Phase I study of oral S-1 and concurrent radiotherapy in patients with head and neck cancer

Author: Nakata Kensei   Sakata Koh-ichi   Someya Masanori   Miura Katsutoshi   Hayashi Junichi   Hori Masakazu   Takagi Masaru   Himi Tetsuo   Kondo Atsushi   Hareyama Masato  

Publisher: Oxford University Press

ISSN: 0449-3060

Source: Journal of Radiation Research, Vol.54, Iss.4, 2013-07, pp. : 679-683

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Abstract

This study investigated the maximum tolerated dose (MTD) of S-1 with concurrent radiotherapy in patients with head and neck cancer, based on the frequency of dose-limiting toxicities (DLT). S-1 was administered orally at escalating doses from 40 mg/m2 b.i.d. on the days of delivering radiotherapy, which was given at a total dose of 6470 Gy in 3235 fractions over 67 weeks. A total of 12 patients (3 patients at 40 mg/m2, 6 patients at 60 mg/m2, and 3 patients at 80 mg/m2) were enrolled in this trial. At the dose of 80 mg/m2, two of the three patients developed DLT (Grade 3 anorexia and rhabdomyolysis) due to S-1, so the MTD was determined to be 80 mg/m2. Among the 12 enrolled patients, 9 (75) showed a complete response and 3 (25) showed a partial response. The overall response rate was 100. The recommended dose of S-1 with concurrent radiotherapy is 60 mg/m2.

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