Tian Tian, Ye Jing, Zhou Sihai
Int J Clin Pharmacol Ther. 2017 Sep;55(9):720-727. doi: 10.5414/CP202921.
INTRODUCTION: Pertuzumab, as an adjunctive therapy to trastuzumab and docetaxel, has been reported to be potentially beneficial for the treatment of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. However, the results remain controversial. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of pertuzumab supplementation in patients with HER2-positive metastatic breast cancer. METHODS: Medline, SCOPUS, Google Scholar, Cochrane library databases, EMBASE, Springer, and Science Direct were systematically searched. Randomized controlled trials (RCTs) assessing the effect of pertuzumab + trastuzumab + docetaxel vs. trastuzumab + docetaxel on the treatment of HER2-positive metastatic breast cancer were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcomes were death, overall survival, and progression-free survival. Meta-analysis was performed using fixed- or random-effect model. RESULTS: Five RCTs involving 3,742 patients were included in the meta-analysis. Overall, compared with placebo and trastuzumab + docetaxel treatment, combination treatment of pertuzumab + trastuzumab + docetaxel treatment was associated with the significantly reduced death (hazard ratio (HR) = 0.67; 95% confidence interval (CI) = 0.57 - 0.78; p < 0.005) as well as improved overall survival (HR = 0.66; 95% CI = 0.35 - 0.67; p = 0.98) and progression-free survival (HR = 0.64; 95% CI = 0.58 - 0.71; p < 0.005). Moreover, pertuzumab supplementation did not increase the number of patients with reductions in the left ventricular ejection fraction (LVEF) of 10% or more (risk ratio (RR) = 0.70; 95% CI = 0.47 - 1.04; p = 0.07). CONCLUSION: Pertuzumab + trastuzumab + docetaxel treatment significantly reduced death, increased overall survival, and progression-free survival in patients with HER2-positive metastatic breast cancer compared to placebo and trastuzumab + docetaxel treatment, but showed no increased adverse events. .
引言：帕妥珠单抗作为曲妥珠单抗和多西他赛的辅助治疗药物，据报道可能对治疗人表皮生长因子受体2（HER2）阳性转移性乳腺癌有益。然而，结果仍存在争议。我们进行了一项系统评价和荟萃分析，以评估帕妥珠单抗补充治疗HER2阳性转移性乳腺癌患者的疗效和安全性。 方法：系统检索了Medline、SCOPUS、谷歌学术、Cochrane图书馆数据库、EMBASE、Springer和Science Direct。纳入评估帕妥珠单抗+曲妥珠单抗+多西他赛与曲妥珠单抗+多西他赛治疗HER2阳性转移性乳腺癌效果的随机对照试验（RCT）。两名研究人员独立检索文章、提取数据并评估纳入研究的质量。主要结局为死亡、总生存期和无进展生存期。采用固定效应或随机效应模型进行荟萃分析。 结果：荟萃分析纳入了5项涉及3742例患者的RCT。总体而言，与安慰剂和曲妥珠单抗+多西他赛治疗相比，帕妥珠单抗+曲妥珠单抗+多西他赛联合治疗可显著降低死亡风险（风险比（HR）=0.67；95%置信区间（CI）=0.57 - 0.78；p<0.005），并改善总生存期（HR=0.66；95%CI=0.35 - 0.67；p=0.98）和无进展生存期（HR=0.64；95%CI=0.58 - 0.71；p<0.005）。此外，补充帕妥珠单抗并未增加左心室射血分数（LVEF）降低10%或更多的患者数量（风险比（RR）=0.70；95%CI=0.47 - 1.04；p=0.07）。 结论：与安慰剂和曲妥珠单抗+多西他赛治疗相比，帕妥珠单抗+曲妥珠单抗+多西他赛治疗可显著降低HER2阳性转移性乳腺癌患者的死亡风险，提高总生存期和无进展生存期，但未显示不良事件增加。
Int J Clin Pharmacol Ther. 2017-9
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