title: Early phase II study of S-1, a new oral fluoropyrimidine, for advanced non-small-cell lung cancer.
abstract: BACKGROUND
  The efficacy and safety of S-1, a new oral fluoropyrimidine, were evaluated in patients with non-small-cell lung cancer (NSCLC). The objective of this study was to determine whether the drug should be investigated in a late phase II study.
  
  
  METHODS
  Each treatment course consisted of an oral dose of S-1, 50 mg/body or 75 mg/body, twice a day for 28 days followed by a 2-week washout period.
  
  
  RESULTS
  Fifty-six eligible patients were enrolled. Five of the 40 previously untreated patients (12.5%; 90% confidence interval, 6.2%-23.5%) showed a partial response (PR), and no tumor response was observed in the 16 previously treated patients. The median survival duration in all eligible patients was 8.4 months, with a 1-year survival rate of 27.3%. The incidences of grade 3 or more severe adverse effects were: anemia, 5.4%; leukopenia, 5.4%; neutropenia, 5.4%; thrombocytopenia, 1.8%; anorexia, 3.6%; diarrhea, 3.6%; and general fatigue, 5.4%. These effects disappeared after cessation of the drug or appropriate treatment. One patient died as a result of aggravated interstitial pneumonitis, but the relationship of this event to S-1 was not clear.
  
  
  CONCLUSIONS
  S-1 showed modest activity with mild toxicity in the treatment of non-small-cell lung cancer. Based on this result, we will progress to the next stage of a late phase II study for advanced NSCLC, and a phase II study of S-1 and cisplatin for advanced gastric cancer. Final results will be reported as they are obtained.
authors.affiliation: Division of Respiratory Diseases, Health Insurance Union Osaka Central Hospital, 3-3-17 Niwashirodai, Sakai, Osaka 590-0133, Japan. ha7k-frs@asahi-net.or.jp
authors.forename: K
authors.initials: K
authors.lastname: Furuse
authors.forename: M
authors.initials: M
authors.lastname: Kawahara
authors.forename: K
authors.initials: K
authors.lastname: Hasegawa
authors.forename: S
authors.initials: S
authors.lastname: Kudoh
authors.forename: M
authors.initials: M
authors.lastname: Takada
authors.forename: T
authors.initials: T
authors.lastname: Sugiura
authors.forename: Y
authors.initials: Y
authors.lastname: Ichinose
authors.forename: M
authors.initials: M
authors.lastname: Fukuoka
authors.forename: Y
authors.initials: Y
authors.lastname: Ohashi
authors.forename: H
authors.initials: H
authors.lastname: Niitani
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D016001:Confidence Intervals; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D005641:Tegafur / Q000627:therapeutic use*
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; D011725:Pyridines; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid