The recently approved taxane cabazitaxel significantly improved overall survival in men with castration-resistant prostate cancer in a multinational phase 3 study.
The TROPIC investigators found that men treated with cabazitaxel plus prednisone had 30% lower risk of death compared with patients treated with mitoxantrone plus prednisone.
The results are reported by Johann Sebastian de Bono, MD, PhD, of the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, Sutton, England, in the October 2 issue of The Lancet.
This open-label study included 755 men with metastatic castration-resistant prostate cancer who had received hormone therapy but whose disease had progressed during or after docetaxel-based treatment. Subjects were randomized to receive either mitoxantrone (12 mg/m2 intravenously over 15 to 30 minutes) or cabazitaxel (25 mg/ m2 intravenously over 1 hour) every 3 weeks in addition to 10 mg of oral prednisone daily.
Median overall survival was 15.1 months in men treated with cabazitaxel compared with 12.7 months in those who received mitoxantrone. Progression-free survival was also significantly greater with cabazitaxel (2.8 months vs 1.4 months).
The most frequent clinically significant grade 3 or higher adverse events were neutropenia (82% with cabazitaxel vs 58% with mitoxantrone) and diarrhea (6% vs <1%). Febrile neutropenia occurred in 8% of patients treated with cabazitaxel compared with 1% of those who received mitoxantrone. Treatment discontinuations due to adverse effects occurred in 18% of patients treated with cabazitaxel and 8% of those who received mitoxantrone.