In this study, researchers from Italy evaluated whether adding leucovorin to 5-fluorouracil plus levamisole prolongs survival in patients with radically resected colon cancer.
The research team included 1703 patients in a large-scale clinical trial within 5 Italian cooperative groups, between 1992 and 1995.
The patients were stratified for center and then randomized to one of 2 treatment arms.
|Gastrointestinal toxicity was more frequent in arm B.|
|Annals of Oncology|
The patients in arm A received both 5-fluorouracil (450 mg/m2 i.v. bolus on days 1 to 5) and levamisole (150 mg orally for 3 days, every 14 days for 6 months).
The patients in arm B received 6-S-leucovorin (100 mg/m2 i.v. bolus) followed by 5-fluorouracil (370 mg/m2 i.v. bolus) on days 1 to 5, plus levamisole, every 4 weeks for 6 cycles.
The physicians determined, after a median follow-up of 6.4 years, that there was no significant difference between the 2 groups for either disease-free survival or 5-year overall survival.
Furthermore, gastrointestinal toxicity was found to be more frequent in arm B, but this was not statistically significant.
Dr Di Costanzo's team concluded, "In this trial the schedules used showed no statistically significant differences in terms of disease-free survival or overall survival in the treatment of colorectal cancer".