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Updated Study Results Reinforce Survival Benefit of Taxotere,(Docetaxel) for Men with Advanced, Hormone-Resistant Prostate,Cancer

ormone refractory prostate cancer treated with regimens of Taxotere(R) plus prednisone (n=335) or mitoxantrone plus prednisone (n=337). The primary analysis published in the New England Journal of Medicine in 2004 demonstrated that Taxotere(R) given every three weeks with prednisone led to a superior survival advantage, versus mitoxantrone plus prednisone. The median survival was 18.9 months in the group given docetaxel every 3 weeks and 16.5 months in the mitoxantrone group (HR=0.76, 95% CI [0.62-0.94], p=0.0094).

The primary endpoint was overall survival. Secondary endpoints measured pain and prostate-specific antigen (PSA) levels. PSA is a substance made by the prostate that may be found in an increased amount in the blood of men who have prostate cancer or other conditions such as enlarged prostate.

The most commonly observed adverse events in TAX 327 were alopecia, fatigue and nausea. Grade 3-4 neutropenia was reported more frequently in the Taxotere(R) group than the mitoxantrone group (32 percent vs. 21.7 percent, p=0.004).

The once every three weeks 75mg/m2 Taxotere(R) (docetaxel) plus 5 mg prednisone regimen has been approved for use as a treatment for androgen independent (hormone-refractory) metastatic prostate cancer in the U.S. since May 2004 and October 2004 in Europe. It is the only standard of care first line chemotherapy option for patients with metastatic hormone refractory prostate cancer.

About Prostate Cancer

Prostate cancer ranks third worldwide in cancer incidence and sixth in cancer mortality among men. In Europe in 2004, according to the International Agency for Research on Cancer, 238,000 men were diagnosed with prostate cancer and 85,000 died from prostate cancer in the same year. Approximately 219,000 men in the U.S. are expected to be diagnosed with the disease in 2007 and over 27,000 men are expected to die from the disease. Although men of any age can get prostate cancer, it is found most often in men
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