EFFICACY OF ORAL TEGAFUR MODULATION BY URACIL AND LEUCOVORIN IN ADVANCED COLORECTAL-CANCER - A PHASE-II STUDY

A phase II study was performed to assess the efficacy and toxicity of UFT (tegafur-uracil in the molar ratio 1 : 4) modulated with leucovori n (LV) in previously untreated patients with advanced colorectal carci noma (CRC). 79 patients with measurable advanced colorectal cancer (CR C) and no prior chemotherapy were included. 75 patients were evaluable for toxicity and response. The regimen consisted of LV 500 mg/m(2) ad ministered intravenously on day 1, followed by oral UFT 390 mg/m(2) on days 1-14. Patients received oral LV 15 mg every 12 h on days 2-14. T reatment was repeated every 28 days for a minimum of four courses per patient. Three hundred and ninety-eight cycles of chemotherapy were de livered (median five per patient). 7 patients (9%) had a complete resp onse, and 22 a partial response for an overall response rate of 39%. M ild gastrointestinal toxicity was dose limiting: grade 3-4 diarrhoea a ppeared in 9% of patients. Other grade 3-4 toxicities were nausea/vomi ting and mucositis in 4% of patients, gastric pain and leucopenia in 3 %. Oral UFT modulated by oral LV is active in advanced CRC and can be administered on an outpatient basis with no significant toxicity requi ring hospitalisation. Given its excellent tolerance profile and low to xicity, the regimen should be thoroughly studied and compared with 5-f luorouracil modulated by LV.