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| |  Investigational Cabazitaxel Extends Survival in Men With Metastatic Prostate Cancer: Presented at ASCO-GU By Ed Susman SAN FRANCISCO -- March 6, 2010 -- An experimental taxane drug, cabazitaxel, appears to extend survival by about 3 months among men with metastatic prostate cancer that has continued to progress despite hormone therapy, researchers said here on March 5 at the 2010 Genitourinary Cancers Symposium (ASCO-GU). “There are no effective treatments available to help men with metastatic castration-resistant prostate cancer whose disease continues to grow despite standard chemotherapy, and this large study shows an unequivocal survival benefit for patients who received cabazitaxel,” said Oliver Sartor, MD, Tulane Cancer Center, New Orleans, Louisiana. In the phase 3, randomised Treatment of Hormone-Refractory Metastatic Prostate Cancer Previously Treated With a Taxotere-Containing Regimen (TROPIC) study, Dr. Sartor and colleagues from 132 institutions in 26 countries recruited 755 men (median age, 68 y; 84% white) diagnosed with metastatic castration-refractory prostate cancer. Patients were randomly assigned to receive cabazitaxel 25 mg/m2 every 3 weeks plus oral prednisone 10 mg daily for 10 cycles (n = 378) or mitoxantrone 12 mg/m2 every 3 weeks plus oral prednisone, also for 10 cycles (n = 377). After a median follow-up of 12.8 months, men in the cabazitaxel group lived a median of 15.1 months, while those in the mitoxantrone group lived 12.7 months -- a difference that was highly statistically significant (P < .0001). All the patients in the study had been treated for metastatic castration-resistant prostate cancer with docetaxel -- the only agent shown to be effective in treating the disease in first-line therapy. Dr. Sartor said the primary outcome indicated there was a 30% reduction in the risk of mortality with cabazitaxel. The treatment with cabazitaxel was more likely to cause grade 3 adverse events such as febrile neutropenia, diarrhoea, nausea, vomiting, and abdominal pain than was treatment with mitoxantrone. Funding for this study was provided by sanofi-aventis. The conference is sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Therapeutic Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO). [Presentation title: Cabazitaxel or Mitoxantrone With Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel: Final Results of a Multinational Phase III Trial (TROPIC). Abstract 9]
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