Tegafur and Uracil plus Leucovorin in Advanced Colorectal Cancer: A Phase II Trial

The objective of this study was to evaluate the activity and toxicity of tegafur and uracil (UFT; 1:4 molar ratio) plus leucovorin (LV) in patients with advanced colorectal cancer. One hundred forty-one patients were entered into the study. The treatment schedule consisted of UFT 300 mg/m 2/day (in...

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Bibliographic Details
Published in:Clinical colorectal cancer 2001-05, Vol.1 (1), p.43-46
Main Authors: Aranda, Enrique, Antón-Torres, Antonio, Sastre, Javier, Navarro, Matilde, Rivera, Fernando, Carrato, Alfredo, Bretón, J.J., Aparicio, Jorge, Fernández-Martos, Carlos, Díaz-Rubio, Eduardo
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biochemical modulation
Colorectal cancer
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - mortality
Colorectal Neoplasms - pathology
Disease-Free Survival
Drug Administration Schedule
Female
Humans
Leucovorin
Leucovorin - administration & dosage
Male
Middle Aged
Oral fluoropyrimidine
Survival Analysis
Tegafur - administration & dosage
Treatment Outcome
UFT
Uracil - administration & dosage
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Summary:The objective of this study was to evaluate the activity and toxicity of tegafur and uracil (UFT; 1:4 molar ratio) plus leucovorin (LV) in patients with advanced colorectal cancer. One hundred forty-one patients were entered into the study. The treatment schedule consisted of UFT 300 mg/m 2/day (in three divided doses) plus oral LV 150 mg/day (50 mg t.i.d.) over 28 days. The treatment cycle was repeated every 5 weeks until progression or unacceptable toxicity was observed. The treatment was interrupted if grade 3/4 toxicity appeared and was resumed at the same dosage on recovery. One hundred thirty-six patients were evaluable for response and 141 were evaluable for toxicity. The response rate was 19.9% (95% confidence interval: 12%-28%). The total number of patients without progression (objective response + stable disease) was 76 (55.9%). The median time to progression was 5.6 months, and the overall survival was 11.6 months. The toxicity profile was low, with 11% of patients experiencing grade 3/4 nausea and vomiting, while 17% had grade 3/4 diarrhea. Oral administration of UFT modulated with LV is a comfortable regimen of chemotherapy for patients with advanced colorectal cancer.
ISSN:1533-0028
1938-0674
DOI:10.3816/CCC.2001.n.004