TM) on behalf of Content Ed Net and was funded by Janssen Pharmaceutical Ltd.Janssen Pharmaceutical Ltd.is not involved in the process of experimental design results or discussion and has no competing interests with this study
主 题：apalutamide Asia event-driven analysis metastatic castration-sensitive prostate cancer overall survival
摘 要：The final analysis of the phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen(TITAN)trial showed improvement in overall survival(OS)and other efficacy endpoints with apalutamide plus androgen deprivation therapy(ADT)versus ADT alone in patients with metastatic castration-sensitive prostate cancer(mCSPC).As ethnicity and regional differences may affect treatment outcomes in advanced prostate cancer,a post hoc final analysis was conducted to assess the efficacy and safety of apalutamide in the Asian ***-driven endpoints were OS,and time from randomization to initiation of castration resistance,prostate-specific antigen(PSA)progression,and second progression-free survival(PFS2)on first subsequent therapy or *** endpoints were assessed using the Kaplan–Meier method and Cox proportional-hazards models without formal statistical testing and adjustment for *** Asian patients received once-daily apalutamide 240 mg(n=111)or placebo(n=110)plus *** a median follow-up of 42.5 months and despite crossover of 47 placebo recipients to open-label apalutamide,apalutamide reduced the risk of death by 32%(hazard ratio[HR]:0.68;95%confidence interval[CI]:0.42–1.13),risk of castration resistance by 69%(HR:0.31;95%CI:0.21–0.46),PSA progression by 79%(HR:0.21;95%CI:0.13–0.35)and PFS2 by 24%(HR:0.76;95%CI:0.44–1.29)relative to *** outcomes were comparable between subgroups with low-and high-volume disease at *** new safety issues were *** provides valuable clinical benefits to Asian patients with mCSPC,with an efficacy and safety profile consistent with that in the overall patient population.
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