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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


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