Abstract

The biochemical modulation of 5-fluorouracil(5-FU) by leucovorin has been demonstrated to enhance the activity of 5-FU in patients with advanced colorectal cancer and the synergism between 5-FU and cisplatin is well known in advanced gastrointestinal tract cancers. We conducted a phase II trial to evaluate the effect of a combination of leucovorin, 5-FU, and cisplatin(LV-FP) in patients with advanced colorectal cancer. LV-FP regimen consisted of leu- covorin 20 mg/m/day IV in day 1-5, 5-FU 1,000 mg/m/day continuous IV. infusion in day 1-5, and cisplatin 20 mg/m/day IV in day 1-5. The regimen was repeated every 3 weeks. Among 46 patients with histologically confirmed advanced colorectal adenocarcinoma, 31 patients had measurable lesion(s) with median age of 55 years(22-70 years). 27 patients had previous histo- ry of chemotherapy and l9 were previously untreated. There was no complete respanse. 11 patients responded partially to the regimen to make the response rate 35%(l1/31). The median time to progression was 16 weeks (2-44 weeks), and the median survival time was 42 weeks(l+~80 weeks). There was no difference in response rates between the previously treated and the previously untreated. Hematologic toxicities were mild and non-hematologic toxicities were also tolerable. There was no treatment-related mortality. These results indicate that the LV-FP regimen is safe and effective in advanced colorectal adenocarcinoma.

• Keywords: Advanced colorectal cancer, Leucovorin, 5-Fluorouracil, Cisplatin, Combination chemotherapy