Journal of Clinical Oncology, Vol 15, 908-914, Copyright © 1997 by American Society of Clinical Oncology
Fluorouracil plus racemic leucovorin versus fluorouracil combined with the pure l-isomer of leucovorin for the treatment of advanced colorectal cancer: a randomized phase III study
W Scheithauer, G Kornek, A Marczell, G Salem, J Karner, E Kovats, D Burger, R Greiner, J Pidlich, B Schneeweiss, M Raderer, H Rosen and D Depisch
Department of Internal Medicine I/Division of Oncology, Vienna University Medical School, Austria.
PURPOSE: To compare the efficacy and toxicity of fluorouracil (FU) and
racemic leucovorin (d,l-LV) versus FU combined with the l-isomer of
leucovorin (l-LV) in the treatment of advanced colorectal cancer. PATIENTS
AND METHODS: A total of 248 patients with advanced measurable colorectal
cancer previously unexposed to chemotherapy were randomly assigned to
treatment with either FU (400 mg/m2/d by intravenous [I.V.] infusion for 2
hours) and racemic LV (100 mg/m2/d by I.V. bolus injection) given for 5
consecutive days, or the combination of FU and the pure l-isomer of LV
using the same dose schedule. In both treatment arms, courses were
administered every 28 days if toxicity allowed for a total of 6 months,
unless evidence of tumor progression was documented earlier. RESULTS: There
were no significant differences between the FU/racemic LV and the FU/l-LV
arm in the overall response rate (25% v 32%), duration of response (7.2 v
8.0 months), median time to progression or death (6.25 v 8.0 months), or
median overall survival time (14.5 v 15.0 months). Except for minor myeloid
toxic effects associated with FU/l-LV, there was also no significant
difference in terms of adverse reactions. Gastrointestinal symptoms,
specifically mucasitis and diarrhea, were less frequent and less severe in
both treatment arms compared with other trials with FU/racemic LV reported
in the literature, which might be because of the prolonged administration
of FU used in both arms. CONCLUSION: The combination of FU/l-LV produced
response rates, response durations, and survival times similar to those
with FU/d,l-LV. Biochemical modulation of FU by either pure l-LV or racemic
LV thus appears to result in equivalent clinical efficacy.
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