TROPIC: Cabazitaxel improved survival by 30% in metastatic castration–resistant prostate cancer
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2010 Genitourinary Cancers Symposium
Final phase-3 results from TROPIC, a randomized trial of the novel taxane cabazitaxel, showed that compared with standard chemotherapy the drug improved OS in patients with metastatic castrationresistant prostate cancer who previously failed while being treated with docetaxel.
During a press conference in advance of the 2010 Genitourinary Cancers Symposium in San Francisco, A. Oliver Sartor, MD, Piltz Professor of Cancer Research at Tulane Cancer Center in New Orleans, said cabazitaxel, a taxane active in docetaxel-resistant tumor cell lines, may provide an important new treatment option for men with this difficult-to-treat disease.
TROPIC involved 755 men with metastatic castrationresistant prostate cancer who were treated at 132 centers in 26 countries. Patients were randomly assigned to 25 mg/m2 cabazitaxel and prednisone (n=317) or 12 mg/m2 mitoxantrone and prednisone (n=317).
After a median follow-up of 12.8 months, men in the cabazitaxel group lived a median of 15.1 months, whereas those in the mitoxantrone group lived 12.7 months (HR=0.70; 95% CI, 0.59-0.83).
This is a superb HR, Sartor said. It translates into a 30% reduction in the rate of deaths over the course of the study. These are the final results; this is a fully mature result for the trial.
Men in the cabazitaxel group also had superior PFS, as well as superior response rates for tumor assessments by RECIST, PSA response and PSA progression. Sartor said he would release data for these secondary endpoints at the symposium.
The most common grade-3/4 toxicity in both groups was neutropenia, observed in 81.7% of the cabazitaxel group and 58% of those assigned to mitoxantrone.
The safety profile was predictable and manageable, Sartor said. I believe that cabazitaxel will potentially represent a new therapeutic option for these patients who are very difficult to treat. by Jason Harris
For more information:
- Sartor OA. #9. Presented at: 2010 Genitourinary Cancers Symposium; March 5-7, 2010; San Francisco.
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