The pivotal phase III trial involved 755 patients with metastatic prostate cancer that had progressed after treatment with a docetaxel-based regimen and hormone therapy. Participants were randomly assigned to receive either cabazitaxel or mitoxantrone during 10 cycles of chemotherapy with prednisone.
Researchers reported that the odds of overall survival were 30% better with cabazitaxel than with mitoxantone. Median survival rose from 12.7 months with mitoxantron to 15.1 months with cabazitaxel.
According to the press release announcing the study, cabazitaxel is a new type of taxane chemotherapy chemically modified to overcome the resistance mechanism that eventually hampers other taxanes.
“The benefit shown in the trial is clearly in the range of FDA acceptability,” noted A. Oliver Sarton, MD, of Tulane Cancer Center in New Orleans. “This success in refractory prostate cancer is likely to quickly lead to trials in other tumor types.”