title: S-1 plus cisplatin with concurrent radiotherapy for locally advanced non-small cell lung cancer: a multi-institutional phase II trial (West Japan Thoracic Oncology Group 3706).
abstract: OBJECTIVE
  To evaluate the combination chemotherapy using oral antimetabolite S-1 plus cisplatin (SP) with concurrent thoracic radiotherapy (RT) followed by the consolidation SP for locally advanced non-small cell lung cancer.
  
  
  METHODS
  Patients with stage III non-small cell lung cancer, 20 to 74 years of age, and Eastern Cooperative Oncology Group performance status 0 to 1 were eligible. The concurrent phase consisted of full dose S-1 (orally at 40 mg/m/dose twice daily, on days 1-14) and cisplatin (60 mg/m on day 1) repeated every 4 weeks for two cycles with RT delivered beginning on day 1 (60 Gy/30 fractions over 6 weeks). After SP-RT, patients received an additional two cycles of SP as the consolidation phase.
  
  
  RESULTS
  Fifty-five patients were registered between November 2006 and December 2007. Of the 50 patients for efficacy analysis, the median age was 64 years; male/female 40/10; Eastern Cooperative Oncology Group performance status 0/1, 21/29; clinical stage IIIA/IIIB 18/32; and adenocarcinoma/others 20/30. There were 42 clinical responses including one complete response with an objective response rate of 84% (95% confidence interval [CI], 71-93%). The 1- and 2-year overall survival rates were 88% (95% CI, 75-94%) and 70% (95% CI, 55-81%), respectively. The median progression-free survival was 20 months. Of the 54 patients for safety analysis, common toxicities in the concurrent phase included grade 3/4 neutropenia (26%), thrombocytopenia (9%), and grade 3 esophagitis (9%) and febrile neutropenia (9%). In one patient, grade 3 pneumonitis was observed in the consolidation phase. There were two treatment-related deaths caused by infection in the concurrent phase.
  
  
  CONCLUSIONS
  SP-RT showed a promising efficacy against locally advanced NCSLC with acceptable toxicity.
authors: Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan. yichinos@nk-cc.go.jp
authors: Yukito
authors: Y
authors: Ichinose
authors: Takashi
authors: T
authors: Seto
authors: Tomonari
authors: T
authors: Sasaki
authors: Takeharu
authors: T
authors: Yamanaka
authors: Isamu
authors: I
authors: Okamoto
authors: Koji
authors: K
authors: Takeda
authors: Masahiro
authors: M
authors: Tanaka
authors: Nobuyuki
authors: N
authors: Katakami
authors: Toshiyuki
authors: T
authors: Sawa
authors: Shinzoh
authors: S
authors: Kudoh
authors: Hideo
authors: H
authors: Saka
authors: Yasumasa
authors: Y
authors: Nishimura
authors: Kazuhiko
authors: K
authors: Nakagawa
authors: Masahiro
authors: M
authors: Fukuoka
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology* / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004338:Drug Combinations; D004941:Esophagitis / Q000209:etiology; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000473:pathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology; D010094:Oxonic Acid / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D013921:Thrombocytopenia / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin