Preliminary analysis of a randomized comparison of 5-fluorouracil versus 5-fluorouracil and high-dose continuous-infusion folinic acid in disseminated colorectal cancer

J. H. Doroshow, M. Bertrand, E. Newman, P. Multhauf, L. Leong, D. Blayney, D. Goldberg, K. Margolin, B. Carr, S. Akman, G. Metter

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

In this study, 50 patients were randomly assigned to treatment with 5-fluorouracil (FUra) or FUra plus high-dose continuous-infusion folinic acid. Five of 27 evaluable patients in the FUra group versus 10 of 21 patients in the FUra plus folinic acid arm of the study had objective partial remissions, P = 0.02. Time to progression was 3.9 months for FUra and 8.0 months for FUra and folinic acid, P = 0.006; however, median survivals (11.9 versus 14.5 months) were not different in this crossover study. Toxicity in both treatment arms was mild, although patients receiving FUra plus folinic acid experienced significantly more stomatitis than patients treated with FUra alone. This study suggests that high-dose, continuous-infusion folinic acid, which produces a steady-state level of biologically active folates of 10 μM, significantly increases the therapeutic activity of FUra.

Original languageEnglish
Title of host publicationNCI Monographs
Pages171-174
Number of pages4
Edition5
Publication statusPublished - 1987

ASJC Scopus subject areas

  • Cancer Research

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