Preoperative concurrent chemotherapy with S-1 and radiotherapy for locally advanced squamous cell carcinoma of the oral cavity: phase I trial.
BACKGROUND
This study was conducted to identify a recommended dose for S-1, used in combination with 40-Gy radiation.


METHODS
Thirty patients, 15 each with stage III and IVA oral carcinoma, were enrolled. All patients received a total dose of 40-Gy. For the S-1 treatment, patients were given either the standard Japanese dose, calculated according to body surface area, or a reduced dose. Groups consisting of at least three patients were given S-1 according to one of 8 regimens.


RESULTS
Hematologic toxicity was mild and reversible. The most common nonhematologic toxicity was mucositis. At level 8 that was the standard S-1 dose for 5 days per week for 4 weeks, dose-limiting toxicity was observed when 2 patients had grade 4 mucositis. This level was thus deemed the maximum tolerated dose for the regimen.


CONCLUSIONS
The recommended dose of S-1 with concurrent radiotherapy was the reduced dose of S-1 given for 5 days per week, for 4 consecutive weeks. Preoperative S-1 and concurrent radiotherapy was well tolerate and feasible and warrants a phase II study.
Harada
Hiroyuki
H
Department of Oral Surgery, Oral Restitution, Division of Oral Health Sciences, Graduate School, Tokyo Medical and Dental University, Japan. hiro-harada.osur@tmd.ac.jp
Omura
Ken
K
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D004307:Dose-Response Relationship, Radiation; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D009362:Neoplasm Metastasis; D010094:Oxonic Acid / Q000008:administration & dosage*; D057234:Preoperative Period; D005641:Tegafur / Q000008:administration & dosage*; D016896:Treatment Outcome
D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid
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