Men with androgen-independent (hormone-refractory) metastatic prostate cancer treated with the breast-cancer drug Taxotere (docetaxel) Injection Concentrate in combination with the drug estramustine survived 20 percent longer than similar patients receiving the standard therapy, according to a landmark Phase III study authored by physician-scientists at NewYork-Presbyterian Hospital/Columbia University Medical Center, and published in today's New England Journal of Medicine.
In the multi-center clinical trial of patients enrolled in the Southwest Oncology Group (SWOG), the 334 men were treated with docetaxel/estramustine lived an average of 17.5 months, compared with 15.6 months for the 332 men treated with the standard chemotherapy treatment mitoxantrone/prednisone. Additionally, cancer progression was slowed by half in the docetaxel/estramustine group (6.3 vs. 3.2 months).
While the incidence of adverse events was greater in the docetaxel/estramustine group than the standard chemotherapy group -- mainly due to gastrointestinal and cardiovascular problems -- this did not result in an increased rate of treatment-related mortality.
"The findings show that docetaxel can effectively treat hormone-refractory metastatic prostate cancer and docetaxel/estramustine can now be considered a benchmark for future clinical trials," said Dr. Daniel P. Petrylak, associate professor of medicine at Columbia University College of Physicians & Surgeons, director of the genitourinary oncology program at NewYork-Presbyterian Hospital/Columbia, and lead investigator of the SWOG study. Dr. Petrylak and his colleagues were the first to investigate docetaxel combined with estramustine for prostate cancer, in earlier Phase I and Phase II trials.