title: Phase II study of UFT with leucovorin and irinotecan (TEGAFIRI): first-line therapy for metastatic colorectal cancer.
abstract: This phase II trial was performed to evaluate the efficacy and tolerability of oral tegafur-uracil (UFT) with leucovorin (LV) combined with intravenous (i.v.) irinotecan every 3 weeks (TEGAFIRI) as first-line treatment for patients with metastatic colorectal cancer (mCRC). Patients received oral UFT 250 mg m(-2) day(-1) and LV 90 mg day(-1) in three divided daily doses for 14 days followed by a 1-week rest and i.v. irinotecan 250 mg m(-2) as a 90-min infusion every 3 weeks. Tumour responses, assessed every two cycles using RECIST criteria, were reviewed by an independent review committee. In 52 evaluable patients, the best overall response rate was 33% (95% confidence intervals (CI) 20-47%; 1 complete and 16 partial responses). The median time to progression was 5.4 months (95% CI 3.02-7.52 months) and median overall survival was 14.9 months (11.73-17.97 months). A total of 307 cycles were administered, with a median number of five cycles per patient (range: 1-10). The most common grade 3/4 toxicities were neutropenia (25% of patients), diarrhoea (22%), vomiting (11%) and anaemia (11%). The TEGAFIRI regimen is a feasible, well-tolerated and convenient treatment option for patients with non-resectable mCRC.
authors.affiliation: Institut Claudius Regaud, 20-24 rue du Pont saint Pierre, Toulouse 31052, France. delord.jean-pierre@claudiusregaud.fr
authors.forename: J-P
authors.initials: JP
authors.lastname: Delord
authors.forename: J
authors.initials: J
authors.lastname: Bennouna
authors.forename: P
authors.initials: P
authors.lastname: Artru
authors.forename: H
authors.initials: H
authors.lastname: Perrier
authors.forename: F
authors.initials: F
authors.lastname: Husseini
authors.forename: F
authors.initials: F
authors.lastname: Desseigne
authors.forename: E
authors.initials: E
authors.lastname: François
authors.forename: R
authors.initials: R
authors.lastname: Faroux
authors.forename: D
authors.initials: D
authors.lastname: Smith
authors.forename: P
authors.initials: P
authors.lastname: Piedbois
authors.forename: H
authors.initials: H
authors.lastname: Naman
authors.forename: J Y
authors.initials: JY
authors.lastname: Douillard
authors.forename: R
authors.initials: R
authors.lastname: Bugat
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage
chemical_list: D005641:Tegafur; D014498:Uracil; D000077146:Irinotecan; D002955:Leucovorin; D002166:Camptothecin