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Studies Showing Significant Survival Improvement with Taxotere(R)-based Regimens in the Induction Treatment of Patients with Locally Advanced Head and Neck Cancer are Published in the Same Issue of the New England Journal of Medicine
Date:10/24/2007

-Farber Cancer Institute in Boston.

"Survival rates among patients with unresectable locoregionally advanced squamous cell carcinoma have always been low. These data give these patients new reason for hope," said Jan B. Vermorken, MD, PhD, Head of Oncology Department, University Hospital Antwerp and Head of the EORTC section on Head and Neck Cancer and Principal Investigator of the EORTC 24971/TAX 323 study.

The approval by the U.S. Food and Drug Administration (FDA) and the positive opinion by the European Agency for the Evaluation of Medicinal products (EMEA) of the indications for Taxotere in combination with cisplatin and 5-fluorouracil for the induction treatment of patients with locally advanced SCCHN were based on the TAX 323 and TAX 324 study results.

About the Studies

Both studies are phase III, randomized, open-label trials that included patients with stage III or IV SCCHN with no distant metastases.

The TAX 323 study (EORTC 24971) enrolled 358 European patients with inoperable tumors. Patients were randomized to receive an infusion of Taxotere 75 mg/m2 plus cisplatin 75 mg/m2 on day one, and a five-day continuous infusion of fluorouracil 750 mg/m2 daily or intravenous cisplatin 100 mg/m2 on day one followed by five-day continuous infusion of fluorouracil 1000 mg/m2 per day. In both groups, treatment was given every three weeks for up to four cycles. Within four to seven weeks from the initiation of the last cycle of chemotherapy, both groups of patients were then given radiation therapy for seven weeks.

The Taxotere-based regimen demonstrated a significantly longer progression-free survival (the primary endpoint of the study). The updated survival analysis performed in 2005 at a median follow-up period of 51.1 months confirmed the survival benefit, demonstrating a 4.3 month higher median overall survival for patients receiving the Taxotere-based regimen than for those receiving the standard chemotherapy (without Taxoter
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