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索拉非尼对HER2阴性转移性乳腺癌治疗效果Meta分析

发布时间:2018-08-05 20:13
【摘要】:目的索拉非尼是首个获准上市的多靶点酪氨酸激酶抑制剂。近年来探讨索拉非尼治疗HER2阴性转移性乳腺癌的临床试验不断开展,但试验结论并不一致。本研究通过Meta分析评价索拉非尼联合化疗治疗HER2阴性转移性乳腺癌的有效性和安全性。方法通过检索Pubmed、Embase以及Central等数据库,截止时间为2016-10,筛选索拉非尼联合化疗治疗HER2阴性的转移性乳腺癌的随机对照试验。试验结果应用Review Manager 5.3进行分析。结果纳入5个临床试验共计1 381例HER2阴性转移性乳腺癌患者,索拉非尼联合化疗与单纯化疗相比,使患者的疾病进展时间(time to progression,TTP)明显延长,2组之间差异有统计学意义,HR=0.77,95%CI为0.60~0.99,P=0.04;而无病生存期(progression-free survival,PFS;HR=0.83,95%CI为0.64~1.07,P=0.14)、总生存期(overall survival,OS;HR=1.06,95%CI为0.90~1.23,P=0.49)、客观反应率(objective response rate,ORR;RR=1.12,95%CI为0.97~1.30,P=0.14)2组之间差异无统计学意义。3~4度的手足综合征、乏力、皮疹、胃炎及贫血发生率明显增多,P0.05;而中性粒细胞减少、血小板减少、腹泻以及高血压的发生率并未明显增加,P0.05。结论相比单纯化疗,HER2阴性转移性乳腺癌患者可以从索拉非尼联合化疗治疗中获益,但手足综合征、皮疹等不良事件发生率有所增加。
[Abstract]:Objective Solafenib is the first multi-target tyrosine kinase inhibitor. In recent years, the clinical trial of Solafenil in the treatment of HER2 negative metastatic breast cancer has been carried out, but the results are not consistent. In this study, Meta analysis was used to evaluate the efficacy and safety of Solafenil combined chemotherapy in the treatment of HER2 negative metastatic breast cancer. Methods A randomized controlled trial of salafenil combined with chemotherapy for HER2 negative metastatic breast cancer was conducted by searching Pubmedus Embase and Central databases with the deadline of 2016-10. The test results were analyzed by Review Manager 5.3. Results 1 381 patients with HER2 negative metastatic breast cancer were enrolled in 5 clinical trials. Solafenil combined chemotherapy was compared with chemotherapy alone. 浣挎偅鑰呯殑鐤剧梾杩涘睍鏃堕棿(time to progression,TTP)鏄庢樉寤堕暱,2缁勪箣闂村樊寮傛湁缁熻瀛︽剰涔,

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