UFT plus or minus calcium folinate for metastatic colorectal cancer in older patients

Two studies were carried out to determine the activity and evaluate the tox icity of oral chemotherapy with uracil and tegafur in a 4:1 molar ratio (UF T) plus or minus calcium folinate in elderly patients with advanced colorec tal cancer. In one study, 106 patients received a fired dose of UFT 400 mg/ day in two daily doses every 12 hours continuously, plus calcium folinate 4 5 mg/day administered in three divided doses every 8 hours continuously. In study 2, calcium folinate was omitted and the dose of UFT was increased to 400 mg/m(2)/day in two daily doses administered every 12 hours continuousl y to 95 patients. Treatments for both studies were administered until grade 3 or grade 4 toxicity occurred or disease progressed. The response rate am ong the 96 available patients in study 1 was 17.7% (95% confidence interval [CI], 10% to 27%); 41 patients (43%) achieved an objective response or sta ble disease. Overall survival was 13.7 months with a statistically signific ant difference between patients with no progressive disease and patients wi th progressive disease (P <.01). In study 2, 62 of 95 patients have now bee n evaluated for response. The response rate was 21% (95% CI, 13% to 30%); 3 8 patients (61%) experienced an objective response or stable disease. The o verall survival for study 2 has not yet been evaluated. Toxicity was genera lly mild, consisting of grade 3 nausea/vomiting (6% in study 1 and 2% in st udy 2), grade 3 or grade 4 diarrhea (11% in study 1 and 7% in study 2), plu s one case of grade 3 mucositis in study 1. These findings suggest that che motherapy with UFT (with or without modulation with calcium folinate) is fe asible for elderly patients with advanced colorectal carcinoma.