Sun Yinghao, Zou Qing, Sun Zhongquan, Li Changling, Du Chuanjun, Chen Zhiwen, Shan Yuxi, Huang Yiran, Jin Jie, Ye Zhang Qun, Xie Liping, Lin Guowen, Feng Yi, De Porre Peter, Liu Weiping, Ye Dingwei
Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.
Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.
Int J Urol. 2016 May;23(5):404-11. doi: 10.1111/iju.13051. Epub 2016 Feb 15.
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.
评估醋酸阿比特龙-泼尼松对比安慰剂-泼尼松用于已接受多西他赛化疗且治疗失败的亚洲转移性去势抵抗性前列腺癌患者的疗效和安全性。
在这项来自中国的双盲3期研究中，214例患者按2:1随机分组，接受醋酸阿比特龙1000 mg每日1次加泼尼松5 mg每日2次，或安慰剂加泼尼松5 mg每日2次，每28天为一个治疗周期。
醋酸阿比特龙-泼尼松治疗使前列腺特异性抗原进展风险显著降低49%，前列腺特异性抗原进展的中位时间更长，醋酸阿比特龙-泼尼松组为5.55个月，安慰剂-泼尼松组为2.76个月（风险比0.506，P = 0.0001，主要终点）。醋酸阿比特龙-泼尼松组有改善总生存的强烈趋势，死亡风险降低40%（风险比0.604，P = 0.0597）；然而，由于随访期短（12.9个月）且观察到的死亡事件数量有限，两组均未达到中位生存期。醋酸阿比特龙-泼尼松组的前列腺特异性抗原缓解率高于安慰剂-泼尼松组（49.7%对14.1%）。该组共有37.1%的患者发生疼痛进展事件，而安慰剂-泼尼松组为50.7%。醋酸阿比特龙-泼尼松显著降低疼痛进展风险50%（风险比0.496，P = 0.0014）。两组不良事件发生率相似；最常见的不良事件分别为贫血（醋酸阿比特龙-泼尼松组为25.9%，安慰剂-泼尼松组为22.5%）、低钾血症（25.9%和11.3%）、骨痛（23.8%和21.1%）、高血压（16.1%和12.7%）以及天门冬氨酸氨基转移酶升高（14.7%和15.5%）。
在多西他赛治疗后的亚洲转移性去势抵抗性前列腺癌患者中，醋酸阿比特龙-泼尼松显著延缓疾病和疼痛进展以及前列腺特异性抗原进展，且获益风险比良好。
