黑龙江省乳腺癌HER2低表达临床病理诊断专家共识(2024版)

doi:10.11904/j.issn.1002-3070.2024.02.001

摘要/Abstract

摘要： 在过去的认知中,人类表皮生长因子受体2(Human epidermal growth factor receptor 2,HER2)低表达被认为对抗HER2靶向治疗无效。新型抗体缀合药物德曲妥珠单抗治疗HER2低表达乳腺癌疗效公布后,HER2低表达乳腺癌患者的诊疗选择成为乳腺肿瘤专家关注的热点。为规范HER2低表达乳腺癌的临床合理诊疗,黑龙江省医学会乳腺肿瘤学组参考国内外最新临床研究以及国内外专家共识,经我省专家组讨论后形成黑龙江省乳腺癌HER2低表达临床病理诊断专家共识,以指导临床医生对HER2低表达乳腺癌患者的诊疗决策,达到改善患者生存及预后的目的。该共识主要包括HER2低表达的定义和判读、HER2低表达结果的影响因素、HER2低表达检测的新方法、HER2低表达临床病理及分子生物学特性以及HER2低表达乳腺癌患者的临床诊疗指导,系统全面地展示了HER2低表达的临床病理诊断和治疗的共识。

关键词: 乳腺癌, HER2低表达, 靶向治疗, 共识

Abstract: In previous studies,low expression of human epidermal growth factor receptor 2(HER2) was considered ineffective against HER2-targeted therapy.After the announcement of the efficacy of new antibody conjugated drug,Detrastuzumab in the treatment of breast cancer with low expression of HER2,the diagnosis and treatment options of breast cancer patients with low expression of HER2 have become the focus of breast cancer experts.In order to standardize the clinical rational diagnosis and treatment of breast cancer with low expression of HER2,the Breast Oncology Group of Heilongjiang Medical Association,referring to the latest clinical research at home and abroad and the consensus of experts at home and abroad,formed the consensus of breast cancer with low expression of HER2 clinicopathological diagnosis experts after the discussion by the expert group in Heilongjiang province,to guide clinicians to make diagnosis and treatment decisions for breast cancer patients with low expression of HER2,so as to improve the survival and prognosis of patients.The consensus mainly includes the definition and interpretation of breast cancer with low expression of HER2,factors influencing the results of HER2 low expression,new detection methods,clinicopathological and molecular biological characteristics,and clinical diagnosis and treatment guidance for breast cancer patients with low expression of HER2,which systematically and comprehensively demonstrates the consensus of clinicopathological diagnosis and treatment for breast cancer with low expression of HER2.

Key words: Breast cancer, Low Human epidermal growth factor receptor 2 expression, Targeted therapy, Consensus

中图分类号:

R737.9

黑龙江省医学会乳腺肿瘤学组. 黑龙江省乳腺癌HER2低表达临床病理诊断专家共识(2024版)[J]. 实用肿瘤学杂志, 2024, 38(2): 71-78.

Breast Oncology Group of Heilongjiang Medical Association. Expert consensus on clinicopathological diagnosis of breast cancer with low expression of HER2 in Heilongjiang province(2024 edition)[J]. Journal of Practical Oncology, 2024, 38(2): 71-78.

