中国乳腺癌患者多中心研究中，HER2低表达和HER2极低表达状态在历史结果与重新评分结果之间的患病率及一致性
Prevalence and concordance of HER2-low and HER2-ultralow status between historical and rescored results in a multicentre study of breast cancer patients in China.
作者信息
Lv Hong, Yue Junqiu, Zhang Qingfu, Xu Fangping, Gao Peng, Yang Haifeng, Nie Xiu, Kong Lingfei, Zhang Guanjun, Li Jianming, Xiao Shiwei, Wu Hongmei, Xing Aiyan, Hong Min, Fan Jun, Guan Huijuan, Cao Peilong, Ni Hengli, Yang Wentao
机构信息
Department of Pathology, Fudan University Shanghai Cancer Center, 270 Dongan Rd, 270, Xuhui District, Shanghai, 200032, China.
Department of Pathology, Hubei Cancer Hospital, Wuhan, Hubei, China.
出版信息
Breast Cancer Res. 2025 Mar 25;27(1):45. doi: 10.1186/s13058-025-02001-0.
BACKGROUND
Accurately assessing HER2-low (immunohistochemistry [IHC] 1 + and IHC 2+/in situ hybridization [ISH]-) and HER2-ultralow (IHC > 0 < 1+) is essential given the emergence of novel therapies. Thorough understanding of the reproducibility of rescoring IHC stained slides or re-staining archived tissue slides is essential.
METHODS
2,869 breast cancer patients diagnosed between July 2021 and July 2022 from 10 hospitals in China were included in this multicentre study. The prevalence of different HER2 expression levels and distribution of HER2 IHC scores were assessed by HER2 status determination from rescored historical slides. Concordance was evaluated across historical results versus rescored results, historical results versus re-stained results, and leading center results versus local site results. Clinicopathological characteristics were retrospectively analyzed as well.
RESULTS
HER2 IHC 0, IHC 1+, IHC 2+, and IHC 3 + were identified in 682 (23.8%), 871 (30.4%), 801 (27.9%), and 515 (18.0%) cases, respectively. HER2-positive, HER2-low, and HER2 IHC 0 (HER2-ultralow and IHC null) were identified in 21.7%, 54.5%, and 23.8% of cases, respectively. The prevalence of HER2-ultralow and IHC null was 10.6% and 13.2%, respectively. The concordance for HER2-ultralow was 43.3%; 30% of cases that were scored as HER2-ultralow at local sites were rescored as HER2-null and 26.7% of cases were rescored as IHC 1 + at the leading site. Overall, there was substantial agreement (83.1%) between rescored and historical IHC results. A high concordance rate of 91.7% was observed for HER2-low classification.
CONCLUSIONS
This is the first multicenter study to determine the prevalence of HER2-low and HER2-ultralow based on rescored results in the Chinese breast cancer population. The concordance analysis carries important implications for the diagnosis of HER2-low and HER2-ultralow cases in clinical practice. The relatively low concordance in identifying HER2-ultralow suggested that the reproducibility of scoring HER2-ultralow needed to be improved through training.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT05203458.
背景
鉴于新型疗法的出现，准确评估HER2低表达（免疫组织化学[IHC]1+和IHC 2+/原位杂交[ISH]-）和HER2极低表达（IHC>0<1+）至关重要。全面了解重新评估IHC染色切片或对存档组织切片进行重新染色的可重复性至关重要。
方法
本多中心研究纳入了2021年7月至2022年7月期间在中国10家医院诊断的2869例乳腺癌患者。通过对重新评估的历史切片进行HER2状态测定，评估不同HER2表达水平的患病率和HER2 IHC评分的分布。对历史结果与重新评估结果、历史结果与重新染色结果以及牵头中心结果与本地结果之间的一致性进行了评估。同时对临床病理特征进行了回顾性分析。
结果
分别在682例（23.8%）、871例（30.4%）、801例（27.9%）和515例（18.0%）病例中鉴定出HER2 IHC 0、IHC 1+、IHC 2+和IHC 3+。HER2阳性、HER2低表达和HER2 IHC 0（HER2极低表达和IHC阴性）分别在21.7%、54.5%和23.8%的病例中被鉴定出来。HER2极低表达和IHC阴性的患病率分别为10.6%和13.2%。HER2极低表达的一致性为43.3%；在本地被评为HER2极低表达的病例中，30%在牵头中心被重新评为HER2阴性，26.7%的病例在牵头中心被重新评为IHC 1+。总体而言，重新评估的IHC结果与历史结果之间存在高度一致性（83.1%）。HER2低表达分类的一致性率高达91.7%。
结论
这是第一项基于重新评估结果确定中国乳腺癌人群中HER2低表达和HER2极低表达患病率的多中心研究。一致性分析对临床实践中HER2低表达和HER2极低表达病例的诊断具有重要意义。在识别HER2极低表达方面相对较低的一致性表明，需要通过培训提高HER2极低表达评分的可重复性。
试验注册
ClinicalTrials.gov标识符NCT05203458。
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