Phase I study of oral S-1 and concurrent radiotherapy in patients with head and neck cancer |
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| Authors: | Kensei Nakata Koh-ichi Sakata Masanori Someya Katsutoshi Miura Junichi Hayashi Masakazu Hori Masaru Takagi Tetsuo Himi Atsushi Kondo Masato Hareyama |
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| Institution: | 1.Department of Radiology, Sapporo Medical University, S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan;2.Department of Otolaryngology, Sapporo Medical University, S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan |
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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 64–70 Gy in 32–35 fractions over 6–7 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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| Keywords: | head and neck cancer chemoradiotherapy S-1 Phase I study |
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