Abstract
BackgroundWe conducted a phase III study to evaluate S-1 as compared with UFT as control in patients after curative therapy for stage III, IVA, or IVB squamous-cell carcinoma of the head and neck (SCCHN).Patients and MethodsPatients were randomly assigned to the UFT group (300 or 400 mg day-1 for 1 year) or the S-1 group (80, 100, or 120 mg day-1 for 1 year). The primary end point was disease-free survival (DFS). Secondary end points were relapse-free survival, overall survival (OS), and safety.ResultsA total of 526 patients were enrolled, and 505 were eligible for analysis. The 3-year DFS rate was 60.0% in the UFT group and 64.1% in the S-1 group (HR, 0.87; 95%CI, 0.66-1.16; p = 0.34). The 3-year OS rate was 75.8% and 82.9%, respectively (HR, 0.64; 95% CI, 0.44-0.94; p = 0.022). Among grade 3 or higher adverse events, the incidences of leukopenia (5.2%), neutropenia (3.6%), thrombocytopenia (2.0%), and mucositis/stomatitis (2.4%) were significantly higher in the S-1 group.ConclusionsAlthough DFS did not differ significantly between the groups, OS was significantly better in the S-1 group than in the UFT group. S-1 is considered a treatment option after curative therapy for stage III, IVA, IVB SCCHN.Trial Registration ClinicalTrials.gov NCT00336947 http://clinicaltrials.gov/show/NCT00336947
Highlights
Stage III or IV, locally advanced, squamous-cell carcinoma of the head and neck (SCCHN) is usually treated by surgery or Concurrent chemoradiotherapy [1,2,3]
The 3-year overall survival (OS) rate was 75.8% and 82.9%, respectively (HR, 0.64; 95% confidence intervals (95% CI), 0.44-0.94; p = 0.022)
disease-free survival (DFS) did not differ significantly between the groups, OS was significantly better in the S-1 group than in the UFT group
Summary
Patients were randomly assigned to the UFT group (300 or 400 mg day-1 for 1 year) or the S-1 group (80, 100, or 120 mg day-1 for 1 year). The primary end point was disease-free survival (DFS). Secondary end points were relapse-free survival, overall survival (OS), and safety. The funding source of the study participated in study design, but had no role in data collection, data management, data analysis, and data interpretation.
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