Phase I pharmacokinetic study of S-1 granules and nedaplatin for advanced head and neck cancer

Aim: We performed a pharmacokinetic phase I trial of the combination of S-1 granules and nedaplatin for head and neck squamous cell carcinoma (HNSCC). Patients and Methods: Patients were treated with both nedaplatin on day 1 at a dose starting at 80 mg/m2 (level 1) escalating up to 90 mg/m2 (level 2), and S-1 granules at a daily dose of 80 mg/m2 on days 1 to 14 every three weeks. The primary end-point was determination of the recommended dose. Results: Twenty patients were enrolled. Dose-limiting toxicities occurred in one out of six patients at dose level 1 (neutropenia) and in all three patients at level 2 (neutropenia and thrombocytopenia). The recommended dose was determined as level 1. Pharmacokinetic parameters of S-1 granule did not differ from the capsula formulation. The response rate was 42.1%. Conclusion: This combination was well-tolerated and manifested a promising activity against HNSCC.