Phase II study of S-1 and docetaxel for previously treated patients with locally advanced or metastatic non-small cell lung cancer
Phase II study of S-1 and docetaxel for previously treated patients with locally advanced or metastatic non-small cell lung cancer
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DOI：
10.1007/s00280-009-1239-7
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发表时间：
2010-10-01
影响因子：
3
通讯作者：
Fukushima, Masanori
中科院分区：
文献类型：
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作者：
Yanagihara, Kazuhiro;Yoshimura, Kenichi;Fukushima, Masanori
本II期研究的目的是评估S-1和多西他赛联合治疗局部晚期或转移性非小细胞肺癌患者的疗效和毒性。方法38例既往治疗的非小细胞肺癌患者每3周给予S-1 （80 mg/m(2)，第1-14天，口服）和多西他赛（40 mg/m(2)，第1天，静脉注射）。结果未观察到完全缓解，7例患者出现部分缓解，总缓解率为18.4% （95% CI, 7.7-34.3%）。中位总生存时间和1年总生存率分别为16.1个月和60%。中位无进展生存期为4.4个月。骨髓抑制是主要毒性，3级或4级中性粒细胞减少和白细胞减少分别占50%和21%。本研究未发现不可逆毒性。结论S-1联合多西紫杉醇治疗局部晚期或转移性非小细胞肺癌患者耐受性良好，疗效显著。比较多西他赛加或不加S-1的三期试验将需要进一步的研究。
Purpose The purpose of the present phase II study was to evaluate both the efficacy and toxicity of the combination of S-1 and docetaxel in previously treated patients with locally advanced or metastatic non-small cell lung cancer.Methods Thirty-eight previously treated patients with non-small cell lung cancer were treated with S-1 (80 mg/m(2), days 1-14, oral) and docetaxel (40 mg/m(2), day 1, intravenous) every 3 weeks.Results No complete response was observed, and seven patients had a partial response, yielding an overall response rate of 18.4% (95% CI, 7.7-34.3%). The median overall survival time and 1-year overall survival rate were 16.1 months and 60%, respectively. The median progression-free survival time was 4.4 months. Myelosuppression was the main toxicity with grade 3 or 4 neutropenia and leukopenia in 50 and 21%, respectively. There was no irreversible toxicity in this study.Conclusions The combination of S-1 and docetaxel is well tolerable and has substantial activity for patients with locally advanced or metastatic non-small cell lung cancer. A phase III trial comparing docetaxel with or without S-1 would warrant further investigation.