Phase I Study of Nedaplatin Prior to S-1 in Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma

Background: We previously reported on the regimen of S-1 plus nedaplatin (NDP), with S-1 was administered orally for 14 days and NDP intravenously on day 8. The maximum tolerated dose (MTD) of NDP was determined to be 90 mg/m(2). The main toxicities were neutropenia and thrombocytopenia. This result was tolerated, but we believe there is a more effective and tolerable regimen. Thus, we investigated the S-1 regimen administered orally for 14 days, and NDP intravenously on day 1 in patients with locally advanced head and neck squamous cell carcinoma. Patients and Methods: Oral administration of S-1 (days 1-14) and intravenous NDP (day 1) were tested for patients with advance head and neck cancer in a phase I setting. The dose of S-1 was fixed and the dose of NDP was escalated from 70 mg/m(2), with an increase of 10 mg/m(2) per step, to find the MTD. Results: A total of 15 patients were registered. The MTD of NDP was determined to be 100 mg/m(2). The main toxicities were neutropenia and thrombocytopenia. The response rate (RR) was 57.1%. Conclusions: The recommended dose of NDP for a phase II study was determined to be 100 mg/m(2). We concluded that our regimen was well tolerated and that the RR was acceptable. (C) 2014 S. Karger AG, Basel