Comparison of a 48-Hour Infusion of 5-Fluorouracil without Folinic Acid with 24-Hour Folinic Acid/5-Fluorouracil in Patients with Metastatic Colorectal Cancer Refractory to Bolus Folinic Acid/5-Fluorouracil

BACKGROUND: Out of various high-dose 5-fluorouracil (5-FU) regimens given with or without folinic acid (FA), the optimal 5-FU schedule has still to be defined as treatment for metastatic colorectal cancer (CRC). Consequently, we compared toxicity, response and survival following two FA/5-FU regimens in 55 CRC patients refractory to bolus FA/5-FU. METHODS: Twenty-eight patients (group A) received 5-FU (60 mg/kg body weight) for 48 h, and 27 (group B) received 2-hour infusions of FA (500 mg/m(2)) and 24-hour infusions of 5-FU (2600 mg/m(2)) until disease progression. RESULTS: Both groups were adequately matched with respect to patient characteristics. While overall toxicities were rare, hand-foot syndrome was more common in A. Tumor control was achieved in 57 and 44%, for A and B, respectively. Survival times were 16 months in A and 9 months in B. CONCLUSIONS: Since both 5-FU infusion protocols showed equivalent palliative effects, FA may be questioned in second-line 5-FU regimens.