阿比特龙联合泼尼松治疗未经化疗转移性去势抵抗性前列腺癌的有效性和安全性

Efficacy and safety of abiraterone combined with prednisone for treating chemotherapynaive metastatic castration-resistant prostate cancer

目的·评价阿比特龙联合泼尼松治疗未经化疗转移性去势抵抗性前列腺癌(m CRPC)患者的有效性和安全性。方法·回顾性分析2012年9月至2016年3月仁济医院收治的60例未经化疗m CRPC患者的临床资料。治疗组为阿比特龙(1 000 mg,每日1次)联合泼尼松(5 mg,每日2次)治疗,共43名;对照组为单纯泼尼松治疗,共17名。观察指标为前列腺特异性抗原无进展生存期(PSA PFS)、影像学无进展生存期(r PFS)和总体生存期(OS)。结果·中位随访时间为14.0月,治疗组11人(25.58%)死亡,对照组8人(47.06%)死亡。治疗组相较对照组中位PSA PFS、r PFS及OS均显著延长。治疗组与对照组最常见三级或四级药物相关不良反应为谷丙转氨酶升高。研究中未发生导致药物无法继续治疗的严重不良反应。结论·阿比特龙联合泼尼松治疗显著延长未经化疗m CRPC患者PSA PFS、r PFS与OS,同时患者耐受性良好,是未经化疗m CRPC患者的有效治疗选择。

Objective· To assess the efficacy and safety of abiraterone acetate(AA) plus prednisone for treating patients with chemotherapy-naive metastatic castration-resistant prostate cancer(m CRPC).Methods · The clinical data of 60 patients with chemotherapy-naive m CRPC who were treated in Renji Hospital from September 2012 to March 2016 were retrospectively analyzed.Fortythree patients received AA(1 000 mg once daily) plus prednisone(5 mg twice daily)(the AA group) and 17 patients received prednisone alone(the control group).Co-primary endpoints were prostate specific antigen progression-free survival(PSA PFS),radiographic progression-free survival(r PFS),and overall survival(OS).Results·The median follow-up time was 14.0 months.There were 11(25.58%) deaths in the AA group and 8(47.06%) deaths in the control group.The AA group had significantly longer median PSA PFS,r PFS,and OS compared with the control group.The most frequently reported grade 3/4 adverse effect(AE) in the two groups was alanine aminotransferase(ALT) increased.There was no AE leading to discontinuation of drug therapy in this study.Conclusion·The AA plus prednisone treatment significantly prolonged PSA PFS,r PFS,and OS in patients with chemotherapy-naive m CRPC.The tolerance of patients was satisfactory and it is an effective and safe option for treating chemotherapy-naive m CRPC patients.