French drugmaker Sanofi-Aventis says that updated analysis of data from a Phase III trial indicates that Taxotere (docetaxel) reduces the risk of death in patients with advanced prostate cancer. The findings, which were presented at the Amercian Society of Clinical Oncology's Prostate Cancer Symposium in Orlando, Florida (see also page 19), confirm the results of an analysis conducted in 2003.
The TAX 327 trial, which was a randomized, non-blinded assessment that ran from March 2000 to June 2002, enrolled 1,006 men with metastatic hormone refractory prostate cancer. Subjects were divided into one of three groups, receiving either: a 75mg/m2 infusion of Taxotere every three weeks; 30mg/m2 per week for five out of every six weeks; or 12mg/m2 of mitoxantrone. In addition, patients were provided with 5mg of oral prednisone on a twice-daily basis.
The most recent analysis of the results shows that patients who received combined Taxotere and prednisone on a threeweekly basis achieved a median survival time of 19.3 months, compared with the 16.3 month average survival observed in the mitoxantrone plus prednisone group. The firm explained that this equates to a 21% reduction in the risk of death in the Taxotere plus prednisone-treated cohort.
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Chairman, Sanofi Aventis UK
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