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Phase I study of S-1 plus nedaplatin in patients with advanced/recurrent head and neck cancer
Yasunao Kogashiwa1, Kohichi Yamauchi, Hiroshi Nagafuji
1Department of Otorhinolaryngology, Head and Neck Surgery, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo, Japan.
Background:
Cisplatin plus fluorouracil is widely used for the treatment of head and neck cancer. However, the cisplatin plus fluorouracil regimen necessitates hospitalization. Therefore, we planned to develop a new regimen that can be administered on an outpatient basis and performed a phase I study of S-1 + nedaplatin.
Methods:
S-1 was given orally at a fixed dose for 14 days, and nedaplatin was administered intravenously on day 8 of S-1 administration. The dose of nedaplatin was increased in 10-mg/m(2) steps to find the maximum tolerated dose, depending on the appearance of dose-limiting toxicities.
Results:
A total of 14 patients were registered. The maximum tolerated dose of nedaplatin was determined to be 90 mg/m(2). The main toxicities were neutropenia and thrombocytopenia. The response rate was 57.1%.
Conclusion:
The recommended dose of nedaplatin for a phase II study was determined to be 80 mg/m(2). We concluded that our regimen was well tolerated and that the response rate was acceptable.
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