[Clinical phase I trial of concurrent chemo-radiotherapy with S-1 for T2NO glottic carcinoma].
We conducted a phase I study to determine a recommended dose (RD) of S-1 for chemo-radiotherapy consisting of S-1+ radiotherapy for T 2 N 0 larynx cancer. The method of administration used to assess the RD was irradiation with 2 Gy/day for 5 days a week until a total dose of 60 Gy, and concomitant administration of S-1 once a day for 2 weeks beginning on the day therapy was started followed by 2 weeks off the drug and 2 weeks on the drug with the dose escalating from S-1 60 mg/body/day (level 1) to 80 mg/body/day (level 2), and then to 100 mg/body/day (level 3). 18 patients were enrolled. 4 patients developed an adverse event of grade 3 radiation dermatitis which became a dose-limiting toxicity (DLT) at level 3. We then concluded that 100 mg/body/day was the maximum tolerated dose (MTD) of S-1 and decided that the RD of S-1 was 80 mg/body/day.
Tsuji
Hiroyuki
H
Dept. of Otolaryngology, Kanazawa Medical University, Ishikawa, Japan.
Nagata
Motoki
M
Inoue
Toshiya
T
Minami
Toyohiko
T
Iwai
Hiroshi
H
Ohnishi
Sumio
S
Yukawa
Hisaya
H
Ogura
Manabu
M
Yamashita
Toshio
T
Nagata
Kenji
K
D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D003680:Deglutition Disorders / Q000209:etiology; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005931:Glottis; D006801:Humans; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D011832:Radiation Injuries / Q000209:etiology; D011855:Radiodermatitis / Q000209:etiology; D011879:Radiotherapy Dosage; D013280:Stomatitis / Q000209:etiology; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects
D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid