CONCLUSIONS:Concurrent chemoradiotherapy with carboplatin and uracil-f tegafur (UFT) seems to be a promising and appropriate regimen for patients with poor performance status (PS) with locally advanced squamous cell carcinoma of the head and neck (SCCHN). OBJECTIVE: We designed a regimen based on divided low-dose administration to reduce toxicity for patients with poor PS with locally advanced SCCHN. PATIENTS AND METHODS: Sixty-two patients with previously untreated stage III-IV SCCHN and PS of 2 or 3 were entered into this study. They received radiotherapy: 70 Gy/35 fractions. The chemotherapy consisted of a combination of carboplatin (Calvert's formula: (GFR+25) x AUC (=5)/4 mg/week; where AUC area under the curve and GFR = glomerular filtration rate) and UFT (300 mg/day, per os). RESULTS: The overall clinical response rate and the pathological complete response (CR) were 90% (56/62) and 61% (38/62), respectively. Grade > or =3 mucositis occurred in only 6% of patients (4/62) and grade 2 > or =3 leukocytopenia and neutropenia occurred in only 5% (3/62).
RCT Entities:
CONCLUSIONS: Concurrent chemoradiotherapy with carboplatin and uracil-f tegafur (UFT) seems to be a promising and appropriate regimen for patients with poor performance status (PS) with locally advanced squamous cell carcinoma of the head and neck (SCCHN). OBJECTIVE: We designed a regimen based on divided low-dose administration to reduce toxicity for patients with poor PS with locally advanced SCCHN. PATIENTS AND METHODS: Sixty-two patients with previously untreated stage III-IV SCCHN and PS of 2 or 3 were entered into this study. They received radiotherapy: 70 Gy/35 fractions. The chemotherapy consisted of a combination of carboplatin (Calvert's formula: (GFR+25) x AUC (=5)/4 mg/week; where AUC area under the curve and GFR = glomerular filtration rate) and UFT (300 mg/day, per os). RESULTS: The overall clinical response rate and the pathological complete response (CR) were 90% (56/62) and 61% (38/62), respectively. Grade > or =3 mucositis occurred in only 6% of patients (4/62) and grade 2 > or =3 leukocytopenia and neutropenia occurred in only 5% (3/62).