5-Fluorouracil Dose Intensity Increase in 5-Fluorouracil and Leucovorin Combination: Results of a Phase II Study

Publisher Website
Google Scholar
Abstract
Summary It was our intention to verify if in the combination of 5-liuiMoiM.nU and leucovorin, the fluoropyrimidine dose intensity is an important determinant of response as noted by Hryniuk when 5-fluorouracil was given alone. By employing the Machover regimen but with cycles repeated every three weeks, a 5-fluorouracil projected dose intensity of 616 mg/nr/wk was obtained. It approximates the maximum toler-ated dose for this drug when used alone by i.v. bolus. 50 patients entered this study and 48 were évaluable for response and toxicity. The overall response rate was 29% (five complete responses and nine partial responses). The dose limiting toxicity was gastrointestinal rather than myelosuppression. 5-fluorouracil dose reduction was needed in seven patients. The mean delivered dose intensity of 5-fluorouracil was 610 mg/m!/wk (582 mg/m'/wk in patients in whom 5-fluorouracil was reduced for toxicity and 616 mg/nr/wk in the others). Our results do not seem to show any advantage in the maximi-zation of 5-fluorouracil dose intensity. Furthermore, in an analysis of data from the literature we did not find any difference in response rate in relation to dose intensity in the 5-fluorouracil/leucovorin combination.