BOLUS INJECTION (2-4 MIN) VERSUS SHORT-TERM (10-20 MIN) INFUSION OF 5-FLUOROURACIL IN PATIENTS WITH ADVANCED COLORECTAL-CANCER - A PROSPECTIVE RANDOMIZED TRIAL

The use of bolus 5-fluorouracil (5-FU) as a short-term infusion over 1 0-30 min is increasing at the cost of a push injection, mainly due to practical advantages. Since even a short prolongation of the administr ation time results in lower 5-FU peak and area under the curve (AUC) l evels, there might be a risk of decreased efficacy. The aim of this st udy was to compare a rapid intravenous (i.v.) 5-FU injection and a sho rt-term 5-FU infusion with respect to objective responses and toxicity in patients with advanced colorectal cancer. 203 patients with measur able advanced colorectal cancer were randomised to bolus 5-FU either a s an injection for 2-4 min or as a short-term infusion lasting 10-20 m in. In both groups, the 5-FU dose was 500 mg/m(2) and leucovorin 60 mg /m(2) was given 40 min after the start of 5-FU. Treatment was given on two successive days every other week until progression. Objective tum our regression was seen in 27/100 (27%) in the injection group and in 13/103 (13%) in the infusion group (P=0.02). Severe toxicity was rare and did not differ significantly between the groups. Progression-free survival tended to be longer in the injection group (P=0.07), but over all survival did not differ between the groups. Bolus 5-FU should be a dministered as a rapid i.v. injection rather than as a short-term infu sion, since the former rate of administration results in a higher resp onse rate without being significantly more toxic. (C) 1998 Elsevier Sc ience Ltd. All rights reserved.