目的:探讨人类表皮生长因子受体2（HER2）阳性乳腺癌HER2蛋白表达水平预测曲妥珠单抗和帕妥珠单抗（HP）为基础新辅助治疗疗效的价值，为合理选择抗HER2靶向治疗模式提供依据。方法:回顾性收集在保定市第一中心医院等河北省共11家三级甲等医院接受曲妥珠单抗及帕妥珠单抗配伍化疗方案新辅助治疗并完成后续手术的HER2阳性乳腺癌患者的临床资料，分析HER2蛋白表达水平与临床病理特征以及总体病理完全缓解（tpCR）率的相关性。结果:共纳入180例患者，其中HER2 IHC3+组157例（87.2%），HER2 IHC2+/FISH+组23例（12.8%）。HER2 IHC3+组tpCR率显著高于HER2 IHC2+/FISH+组（65.0% vs 17.4%，P＜0.001）。HER2蛋白表达水平与激素受体（hormone receptor，HR）状态相关，HER2 IHC 2+/FISH+组HR阳性率显著高于HER2 IHC 3+组（87% vs 49.7%，P=0.001），与年龄、月经状态、肿瘤大小、淋巴结状况、肿瘤临床分期、Ki-67增殖指数等无相关性。结论:乳腺癌HER2蛋白表达水平对曲妥珠单抗和帕妥珠单抗配伍化疗新辅助治疗方案的疗效有一定的预测价值，HER2 IHC2+/FISH+患者疗效欠佳，有必要探索适合此类患者的抗HER2靶向治疗模式。
HER2 protein expression levels predict efficacy of neoadjuvant therapy in breast cancer: A real-world study
Objective:To assess the value of human epidermal growth factor receptor 2 (HER2) protein expression levels in predicting the efficacy of trastuzumab plus pertuzumab (HP) as a basic neoadjuvant therapy for HER2-positive breast cancer patients, so as to provide a basis for the rational selection of HER2-targeted therapy mode.Methods:The clinical data of HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab plus pertuzumab chemotherapy and underwent subsequent surgery at 11 tertiary hospitals in Hebei Province, including Baoding No.1 Central Hospital,,were retrospectively collected to analyze the association between HER2 expression levels and clinicopathological characteristics and total pathological complete response (tpCR) rate.Results:A total of 180 patients were enrolled, including 157 (87.2%) in the HER2 IHC3+ group and 23 (12.8%) in the HER2 IHC2+/FISH+ group. The tpCR rate in the HER2 IHC3+ group was significantly higher than that in the HER2 IHC2+/FISH+ group (65.0% vs 17.4%, P＜0.001). The expression levels of HER2 protein were related to hormone receptor (HR) status, and the positive rate of HR in the HER2 IHC2+/FISH+ group was significantly higher than that in the HER2 IHC 3+ group (87.0% vs 49.7%, P=0.001), and the expression levels of HER2 protein had no correlation with age, menstrual status, tumor size, lymph node status, tumor clinical stage, or Ki-67 proliferation index.Conclusion:The expression level of HER2 protein in breast cancer has appreciated predictive value for the efficacy of neoadjuvant therapy with trastuzumab and pertuzumab in combination with chemotherapy, and HER2 IHC2+ patients have poor efficacy. It is necessary to explore anti-HER2-targeted therapy mode which is suitable for HER2 IHC2+ patients.
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