The Spanish experience with high-dose infusional 5-fluorouracil (5-FU) in colorectal cancer. The Spanish Cooperative Group For Gastrointestinal Tumor Therapy (TTD).

摘要: Background In a previous phase I to II trial, we have shown that the maximum tolerable dose (MTD) of 5-Fluorouracil (5-FU) in 48-hour continuous infusion (CI) weekly was 3.5 gr/m2. subsequent confirmative trial with 85 evaluable patients, 38.5% response rate obtained and median survival reached 12 months. These data were comparable those achieved by biochemical modulation 5-FU Leucovorin. On this basis tried modulate high-dose (3 gr/m2) oral leucovorin (LV) but regimen too toxic had be reduced. A new 2 g/m2/week plus planned. Patients received intensity 1.6 (range 0.9-2). Three complete responses 36 partial observed. Overall 37.5% (95% CI, 28% 46.8%). Median time progression has been 7.4 months, 14.4 WHO grade 3 diarrhea seen 27 patients (24.5%). Grade mucositis also 9 (8.1%) 4 observed one. nausea vomiting reported 13 (11.7%) patients. hand-foot syndrome detected only 5 (4.5%) leukopenia 1 case thrombocytopenia two cases, respectively. Oral at g/m2 is an active regimen, as main limiting toxicities. Its antitumor activity does not seem superior 48 hour alone g/m2.