title: Tegafur and uracil plus leucovorin in advanced colorectal cancer: a phase II trial.
abstract: 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/m2/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.
authors.affiliation: Medical Oncology Dept., Hospital Universitario Reina Sofía, Avenida Menéndez Pidal, s/n 14004, Córdoba, Spain. earanda@ene.es
authors.forename: E
authors.initials: E
authors.lastname: Aranda
authors.forename: A
authors.initials: A
authors.lastname: Antón-Torres
authors.forename: J
authors.initials: J
authors.lastname: Sastre
authors.forename: M
authors.initials: M
authors.lastname: Navarro
authors.forename: F
authors.initials: F
authors.lastname: Rivera
authors.forename: A
authors.initials: A
authors.lastname: Carrato
authors.forename: J J
authors.initials: JJ
authors.lastname: Bretón
authors.forename: J
authors.initials: J
authors.lastname: Aparicio
authors.forename: C
authors.initials: C
authors.lastname: Fernández-Martos
authors.forename: E
authors.initials: E
authors.lastname: Díaz-Rubio
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage
chemical_list: D005641:Tegafur; D014498:Uracil; D002955:Leucovorin