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

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

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

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

Respirology

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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/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.

Original language	English
Pages (from-to)	5699-5706
Number of pages	8
Journal	Anticancer research
Volume	33
Issue number	12
Publication status	Published - Dec 1 2013

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Oncology
Cancer Research

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Hayashi, H., Okamoto, I., Ueda, S., Tanaka, K., Okamoto, K., Kawakami, H., ... Nakagawa, K. (2013). Phase I pharmacokinetic study of S-1 granules and nedaplatin for advanced head and neck cancer. Anticancer research, 33(12), 5699-5706.

Phase I pharmacokinetic study of S-1 granules and nedaplatin for advanced head and neck cancer. / Hayashi, Hidetoshi; Okamoto, Isamu; Ueda, Shinya; Tanaka, Kaoru; Okamoto, Kunio; Kawakami, Hisato; Nishina, Shinichi; Takeda, Masayuki; Fujisaka, Yasuhito; Satoh, Taroh; Terao, Kyoichi; Nishimura, Yasumasa; Doi, Katsumi; Nakagawa, Kazuhiko.

In: Anticancer research, Vol. 33, No. 12, 01.12.2013, p. 5699-5706.

Research output: Contribution to journal › Article

Hayashi, Hidetoshi ; Okamoto, Isamu ; Ueda, Shinya ; Tanaka, Kaoru ; Okamoto, Kunio ; Kawakami, Hisato ; Nishina, Shinichi ; Takeda, Masayuki ; Fujisaka, Yasuhito ; Satoh, Taroh ; Terao, Kyoichi ; Nishimura, Yasumasa ; Doi, Katsumi ; Nakagawa, Kazuhiko. / Phase I pharmacokinetic study of S-1 granules and nedaplatin for advanced head and neck cancer. In: Anticancer research. 2013 ; Vol. 33, No. 12. pp. 5699-5706.

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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/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.",

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AU - Hayashi, Hidetoshi

AU - Okamoto, Isamu

AU - Ueda, Shinya

AU - Tanaka, Kaoru

AU - Okamoto, Kunio

AU - Kawakami, Hisato

AU - Nishina, Shinichi

AU - Takeda, Masayuki

AU - Fujisaka, Yasuhito

AU - Satoh, Taroh

AU - Terao, Kyoichi

AU - Nishimura, Yasumasa

AU - Doi, Katsumi

AU - Nakagawa, Kazuhiko

PY - 2013/12/1

Y1 - 2013/12/1

N2 - 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.

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.

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

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