title: Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Yinghao
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Zou
authors.affiliation: Department of Urology, Huadong Hospital, Fudan University, Shanghai, China.
authors.forename: Zhongquan
authors.initials: Z
authors.lastname: Sun
authors.affiliation: Department of Urology, Cancer Institute (Hospital), Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Changling
authors.initials: C
authors.lastname: Li
authors.affiliation: Department of Urology, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
authors.forename: Chuanjun
authors.initials: C
authors.lastname: Du
authors.affiliation: Urology Center, Southwest Hospital, Third Military Medical University, Chongqing, China.
authors.forename: Zhiwen
authors.initials: Z
authors.lastname: Chen
authors.affiliation: Department of Urinary Surgery, Second Affiliated Hospital of Soochow University, Suzhou, China.
authors.forename: Yuxi
authors.initials: Y
authors.lastname: Shan
authors.affiliation: Department of Urology, School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, China.
authors.forename: Yiran
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Department of Urology, Peking University First Hospital and Institute of Urology, Peking University, National Urological Cancer, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Jin
authors.affiliation: Department of Urology, Tongji Medical College, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Zhang Qun
authors.initials: ZQ
authors.lastname: Ye
authors.affiliation: Department of Urology, School of Medicine, First Affiliated Hospital, Zhejiang University, Hangzhou, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Xie
authors.affiliation: Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.
authors.forename: Guowen
authors.initials: G
authors.lastname: Lin
authors.affiliation: Janssen Research & Development, Beijing, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Feng
authors.affiliation: Janssen Research & Development, Beerse, Belgium.
authors.forename: Peter
authors.initials: P
authors.lastname: De Porre
authors.affiliation: Janssen Research & Development, Beijing, China.
authors.forename: Weiping
authors.initials: W
authors.lastname: Liu
authors.affiliation: Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.
authors.forename: Dingwei
authors.initials: D
authors.lastname: Ye
mesh_terms: D000069501:Abiraterone Acetate / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002681:China; D018572:Disease-Free Survival; D000077143:Docetaxel; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D011241:Prednisone / Q000627:therapeutic use; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy*; D043823:Taxoids / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D000069501:Abiraterone Acetate; D011241:Prednisone
keywords: Asian population; abiraterone acetate; castration-resistant prostate cancer; docetaxel; phase 3