Randomized trial comparing weekly bolus 5-fluorouracil plus leucovorin versus monthly 5-day 5-fluorouracil plus leucovorin in metastatic colorectal cancer

W. S. Wang, J. K. Lin, T. J. Chiou, J. H. Liu, F. S. Fan, C. C. Yen, T. C. Lin, J. K. Jiang, S. H. Yang, P. M. Chen*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

13 Scopus citations

Abstract

Background/Aims: The purpose of this study was to compare the efficacy and toxicity profiles of weekly intravenous (i.v.) bolus injection of 5-fluorouracil plus low-dose leucovorin with the Mayo Clinics' monthly 5-day schedule of 5-fluorouracil and leucovorin in the treatment of metastatic colorectal cancer. Methodology: A total of 96 patients with previously untreated metastatic colorectal cancer were randomized to receive either a weekly i.v. bolus injection of 5-fluorouracil 400mg/m2 plus leucovorin 20mg/m2 (weekly arm), or i.v. bolus injection of 5-fluorouracil 425mg/m2 plus leucovorin 20mg/m2 for 5 consecutive days every 4 or 5 weeks (monthly arm). Therapy was continued until disease progression or unacceptable toxicity appeared. In the presence of disease progression, the study regimen was stopped and second-line treatment was instituted after the patient was discontinued from this study. Results: There was no significant difference of response rates between both regimens. The response rate were 14.3% in the weekly arm (2 CR and 5 PR, 95% CI: 2.6-25.2%) and 10.6% in the monthly arm (1 CR and 4 PR; 95% CI: 6.5-32.3%), respectively (P=0.8957). The survival times were also similar between the two (P=0.4207, log-rank test). The median survival were 15.8 months in the monthly arm and 18.4 months in the weekly arm. Hematologic toxicity was minimal in both arms. However, the monthly arm produced a higher toxicity in severe (grade 3-4) diarrhea (14.9% vs. 2%; P=0.029) and stomatitis (8.5% vs. 0; P=0.054). Conclusions: Weekly bolus injection of 5-fluorouracil and low-dose leucovorin achieved a similar response rate and survival as compared with the Mayo Clinics' monthly 5-day schedule, but severe toxicity was less commonly seen using the weekly regimen. As current chemotherapeutic treatment for metastatic colorectal cancer is largely palliative rather than curative, the weekly bolus regimen may be a more favorable approach in managing metastatic colorectal cancer.

Original languageEnglish
Pages (from-to)1599-1603
Number of pages5
JournalHepato-Gastroenterology
Volume47
Issue number36
StatePublished - Nov 2000

Keywords

  • 5-Fluorouracil
  • Leucovorin
  • Metastatic colorectal cancer
  • Monthly
  • Weekly

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