Monday, June 10, 2013

Taiho Pharma - TS-1 shows statistically significant survival benefit over standard therapy in patients with Head and Neck Cancer

In the Phase III trial comparing TS-1 (Tegafur+gimeracil+oteracl) with UFT (tegafur + a pro-5FU drug ) in patients who underwent curative treatment for squamous cell carcinoma of the head and neck, TS-1 demonstrated a statistical significant advantage in survival rate compared to standard therapy UFT

The trial showed that 3-year DFS was 60.0% in the UFT group and 64.1% in the TS-1 group, which did not demonstrate the superiority of TS-1 in DFS (HR = 0.87; 95% CI: 0.66-1.16, p=0.34). However, the 3-year survival rate in the UFT group was 75.8% compared to 82.9% in the TS-1 group, which indicated a statistically significant advantage for the TS-1 group (HR = 0.64; 95% CI: 0.44-0.94, p=0.02). 
Adverse events of grade 3 or higher in the TS-1 group included the following (Note: figures in parentheses indicate the incidence rate of grade 3 and 4 adverse events in the TS-1 group): oral mucositis/stomatitis (2.4%), leukopenia (5.2%), neutropenia (3.6%), and thrombocytepenia (2.0%).

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