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 o...( Results of Two Major Clinical Stu...),Health

Results of Two Major Clinical Studies TAX 323 and TAX 324 Published

BRIDGEWATER, N.J., Oct. 24 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that results of two clinical studies demonstrating that Taxotere(R) (docetaxel) Injection Concentrate, when added to cisplatin and 5- fluorouracil for induction therapy, significantly improved overall survival (OS) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) are published in the October 25 issue of the New England Journal of Medicine (NEJM).

In the TAX 324 trial, which included primarily North American centers, patients who received Taxotere added to cisplatin and 5-fluorouracil (TPF, n=255) experienced a longer median overall survival (OS) of 71 months vs. 30 months (p=0.006) for patients receiving cisplatin and 5-fluorouracil alone (PF, n=246), representing a more than three-year improvement in median OS for patients treated with TPF and a 30% decrease in the relative risk of death.

In the European TAX 323 (EORTC 24971) trial, conducted on inoperable patients only, the patients treated with TPF (n=177) experienced a significantly longer progression free survival of 11.0 months, compared with 8.2 months for patients treated with PF alone (n=181). At a median follow-up period of 51.1 months, patients receiving the Taxotere-based regimen demonstrated a median OS improvement of 4.3 months compared to those receiving the standard chemotherapy (without Taxotere): 18.8 months vs. 14.5 months (HR: 0.73; p=0.02). Treatment with TPF in the TAX 323 study resulted in a 27% reduction in the risk of death.

"TAX 324 study results show that sequential therapy starting with a Taxotere-based chemotherapy regimen significantly increases survival in patients who are suffering from this particularly deadly form of cancer," said the lead clinical investigator of the TAX 324 study, Marshall Posner, MD, Medical Director of the Head and Neck Oncology Program at Dana
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