Cancer Res Treat.  2001 Jun;33(3):225-228.

A Phase II Trial of UFT-E and Oral Leucovorin in Advanced Colorectal Cancer

• Lee WS
• Lee KS
• Kim KH
• Ryoo BY
• Kim WS
• Kang WK
• Kang YK
• Heo DS
• Bang YJ
• Kim NK

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.

Keyword

Colorectal neoplasm; Chemotherapy; UFT- E; Oral leucovorin

MeSH Terms

Adenocarcinoma
Chemotherapy, Adjuvant
Colorectal Neoplasms*
Diarrhea
Disulfiram
Drug Therapy
Fluorouracil
Gastrointestinal Tract
Hospitalization
Humans
Infusion Pumps
Leucovorin*
Patient Compliance
Disulfiram
Fluorouracil
Leucovorin