title: Feasibility of adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 for completely resected non-small-cell lung cancer: results of the Setouchi Lung Cancer Group Study 1001.
abstract: BACKGROUND
  This multicenter study evaluated the feasibility of novel adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent, long-term maintenance with S-1 in patients with completely resected stage II-IIIA non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Patients received four cycles of S-1 (80 mg/m2/day for 2 weeks, followed by 2 weeks rest) plus carboplatin (area under the curve 5, day 1) followed by S-1 (80 mg/m2/day for 2 weeks, followed by a 1-week rest). Patients unable to continue S-1 plus carboplatin because of severe toxicity converted to single-agent S-1 maintenance. The duration of adjuvant chemotherapy was 10 months in both situations. The primary endpoint was feasibility, defined as the proportion of patients who completed four cycles of S-1 plus carboplatin and single-agent S-1 maintenance for 10 months. The treatment completion rate was determined; treatment was considered feasible if the lower 90% confidence interval (CI) was ≥50%.
  
  
  RESULTS
  Eighty-nine patients were enrolled, of whom 87 were eligible and assessable. Seventy-eight patients (89.7%) completed four cycles of S-1 plus carboplatin and 55 (63.2%) completed the following S-1 maintenance therapy for a total of 10 months. The treatment completion rate was 63.2% (90% CI, 54.4-71.2%), indicating feasibility. There were no treatment-related deaths. Grade 3/4 toxicities included neutropenia (13.8%), thrombocytopenia (11.5%), and anorexia (4.6%). The 2-year relapse-free survival rate was 59.8%.
  
  
  CONCLUSIONS
  We concluded that adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 is feasible and tolerable in patients with completely resected NSCLC.
  
  
  BACKGROUND
  UMIN000005041.
authors.affiliation: Department of Thoracic Surgery, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama, 710-8602, Japan. no7869@kchnet.or.jp.
authors.forename: Norihito
authors.identifier: http://orcid.org/0000-0001-6850-6284
authors.initials: N
authors.lastname: Okumura
authors.affiliation: Department of Thoracic Surgery, Kyoto University Graduate School of Medicine, 54 Shogoinkawara-cho, Sakyo-ku, Kyoto, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Sonobe
authors.affiliation: Division of Thoracic Surgery, Yamaguchi Ube Medical Center, 685 Higashikiwa, Ube, Japan.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Okabe
authors.affiliation: Division of General Thoracic Surgery, Department of Surgery, Faculty of Medicine, Tottori University, 36-1 Nishi-cho, Yonago, Japan.
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Nakamura
authors.affiliation: Department of Surgery, Okayama Saiseikai General Hospital, 1-17-18 Ifuku-cho, Kita-ku, Okayama, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kataoka
authors.affiliation: Department of Thoracic Surgery, Shikoku Cancer Center, 160 Minamiumemoto, Matsuyama, Japan.
authors.forename: Motohiro
authors.initials: M
authors.lastname: Yamashita
authors.affiliation: Department of General Thoracic Surgery, Kawasaki Medical School, 577 Matsushima, Kurashiki, Japan.
authors.forename: Masao
authors.initials: M
authors.lastname: Nakata
authors.affiliation: Department of Thoracic Surgery, Iwakuni Clinical Center, 1-1-1 Atagomachi, Iwakuni, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Kataoka
authors.affiliation: Department of Thoracic Surgery, Kure Medical Center/Chugoku Cancer Center, 3-1 Aoyamacho, Kure, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Yamashita
authors.affiliation: Department of Thoracic, Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine and Dentistry, 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Soh
authors.affiliation: Department of Respiratory Medicine, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Japan.
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Yoshioka
authors.affiliation: Department of Hematology and Oncology, Okayama University Graduate School of Medicine and Dentistry, 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.affiliation: Division of Molecular Medicine, Aichi Cancer Center Research Institute, 1-1 Kanokoden, Chikusa-ku, Nagoya, Japan.
authors.forename: Keitaro
authors.initials: K
authors.lastname: Matsuo
authors.affiliation: Tokai Central Hospital, 4-6-2 Soharahigashijima, Kakamigahara, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.affiliation: Department of Thoracic, Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine and Dentistry, 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan.|Department of Clinical Genomic Medicine, Okayama University Graduate School of Medicine and Dentistry, 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Toyooka
authors.affiliation: Department of Thoracic Surgery, Kyoto University Graduate School of Medicine, 54 Shogoinkawara-cho, Sakyo-ku, Kyoto, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Date
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; 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; D017024:Chemotherapy, Adjuvant; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D011379:Prognosis; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D016190:Carboplatin
keywords: Adjuvant chemotherapy; Carboplatin; Maintenance therapy; Non-small-cell lung cancer; S-1