This study aimed to prospectively evaluate the potential influence of
folate status on the toxicity induced by
5-fluorouracil (5-FU)-based
chemotherapy in patients with gastrointestinal
tumors. 105 patients with colorectal, pancreatic or
gastric cancer were entered into the study. Treatment regimens consisted of bolus 5-FU/
leucovorin or infusional
5-FU combined with
cisplatin. Baseline
homocysteine,
vitamin B(12) and
folic acid serum levels were determined in all patients. Univariate and multivariate logistic regression models were used to identify predictive factors for toxicity. Univariate analysis showed a significant association between older age, low BSA, gastric/
pancreatic cancer and treatment with 5-FU/
cisplatin and the incidence of grade 3-4 hematological toxicity, and between female sex, low BSA and gastric/
pancreatic cancer and the incidence of severe non-hematological toxicity. Variables that retained independent prognostic value in the multivariate model were
tumor type,
chemotherapy schedule and BSA for both hematological and non-hematological toxicities. Baseline
homocysteine,
vitamin B(12) or
folate status were not significant predictors of any kind of toxicity either according to univariate or multivariate analysis. This study failed to demonstrate a significant association between a patient s nutritional
folate status and the toxicity induced by fluoropyrimidine-based
chemotherapy in a cohort of patients with various gastrointestinal
malignancies.