Study drug improves survival for advanced prostate cancer

Results from a phase 3 trial by Sanofi-aventis have shown that the investigational compound, cabazitaxel, plus prednisone/prednisolone markedly enhanced overall and progression-free survival in patients with metastatic hormone-refractory prostate cancer in which the disease advanced after treatment with docetaxel-based chemotherapy.

In the multicenter, randomized TROPIC trial, conducted across 26 countries including the United States, researchers compared the combined treatment of cabazitaxel plus prednisone/prednisolone with mitoxantrone plus prednisone/prednisolone for a total of 755 patients with metastatic hormone-refractory prostate cancer.

“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, Plitz Professor for Cancer Research,Tulane Medical School, New Orleans.

The trial was intended to evaluate those with metastatic hormone-refractory prostate cancer whose disease had advanced after treatment with docetaxel-based chemotherapy. Risk of death was reduced by 30% [HR=0.70; 95% CI, 0.59–0.83; P.0001] as a result of the combination of cabazitaxel and prednisone/prednisolone with a clinically meaningful median overall survival of 15.1 months in the cabazitaxel combination arm, compared with 12.7 months in the mitoxantrone combination arm.

The most frequent grade 3/4 hematological adverse events with cabazitaxel were neutropenia (81.7%), febrile neutropenia (7.5%), and infections (10.2%); frequent grade 3/4 non-hematological adverse events are nausea (1.9%), vomiting (1.9%), and diarrhea (6.2%). Deaths associated with adverse events were 4.9% for those treated with cabazitaxel, compared with 1.9% for those taking mitoxantrone.