1Department of Internal Medicine and Clinical ResearchInstitute, Seoul National University College of Medicine. 2Division of Hematology-Oncology, Department of InternalMedicine, Samsung Medical Center, Sungkyunkwan UniversitySchool of Medicine. 3Division of Hematology-Oncology, Department of InternalMedicine, Korea Cancer Center Hospital, Seoul, Korea.
Published online: June 30, 2001.
ABSTRACT
PURPOSE: To determine the efficacy and toxicity of UFT-E plus oral calcium leucovorin in the treatment of patients with advanced colorectal cancer.
MATERIALS AND METHODS: Forty-three patients with advanced, bidimensionally measurable colorectal adenocarcinoma were enrolled in the trial. No patients had received prior palliative chemotherapy. The patients that had received previous adjuvant chemotherapy were enrolled when more than 6 months had elapsed after the completion of adjuvant therapy.
Patients were treated with 300 mg/m2/day of UFT-E (tegafur-based) plus 90 mg/day of leucovorin administered orally in three divided daily doses, every 8 hours for 28 days followed by a 7-day rest period. Response was evaluated after two or three courses of therapy.
RESULTS: Thirty-six of forty-three patients were evaluable for response; seven dropped out due to infection, toxicity and patients' refusal. Ten patients had partial responses and one patient complete response (response rate, 31%; 95% confidence interval, 16~46%). The median response duration for the UFT-E plus leucovorin regimen was 28 weeks. Grade III toxicity was seen in one case, with diarrhea.
CONCLUSION: This oral regimen proved effective and well tolerated. This schema also avoided inconveniences, such as hospitalization and the use of infusion pumps, which are associated with 5-FU infusion regimens. The regimen used showed minimal toxicity, especially in the upper digestive tract, with good patient compliance.
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