Wang Chaoyang, Xiao Dong, Zhai Chao
3201 Hospital of Xi'an Jiaotong University Health Science Center, Shaanxi, China.
BMC Cancer. 2025 Jul 1;25(1):1072. doi: 10.1186/s12885-025-14404-5.
This study aimed to evaluate the efficacy and safety of small-molecule TKIs in neoadjuvant treatment of HER2-positive breast cancer using a network meta-analysis approach.
A systematic literature search was conducted in the Medline, Embase, and Web of Science databases. Eligible studies that included HER2-positive breast cancer patients receiving neoadjuvant treatment with small-molecule TKIs before surgery were included. A Bayesian framework within a random-effects model was used for network meta-analysis to summarize direct and indirect evidence. Outcome measures included breast pathological complete response (breast pCR), total pathological complete response (total pCR) of the breast and lymph nodes, and selected safety endpoints.
Eight eligible studies involving a total of 1,841 participants were included. The most common treatment regimens were Trastuzumab (n = 8), Lapatinib (n = 6), and Lapatinib plus Trastuzumab (n = 6), while there were fewer studies on Pyrotinib plus Trastuzumab (n = 2). No studies about tucatinib and neratinib were enrolled. The rankings of efficacy for the breast pCR and total pCR endpoints were as follows: (i) Pyrotinib plus Trastuzumab, (ii) Lapatinib plus Trastuzumab, (iii) Trastuzumab, (iv) Lapatinib. Regarding safety endpoints of grade 3 or higher diarrhea, neutropenia, fatigue, and skin disorders, the rankings were as follows: (i) Trastuzumab, (ii) Lapatinib, (iii) Lapatinib plus Trastuzumab, (iv) Pyrotinib plus Trastuzumab for diarrhea; (i) Pyrotinib plus Trastuzumab, (ii) Trastuzumab, (iii) Lapatinib plus Trastuzumab, (iv) Lapatinib for neutropenia; (i) Lapatinib plus Trastuzumab, (ii) Trastuzumab, (iii) Lapatinib for fatigue; (i) Trastuzumab, (ii) Lapatinib plus Trastuzumab, (iii) Lapatinib for skin disorders.
For HER2-positive breast cancer patients, the use of small-molecule TKIs in combination with trastuzumab as neoadjuvant treatment has certain advantages in improving the rate of pathological response. Dual-targeted therapy with pyrotinib shows objective efficacy and acceptable safety; however, further research is still needed to confirm these findings.
本研究旨在采用网状Meta分析方法评估小分子酪氨酸激酶抑制剂（TKIs）在HER2阳性乳腺癌新辅助治疗中的疗效和安全性。
在Medline、Embase和Web of Science数据库中进行系统的文献检索。纳入符合条件的研究，这些研究包括术前接受小分子TKIs新辅助治疗的HER2阳性乳腺癌患者。采用随机效应模型中的贝叶斯框架进行网状Meta分析，以总结直接和间接证据。观察指标包括乳腺病理完全缓解（乳腺pCR）、乳腺和淋巴结的总病理完全缓解（总pCR）以及选定的安全性终点。
纳入了8项符合条件的研究，共1841名参与者。最常见的治疗方案是曲妥珠单抗（n = 8）、拉帕替尼（n = 6）以及拉帕替尼联合曲妥珠单抗（n = 6），而吡咯替尼联合曲妥珠单抗的研究较少（n = 2）。未纳入关于图卡替尼和奈拉替尼的研究。乳腺pCR和总pCR终点的疗效排名如下：（i）吡咯替尼联合曲妥珠单抗，（ii）拉帕替尼联合曲妥珠单抗，（iii）曲妥珠单抗，（iv）拉帕替尼。关于3级或更高等级的腹泻、中性粒细胞减少、疲劳和皮肤疾病的安全性终点，排名如下：腹泻方面：（i）曲妥珠单抗，（ii）拉帕替尼，（iii）拉帕替尼联合曲妥珠单抗，（iv）吡咯替尼联合曲妥珠单抗；中性粒细胞减少方面：（i）吡咯替尼联合曲妥珠单抗，（ii）曲妥珠单抗，（iii）拉帕替尼联合曲妥珠单抗，（iv）拉帕替尼；疲劳方面：（i）拉帕替尼联合曲妥珠单抗，（ii）曲妥珠单抗，（iii）拉帕替尼；皮肤疾病方面：（i）曲妥珠单抗，（ii）拉帕替尼联合曲妥珠单抗，（iii）拉帕替尼。
对于HER2阳性乳腺癌患者，使用小分子TKIs联合曲妥珠单抗作为新辅助治疗在提高病理缓解率方面具有一定优势。吡咯替尼的双靶点治疗显示出客观疗效和可接受的安全性；然而，仍需进一步研究来证实这些发现。
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