International Journal of Clinical Oncology

, Volume 22, Issue 2, pp 274–282 | Cite as

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

  • Norihito Okumura
  • Makoto Sonobe
  • Kazunori Okabe
  • Hiroshige Nakamura
  • Masafumi Kataoka
  • Motohiro Yamashita
  • Masao Nakata
  • Kazuhiko Kataoka
  • Yoshinori Yamashita
  • Junichi Soh
  • Hiroshige Yoshioka
  • Katsuyuki Hotta
  • Keitaro Matsuo
  • Junichi Sakamoto
  • Shinichi Toyooka
  • Hiroshi Date
Original Article



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).


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%.


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%.


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.

Clinical registration number



Non-small-cell lung cancer Adjuvant chemotherapy S-1 Carboplatin Maintenance therapy 



This work was supported, in part, by a non-profit organization, Epidemiological and Clinical Research Information Network (ECRIN). We are indebted to Ms. Yumi Miyashita (ECRIN) for data management, and Dr. Hideyuki Nishi (Okayama Rousai Hospital), Dr. Minoru Fukuda (Japanese Red Cross Nagasaki Genbaku Hospital), Dr. Shingo Harita (Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers), Dr. Yoshifumi Sano (Ehime University Hospital), Dr. Masayoshi Teramachi (Osaka Saiseikai Noe Hospital), Dr. Shinji Kosaka (Shimane Prefectural Central Hospital), Dr. Takuji Fujinaga (Nagara Medical Center), Dr. Ryo Miyahara (Kyoto City Hospital), Dr. Eiji Miyahara (Saiseikai Hiroshima Hospital), Dr. Hidetoshi Inokawa (Mitoyo General Hospital), and Dr. Shinsuke Kajiwara (Uwajima City Hospital) for their contributions to this study.

Compliance with ethical standards

Conflict of interest

N.O., S.T., K.H., H.Y., and H.D. received honoraria from Taiho Pharmaceutical in Japan. All other authors declared no conflicts of interest regarding this study.

Supplementary material

10147_2016_1067_MOESM1_ESM.docx (18 kb)
Supplementary material 1 (DOCX 18 kb)
10147_2016_1067_MOESM2_ESM.docx (18 kb)
Supplementary material 2 (DOCX 17 kb)


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Copyright information

© Japan Society of Clinical Oncology 2016

Authors and Affiliations

  • Norihito Okumura
    • 1
  • Makoto Sonobe
    • 3
  • Kazunori Okabe
    • 4
  • Hiroshige Nakamura
    • 5
  • Masafumi Kataoka
    • 6
  • Motohiro Yamashita
    • 7
  • Masao Nakata
    • 8
  • Kazuhiko Kataoka
    • 9
  • Yoshinori Yamashita
    • 10
  • Junichi Soh
    • 11
  • Hiroshige Yoshioka
    • 2
  • Katsuyuki Hotta
    • 13
  • Keitaro Matsuo
    • 14
  • Junichi Sakamoto
    • 15
  • Shinichi Toyooka
    • 11
    • 12
  • Hiroshi Date
    • 3
  1. 1.Department of Thoracic SurgeryKurashiki Central HospitalKurashikiJapan
  2. 2.Department of Respiratory MedicineKurashiki Central HospitalKurashikiJapan
  3. 3.Department of Thoracic SurgeryKyoto University Graduate School of MedicineKyotoJapan
  4. 4.Division of Thoracic SurgeryYamaguchi Ube Medical CenterUbeJapan
  5. 5.Division of General Thoracic Surgery, Department of Surgery, Faculty of MedicineTottori UniversityYonagoJapan
  6. 6.Department of SurgeryOkayama Saiseikai General HospitalOkayamaJapan
  7. 7.Department of Thoracic SurgeryShikoku Cancer CenterMatsuyamaJapan
  8. 8.Department of General Thoracic SurgeryKawasaki Medical SchoolKurashikiJapan
  9. 9.Department of Thoracic SurgeryIwakuni Clinical CenterIwakuniJapan
  10. 10.Department of Thoracic SurgeryKure Medical Center/Chugoku Cancer CenterKureJapan
  11. 11.Department of Thoracic, Breast and Endocrinological SurgeryOkayama University Graduate School of Medicine and DentistryOkayamaJapan
  12. 12.Department of Clinical Genomic MedicineOkayama University Graduate School of Medicine and DentistryOkayamaJapan
  13. 13.Department of Hematology and OncologyOkayama University Graduate School of Medicine and DentistryOkayamaJapan
  14. 14.Division of Molecular MedicineAichi Cancer Center Research InstituteNagoyaJapan
  15. 15.Tokai Central HospitalKakamigaharaJapan

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