【摘要】：目的索拉非尼是首個(gè)獲準(zhǔn)上市的多靶點(diǎn)酪氨酸激酶抑制劑。近年來(lái)探討索拉非尼治療HER2陰性轉(zhuǎn)移性乳腺癌的臨床試驗(yàn)不斷開(kāi)展,但試驗(yàn)結(jié)論并不一致。本研究通過(guò)Meta分析評(píng)價(jià)索拉非尼聯(lián)合化療治療HER2陰性轉(zhuǎn)移性乳腺癌的有效性和安全性。方法通過(guò)檢索Pubmed、Embase以及Central等數(shù)據(jù)庫(kù),截止時(shí)間為2016-10,篩選索拉非尼聯(lián)合化療治療HER2陰性的轉(zhuǎn)移性乳腺癌的隨機(jī)對(duì)照試驗(yàn)。試驗(yàn)結(jié)果應(yīng)用Review Manager 5.3進(jìn)行分析。結(jié)果納入5個(gè)臨床試驗(yàn)共計(jì)1 381例HER2陰性轉(zhuǎn)移性乳腺癌患者,索拉非尼聯(lián)合化療與單純化療相比,使患者的疾病進(jìn)展時(shí)間(time to progression,TTP)明顯延長(zhǎng),2組之間差異有統(tǒng)計(jì)學(xué)意義,HR=0.77,95%CI為0.60~0.99,P=0.04;而無(wú)病生存期(progression-free survival,PFS;HR=0.83,95%CI為0.64~1.07,P=0.14)、總生存期(overall survival,OS;HR=1.06,95%CI為0.90~1.23,P=0.49)、客觀反應(yīng)率(objective response rate,ORR;RR=1.12,95%CI為0.97~1.30,P=0.14)2組之間差異無(wú)統(tǒng)計(jì)學(xué)意義。3~4度的手足綜合征、乏力、皮疹、胃炎及貧血發(fā)生率明顯增多,P0.05;而中性粒細(xì)胞減少、血小板減少、腹瀉以及高血壓的發(fā)生率并未明顯增加,P0.05。結(jié)論相比單純化療,HER2陰性轉(zhuǎn)移性乳腺癌患者可以從索拉非尼聯(lián)合化療治療中獲益,但手足綜合征、皮疹等不良事件發(fā)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?zhèn)ｈ�呯殑鐤劇梾榪涘睍鏃墮棿(time to progression,TTP)鏄庢樉寤墮暱,2緇勪箣闂村樊寮傛湁緇熻瀛︽剰涔，

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