TY - JOUR
T1 - A phase II randomized trial of adjuvant chemotherapy with S-1 versus S-1 plus cisplatin for completely resected pathological stage II/IIIA non-small cell lung cancer
AU - for the Kyushu University Lung Surgery Study Group (KLSS) Japan
AU - Okamoto, Tatsuro
AU - Yano, Tokujiro
AU - Shimokawa, Mototugu
AU - Takeo, Sadanori
AU - Yamazaki, Koji
AU - Sugio, Kenji
AU - Takenoyama, Mitsuhiro
AU - Nagashima, Akira
AU - Tsukamoto, Shuichi
AU - Hamatake, Motoharu
AU - Yokoyama, Hideki
AU - Ueda, Hitoshi
AU - Motohiro, Akira
AU - Tagawa, Tetsuzo
AU - Shoji, Fumihiro
AU - Kometani, Takuro
AU - Saito, Genkichi
AU - Fukuyama, Yasuro
AU - Toyokawa, Gouji
AU - Osoegawa, Atsushi
AU - Emi, Yasunori
AU - Maehara, Yoshihiko
N1 - Funding Information:
Mitsuhiro Takenoyama reports honoraria from AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Covidien Japan, Eli Lilly Japan, Kyowa Hakko Kirin, MSD, Nippon Boehringer Ingelheim, Ono Pharmaceutical and Taiho Pharmaceutical outside the submitted work. Yoshihiko Maehara reports grants from Taiho Pharmaceutical Co., Ltd outside the submitted work. All remaining authors have declared no conflicts of interest.
Publisher Copyright:
© 2018 Elsevier B.V.
PY - 2018/10
Y1 - 2018/10
N2 - Objectives: Platinum-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 methods: We conducted a phase II randomized open-label multi-institutional study in patients with pathological stage II/IIIA NSCLC (7 th 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. Results: A 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%). Conclusions: Long-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.
AB - Objectives: Platinum-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 methods: We conducted a phase II randomized open-label multi-institutional study in patients with pathological stage II/IIIA NSCLC (7 th 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. Results: A 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%). Conclusions: Long-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.
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U2 - 10.1016/j.lungcan.2018.08.015
DO - 10.1016/j.lungcan.2018.08.015
M3 - Article
C2 - 30268470
AN - SCOPUS:85052326404
VL - 124
SP - 255
EP - 259
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
ER -