title: Uracil-tegafur/leucovorin and mitomycin C salvage therapy in patients with advanced colorectal cancer: a phase II study.
abstract: We investigated the efficacy and safety of oral Uracil/tegafur (UFT) with leucovorin and mitomycin C (MMC) as third-line treatment for patients with extensively pretreated metastatic colorectal cancer (mCRC). This was a multicenter, prospective phase II study. Patients received MMC 7 mg/m² on day 1 and UFT 300 mg/m² with leucovorin 90 mg, both divided into three daily doses, on days 1-28 every 5 weeks. All patients had failed prior treatment with irinotecan, oxaliplatin, fluoropyrimidine, bevacizumab, and cetuximab. The primary endpoint was tumor control rate evaluated after 2 cycles. Twenty-one patients were included: median age was 66 years (41.1-87.8 years). Tumor control rate was observed in 26.7% of the 15 patients evaluable for response. Median overall survival was 6.4 months. Grade 3 adverse events were asthenia, anorexia, and vomiting. In patients with mCRC who have progressed after as many as two prior therapies, the combination of UFT/leucovorin and MMC is safe and may produce a short stabilization of disease in approximately 25% of patients.
authors.affiliation: Department of Medical Oncology, Antoine Lacassagne Cancer Research Center, Nice, France. eric.francois@nice.unicancer.fr
authors.forename: Eric
authors.initials: E
authors.lastname: Francois
authors.forename: Denis
authors.initials: D
authors.lastname: Smith
authors.forename: Laetitia
authors.initials: L
authors.lastname: Dahan
authors.forename: Cecile
authors.initials: C
authors.lastname: Michel
authors.forename: Hervé
authors.initials: H
authors.lastname: Perrier
authors.forename: Véronique
authors.initials: V
authors.lastname: Mari
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Seitz
authors.forename: Philippe
authors.initials: P
authors.lastname: Follana
authors.forename: Ludovic
authors.initials: L
authors.lastname: Evesque
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Chamorey
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001247:Asthenia / Q000139:chemically induced; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004338:Drug Combinations; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D060787:Neoplasm Grading; D016879:Salvage Therapy / Q000009:adverse effects; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D047368:Tumor Burden / Q000187:drug effects; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; C096910:UFT(R) drug; D005641:Tegafur; D016685:Mitomycin; D014498:Uracil; D002955:Leucovorin