Investigational drug may boost survival for certain prostate cancer patients

Cabazitaxel, an investigational compound under development by Sanofi-Aventis, plus prednisone/prednisolone, is associated with improved overall survival and progression-free survival in patients with metastatic (advanced) hormone-refractory prostate cancer whose disease advanced after treatment with docetaxel-based chemotherapy.

The TROPIC phase-3 trial conducted in 146 sites in 26 countries and involving 755 patients, analyzed the combination of cabazitaxel plus prednisone/prednisolone against the active agent mitoxantrone plus prednisone/prednisolone.

"Improved overall survival was demonstrated in this trial – and these are the first data to show a statistical improvement in overall survival in patients with this difficult-to-treat and aggressive form of prostate cancer,” said Oliver Sartor, MD, North American principal investigator, Tulane Medical School, New Orleans.

Findings demonstrated that the combination of cabazitaxel and prednisone/prednisolone significantly reduced the risk of death by 30% (P.0001) with a clinically significant enhancement in the median overall survival of 15.1 months in the cabazitaxel combination arm versus 12.7 months in the mitoxantrone combination arm. Patients taking the combination treatment with cabazitaxel also showed a significant increase in median progression-free survival (2.8 months vs. 1.4 months; P.0001).