title: A phase II study of UFT and Leucovorin in combination with mitomycin C in patients with metastatic colorectal cancer.
abstract: The main objectives of this phase II study were to determine efficacy and safety of the combination of UFT with Leucovorin and mitomycin C in patients with metastatic colorectal cancer. Ninety-seven patients were treated with UFT (91 patients 300 mg/m2, 6 patients 250 mg/m2) + Leucovorin 90 mg days 1-28 q 5 weeks. During the first 4 cycles the patients also received mitomycin C 7 mg/m2 on day 1. At the end of 4 courses patients with benefit from the treatment could receive further courses of UFT and Leucovorin alone. Two patients had a complete response (2%), 20 (21%) had a partial response, 40 (41%) had no change, 19 (20%) had progression, and 16 (17%) were not evaluable for response. The overall response rate by intention to treat was 22/97 (23%). Median time to progression was 5 months and median survival 13 months. Severe (grade 3-4) toxicities included: anorexia 3%, nausea 6%, vomiting 7%, diarrhoea 7%, and fatigue 9%. Febrile neutropenia, renal failure, and thrombocytopenia were seen in 1% of the patients, respectively. The combination of UFT with Leucovorin and mitomycin C shows similar clinical activity with regard to overall response rate (23%) and survival (13 months) to other frontline 5-fluorouracil-based therapies in metastatic colorectal cancer patients. The results indicate that mitomycin C did not increase either efficacy or toxicity. Therefore, phase III trials with this regimen cannot be recommended.
authors.affiliation: Department of Oncology, Vejle Hospital, Vejle, Denmark.
authors.forename: Niels
authors.initials: N
authors.lastname: Gyldenkerne
authors.forename: Bengt
authors.initials: B
authors.lastname: Glimelius
authors.forename: Jan Erik
authors.initials: JE
authors.lastname: Frödin
authors.forename: Mogens
authors.initials: M
authors.lastname: Kjaer
authors.forename: Per
authors.initials: P
authors.lastname: Pfeiffer
authors.forename: Flemming
authors.initials: F
authors.lastname: Hansen
authors.forename: Nina
authors.initials: N
authors.lastname: Keldsen
authors.forename: Erik
authors.initials: E
authors.lastname: Sandberg
authors.forename: Anders
authors.initials: A
authors.lastname: Jakobsen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000627:therapeutic use*; D009362:Neoplasm Metastasis; D005641:Tegafur / Q000627:therapeutic use*; D016896:Treatment Outcome; D014498:Uracil / Q000627:therapeutic use*
chemical_list: D005641:Tegafur; D016685:Mitomycin; D014498:Uracil; D002955:Leucovorin