School of Medical and Life Sciences, Chengdu University of Traditional Chinese Medicine, China; Breast Surgery Department, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, China.
Department of Epidemiology, School of Medicine, Jinan University, Guangzhou, China.
Breast. 2023 Oct;71:69-73. doi: 10.1016/j.breast.2023.07.008. Epub 2023 Jul 24.
This study investigated the differences in efficacy between IHC(2+)/FISH-positive and IHC(3+) in HER2-positive breast cancer (BC) during neoadjuvant chemotherapy (NAC) combined with trastuzumab and pertuzumab. The research also aimed to provide insight into treatment strategies for clinical HER2(2+)/FISH-positive and HER2(3+) BC.
A retrospective analysis was performed on the clinical and pathological data of patients with confirmed diagnoses of invasive BC treated via combined NAC and dual-target therapy who underwent surgery at the Breast Surgery Center of Sichuan Cancer Hospital between June 2019 and June 2022. The correlation between the clinicopathological characteristics and pathological complete response (pCR) was analyzed via the χ2 test, while logistic regression was performed using the SAS 9.4 statistical analysis software.
This study examined 224 patients with an overall pCR rate of approximately 59.82%, which included 36 IHC(2+)/FISH-positive and 188 IHC(3+) cases with approximate pCR rates of 41.67% and 63.30%, respectively. Univariate and multifactorial analysis of the clinical and pathological data determined that age, menstrual status, family history, Ki67 expression, number of treatment cycles, and treatment regimen did not influence pCR. No statistical differences were evident between the univariate and multivariate models. However, the clinical stage, hormone receptor, and HER2 expression status significantly impacted pCR, with considerable consistent differences between the univariate and multifactor analyses.
HER2 IHC(3+) BC displays a higher pCR rate than HER2 IHC(2+)/FISH-positive BC (p ≤ 0.05), with a positive correlation between the HER2 protein expression levels and the response to anti-HER2 therapy.
本研究旨在探讨曲妥珠单抗和帕妥珠单抗联合新辅助化疗（NAC）治疗过程中 HER2 阳性乳腺癌（BC）患者免疫组织化学（IHC）（2+）/荧光原位杂交（FISH）阳性和 IHC（3+）的疗效差异，并为临床 HER2（2+）/FISH 阳性和 HER2（3+）BC 的治疗策略提供参考。
回顾性分析 2019 年 6 月至 2022 年 6 月在四川省肿瘤医院乳腺外科接受曲妥珠单抗和帕妥珠单抗联合 NAC 治疗并接受手术的经病理证实为浸润性 BC 患者的临床和病理资料。采用 χ2 检验分析临床病理特征与病理完全缓解（pCR）的相关性，SAS 9.4 统计软件进行 Logistic 回归分析。
本研究共纳入 224 例患者，总体 pCR 率约为 59.82%，其中 IHC（2+）/FISH 阳性患者 36 例，pCR 率约为 41.67%；IHC（3+）患者 188 例，pCR 率约为 63.30%。单因素和多因素分析临床和病理资料发现，年龄、月经状态、家族史、Ki67 表达、治疗周期数和治疗方案对 pCR 无影响。单因素和多因素模型无统计学差异。然而，临床分期、激素受体和 HER2 表达状态显著影响 pCR，单因素和多因素分析结果具有一致性。
HER2 IHC（3+）BC 的 pCR 率高于 HER2 IHC（2+）/FISH 阳性 BC（p≤0.05），HER2 蛋白表达水平与抗 HER2 治疗反应呈正相关。
