title: UFT plus vinorelbine in advanced non-small cell lung cancer: a phase I and an elderly patient-directed phase II study.
abstract: OBJECTIVE
  The combination of tegafur-uracil (UFT) with vinorelbine has provided synergistic activity against non-small cell lung cancer (NSCLC) in experimental models. The recommended dose of UFT in combination with vinorelbine in NSCLC was determined in a phase I study. The phase II study evaluated efficacy and tolerability of this combination in elderly patients.
  
  
  METHODS
  Vinorelbine was infused on days 1 and 8, and UFT was administered twice daily on days 2 to 6 and days 9 to 13 of a 3-week cycle. UFT and vinorelbine were increased during the phase I study from 400 to 600 mg/d and 20 to 25 mg/m(2), respectively, in 12 patients. In the phase II portion, previously untreated elderly patients were treated with 600 mg/d UFT and 20 mg/m(2) vinorelbine.
  
  
  RESULTS
  At the dose level of 600 mg/d UFT and 25 mg/m(2) vinorelbine, dose-limiting toxicity of neutropenia or neutropenic fever was observed in two of three patients, determining the recommended dose of 600 mg/d UFT and 20 mg/m(2) vinorelbine. In 30 evaluable elderly patients of the phase II study, the response rate was 27% (8/30). The median survival and progression-free survival time was 11.8 (range 2.7-34.8) and 5.0 (range 0.5-32.5) months, respectively. Grade 3 or grade 4 neutropenia and grade 3 anemia occurred in 40% and 7% of phase II patients, respectively. Gastrointestinal toxicity was frequent but mild. As the most serious toxicity, pneumonitis was observed in three patients.
  
  
  CONCLUSIONS
  This combination of UFT and vinorelbine is both feasible and active in the treatment of elderly patients with advanced NSCLC.
authors.affiliation: Division of Medical Oncology and Molecular Respirology, Faculty of Medicine, Tottori University, Yonago, Japan. igishi@grape.med.tottoriu.ac.jp
authors.forename: Tadashi
authors.initials: T
authors.lastname: Igishi
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Shigeoka
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Yasuda
authors.forename: Hisashi
authors.initials: H
authors.lastname: Suyama
authors.forename: Satoru
authors.initials: S
authors.lastname: Katayama
authors.forename: Akinori
authors.initials: A
authors.lastname: Sugitani
authors.forename: Shingo
authors.initials: S
authors.lastname: Matsumoto
authors.forename: Mitsunobu
authors.initials: M
authors.lastname: Yamamoto
authors.forename: Yasuto
authors.initials: Y
authors.lastname: Ueda
authors.forename: Kenichi
authors.initials: K
authors.lastname: Takeda
authors.forename: Takashi
authors.initials: T
authors.lastname: Sumikawa
authors.forename: Takanori
authors.initials: T
authors.lastname: Sako
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kodani
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Hitsuda
authors.forename: Eiji
authors.initials: E
authors.lastname: Shimizu
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D015577:Geriatric Assessment; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology*; D009367:Neoplasm Staging; D011336:Probability; D012307:Risk Factors; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D005641:Tegafur; D014747:Vinblastine; D000077235:Vinorelbine