Efficacy and safety of docetaxel and prednisolone for castration-resistant prostate cancer: a multi-institutional retrospective study in Japan.

Objective: Although some new drugs for castration-resistant prostate cancer are available, docetaxel still plays an important role in castration-resistant prostate cancer treatment. In this study, we evaluated the efficacy and safety of docetaxel and prednisolone in patients with castration-resistant prostate cancer. Methods: We conducted a retrospective chart review of castration-resistant prostate cancer patients who received docetaxel and prednisolone at 14 hospitals in the Sapporo Medical University Urologic Oncology Consortium from August 2004 to December 2011. Results: A total of 140 patients with castration-resistant prostate cancer received docetaxel and prednisolone (median age, 73.8 years; median prostate specific antigen, 54.7 ng/ml). A median of six cycles (range: 1–43) of docetaxel and prednisolone was administered per patient. Median follow-up was 13.7 months. Median overall survival was 22.0 months. The log-rank test revealed that prostate specific antigen before docetaxel and prednisolone (<50 ng/ml) and the prostate specific antigen reduction rate (≥30%) were associated with overall survival (P < 0.001 and P < 0.001, respectively). Eighty patients (57.1%) achieved a prostate specific antigen reduction rate of over 30%. All except two (97.5%) reached 30% prostate specific antigen reduction within five cycles of docetaxel and prednisolone. There were two (1.4%) treatment-related deaths due to adverse events, which were interstitial lung disease, and febrile neutropenia and bacterial pneumonia. Interstitial lung disease occurred in 14 (10.0%) patients within a median of 2.5 cycles of docetaxel and prednisolone. Grade 5 interstitial lung disease was seen after three cycles of docetaxel and prednisolone.