[Artesunate combined with vinorelbine plus cisplatin in treatment of advanced non-small cell lung cancer: a randomized controlled trial].
[Artesunate combined with vinorelbine plus cisplatin in treatment of advanced non-small cell lung cancer: a randomized controlled trial].
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DOI：
10.3736/jcim20080206
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发表时间：
2008-02
期刊：
影响因子：
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通讯作者：
Zhu-Yi Zhang;Shi-qing Yu;L. Miao;Xiao-ying Huang;Xiaoping Zhang;Yu-Ping Zhu;Xiaoting Xia;Dan-Qi Li
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文献类型：
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作者：
Zhu-Yi Zhang;Shi-qing Yu;L. Miao;Xiao-ying Huang;Xiaoping Zhang;Yu-Ping Zhu;Xiaoting Xia;Dan-Qi Li
目的青蒿琥酯治疗肺癌的临床研究尚未见报道。本研究旨在比较青蒿琥酯联合NP（长春瑞滨和顺铂的化疗方案）与NP单药治疗晚期非小细胞肺癌（NSCLC）的疗效和毒性。方法将120例晚期非小细胞肺癌患者随机分为单纯化疗组（对照组，n=60）和青蒿琥酯联合化疗组（试验组，n=60）。对照组采用NP方案治疗，包括长春瑞滨（25 mg/m（2），静脉注射，每天一次，第1、8天）和顺铂（25 mg/m（2），静脉滴注，每天一次，第2 ~ 4天）。治疗组给予NP基础治疗（方法和剂量同对照组），青蒿琥酯120 mg，静脉注射，1次/d，第1 ~ 8天，共8天。至少进行两个21天周期的治疗。以近期生存率、疾病控制率（DCR）、疾病进展时间（TTP）、平均生存时间（MST）和1年生存率为主要观察指标，评价毒副反应和安全性。结果试验组和对照组的近期生存率、MST和1年生存率分别为45.1%和34.5%，44周和45周，45.1%和32.7%，差异均无统计学意义（P>0.05）。试验组的DCR（88.2%）明显高于对照组（72.7%）（P0.05）。结论青蒿琥酯可用于治疗非小细胞肺癌。青蒿琥酯联合NP治疗晚期非小细胞肺癌可提高近期生存率，延长TTP，且无明显毒副作用。
OBJECTIVE To our knowledge, there has been no clinical report of artesunate in the treatment of lung cancer. This study was designed to compare the efficacy and toxicity of artesunate combined with NP (a chemotherapy regimen of vinorelbine and cisplatin) and NP alone in the treatment of advanced non-small cell lung cancer (NSCLC). METHODS One hundred and twenty cases of advanced NSCLC were randomly divided into simple chemotherapy group (control group, n=60) and combined artesunare with chemotherapy group (trial group, n=60). Patients in the control group were treated with NP regimen, including vinorelbine (25 mg/m(2), once-a-day intravenous injection, at the 1st and 8th day) and cisplatin (25 mg/m(2), once-a day intravenous drip, at the 2nd to 4th day). Patients in the trial group were treated with the basal therapy NP (in the same method and doses as control group) and artesunate (120 mg, once-a-day intravenous injection, from the 1st day to 8th day, for 8 days). At least two 21-day-cycles of treatment were performed. The short-term survival rate, disease controlled rate (DCR), time to progression (TTP), mean survival time (MST) and 1-year survival rate were analyzed as the primary end points, and the toxicity and safety were estimated. RESULTS There were no significant differences in the short-term survival rate, MST and 1-year survival rate between the trial group and the control group, which were 45.1% and 34.5%, 44 weeks and 45 weeks, 45.1% and 32.7%, respectively (P>0.05). The DCR of the trial group (88.2%) was significantly higher than that of the control group (72.7%) (P0.05). CONCLUSION Artesunate can be used in the treatment of NSCLC. Artesunate combined with NP can elevate the short-term survival rate and prolong the TTP of patients with advanced NSCLC without extra side effects.