title: Phase II study of S-1 monotherapy in platinum-refractory, advanced non-small cell lung cancer.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy and toxicity of a novel oral 5-fluorouracil formulation (S-1) as second-line therapy after platinum agent chemotherapy for advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  S-1 was administered orally at a dose of 80 mg/m(2) for 28 days, followed by 14 days of rest (1 cycle); treatment was repeated until disease progression, unacceptable toxicity, or patient refusal.
  
  
  RESULTS
  Of the 46 patients enrolled in this study, 44 were evaluable. Six patients (14%) exhibited a partial response and 28 (64%) showed stable disease. Disease-control rate was 77.3% (34/44) (95% CI, 64.9-89.7%). The overall response rate was 14% (6/44) (95% CI, 3.5-23.8%). Median progression-free survival was 4.2 months. The median survival time was 16.4 months, and the one-year survival rate 60.3%. Grade 3/4 hematological toxicities were minor. All of those adverse reactions were tolerable and reversible.
  
  
  CONCLUSIONS
  This study demonstrated the efficacy of S-1 monotherapy as second-line treatment for advanced NSCLC.
authors.affiliation: Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-chou, Tennoji-ku, Osaka 543-0035, Japan. takayuki.s12@hotmail.co.jp
authors.forename: Takayuki
authors.initials: T
authors.lastname: Shiroyama
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Komuta
authors.forename: Fumio
authors.initials: F
authors.lastname: Imamura
authors.forename: Tomonori
authors.initials: T
authors.lastname: Hirashima
authors.forename: Takashi
authors.initials: T
authors.lastname: Kijima
authors.forename: Isao
authors.initials: I
authors.lastname: Tachibana
authors.forename: Ichiro
authors.initials: I
authors.lastname: Kawase
mesh_terms: D000284:Administration, Oral; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000503:physiopathology; D018450:Disease Progression; D018572:Disease-Free Survival; D004338:Drug Combinations; D019008:Drug Resistance, Neoplasm; D005260:Female; D005500:Follow-Up Studies; D006402:Hematologic Diseases / Q000209:etiology; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D017671:Platinum Compounds / Q000627:therapeutic use; D012008:Recurrence; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D017671:Platinum Compounds; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid