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.
Clinical registration number
UMIN000005041.
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Acknowledgements
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.
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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.
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Meeting presentation: 16th World Conference on Lung Cancer, Denver (Colorado, USA), 09/08/2015.
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Okumura, N., Sonobe, M., Okabe, K. et al. 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. Int J Clin Oncol 22, 274–282 (2017). https://doi.org/10.1007/s10147-016-1067-9
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DOI: https://doi.org/10.1007/s10147-016-1067-9