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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.

The SWOG trial investigators also reported a 27 percent increase in progression-free survival (PFS), a 85 percent increase in prostate specific antigen (PSA) response and a 55 percent increase in objective response rate in the Taxotere® containing arm. The study was first presented at the American Society of Clinical Oncology's (ASCO) 40th Annual Meeting in New Orleans.

As a result of a concurrent study (TAX 327) of Taxotere® (docetaxel) in combination with prednisone (a steroid), on May 19, 2004, the Food and Drug Administration (FDA) approved Taxotere® for the treatment of patients with androgen-independent (hormone-refractory) metatstatic prostate cancer.

Prostate cancer is the second leading cause of cancer death in men. The American Cancer Society estimates there will be about 230,900 new cases of prostate cancer in the United States in 2004. About 29,900 men will die of this disease this year alone.

Taxotere® works by inhibiting tubulin, a protein essential to cell division, thus preventing cancer cells from dividing and growing in number. The drug is manufactured by Aventis, part of the sanofi-aventis Group.