上海交通大学学报（医学版）

上海交通大学学报（医学版）

• 论著（临床研究） • 上一篇    下一篇

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

樊连城， 董柏君*， 迟辰斐， 潘家骅， 沙建军， 黄翼然， 周立新， 薛蔚   

  1. 上海交通大学 医学院附属仁济医院泌尿科， 上海 200127
  • 出版日期:2016-09-28 发布日期:2016-10-31
  • 通讯作者: 薛蔚, 电子信箱: uroxuewei@163.com。 周立新, 电子信箱: zhou_li_xin@hotmail.com。
  • 作者简介:樊连城 （1993—）， 男， 硕士生; 电子信箱: 787371380@qq.com。 董柏君（1978—），男，主治医师，博士; 电子信箱: 787371380@qq.com。 *共同第一作者。
  • 基金资助:

    国家自然科学基金（81572536)；上海市浦东新区卫生系统重点学科群建设（PWZxq2014-05）；上海市教育委员会高峰高原学科建设计划 （20152215）

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

FAN Lian-cheng, DONG Bai-jun*, CHI Chen-fei, PAN Jia-hua, SHA Jian-jun, HUANG Yi-ran, ZHOU Li-xin, XUE Wei   

  1. Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China
  • Online:2016-09-28 Published:2016-10-31
  • Supported by:

    National Nature Science Foundation of China, 81572536; Key Disciplines Group Construction Project of Pudong Health Bureau of Shanghai, PWZxq2014-05; Shanghai Municipal Education Commission—Gaofeng Clinical Medicine Grant Support, 20152215

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摘要：

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（mCRPC）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mCRPC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（rPFS）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、rPFS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mCRPC患者PSA PFS、rPFS与OS，同时患者耐受性良好，是未经化疗mCRPC患者的有效治疗选择。

关键词: 阿比特龙, 去势抵抗性前列腺癌, 有效性, 安全性

Abstract:

Objective·To assess the efficacy and safety of abiraterone acetate (AA) plus prednisone for treating patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC). Methods·The clinical data of 60 patients with chemotherapy-naive mCRPC who were treated in Renji Hospital from September 2012 to March 2016 were retrospectively analyzed. Forty-three 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 (rPFS), 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, rPFS, 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, rPFS, and OS in patients with chemotherapy-naive mCRPC. The tolerance of patients was satisfactory and it is an effective and safe option for treating chemotherapy-naive mCRPC patients.

Key words: abiraterone, castration-resistant prostate cancer, efficacy, safety