RT Journal Article SR Electronic T1 Phase I Pharmacokinetic Study of S-1 Granules and Nedaplatin for Advanced Head and Neck Cancer JF Anticancer Research JO Anticancer Res FD International Institute of Anticancer Research SP 5699 OP 5705 VO 33 IS 12 A1 HIDETOSHI HAYASHI A1 ISAMU OKAMOTO A1 SHINYA UEDA A1 KAORU TANAKA A1 KUNIO OKAMOTO A1 HISATO KAWAKAMI A1 SHINICHI NISHINA A1 MASAYUKI TAKEDA A1 YASUHITO FUJISAKA A1 TAROH SATOH A1 KYOICHI TERAO A1 YASUMASA NISHIMURA A1 KATSUMI DOI A1 KAZUHIKO NAKAGAWA YR 2013 UL http://ar.iiarjournals.org/content/33/12/5699.abstract AB 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.