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. A prospective cohort study.
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.
Moehler
Markus
M
First Department of Internal Medicine, University of Mainz, Mainz, Germany. moehler@uni-mainz.de
Gutzler
Frank
F
Steinmann
Silke
S
Boehme
Michael
M
Raeth
Ulrich
U
Stremmel
Wolfgang
W
Galle
Peter R
PR
Rudi
Jochen
J
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D005533:Foot Dermatoses / Q000139:chemically induced; D006229:Hand Dermatoses / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016879:Salvage Therapy; D016019:Survival Analysis
D002955:Leucovorin; D005472:Fluorouracil