[An institution-randomized trial of 5-fluorouracil and l-leucovorin therapy given monthly versus every two months to patients with advanced colorectal carcinoma]

Gan To Kagaku Ryoho. 2004 May;31(5):729-33.
[Article in Japanese]


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.

Publication types

  • Clinical Trial
  • English Abstract
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bone Marrow / drug effects
  • Case-Control Studies
  • Colonic Neoplasms / drug therapy*
  • Colonic Neoplasms / mortality
  • Diarrhea / chemically induced
  • Drug Administration Schedule
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Gastrointestinal Diseases / chemically induced
  • Humans
  • Leucovorin / administration & dosage
  • Leucovorin / adverse effects
  • Male
  • Middle Aged
  • Prospective Studies
  • Rectal Neoplasms / drug therapy*
  • Rectal Neoplasms / mortality
  • Remission Induction
  • Survival Rate


  • Leucovorin
  • Fluorouracil