title: Cisplatin and UFT modulated with leucovorin for the treatment of Advanced non-small-cell lung cancer.
abstract: We performed a phase II study to assess the efficacy and toxicity of the cisplatin-UFT-leucovorin (LV) combination in patients with advanced non-small-cell lung cancer (NSCLC). Twenty-five patients with measurable disease who had not received prior chemotherapy were entered into the trial. The therapeutic regimen consisted of cisplatin 90 mg/m(2) and i.v. LV 500 mg/m(2) on day 1, followed by oral UFT 390 mg/m(2)/day (in two doses on days 1 through 14. Patients also received oral LV 15 mg/12 h on days 2 through 14. Seventeen patients required reduced doses of UFT (200 mg/m(2) due to toxicity. Courses were repeated every 28 days for a minimum of three per patient. Three of 25 patients (12%) achieved a partial response (95% CI: 2.6 to 32.2%), two with 390 mg/m(2)/day and one with 200 mg/m(2)/day of UFT. The main side effects were hematological and gastrointestinal. In the courses including 390 mg/m(2)/day of UFT, grade 3-4 toxicity was leucopenia in 18% of the courses, nausea/vomiting in 27%, and diarrhea and epigastralgia in 13% each. Grade 3-4 toxicities for 200 mg/m(2)/day of UFT were leucopenia 2%, nausea/vomiting 9% and diarrhea 7%. In conclusion, this regimen cannot be recommend for the treatment of advanced NSCLC due to its low response rate and high toxicity.
authors.affiliation: Servicio de Oncologia Medica, Hospital La Paz, U.A.M., Madrid, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Feliu
authors.forename: M
authors.initials: M
authors.lastname: Gonzalez-Baron
authors.forename: E
authors.initials: E
authors.lastname: Espinosa
authors.forename: J
authors.initials: J
authors.lastname: de Castro
authors.forename: A
authors.initials: A
authors.lastname: Ordonez
authors.forename: P
authors.initials: P
authors.lastname: Zamora
authors.forename: J
authors.initials: J
authors.lastname: Gomez-Navarro
authors.forename: J
authors.initials: J
authors.lastname: Espinosa
authors.forename: Y
authors.initials: Y
authors.lastname: Vilches
authors.forename: I
authors.initials: I
authors.lastname: de la Gandara
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage* / Q000009:adverse effects; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D012074:Remission Induction; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D005641:Tegafur; D002945:Cisplatin; D002955:Leucovorin