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First Drug for Advanced Prostate Cancer To Show a Survival Benefit

Men with androgen-independent (hormone-refractory) metastatic prostate cancer treated with Taxotere® (docetaxel) Injection Concentrate in combination with 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.

The data was presented today during the plenary session at the American Society of Clinical Oncology's (ASCO) 40th Annual Meeting in New Orleans.

In multi-center clinical trial of patients enrolled in the Southwest Oncology Group (SWOG), the 334 men treated with docetaxel/estramustine lived an average of 18 months, compared with 16 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 (six vs. three months). The SWOG trial investigators reported a 27-percent increase in disease-progression-free survival and a 55-percent increase in objective response rate in the Taxotere®-containing arm. In addition, the majority of patients had a PSA decline of more than 50 percent.

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 androgen-independent (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 New York-Presbyterian Hospital, 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.

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) metastatic 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 Pharmaceuticals Inc. of Bridgewater, NJ.