title: Phase I study of oral S-1 and concurrent radiotherapy in patients with head and neck cancer.
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/m(2) 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/m(2), 6 patients at 60 mg/m(2), and 3 patients at 80 mg/m(2)) were enrolled in this trial. At the dose of 80 mg/m(2), 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/m(2). 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/m(2).
authors.affiliation: Department of Radiology, Sapporo Medical University, S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan. kensei@sapmed.ac.jp
authors.forename: Kensei
authors.initials: K
authors.lastname: Nakata
authors.forename: Koh-Ichi
authors.initials: K
authors.lastname: Sakata
authors.forename: Masanori
authors.initials: M
authors.lastname: Someya
authors.forename: Katsutoshi
authors.initials: K
authors.lastname: Miura
authors.forename: Junichi
authors.initials: J
authors.lastname: Hayashi
authors.forename: Masakazu
authors.initials: M
authors.lastname: Hori
authors.forename: Masaru
authors.initials: M
authors.lastname: Takagi
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Himi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kondo
authors.forename: Masato
authors.initials: M
authors.lastname: Hareyama
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy / Q000379:methods; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D012206:Rhabdomyolysis / Q000139:chemically induced; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid
keywords: Phase I study; S-1; chemoradiotherapy; head and neck cancer