Treatment of advanced colorectal cancer with high-dose intensity folinic acid and 5-fluorouracil plus supportive care

Eur J Cancer. 1995 Nov;31A(12):2105-8. doi: 10.1016/0959-8049(95)00488-2.


This randomised clinical trial, involving patients with advanced colorectal cancer, was carried out to compare the effectiveness of accelerated folinic acid (FA) plus 5-fluorouracil (5-FU) with that of the conventional regimen of 5-FU alone. Both regimens were administered with simulataneous supportive care. 185 patients were eligible: 94 were randomly allocated to receive FA 200 mg/m2 i.v. plus 5-FU 400 mg/m2 i.v. on days 1-5 every 3 weeks; and 91 to receive 5-FU 400 mg/m2 i.v. on days 1-5 every 4 weeks. The response rate was 33.3% in the accelerated FA/5-FU and 18.6% in the 5-FU arm (P = 0.045). Median survival was 13.5 months in the FA/5-FU arm and 7.5 months in the 5-FU arm (P = 0.039). Toxicity was mild and slightly more pronounced in the FA/5-FU arm (P = 0.078). This study indicates that, in patients with advanced colorectal cancer, accelerated chemotherapy with FA and 5-FU and simultaneous supportive care is capable of achieving a higher response rate and longer survival than conventional 5-FU alone, without severe toxicity.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antidotes / administration & dosage*
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Colorectal Neoplasms / drug therapy*
  • Drug Administration Schedule
  • Drug Synergism
  • Drug Therapy, Combination
  • Fluorouracil / administration & dosage*
  • Fluorouracil / adverse effects
  • Humans
  • Leucovorin / administration & dosage*
  • Leucovorin / adverse effects
  • Middle Aged
  • Prognosis
  • Risk Factors
  • Survival Rate


  • Antidotes
  • Antimetabolites, Antineoplastic
  • Leucovorin
  • Fluorouracil