title: Randomized feasibility study of S-1 for adjuvant chemotherapy in completely resected Stage IA non-small-cell lung cancer: results of the Setouchi Lung Cancer Group Study 0701.
abstract: OBJECTIVE
  The aim of this multicenter study was to determine the appropriate administration schedule for S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in patients with completely resected pathological-Stage IA (tumor diameter, 2-3 cm) non-small-cell lung cancer.
  
  
  METHODS
  Patients were randomly assigned to receive adjuvant chemotherapy consisting of either the 4-week oral administration of S-1 (80-120 mg/body/day) followed by a 2-week rest (Group A), or the 2-week oral administration of S-1 (80-120 mg/body/day) followed by a 1-week rest (Group B). The duration of adjuvant chemotherapy was 1 year in both arms. The primary endpoint was compliance, namely drug discontinuation-free survival, which was calculated using the Kaplan-Meier method with log-rank test.
  
  
  RESULTS
  Eighty patients were enrolled in this study, and 76 patients actually received S-1 treatment. The drug discontinuation-free survival rates at 1 year were 49.1% in Group A and 52.7% in Group B (P = 0.373). The means of the relative dose intensities were 55.3% in Group A and 64.6% in Group B (P = 0.237). There were no treatment-related deaths. Patients with grade 3/4 toxicities were significantly more frequent in Group A (40.5%) than in Group B (15.4%, P = 0.021). The 2-year relapse-free survival rates were 97.5% in Group A and 92.5% in Group B, and the 2-year overall survival rates were 100% in both groups.
  
  
  CONCLUSIONS
  The feasibility showed no significant difference between the two groups among patients with completely resected Stage IA (tumor diameter, 2-3 cm) non-small-cell lung cancer.
authors.affiliation: Department of Thoracic, Breast and Endocrinological Surgery, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama soh-j@cc.okayama-u.ac.jp.
authors.forename: Junichi
authors.initials: J
authors.lastname: Soh
authors.affiliation: Department of Thoracic Surgery, Kurashiki Central Hospital, Kurashiki, Okayama.
authors.forename: Norihito
authors.initials: N
authors.lastname: Okumura
authors.affiliation: Department of General Thoracic Surgery, Kawasaki Medical School, Kurashiki, Okayama.
authors.forename: Masao
authors.initials: M
authors.lastname: Nakata
authors.affiliation: Division of General Thoracic Surgery, Tottori University Hospital, Yonago, Tottori.
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Nakamura
authors.affiliation: Second Department of Internal Medicine, Nagasaki University Hospital, Nagasaki Clinical Oncology Center, Nagasaki University Hospital, Nagasaki.
authors.forename: Minoru
authors.initials: M
authors.lastname: Fukuda
authors.affiliation: Department of Surgery, Okayama Saiseikai General Hospital, Okayama.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kataoka
authors.affiliation: Department of Surgery, Uwajima City Hospital, Uwajima, Ehime.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Kajiwara
authors.affiliation: Center of Chest Medicine and Surgery, Ehime University, Toon, Ehime.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Sano
authors.affiliation: Department of Surgery, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa.
authors.forename: Motoi
authors.initials: M
authors.lastname: Aoe
authors.affiliation: Department of Thoracic Surgery, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Yamaguchi.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Kataoka
authors.affiliation: Department of Hematology, Oncology and Respiratory Medicine, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.affiliation: Division of Molecular Medicine, Aichi Cancer Center Research Institute, Nagoya, Aichi.
authors.forename: Keitaro
authors.initials: K
authors.lastname: Matsuo
authors.affiliation: Department of Thoracic, Breast and Endocrinological Surgery, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama Department of Clinical Genomic Medicine, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Toyooka
authors.affiliation: Department of Thoracic Surgery, Kyoto University, Kyoto, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Date
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006402:Hematologic Diseases / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D011725:Pyridines; D005641:Tegafur; D010094:Oxonic Acid; C104201:gimeracil
keywords: S-1; adjuvant chemotherapy; clinical trials; non–small-cell lung cancer