title: Phase I trial of preoperative chemoradiation therapy with S-1 for low rectal cancer.
abstract: OBJECTIVE
  A phase I study was performed to evaluate the dose-limiting toxicity and the recommended dose of the oral fluoropyrimidine S-1 when administered concurrently with radiation therapy to 9 Japanese patients with low rectal cancer.
  
  
  METHODS
  S-1 was given orally for a total of 9 weeks (4 weeks alone and 5 weeks during radiation therapy) at oral doses of 65 mg/m2/day (n = 3 patients) or 80 mg/m2/day (n = 6 patients). Radiation therapy was administered in 1.5 gray fractions five times weekly (Monday to Friday) for a total dose of 45 gray.
  
  
  RESULTS
  All patients achieved the planned 45 gray of radiation therapy. There was no grade > or = 3 toxicity. The recommended dose of S-1 was determined to be 80 mg/m2/ day. The dose intensity of S-1 was well maintained, and the combination of S-1 plus radiation therapy was well tolerated by all patients. Sphincter-preserving procedures were possible in all but one (89%) patient. High rates of tumor shrinkage and nodular downstaging were achieved. The histological response rate was 78%, including one complete response.
  
  
  CONCLUSIONS
  The recommended dose of S-1 with concurrent radiation therapy was 80 mg/m2/day. Pre-operative chemoradiation therapy with S-1 was feasible and well tolerated by patients with low rectal cancer.
authors.forename: Kimihiko
authors.initials: K
authors.lastname: Funahashi
authors.forename: Junichi
authors.initials: J
authors.lastname: Koike
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Shiokawa
authors.forename: Mitsunori
authors.initials: M
authors.lastname: Ushigome
authors.forename: Hideaki
authors.initials: H
authors.lastname: Shimada
authors.forename: Hironori
authors.initials: H
authors.lastname: Kaneko
authors.forename: Atsuro
authors.initials: A
authors.lastname: Terahara
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D004338:Drug Combinations; D006801:Humans; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000627:therapeutic use*; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D005641:Tegafur / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid