这项系统评价和荟萃分析研究调查了PIK3CA突变对使用酪氨酸激酶抑制剂（TKI）治疗HER2阳性乳腺癌的预测和预后价值。在Medline、Embase和Cochrane图书馆数据库中搜索到17项符合条件的研究（共1706名患者）。在10项新辅助疗法研究中，野生型PIK3CA（WT）患者的病理完全缓解率显著高于突变型PIK3CA（MT）患者（OR=0.45，95% CI=0.31-0.65，P<0.001）。在5项转移疗法研究中，野生型患者的汇总客观缓解率显著高于突变型患者（OR=0.40，95% CI=0.23-0.70，P=0.001）。4项转移疗法研究表明，PIK3CA突变与进展无病生存和总生存率差的关系具有边际显著性。因此，PIK3CA突变对使用TKI含量方案治疗早期/晚期HER2阳性乳腺癌的治疗反应具有预测价值。版权所有©2023 Elsevier B.V.。保留所有权利。

This systematic review and meta-analysis study investigates the predictive and prognostic value of PIK3CA mutations for HER2-positive breast cancer treated with tyrosine kinase inhibitors (TKIs). A search of the Medline, Embase, and Cochrane Library databases yielded 17 eligible studies (1706 patients). In 10 neoadjuvant studies, the pathological complete response rate was significantly higher in wild-type PIK3CA (WT) patients than in mutated PIK3CA (MT) patients (OR = 0.45; 95% CI = 0.31-0.65; P < 0.001). In five metastasis studies, the pooled objective response rate was significantly higher in WT patients than in MT patients (OR = 0.40; 95% CI = 0.23-0.70; P = 0.001). Four metastasis studies indicated that PIK3CA mutations had a marginally significant relationship with poor progression-free survival and overall survival. Thus, PIK3CA mutations have predictive value for the treatment response of early/advanced-stage HER2-positive breast cancer treated with TKI-containing regimens.Copyright © 2023 Elsevier B.V. All rights reserved.