Archive for March, 2010

XRP6258 (Cabazitaxel) Increased Survival for Patients with Advanced Hormone Refractory Prostate Cancer

March 10, 2010

Data from the TROPIC clinical trial was announced at the American Society of Clinical Oncology (ASCO) 2010 Genitourinary Cancer Symposium. This phase III study was conducted at 146 sites in 26 countries. CORT was the study site in Dallas, TX. The study included 755 men patients with hormone refractory prostate cancer whose disease had progressed despite previous docetaxel (Taxotere) chemotherapy.

The primary endpoint of the study was overall survival. Patients were randomly assigned to receive XRP6258 (Cabazitaxel) plus prednisone/prednisolone or mitoxantrone plus prednisone/prednisolone, the latter being an existing stardard-of-care therapy for second-line chemotherapy in such patients.

The results showed that the combination of cabazitaxel plus prednisone/prednisolone signficantly reduced the risk of death by 30% (hazard ratio (HR)=0.70; CI: 0.59-0.83; p<0.0001) with a clinically meaningful improvement in median overall survival of 15.1 months in the cabazitaxel combination arm versus 12.7 months in the mitoxantrone combination arm.

CORT wishes to thank the patients who participated in this clinical trial. Their courage and generosity of spirit enabled such critical reseach to be done.

Based on important clinical trial information such as was obtained in this study, cabazitaxel recently received fast track designation from the US FDA.