• Tatsuro Okamoto, Tokujiro Yano, Mototsugu Shimokawa, Sadanori Takeo, Koji Yamazaki, Kenji Sugio, Mitsuhiro Takenoyama, Akira Nagashima, Shuichi Tsukamoto, Motoharu Hamatake, Hideki Yokoyama, Hitoshi Ueda, Akira Motohiro, Tetsuzo Tagawa, Fumihiro Shoji, Takuro Kometani, Genkichi Saito, Yasuro Fukuyama, Gouji Toyokawa, Atsushi Osoegawa, Yasunori Emi, Yoshihiko Maehara, and Kyushu University Lung Surgery Study Group (KLSS) Japan.
• Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Department of Thoracic and Breast Surgery, Oita University Faculty of Medicine, Oita, Japan. Electronic address: tatsuro@surg2.med.kyushu-u.ac.jp.
• Lung Cancer. 2018 Oct 1; 124: 255-259.

ObjectivesPlatinum-based combination chemotherapy is the standard postoperative adjuvant treatment for pathological stage II/III non-small cell lung cancer (NSCLC). Oral S-1 therapy has good efficacy and relatively low toxicity for the treatment of advanced NSCLC. We investigated whether long-term S-1 monotherapy is also useful as an adjuvant therapy after surgery in patients with NSCLC.Patients And MethodsWe conducted a phase II randomized open-label multi-institutional study in patients with pathological stage II/IIIA NSCLC (7th TNM classification) who underwent complete resection from 2009 to 2013. The primary endpoint, the 2-year disease-free survival (DFS) rate, was evaluated using the Bayesian method. Eligible patients were randomly assigned to two arms: oral S-1 monotherapy (S-1 arm) and S-1 plus cisplatin combination therapy followed by S-1 (S-1 plus cisplatin arm) both for a total of 1 year.ResultsA total of 70 and 71 patients were enrolled in S-1 arm and S-1 plus cisplatin arm, respectively. The 2-year DFS rates were 52% (95% confidence interval [CI], 0.40-0.63) and 61% (95% CI, 0.48-0.70) for S-1 arm and S-1 plus cisplatin arm, respectively. Both arms met the primary endpoint. Neither DFS nor OS was significantly different between the arms (log-rank test: P =  0.1695 and P =  0.8684, respectively). The main G3/4 adverse events were loss of appetite and anemia (S-1 vs. S-1 plus cisplatin: 4.3% vs. 11.6% and 0% vs. 5.8%, respectively). The treatment completion rate did not differ between the two arms (S-1 vs. S-1 plus cisplatin: 45.7%, 95% CI, 41.9-66.3% vs. 43.5% 95% CI, 44.0-68.4%).ConclusionsLong-term adjuvant chemotherapy with S-1 was a feasible and promising treatment for patients with completely resected NSCLC, regardless of cisplatin addition. S-1 monotherapy should be investigated further, based on its low toxicity and practical convenience.Copyright © 2018 Elsevier B.V. All rights reserved.

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