参考文献

1 Nielsen S,Finetek S,Calero VM,et al.Comparative analysis of four immunohistochemical assays for HER2 expression in breast carcinoma – correlation with HER2 gene amplification and perspectives for HER2 low expression[J].Laboratory Investigation,2023,103(3,Suppl):100081.
2 Marchio C,Annaratone L,Marques A,et al.Evolving concepts in HER2 evaluation in breast cancer:heterogeneity,HER2-low carcinomas and beyond[J].Semin Cancer Biol,2021,72:123-135.
3 Miglietta F,Griguolo G,Bottosso M,et al.HER2-low-positive breast cancer:evolution from primary tumor to residual disease after neoadjuvant treatment[J].NPJ Breast Cancer,2022,8(1):66.
4 Hein A,Hartkopf AD,Emons J,et al.Prognostic effect of low-level HER2 expression in patients with clinically negative HER2 status[J].Eur J Cancer,2021,155:1-12.
5 Almstedt K,Krauthauser L,Kappenberg F,et al.Discordance of HER2-Low between primary tumors and matched distant metastases in breast cancer[J].Cancers(Basel),2023,15(5):1413.
6 Miglietta F,Griguolo G,Bottosso M,et al.Evolution of HER2-low expression from primary to recurrent breast cancer[J].NPJ Breast Cancer,2021,7(1):137.
7 Moutafi M,Robbins CJ,Yaghoobi V,et al.Quantitative measurement of HER2 expression to subclassify ERBB2 unamplified breast cancer[J].Lab Invest,2022,102(10):1101-1108.
8 Steiner C,Tille JC,Lamerz J,et al.Quantification of HER2 by targeted mass spectrometry in Formalin-Fixed Paraffin-Embedded(FFPE)breast cancer tissues[J].Mol Cell Proteomics,2015,14(10):2786-2799.
9 Do M,Kim H,Yeo I,et al.Clinical application of multiple reaction monitoring-mass spectrometry to Human Epidermal Growth Factor Receptor 2 measurements as a potential diagnostic tool for breast cancer therapy[J].Clin Chem,2020,66(10):1339-1348.
10 Nuciforo P,Thyparambil S,Aura C,et al.High HER2 protein levels correlate with increased survival in breast cancer patients treated with anti-HER2 therapy[J].Mol Oncol,2016,10(1):138-147.
11 Kennedy JJ,Whiteaker JR,Kennedy LC,et al.Quantification of Human Epidermal Growth Factor Receptor 2 by immunopeptide enrichment and targeted mass spectrometry in Formalin-Fixed Paraffin-Embedded and Frozen Breast Cancer Tissues[J].Clin Chem,2021,67(7):1008-1018.
12 Jordan NV,Bardia A,Wittner BS,et al.HER2 expression identifies dynamic functional states within circulating breast cancer cells[J].Nature,2016,537(7618):102-106.
13 Yue M,Zhang J,Wang X,et al.Can AI-assisted microscope facilitate breast HER2 interpretation? A multi-institutional ring study[J].Virchows Arch,2021,479(3):443-449.
14 Huang Z,Shao W,Han Z,et al.Artificial intelligence reveals features associated with breast cancer neoadjuvant chemotherapy responses from multi-stain histopathologic images[J].NPJ Precis Oncol,2023,7(1):14.
15 Iii GO,Reis-Filho J,Klimstra D,et al.Abstract P5-02-33:Deep learning-based assessment of HER2-low expression on breast cancer H&E digital whole slide images[J].Cancer Res,2023,83(5_Supplement):P5-02-33.
16 Spitzmüller A,Kapil A,Shumilov A,et al.Abstract P6-04-03:Computational pathology based HER2 expression quantification in HER2-low breast cancer[J].Cancer Res,2023,83(5_Supplement):P6-04-3.
17 Schettini F,Chic N,Braso-Maristany F,et al.Clinical,pathological,and PAM50 gene expression features of HER2-low breast cancer[J].NPJ Breast Cancer,2021,7(1):1.
18 Tarantino P,Hamilton E,Tolaney SM,et al.HER2-low breast cancer:pathological and clinical landscape[J].J Clin Oncol,2020,38(17):1951-1962.
19 de Nonneville A,Houvenaeghel G,Cohen M,et al.Pathological complete response rate and disease-free survival after neoadjuvant chemotherapy in patients with HER2-low and HER2-0 breast cancers[J].Eur J Cancer,2022,176:181-188.
20 Yang C,Zhang X,Chen Y,et al.Survival differences between HER2-0 and HER2-low-expressing breast cancer:a meta-analysis of early breast cancer patients[J].Crit Rev Oncol Hematol,2023,185:103962.
21 Denkert C,Seither F,Schneeweiss A,et al.Clinical and molecular characteristics of HER2-low-positive breast cancer:pooled analysis of individual patient data from four prospective,neoadjuvant clinical trials[J].Lancet Oncol,2021,22(8):1151-1161.
22 Tan R,Ong WS,Lee KH,et al.HER2 expression,copy number variation and survival outcomes in HER2-low non-metastatic breast cancer:an international multicentre cohort study and TCGA-METABRIC analysis[J].BMC Med,2022,20(1):105.
23 Agostinetto E,Rediti M,Fimereli D,et al.HER2-low breast cancer:molecular characteristics and prognosis[J].Cancers(Basel),2021,13(11):2824.
24 Tarantino P,Jin Q,Tayob N,et al.Prognostic and biologic significance of ERBB2-low expression in early-stage breast cancer[J].JAMA Oncol,2022,8(8):1177-1183.
25 Modi S,Jacot W,Yamashita T,et al.Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer[J].N Engl J Med,2022,387(1):9-20.
26 中国临床肿瘤学会乳腺癌专家委员会,中国抗癌协会乳腺癌专业委员会.人表皮生长因子受体2阳性乳腺癌临床诊疗专家共识(2021版)[J].中华医学杂志,2021,101(17):1226-1231.
27 Shanu M,Naoki N,Toshinari Y,et al.Trastuzumab deruxtecan(T-DXd)vs treatment of physician's choice(TPC)in patients(pts)with HER2-low,hormone receptor-positive(HR+)unresectable and/or metastatic breast cancer(mBC):Exploratory biomarker analysis of DESTINY-Breast04[J].J Clin Oncol,2023,41(16_suppl):1020.

