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

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 

机构地区：[1]Gangnam Severance Hospital,Yonsei University College of Medicine,Seoul 06273,South Korea [2]Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangzhou 510123,China [3]Yokohama City University Medical Center,Minami-ku,Yokohama,Kanagwa 232-0024,Japan [4]Severance Hospital,Yonsei University College of Medicine,Seoul 03722,South Korea [5]Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China [6]Toho University Sakura Medical Center,Chiba 285-0841,Japan [7]Chonnam National University Hospital and Medical School,Gwangju 61469,South Korea [8]Department of Urology,The First Affiliated Hospital of Xi’an Jiaotong University,Xi’an 710061,China [9]Prostate Cancer Center,National Cancer Center,Goyang 10408,South Korea [10]Janssen Research and Development,Spring House,PA 19002,USA [11]Ludwig Maximilians University,Munich 80539,Germany [12]Janssen Research and Development,Raritan,NJ 08869,USA [13]Janssen Medical Affairs,Asia Pacific,Singapore 118222,Singapore [14]Guy’s and St Thomas’NHS Foundation Trust,London SE14YB,UK [15]University of Utah Huntsman Cancer Institute,Salt Lake City,UT 84112,USA [16]Fudan University Shanghai Cancer Center,Shanghai 200032,China [17]Vancouver Prostate Centre,University of British Columbia,Vancouver,British Columbia V6H 3Z6,Canada [18]Kindai University,Faculty of Medicine,Osaka-Sayama 589-8511,Japan

出　　处：《Asian Journal of Andrology》2023年第6期653-661,共9页亚洲男性学杂志（英文版）

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.

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 subpopulation.Event-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 death.Efficacy endpoints were assessed using the Kaplan–Meier method and Cox proportional-hazards models without formal statistical testing and adjustment for multiplicity.Participating Asian patients received once-daily apalutamide 240 mg(n=111)or placebo(n=110)plus ADT.After 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 placebo.The outcomes were comparable between subgroups with low-and high-volume disease at baseline.No new safety issues were identified.Apalutamide 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 

分 类 号：R737.25[医药卫生—肿瘤]