Objective: We investigated the efficacy and toxicity of concurrent chemoradiotherapy with nedaplatin and S-1 for head and neck cancer, as an alternative to cisplatin and 5-fluorouracil. Methods: A total of 31 patients were enrolled in this study. S-1 was administered orally twice a day for 14 days followed by a 2-week rest. Nedaplatin was intravenously administered on day 4. If possible, two courses of chemotherapy were performed. The radiotherapy was started concurrently with the

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... of S-1. Results: The overall complete response rate was 81%. The 2-year overall survival rate was 96%. The 2-year relapse-free survival rate was 94%. The main adverse events were hematological toxicity, mucositis and dermatitis. Conclusions: Our findings suggest that this therapeutic regimen has either an equal or lower toxicity than the conventional cisplatin and 5-fluorouracil, and that it has equal efficacy with regard to the clinical response and short-term outcome. Moreover, it is possible to successfully perform this treatment in an outpatient setting.