[1]	孟凡岗, 陈飞, 甄立军. DLX2对乳腺癌细胞增殖、迁移、侵袭、凋亡及乳腺癌干细胞特性的影响[J]. 实用肿瘤学杂志, 2024, 38(2): 88-95.
[2]	郑鹏飞, 董良鹏, 高延鑫, 张一夫, 秦双. 白细胞介素-38对乳腺癌患者CD8⁺T淋巴细胞功能的影响[J]. 实用肿瘤学杂志, 2024, 38(1): 30-36.
[3]	谢俊岭. 活化白细胞黏附分子在乳腺癌中的研究进展[J]. 实用肿瘤学杂志, 2024, 38(1): 45-49.
[4]	冯楚然, 曹剑钊, 陈子印, 张大昕, 鲁海玲. 乳腺癌放射性心脏损伤及其预防措施的研究进展[J]. 实用肿瘤学杂志, 2023, 37(6): 513-518.
[5]	赵诗璐, 庞达. 乳腺癌预后相关基因的生物信息学筛选与分析[J]. 实用肿瘤学杂志, 2023, 37(5): 422-428.
[6]	樊婷婷, 丁丹妮, 赵子雪, 于洋, 韩凤娟. 脂肪酸代谢与卵巢癌[J]. 实用肿瘤学杂志, 2023, 37(5): 429-433.
[7]	初思彤, 许庆勇. 三阴性乳腺癌免疫治疗耐药机制的研究进展[J]. 实用肿瘤学杂志, 2023, 37(5): 449-453.
[8]	王新萍, 张自云, 王学东. 非编码RNA在乳腺癌化疗耐药中作用的研究进展[J]. 实用肿瘤学杂志, 2023, 37(5): 454-458.
[9]	鲁泓男, 夏冰舒, 乔坤, 张世园, 黄元夕, 鲁祥石. GAS1与乳腺癌免疫治疗及药物敏感性的关系[J]. 实用肿瘤学杂志, 2023, 37(4): 351-359.
[10]	陈飞, 王颖, 曾传琴. B7-H4在乳腺癌组织中的表达及其与患者新辅助化疗后腋窝淋巴结转移的相关性分析[J]. 实用肿瘤学杂志, 2023, 37(4): 360-366.
[11]	李福程, 贾斯媛, 巴玉玲, 罗丹利, 肖敏. 免疫检查点抑制剂在早期乳腺癌新辅助治疗中的研究进展[J]. 实用肿瘤学杂志, 2023, 37(4): 367-371.
[12]	马艳玲, 钱立庭, 魏东华, 尹惠萍, 张娟, 张小鹏. 2014—2017年安徽省合肥市城市乳腺癌高危人群筛查率及其影响因素分析[J]. 实用肿瘤学杂志, 2023, 37(3): 200-206.
[13]	隋世尧, 郑玮, 杨子涵, 庞达. lncRNA SNHG4通过EP300-SNHG4-GPX4轴抑制乳腺癌细胞铁死亡[J]. 实用肿瘤学杂志, 2023, 37(3): 215-223.
[14]	张庆怀, 韩阿蒙, 杨森, 李秀梅, 赵健鑫, 张彦秋. 乳腺癌患者保乳术后五种放疗技术的疗效比较研究[J]. 实用肿瘤学杂志, 2023, 37(3): 224-229.
[15]	伦立鑫, 钟振滨, 赵新宇, 吴筹, 郝春成. 抗EGFR治疗在头颈部鳞癌中的研究进展[J]. 实用肿瘤学杂志, 2023, 37(3): 276-280.