title: Phase II trial of S-1 as second-line therapy in patients with advanced non-small cell lung cancer.
abstract: OBJECTIVE
  Currently available agents for the treatment of advanced stage non-small cell lung cancer (NSCLC) have limited efficacy. S-1 is a novel formulation of oral fluoropyrimidine shown to be tolerable and active in patients with NSCLC in Japan. We conducted a multicenter phase II study in previously treated patients with NSCLC to evaluate the efficacy of single-agent S-1 in a predominantly non-Asian population.
  
  
  METHODS
  Patients with advanced NSCLC and previously treated with only one line of chemotherapy received oral S-1 at 30 mg/m every 12 hours for 14 consecutive days followed by a 7-day rest until meeting discontinuation criteria. The primary end point was to evaluate the overall response rate.
  
  
  RESULTS
  Fifty-seven patients were accrued from 21 centers across the United States. Overall response rates and stable disease according to independent review were 7.1% and 48.2%, respectively, with a disease control rate of 55.3%. Progression-free survival was 2.9 months, median overall survival 7.3 months, and 1-year survival 31.6%. There were no significant differences in survival according to histologic subtype. The treatment was well tolerated, with the most common treatment-related side effects being nausea (54%) and diarrhea (49%).
  
  
  CONCLUSIONS
  Single-agent S-1 is well tolerated and has activity comparable with the other agents approved for use in recurrent/relapsed NSCLC.
authors.affiliation: Division of Oncology, Department of Medicine, Washington University School of Medicine, St Louis, Missouri 63110, USA. rgovinda@dom.wustl.edu
authors.forename: Ramaswamy
authors.initials: R
authors.lastname: Govindan
authors.forename: Daniel
authors.initials: D
authors.lastname: Morgensztern
authors.forename: Michael D
authors.initials: MD
authors.lastname: Kommor
authors.forename: Roy S
authors.initials: RS
authors.lastname: Herbst
authors.forename: Paul
authors.initials: P
authors.lastname: Schaefer
authors.forename: Jitendra
authors.initials: J
authors.lastname: Gandhi
authors.forename: Kaku
authors.initials: K
authors.lastname: Saito
authors.forename: Christopher
authors.initials: C
authors.lastname: Zergebel
authors.forename: Joan
authors.initials: J
authors.lastname: Schiller
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000473:pathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000627:therapeutic use*; D011379:Prognosis; D016879:Salvage Therapy; D015996:Survival Rate; D005641:Tegafur / Q000627:therapeutic use*
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid