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Apalutamide for metastatic castration-sensitive prostate cancer:final analysis of the Asian subpopulation in the TITAN trial

引用

Asian Journal of Andrology 2023年第6期25卷 653-661页

作者： Byung Ha Chung Jian Huang Hiroji Uemura Young Deuk Choi Zhang-Qun Ye Hiroyoshi Suzuki Taek Won Kang Da-Lin He Jae Young Joung Sabine D Brookman-May Sharon McCarthy Amitabha Bhaumik anildeep singh Suneel Mundle Simon Chowdhury Neeraj Agarwal Ding-Wei Ye Kim N Chi Hirotsugu Uemura Gangnam Severance Hospital Yonsei University College of MedicineSeoul 06273South Korea Sun Yat-Sen Memorial Hospital Sun Yat-Sen UniversityGuangzhou 510123China Yokohama City University Medical Center Minami-kuYokohamaKanagwa 232-0024Japan Severance Hospital Yonsei University College of MedicineSeoul 03722South Korea Tongji Hospital Tongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China Toho University Sakura Medical Center Chiba 285-0841Japan Chonnam National University Hospital and Medical School Gwangju 61469South Korea Department of Urology The First Affiliated Hospital of Xi’an Jiaotong UniversityXi’an 710061China Prostate Cancer Center National Cancer CenterGoyang 10408South Korea Janssen Research and Development Spring HousePA 19002USA Ludwig Maximilians University Munich 80539Germany Janssen Research and Development RaritanNJ 08869USA Janssen Medical Affairs Asia PacificSingapore 118222Singapore Guy’s and St Thomas’NHS Foundation Trust London SE14YBUK University of Utah Huntsman Cancer Institute Salt Lake CityUT 84112USA Fudan University Shanghai Cancer Center Shanghai 200032China Vancouver Prostate Centre University of British ColumbiaVancouverBritish Columbia V6H 3Z6Canada Kindai University Faculty of MedicineOsaka-Sayama 589-8511Japan

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.

关键词： apalutamide Asia event-driven analysis metastatic castration-sensitive prostate cancer overall survival

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