title: A multi-institutional phase II trial of consolidation S-1 after concurrent chemoradiotherapy with cisplatin and vinorelbine for locally advanced non-small cell lung cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and feasibility of the consolidation therapy of the oral fluoropyrimidine agent S-1 after concurrent chemoradiotherapy for unresectable stage III non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Eligible patients had unresectable stage III NSCLC with performance status of 0 or 1. Chemoradiotherapy at a total dose of 60 Gy consisted of cisplatin (80 mg/m(2)) on days 1 and 29, vinorelbine (20 mg/m(2)) on days 1, 8, 29 and 36. Sequential consolidation S-1 therapy was commenced at a dose of 80-120 mg twice daily on day 57 with two cycles of 4 weeks administration and 2 weeks withdrawal.
  
  
  RESULTS
  Of the 66 patients, 65 were evaluated. Chemoradiotherapy was completed in 57 (87.7%) patients, and S-1 consolidation therapy was administered in 45 (69.2%) and completed in 31 (47.6%). Grade 3 pneumonitis developed in three patients with one dying of it. The response rate was 61.5% (95% confidence interval [CI], 48.6-73.3%). The median progression-free survival was 10.2 (95%CI, 8.6-13.7) months and median survival time 21.8 (95%CI, 15.6-27.6) months. The 1- and 3-year survival rates were 73.9% and 34.0%, respectively.
  
  
  CONCLUSIONS
  Chemoradiotherapy with cisplatin and vinorelbine followed by S-1 consolidation demonstrated a reasonable overall survival in patients with stage III NSCLC. However, less than half of the patients completed this regimen, and the additional effect of S-1 was marginal compared with historical control. We concluded that chemoradiotherapy alone is still the recommended standard treatment for patients.
authors.affiliation: National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai, Osaka 591-8555, Japan. t-kawaguchi@kch.hosp.go.jp
authors.forename: Tomoya
authors.initials: T
authors.lastname: Kawaguchi
authors.forename: Minoru
authors.initials: M
authors.lastname: Takada
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ando
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Okishio
authors.forename: Shinji
authors.initials: S
authors.lastname: Atagi
authors.forename: Yuka
authors.initials: Y
authors.lastname: Fujita
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Tomizawa
authors.forename: Kenji
authors.initials: K
authors.lastname: Hayashihara
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Okano
authors.forename: Fumiaki
authors.initials: F
authors.lastname: Takahashi
authors.forename: Ryusei
authors.initials: R
authors.lastname: Saito
authors.forename: Akihide
authors.initials: A
authors.lastname: Matsumura
authors.forename: Atsuhisa
authors.initials: A
authors.lastname: Tamura
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D014747:Vinblastine; D010094:Oxonic Acid; D002945:Cisplatin; D000077235:Vinorelbine