本研究旨在探讨曲妥珠单抗联合酪氨酸激酶抑制剂（TKIs）与曲妥珠单抗治疗人表皮生长因子受体（HER2）阳性乳腺癌患者的疗效和安全性。从PubMed、Embase、Cochrane和Web of Science数据库中系统检索相关文章，时间跨度为从建库至2022年11月。主要观察指标为总生存期（OS）和无进展生存期（PFS）。根据疾病状态、TKI类型和激素受体状态进行亚组分析。本次分析共纳入16项研究。曲妥珠单抗联合TKI在改善OS和PFS方面显著优于曲妥珠单抗。在新辅助治疗中，曲妥珠单抗联合TKI明显提高了病理完全缓解（pCR）率。此外，曲妥珠单抗联合TKI也显著增加了目标反应率（ORR）。接受联合治疗的患者发生停药、所有级别腹泻以及≥3级腹泻的发病率较高。对于HER2阳性乳腺癌不同阶段的治疗，曲妥珠单抗联合TKI优于曲妥珠单抗。曲妥珠单抗联合TKI抗HER2治疗的安全性是可控的。不同TKI与曲妥珠单抗联合治疗的不同疗效可能与不同TKI的作用机制有关，需要进一步研究。 ©2023年版权归Elsevier B.V.所有。

This study aimed to explore the efficacy and safety of trastuzumab plus tyrosine kinase inhibitors (TKIs) compared with those of trastuzumab monotherapy in patients with human epidermal growth factor receptor (HER2)-positive breast cancer.The PubMed, Embase, Cochrane, and Web of Science databases were systematically searched for relevant articles from inception until Nov 2022. The primary outcomes were overall survival (OS) and progression-free survival (PFS). Subgroup analyses were performed based on disease status, TKI type, and hormone receptor status.Sixteen studies were included in the current analysis. Trastuzumab plus TKI significantly improved OS and PFS compared to trastuzumab monotherapy. In the neoadjuvant setting, trastuzumab plus TKI significantly increased the pathologic complete response (pCR) rate compared to trastuzumab monotherapy. Moreover, a higher objective response rate (ORR) was observed with trastuzumab plus TKI. Patients who received the combination therapy had a higher incidence of discontinuation, all-grade diarrhea, and grade ≥ 3 diarrhea.Trastuzumab plus TKI was better than trastuzumab monotherapy for treating different stages of HER2-positive breast cancer. The safety of trastuzumab plus TKI anti-HER2 therapy was controllable. The different efficacies of TKIs combined with trastuzumab may be related to the mechanism of action of the different TKIs, needing further investigations.Copyright © 2023. Published by Elsevier B.V.