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

Abstract

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/m(2) (level 1) escalating up to 90 mg/m(2) (level 2), and S-1 granules at a daily dose of 80 mg/m(2) 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.

• Authors: Hidetoshi Hayashi, Isamu Okamoto, Shinya Ueda, Kaoru Tanaka, Kunio Okamoto, Hisato Kawakami, Shinichi Nishina, Masayuki Takeda, Yasuhito Fujisaka, Taroh Satoh, Kyoichi Terao, Yasumasa Nishimura, Katsumi Doi, Kazuhiko Nakagawa
• Journal: Anticancer research (Anticancer Res) Vol. 33 Issue 12 Pg. 5699-705 (Dec 2013) ISSN: 1791-7530 [Electronic] Greece
• PMID: 24324120 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Drug Combinations
• Organoplatinum Compounds
• S 1 (combination)
• Tegafur
• Oxonic Acid
• nedaplatin

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, pharmacokinetics, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy)
• Drug Combinations
• Female
• Head and Neck Neoplasms (drug therapy)
• Humans
• Male
• Middle Aged
• Organoplatinum Compounds (administration & dosage, pharmacokinetics, therapeutic use)
• Oxonic Acid (administration & dosage, pharmacokinetics, therapeutic use)
• Tegafur (administration & dosage, pharmacokinetics, therapeutic use)