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A phase 3,double-blind,randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapynaı¨ve patients with mCRPC in China,Malaysia,Thailand and Russia

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Asian Journal of Urology 2017年第2期4卷 75-85页

作者： Dingwei Ye Yiran Huang Fangjian Zhou Keji Xie Vsevolod Matveev Changling Li Boris Alexeev Ye Tian Mingxing Qiu Hanzhong Li Tie Zhou peter de porre Margaret Yu Vahid Naini Hongchuan Liang Zhuli Wu Yinghao Sun department of Urology Fudan University Shanghai Cancer CenterShanghaiChina department of Urology Renji HospitalShanghai Jiao Tong University School of MedicineShanghaiChina Laboratory of Oncology in South China Sun Yat-sen University Cancer CenterGuangzhouGuangdongChina Guangzhou First Municipal People’s Hospital GuangzhouGuangdongChina department of Urology Russian Academy of Medical SciencesMoscowRussia department of Urology Cancer Institute(Hospital)Peking Union Medical College and Chinese Academy of Medical SciencesBeijingChina department of Oncology Moscow Oncology Research InstituteMoscowRussia department of Stomatology Beijing Friendship HospitalCapital Medical UniversityBeijingChina department of Urology Sichuan Academy of Medical Science&Sichuan Provincial People’s HospitalChengduSichuanChina department of Oncology Peking Union Medical College HospitalBeijingChina department of Urology Changhai HospitalSecond Military Medical UniversityShanghaiChina department of Oncology Janssen Research&DevelopmentBeerseBelgium department of Medical Oncology Janssen Research&DevelopmentSan DiegoCAUSA department of Urology Janssen Research&DevelopmentBeijingChina

Objective:This double-blind,placebo-controlled phase 3 study was designed to compare efficacy and safety of abiraterone acetate+prednisone(abiraterone)to prednisone alone in chemotherapy-naı¨ve,asymptomatic or mildly symptomatic metastatic castrationresistant prostate cancer(mCRPC)patients from China,Malaysia,Thailand and ***:Adult chemotherapy-naı¨ve patients with confirmed prostate adenocarcinoma,Eastern Cooperative Oncology Group(ECOG)performance status(PS)grade 0e1,ongoing androgen deprivation(serum testosterone<50 ng/dL)with prostate specific antigen(PSA)or radiographic progression were randomized to receive abiraterone acetate(1000 mg,QD)t prednisone(5 mg,BID)or placebo t prednisone(5 mg,BID),until disease progression,unacceptable toxicity or consent *** endpoint was improvements in time to PSA progression(TTPP).Results:Totally,313 patients were randomized(abiraterone:n Z 157;prednisone:n Z 156);and baseline characteristics were *** clinical cut-off(median follow-up time:3.9 months),80% patients received treatment(abiraterone:n Z 138,prednisone:n Z 112).Median time to PSA progression was not reached with abiraterone versus 3.8 months for prednisone,attaining 58%reduction in PSA progression risk(HR=0.418;p<0.0001).Abirateronetreated patients had higher confirmed PSA response rate(50%vs.21%;relative odds=2.4;p<0.0001)and were 5 times more likely to achieve radiographic response than prednisonetreated patients(22.9%vs.4.8%,p=0.0369).Median survival was not *** common(≥10% abiraterone ***-treated)adverse events:bone pain(7%vs.14%),pain in extremity(6%vs.12%),arthralgia(10%vs.8%),back pain(7%vs.11%),and hypertension(15%vs.14%).Conclusion:Interim analysis confirmed favorable benefit-to-risk ratio of abiraterone in chemotherapy-naı¨ve men with mCRPC,consistent with global study,thus supporting use of abiraterone in this patient population.

关键词： Abiraterone Chemotherapy-naı¨ve Metastatic castrationresistant prostate cancer Prostate specific antigen Prednisone

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