Colak Rumeysa, Kapar Caner, Degerli Ezgi, Tacar Seher Yildiz, Gemici Aysegul Akdogan, Gergerlioglu Nursadan, Altinay Serdar, Yilmaz Mesut
Department of Medical Oncology, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul 34147, Turkey.
Department of Radiology, Istanbul Medipol Mega University Hospital, Istanbul 34214, Turkey.
Medicina (Kaunas). 2025 Jun 27;61(7):1168. doi: 10.3390/medicina61071168.
: The clinical value of HER2-low breast cancer (BC), defined by immunohistochemistry (IHC) scores of 1+ or 2+/ISH-negative without HER2 amplification, remains unclear in the neoadjuvant setting. This study aimed to determine whether HER2-low and HER2-zero tumors differ in pathological complete response (pCR) rates and disease-free survival (DFS) among early-stage breast cancer patients undergoing neoadjuvant chemotherapy (NAC). : We retrospectively analyzed 134 early BC patients treated with NAC between 2017 and 2023. Patients were categorized as HER2-zero (IHC 0) or HER2-low (IHC 1+ or 2+/ISH-). The primary endpoint was total pCR (tpCR); secondary endpoints included breast (bpCR), nodal (npCR), and radiologic complete response (rCR), alongside DFS analysis stratified by hormone receptor (HR) status. : Of the cohort, 91 patients (67.9%) were HER2-zero and 43 (32.1%) were HER2-low. There was no statistically significant difference in tpCR (26.4% vs. 27.9%, = 0.852), bpCR (28.6% vs. 30.2%, = 0.843), npCR (37.4% vs. 32.6%, = 0.588), and rCR (23.1% vs. 30.2%, = 0.374) between HER2-zero and HER2-low groups. DFS did not significantly differ between HER2-zero and HER2-low groups overall ( = 0.714), nor within HR-positive ( = 0.540) or TNBC ( = 0.523) subgroups. : HER2-low tumors demonstrated similar pathological responses and survival outcomes compared to HER2-zero tumors. While a HER2-low status does not appear to define a distinct biological subtype in early BC, it remains a relevant classification for emerging HER2-targeted therapies, needing further investigation in prospective studies.
通过免疫组织化学(IHC)评分为1+或2+/原位杂交(ISH)阴性且无HER2扩增所定义的HER2低表达乳腺癌(BC)在新辅助治疗背景下的临床价值仍不明确。本研究旨在确定在接受新辅助化疗(NAC)的早期乳腺癌患者中,HER2低表达和HER2零表达肿瘤在病理完全缓解(pCR)率和无病生存期(DFS)方面是否存在差异。我们回顾性分析了2017年至2023年间接受NAC治疗的134例早期BC患者。患者被分为HER2零表达(IHC 0)或HER2低表达(IHC 1+或2+/ISH-)。主要终点是总pCR(tpCR);次要终点包括乳腺(bpCR)、淋巴结(npCR)和影像学完全缓解(rCR),以及按激素受体(HR)状态分层的DFS分析。在该队列中,91例患者(67.9%)为HER2零表达,43例(32.1%)为HER2低表达。HER2零表达组和HER2低表达组在tpCR(26.4%对27.9%,P = 0.852)、bpCR(28.6%对30.2%,P = 0.843)、npCR(37.4%对32.6%,P = 0.588)和rCR(23.1%对30.2%,P = 0.374)方面无统计学显著差异。HER2零表达组和HER2低表达组总体DFS无显著差异(P = 0.714),在HR阳性(P = 0.540)或三阴性乳腺癌(TNBC,P = 0.523)亚组中也无显著差异。与HER2零表达肿瘤相比,HER2低表达肿瘤表现出相似的病理反应和生存结果。虽然HER2低表达状态在早期BC中似乎并未定义一种独特的生物学亚型,但它仍然是新兴HER2靶向治疗的一个相关分类,需要在前瞻性研究中进一步调查。
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