SAN FRANCISCO, CA, USA (UroToday.com) - Dr. A. Oliver Sartor and colleagues presented much awaited results from the TROPIC trial which looked at cabazitaxel or mitoxantrone with prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel.
In a phase III trial, from January 2007 to October 2008, 755 men with castrate resistant metastatic prostate cancer who had progressed despite hormone and docetaxel-based therapy were randomized to either cabazitaxel or mitoxantrone. Men were randomized to cabazitaxel 25 mg/m2 or mitoxantrone 12 mg/m2 3 times a week; both groups received 10 mg/day of prednisone. Cabazitaxel increased survival by 30% in men from a median of 12.7 months to 15.1 months (p < 0.001), compared with mitoxantrone. The safety profile of cabazitaxel was as expected with neutropenia seen in 81.7% of patients and also major grade 3/4 toxicity -7.5% versus 1.3% in the mitoxantrone group.
While the primary end point of the TROPIC trial was overall survival, the authors pointed out that all secondary end points (progression-free survival, tumor response rates, PSA response, and PSA progression) also favored the cabazitaxel group. The study concluded that cabazitaxel conferred a statistically significantly longer overall survival in patients with metastatic castrate resistant prostate cancer progressing after treatment with a docetaxel-containing regimen, which offers a new tool in the armamentarium against this disease.
Presented by A. Oliver Sartor, MD of Tulane University Medical Center at the 2010 Genitourinary Cancers Symposium - March 5 - 7, 2010 - San Francisco Marriott - San Francisco, California
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