Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan.
Lung Cancer. 2013 Dec;82(3):449-54. doi: 10.1016/j.lungcan.2013.09.004. Epub 2013 Sep 19.
To determine the efficacy and safety of oral S-1 in combination with cisplatin and thoracic radiotherapy in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
S-1 (50mg/m(2)) was administered orally twice daily for 14 days, with cisplatin (40 mg/m(2)) on days 1 and 8 of each cycle every 3 weeks, for 2-4 cycles. Thoracic radiation therapy was administered in 2 Gy fractions five times weekly for a total dose of 60 Gy. The primary endpoint was the response rate, and secondary endpoints included progression-free survival, overall survival and safety.
Forty-one patients were enrolled in this study. The objective response rate was 87.8% (98% CI: 77.8-97.8%). The median progression-free survival was 467 days (15.4 months), and the median survival time was 904 days (29.7 months). The overall survival rates at 1- and 2-years were 85.7% and 52.9%, respectively. Hematological toxicities included grade 3/4 neutropenia (17%) and grade 3/4 leukopenia (27%). No grade 3 febrile neutropenia was detected, and grade 3/4 non-hematological toxicities were also mild. A grade 3 gastrointestinal hemorrhage was observed in one patient.
The combination of oral S-1 plus cisplatin with concurrent radiotherapy is a promising treatment with a high efficacy and lower toxicity in patients with locally advanced NSCLC.
评估口服 S-1 联合顺铂与胸部放疗治疗不可切除的 III 期非小细胞肺癌（NSCLC）患者的疗效和安全性。
S-1（50mg/m²）每天口服两次，连用 14 天，每 3 周的第 1 和第 8 天给予顺铂（40mg/m²），共 2-4 个周期。胸部放射治疗采用 2Gy 分 5 次/周，总剂量为 60Gy。主要终点是缓解率，次要终点包括无进展生存期、总生存期和安全性。
本研究共纳入 41 例患者。客观缓解率为 87.8%（98%可信区间：77.8-97.8%）。中位无进展生存期为 467 天（15.4 个月），中位总生存期为 904 天（29.7 个月）。1 年和 2 年的总生存率分别为 85.7%和 52.9%。血液学毒性包括 3/4 级中性粒细胞减少（17%）和 3/4 级白细胞减少（27%）。未发现 3 级发热性中性粒细胞减少症，3/4 级非血液学毒性也较轻。1 例患者出现 3 级胃肠道出血。
口服 S-1 联合顺铂与同期放疗治疗局部晚期 NSCLC 患者具有疗效高、毒性低的潜力。
