Tassinari Davide, Cherubini Chiara, Roudnas Britt, Tamburini Emiliano, Drudi Fabrizio, Bianchi Emanuela, Fantini Manuela, Montanari Francesco, Sartori Sergio
Department of Oncology, City Hospital, Rimini, Italy.
Department of Pharmacology, City Hospital, Rimini, Italy.
Rev Recent Clin Trials. 2018;13(3):226-237. doi: 10.2174/1574887113666180404120540.
To compare the efficacy of abiraterone acetate, enzalutamide, cabazitaxel and Radium-223 in the treatment of castration-resistant, docetaxel-resistant metastatic prostate cancer.
An indirect comparison of Overall Survival (OS) and time to PSA progression among abiraterone acetate, enzalutamide, cabazitaxel and Radium-223 was performed with a network metaanalysis. OS in the entire population of patients was the primary endpoint. OS in ECOG 0-1/2, BPISF≤ 4/>4, pretreated with 1 or 2 courses of chemotherapy, age≤65/>65 patients, patients with only bone metastases or bone and visceral metastases, and time to PSA progression were the secondary endpoints. An indirect comparison of the Hazard Ratio and the 95% Confidence Interval was performed, assuming an alpha error of 5% as an index of statistical significance. The among-the-trial heterogeneity was assessed using a qualitative methodological and clinical analysis.
Four trials were selected. In three trials, the comparator was placebo, in one trial it was mitoxantrone, the effect of which in improving survival was considered negligible. No significant difference in OS among abiraterone acetate, enzalutamide, cabazitaxel and radium 223 was observed in neither the entire population nor all the subgroups of patients. Enzalutamide resulted significantly better than abiraterone acetate, cabazitaxel or radium-223 in time to PSA progression.
Since no significant difference in efficacy seems to exist between the four therapeutic options in the treatment of castration-resistant, docetaxel-resistant, metastatic prostate cancer, the safety of the treatment, patient's compliance and costs should represent the criteria to guide clinicians' choice in clinical practice.
比较醋酸阿比特龙、恩杂鲁胺、卡巴他赛和镭-223治疗去势抵抗性、多西他赛抵抗性转移性前列腺癌的疗效。
采用网状Meta分析对醋酸阿比特龙、恩杂鲁胺、卡巴他赛和镭-223的总生存期（OS）和PSA进展时间进行间接比较。患者总体人群的OS为主要终点。ECOG 0-1/2、BPISF≤4/>4、接受过1或2个疗程化疗预处理、年龄≤65/>65岁的患者、仅骨转移或骨与内脏转移患者的OS以及PSA进展时间为次要终点。以5%的α错误作为统计学显著性指标，对风险比和95%置信区间进行间接比较。采用定性方法学和临床分析评估试验间的异质性。
选取了四项试验。在三项试验中，对照为安慰剂，在一项试验中为米托蒽醌，其改善生存的效果被认为可忽略不计。在总体人群或所有患者亚组中，未观察到醋酸阿比特龙、恩杂鲁胺、卡巴他赛和镭-223在OS方面存在显著差异。恩杂鲁胺在PSA进展时间方面显著优于醋酸阿比特龙、卡巴他赛或镭-223。
由于在治疗去势抵抗性、多西他赛抵抗性转移性前列腺癌的四种治疗方案之间似乎不存在显著疗效差异，治疗安全性、患者依从性和成本应成为指导临床医生在临床实践中做出选择的标准。
