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Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study

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单位: [1]Second Mil Med Univ, Shanghai Changhai Hosp, Dept Urol, Shanghai, Peoples R China [2]Jiangsu Canc Hosp, Dept Oncol, Nanjing, Jiangsu, Peoples R China [3]Fudan Univ, Huadong Hosp, Dept Urol, Shanghai 200433, Peoples R China [4]Peking Union Med Coll, Canc Inst Hosp, Dept Urol, Beijing 100021, Peoples R China [5]Chinese Acad Med Sci, Beijing 100730, Peoples R China [6]Zhejiang Univ, Sch Med, Affiliated Hosp 2, Dept Urol, Hangzhou 310003, Zhejiang, Peoples R China [7]Third Mil Med Univ, Southwest Hosp, Urol Ctr, Chongqing, Peoples R China [8]Soochow Univ, Affiliated Hosp 2, Dept Urinary Surg, Suzhou, Peoples R China [9]Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Dept Urol, Shanghai 200030, Peoples R China [10]Peking Univ, Hosp 1, Dept Urol, Beijing 100871, Peoples R China [11]Peking Univ, Inst Urol, Natl Urol Canc, Beijing 100871, Peoples R China [12]Huazhong Univ Sci & Technol,Tongji Hosp,Tongji Med Coll,Dept Urol,Wuhan 430074,Peoples R China [13]Zhejiang Univ, Affiliated Hosp 1, Sch Med, Dept Urol, Hangzhou 310003, Zhejiang, Peoples R China [14]Fudan Univ, Shanghai Canc Ctr, Dept Urol, 270 Dongan Rd, Shanghai 200032, Peoples R China [15]Janssen Res & Dev, Beijing, Peoples R China [16]Janssen Res & Dev, Beerse, Belgium
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关键词: abiraterone acetate Asian population castration-resistant prostate cancer docetaxel phase 3

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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.

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出版当年[2015]版:
大类 | 4 区 医学
小类 | 3 区 泌尿学与肾脏学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 泌尿学与肾脏学
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出版当年[2014]版:
Q2 UROLOGY & NEPHROLOGY
最新[2023]版:
Q3 UROLOGY & NEPHROLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2014版] 出版当年五年平均 出版前一年[2013版] 出版后一年[2015版]

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第一作者单位: [1]Second Mil Med Univ, Shanghai Changhai Hosp, Dept Urol, Shanghai, Peoples R China
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