Randomised comparison of weekly bolus 5-fluorouracil with or without leucovorin in metastatic colorectal carcinoma

M. T. Nobile, R. Rosso, M. R. Sertoli, A. Rubagotti, M. G. Vidili, A. Guglielmi, M. Venturini, L. Canobbio, T. Fassio, L. Gallo, E. Galligioni, P. Gallotti, P. Bruzzi, A. Sobrero

Research output: Contribution to journalArticle

Abstract

148 patients with advanced untreated colorectal cancer were randomised to receive a weekly bolus of 5-fluorouracil (5-FU) 600 mg/m2 alone, with or without leucovorin (LV) 500 mg/m2. 5-FU plus LV produced a higher response rate than 5-FU alone: 23% (5 complete response, 11 partial response) vs. 8% (2 complete response, 4 partial response) (P = 0.03) out of 70 and 72 evaluable patients, respectively. Median survival was 11 months in both groups and median time to progression was not significantly different (P = 0.08). The combined regimen was more toxic than 5-FU alone, as evidenced by (a) a higher percentage of grade 3-4 diarrhoea, 19.5% vs. 8.5% (P = 0.045) and conjunctivitis, 26.5% vs. 5.6% (P = 0.0025); (b) the recording of one toxic death in the combined arm; and (c) the reduction of the median dose intensity of 5-FU actually delivered during the first 2 months of treatment. We conclude that 5-FU plus LV at a price of a higher toxicity is more active than 5-FU alone without improving survival and progression-free survival.

Original languageEnglish
Pages (from-to)1823-1827
Number of pages5
JournalEuropean Journal of Cancer
Volume28
Issue number11
DOIs
Publication statusPublished - 1992

ASJC Scopus subject areas

  • Cancer Research
  • Hematology
  • Oncology

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    Nobile, M. T., Rosso, R., Sertoli, M. R., Rubagotti, A., Vidili, M. G., Guglielmi, A., Venturini, M., Canobbio, L., Fassio, T., Gallo, L., Galligioni, E., Gallotti, P., Bruzzi, P., & Sobrero, A. (1992). Randomised comparison of weekly bolus 5-fluorouracil with or without leucovorin in metastatic colorectal carcinoma. European Journal of Cancer, 28(11), 1823-1827. https://doi.org/10.1016/0959-8049(92)90013-R