Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study
机构：[1]Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai,[2]Department of Oncology, Jiangsu Cancer Hospital, Nanjing,[3]Department of Urology, Huadong Hospital, Fudan University, Shanghai,[4]Department of Urology, Cancer Institute (Hospital), Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing,[5]Department of Urology, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou,[6]Urology Center, Southwest Hospital, Third Military Medical University, Chongqing,[7]Department of Urinary Surgery, Second Affiliated Hospital of Soochow University, Suzhou,[8]Department of Urology, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai,[9]Department of Urology, Peking University First Hospital and Institute of Urology, Peking University, National Urological Cancer, Beijing,[10]Department of Urology, Tongji Medical College, Tongji Hospital, Huazhong University of Science and Technology, Wuhan,[11]Department of Urology, School of Medicine, First Affiliated Hospital, Zhejiang University, Hangzhou,[12]Department of Urology, Fudan University Shanghai Cancer Center, Shanghai[13]Janssen Research & Development, Beijing, China[14]Janssen Research & Development, Beerse, Belgium
Objectives: To evaluate the efficacy and safety of abiraterone acetate-prednisone versus placebo-prednisone in Asian metastatic castration-resistant prostate cancer patients who have failed docetaxel-based chemotherapy. Methods: In this double-blind, phase 3 study from China, 214 patients were randomized (2:1) to abiraterone acetate 1000 mg once daily plus prednisone 5 mg twice daily and placebo plus prednisone 5 mg twice daily in 28-day treatment cycles. Results: Abiraterone acetate-prednisone treatment significantly decreased prostate-specific antigen progression risk by 49%, with longer median time to prostate-specific antigen progression of 5.55 months versus 2.76 months in the placebo-prednisone group (hazard ratio 0.506, P = 0.0001, primary end-point). There was a strong trend for improved overall survival in the abiraterone acetate-prednisone group, with a 40% decrease in the risk of death (hazard ratio 0.604, P = 0.0597); however, median survival was not reached in either group because of the short follow-up period (12.9 months) and limited number of observed death events. The prostate-specific antigen response rate was higher in the abiraterone-prednisone group (49.7%) than in the placebo-prednisone group (14.1%). A total of 37.1% patients in this group had pain progression events compared with 50.7% in the placebo-prednisone group. Abiraterone-prednisone significantly decreased the risk of pain progression by 50% (hazard ratio 0.496, P = 0.0014). The incidence of adverse events was similar between the two groups; the most common adverse events being anemia (25.9% for abiraterone-prednisone vs 22.5% for placebo-prednisone), hypokalemia (25.9% and 11.3%), bone pain (23.8% and 21.1%), hypertension (16.1% and 12.7%) and increased aspartate aminotransferase (14.7% and 15.5%), respectively. Conclusions: Abiraterone-prednisone significantly delays disease and pain progression, and prostate-specific antigen, with a favorable benefit-risk ratio in Asian metastatic castration-resistant prostate cancer patients in the post-docetaxel setting.
第一作者机构：[1]Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai,
通讯作者：
通讯机构：[*1]Department of Urology, Fudan University Shanghai Cancer Center, 270 Dongan Road, Shanghai 200032, China
推荐引用方式(GB/T 7714)：
Yinghao Sun,Qing Zou,Zhongquan Sun,et al.Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study[J].INTERNATIONAL JOURNAL OF UROLOGY.2016,23(5):404-11.doi:10.1111/iju.13051.
APA：
Yinghao Sun,Qing Zou,Zhongquan Sun,Changling Li,Chuanjun Du...&Dingwei Ye.(2016).Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study.INTERNATIONAL JOURNAL OF UROLOGY,23,(5)
MLA：
Yinghao Sun,et al."Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study".INTERNATIONAL JOURNAL OF UROLOGY 23..5(2016):404-11
