Advanced PCa treatment increases progression-free survival in phase III study

March 25, 2010

Results from a phase III trial have shown that cabazitaxel, an investigational compound, plus prednisone/prednisolone significantly improved overall survival and progression-free survival in patients with metastatic hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel (Taxotere)-based chemotherapy.

Results from a phase III trial have shown that cabazitaxel, an investigational compound, plus prednisone/prednisolone significantly improved overall survival and progression-free survival in patients with metastatic hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel (Taxotere)-based chemotherapy.

The TROPIC (Treatment of Hormone-Refractory Metastatic Prostate Cancer Previously Treated with a Taxotere-Containing Regiment) trial compared the combination of cabazitaxel plus prednisone/prednisolone with the active agent mitoxantrone (Novantrone) plus prednisone/prednisolone.

"These are significant results in the development of this investigational drug," said principal investigator Oliver Sartor, MD of Tulane University Medical School, New Orleans. "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."

Results showed that the combination of cabazitaxel and prednisone/prednisolone significantly reduced the risk of death by 30% (HR=0.70 [95% CI: 0.59-0.83]; pp

The most frequent grade 3/4 hematologic adverse events with cabazitaxel included neutropenia (81.7%), febrile neutropenia (7.5%), and infections (10.2%); the most frequent grade 3/4 non-hematologic adverse events included nausea (1.9%), vomiting (1.9%), and diarrhea (6.2%). Most frequent treatment-emergent adverse events leading to discontinuation in the cabazitaxel arm were neutropenia (2.4%), hematuria (1.3%), diarrhea (1.1%), and fatigue (1.1%).

Dr. Sartor and co-authors of this study disclosed financial interest or other relationship with sanofi-aventis.