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| |  Study Affirms Benefit of Cabazitaxel in Castration-Resistant Prostate Cancer: Presented at ASCO By Ed Susman CHICAGO -- June 9, 2010 -- Men with castration-resistant prostate cancer can achieve an extended survival if they are treated with the investigational taxane cabazitaxel, researchers said here at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO). Researchers said that the final results of the Treatment of Hormone-Refractory Metastatic Prostate Cancer Previously Treated With a Taxotere-Containing Regimen (TROPIC) trial confirmed that treatment with the investigative drug was associated with a relative risk reduction of mortality of 28% when compared with treatment with mitoxantrone therapy (P < .0001). "Cabazitaxel is the first treatment to show a survival benefit to patients with metastatic castrate-resistant prostate cancer after failure of docetaxel-based therapy," said Johann De Bono, MD, Royal Marsden Hospital, London, United Kingdom, during an oral presentation here on June 6. Overall, the mean survival of these patients with advanced cancer was 15.1 months on cabazitaxel and 12.7 months on mitoxantrone. The hazard ratio was 0.72 (95% confidence interval, 0.61-0.84), Dr. De Bono said. He also reported that patients receiving cabazitaxel also showed significant improvement in progression-free-survival, in the tumour response rate and in time to progression. In the trial 371 patients were assigned to received mitoxantrone 12 mg/m2 every 3 weeks. A second group of 371 patients were treated with cabazitaxel 25 mg/m2 every 3 weeks, Dr. De Bono said. All participants got prednisone 10 mg/day for 10 cycles of chemotherapy. Almost all the patients in the study experienced neutropenia. About 58% of the mitoxantrone-treated patients experienced grade 3 or greater neutropenia; 81.7% of the patients on cabazitaxel also experienced greater than grade 3 neutropenia. Prophylactic use of white blood cell growth factors was permitted at the discretion of the investigator, except for the first cycle of treatment. "Proactive management of side effects is recommended," Dr. De Bono said. The trial discussant, Ian Tannock, MD, Ontario Cancer Institute, Princess Margaret Hospital, Toronto, Ontario, suggested that the rate of toxic deaths -- about 5% of the patients on cabazitaxel -- might have been mitigated if the researchers had used a lower dose of the drug; a dose which was found to have fewer side effects in breast cancer. "Cabazitaxel significantly improved survival when compared with mitoxantrone in men who received prior docetaxel," he said, "and will likely to become standard of care." He also suggested that the selection of mitoxantrone as the comparator drug was appropriate in the trial. "There is no US Food and Drug Administration-approved treatment after docetaxel," he said. Funding for this study was provided by sanofi-aventis. [Presentation title: Cabazitaxel or Mitoxantrone With Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Docetaxel: Final Results of a Multinational Phase III Trial (TROPIC). Abstract 4508]
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