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- Title
Continuous infusion of high-dose 5-fluorouracil in combination with leucovorin and recombinant interferon-alpha-2b in patients with advanced colorectal cancer. A Multicenter Phase II study.
- Authors
Punt, Cornelis J. A.; Burghouts, Jos Th. M.; Croles, Jelle J.; van Liessum, Peter A.; de Mulder, Pieter H. M.; Kamm, Yvonne; Punt, C J; Burghouts, J T; Croles, J J; van Liessum, P A; de Mulder, P H; Kamm, Y
- Abstract
<bold>Background: </bold>5-Fluorouracil (5-FU), when combined with leucovorin (LV) or interferon-alpha (IFN-alpha), may result in improved response rates compared with 5-FU alone in patients with advanced colorectal cancer. The authors investigated the clinical efficacy of combining these three agents for patients in this group.<bold>Methods: </bold>Forty-five patients were administered outpatient high-dose 5-FU, 60 mg/kg/48 hours (2400 mg/m2/48 hours) continuous intravenous infusion on days 1 and 2; LV, 90 mg orally every 6 hour, 8 times during 5FU infusion; and recombinant IFN-alpha-2b, 10 x 10(6) IU/dose subcutaneously on days 1, 3, and 5. Cycles were repeated weekly for 4 weeks and every 2 weeks thereafter.<bold>Results: </bold>Forty-four patients were evaluable for response, and 11 patients (25%; 95% confidence interval, 12-38%) achieved a partial response with a median duration of 11 months. Median survival time for all patients was 11 months. Grade 3 and Grade 4 toxicities occurred in 21 patients (47%), which necessitated discontinuation of treatment in 2 patients (4%); permanent dose reductions were necessary in 11 patients (24%). The addition of IFN-alpha produced more 5-FU-related toxicity compared with a previous study in which the same dosage and schedule of 5-FU plus LV was used.<bold>Conclusions: </bold>The efficacy of 5-FU continuous infusion combined with LV and IFN-alpha does not appear to differ significantly from earlier reports on treatment using 5-FU plus LV or 5-FU plus IFN-alpha for patients with colorectal cancer. However, this schedule of 5-FU combined with LV and IFN-alpha produces less toxicity compared with previous trials using bolus 5-FU plus IFN-alpha.
- Publication
Cancer (0008543X), 1993, Vol 72, Issue 7, p2107
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/1097-0142(19931001)72:7<2107::AID-CNCR2820720708>3.0.CO;2-M