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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

e): 18.8 months vs. 14.5 months (HR: 0.73; p=0.02). Treatment with TPF resulted in a 27% reduction in the risk of death. In addition, the best overall response to chemotherapy was significantly higher in the Taxotere(R)-based regimen arm compared to the standard arm: 68% (n=120) versus 54% (n=98) (p=0.006).

Patients in the TPF arm compared to the cisplatin and fluorouracil arm (PF) had grade 3/4 neutropenia (76.9% vs. 52.5%), alopecia (11.6% vs. 0%), anemia (9.2% vs. 12.8%) and infection (6.9% vs. 6.1%). Patients receiving the PF regimen had greater grade 3/4 nausea (6.7% vs. 0.6%), vomiting (4.5% vs. 0.6%) and stomatitis (11.2% vs. 4.6%). Commonly seen adverse events in the Taxotere-based regimen included febrile neutropenia (5.2%) and neutropenic infection (13.9%).

The Tax 324 study included not only inoperable patients, but also patients whose tumors were considered potentially operable with low surgical cure or whose tumors were not removed in order to preserve organ function. Patients were randomly assigned to be treated every three weeks for three cycles either with an intravenous infusion of Taxotere 75 mg/m(2) plus cisplatin 100 mg/m(2) on day one and fluorouracil 1000 mg/m(2) per day on days one through four, or the standard therapy, which was intravenous cisplatin 100 mg/m(2) followed by fluorouracil 1000 mg/m(2) per day for five days. Both groups of patients were then given concomitant weekly chemotherapy and radiation therapy for seven weeks. Surgery was performed for those patients considered candidates at the end of the above treatment sequence.

Median overall survival (the primary end point of the study) was significantly improved for patients treated with the Taxotere-based therapy: 71 months vs. 30 months for patients receiving the standard treatment, with a relative risk of death that was 30% lower (HR 0.70; p=0.006). This represents a more than three year absolute improvement in median overall survival. The probability to survive
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