title: [An institution-randomized trial of 5-fluorouracil and l-leucovorin therapy given monthly versus every two months to patients with advanced colorectal carcinoma].
abstract: The aim of this study was to evaluate the efficacy and toxicity of 5-fluorouracil (5-FU) and l-leucovorin (l-LV) given at the same dose intensity and administered monthly (given weekly for 3 weeks followed by a week of rest; arm A) or every 2 months (given weekly for 6 weeks followed by 2 weeks rest; arm B) to patients with advanced colorectal carcinoma. The dose of 5-FU was 500 mg/body or 750 mg/body, with an average dose of 432.8 mg/m2. A total of 7 institutions participated in this multi-center study and were randomly divided into 2 groups of arms A and B. Thirty-three patients were entered into arm A and 21 into B. The overall response rate was significantly (p = 0.007) greater in arm B (23.5%) than in arm A (0%). The most frequently observed toxicity was diarrhea, which was observed in 6.5% of arm A and in 33.3% of arm B, marking a significant difference (p = 0.034). These data suggest that a monthly 5-FU/l-LV regimen might be less toxic than a 2-months regimen and less effective at the dose given as above. Further study is needed to evaluate the efficacy of a monthly regimen.
authors.affiliation: Dept. of Surgery, Yokohama City Kowan Hospital.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Hasegawa
authors.forename: Makoto
authors.initials: M
authors.lastname: Akaike
authors.forename: Yuji
authors.initials: Y
authors.lastname: Yamamoto
authors.forename: Ryuji
authors.initials: R
authors.lastname: Shiraishi
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Ozawa
authors.forename: Hiroharu
authors.initials: H
authors.lastname: Suzuki
authors.forename: Takuya
authors.initials: T
authors.lastname: Miyazaki
authors.forename: Akio
authors.initials: A
authors.lastname: Kasahara
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Makino
authors.forename: Isao
authors.initials: I
authors.lastname: Tamura
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Tanabe
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Rino
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001853:Bone Marrow / Q000187:drug effects; D016022:Case-Control Studies; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D012074:Remission Induction; D015996:Survival Rate
chemical_list: D002955:Leucovorin; D005472:Fluorouracil