title: Efficacy and safety analysis according to histology for S-1 in combination with carboplatin as first-line chemotherapy in patients with advanced non-small-cell lung cancer: updated results of the West Japan Oncology Group LETS study.
abstract: BACKGROUND
  A phase III study (Lung Cancer Evaluation of TS-1) previously demonstrated noninferiority in terms of overall survival (OS) at interim analysis for carboplatin-S-1 compared with carboplatin-paclitaxel for first-line treatment of advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  A total of 564 patients were randomly assigned to receive either carboplatin on day 1 plus oral S-1 on days 1-14 or carboplatin-paclitaxel on day 1 every 21 days. Updated results and post hoc subgroup analysis according to tumor histology are presented.
  
  
  RESULTS
  The updated analysis revealed a median OS of 15.2 months in the carboplatin-S-1 arm and 13.1 months in the carboplatin-paclitaxel arm, with a hazard ratio (HR) of 0.956 [95% confidence interval (CI) 0.793-1.151], consistent with the previous primary analysis. Median OS was 14.0 months in the carboplatin-S-1 arm and 10.6 months in the carboplatin-paclitaxel arm (HR 0.713; 95% CI 0.476-1.068) for patients with squamous cell carcinoma (SCC), with corresponding values of 15.5 and 13.9 months (HR 1.060; 95% CI 0.859-1.308) for those with non-SCC.
  
  
  CONCLUSIONS
  These results establish the efficacy and safety of carboplatin-S-1 in patients with advanced NSCLC regardless of tumor histology.
authors.affiliation: Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Yoshioka
authors.forename: I
authors.initials: I
authors.lastname: Okamoto
authors.forename: S
authors.initials: S
authors.lastname: Morita
authors.forename: M
authors.initials: M
authors.lastname: Ando
authors.forename: K
authors.initials: K
authors.lastname: Takeda
authors.forename: T
authors.initials: T
authors.lastname: Seto
authors.forename: N
authors.initials: N
authors.lastname: Yamamoto
authors.forename: H
authors.initials: H
authors.lastname: Saka
authors.forename: S
authors.initials: S
authors.lastname: Atagi
authors.forename: T
authors.initials: T
authors.lastname: Hirashima
authors.forename: S
authors.initials: S
authors.lastname: Kudoh
authors.forename: M
authors.initials: M
authors.lastname: Satouchi
authors.forename: N
authors.initials: N
authors.lastname: Ikeda
authors.forename: Y
authors.initials: Y
authors.lastname: Iwamoto
authors.forename: T
authors.initials: T
authors.lastname: Sawa
authors.forename: Y
authors.initials: Y
authors.lastname: Nakanishi
authors.forename: K
authors.initials: K
authors.lastname: Nakagawa
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D003432:Cross-Linking Reagents / Q000009:adverse effects / Q000627:therapeutic use; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003432:Cross-Linking Reagents; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D016190:Carboplatin; D017239:Paclitaxel