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Sanofi-Aventis and Geicam Report Positive Results From Breast Cancer Study

Posted on: Wednesday, 28 May 2008, 12:00 CDT

Sanofi-aventis and Geicam have announced that for women with high-risk node-negative early stage breast cancer, adjuvant treatment with Taxotere Injection Concentrate as part of the TAC regimen was associated with a significant improvement in disease free survival compared to a standard FAC regimen in the Geicam 9805 study.

Geicam 9805 is the first taxane-based study to exclusively enroll women with node-negative early stage breast cancer considered to be at high risk for recurrence. The 1,059 women enrolled in this multicenter, Phase III study were randomized to receive either TAC (n=539) or FAC (n=520) after surgical resection of their tumor. Therapy was given every three weeks for a total of six cycles. The primary endpoint was disease free survival (DFS) and secondary endpoints included overall survival (OS), safety and quality of life.

Analysis of efficacy, determined by DFS, was performed after a minimum of five-years of follow-up. The study showed a significant improvement in five-year DFS that was demonstrated in the TAC arm over the FAC arm, with 91% and 86% patients, respectively, alive and disease free (HR 0.66, 95% CI 0.46-0.94, p=0.0202). The OS data are immature; estimated five-year OS is 97% for TAC and 95% for FAC (HR 0.72, 95% CI 0.40-1.30, p=0.2677).

Miguel Martin, principal investigator of the 9805 study, said: "This study showed that the TAC regimen improves DFS in women with high-risk node-negative breast cancer."

Source: Datamonitor

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