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乳腺癌HER2检测指南（2024版）
《乳腺癌HER2检测指南（2024版）》编写组
作者及单位信息
·
DOI： 10.3760/cma.j.cn112151-20241009-00664
Guideline for HER2 testing in breast cancer (2024 version)
Members of Breast Cancer Expert Panel on Guideline for HER2 Testing in Breast Cancer (2024 version)
Yang Wentao
Liu Yueping
Liang Zhiyong
Bu Hong
Authors Info & Affiliations
Members of Breast Cancer Expert Panel on Guideline for HER2 Testing in Breast Cancer (2024 version)
Yang Wentao
Department of Pathology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China
Liu Yueping
Department of Pathology, the Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, Shijiazhuang 050011, China
Liang Zhiyong
Department of Pathology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing 100730, China
Bu Hong
Department of Pathology, West China Hospital, Sichuan University, Chengdu 610041, China
·
DOI： 10.3760/cma.j.cn112151-20241009-00664
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摘要

随着抗HER2靶向治疗的进展及循证依据的更新，HER2检测与诊断亟需进一步规范和标准化。因此，本指南基于《乳腺癌HER2检测指南（2019版）》，围绕10个主要相关问题进行了全面覆盖，特别详述了HER2诊断流程和报告内容（包括HER2低/超低表达）、HER2异质性、质量控制流程优化，以及人工智能技术在乳腺癌HER2检测中的应用前景，旨在提高HER2检测的准确性和可重复性，为临床抗HER2靶向治疗策略提供有力支持。

引用本文

《乳腺癌HER2检测指南（2024版）》编写组. 乳腺癌HER2检测指南（2024版）[J]. 中华病理学杂志,2024,53(12)：1192-1202.

DOI:10.3760/cma.j.cn112151-20241009-00664

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正确检测和评定乳腺癌的HER2蛋白表达和基因扩增状态对乳腺癌的临床治疗及预后判断至关重要 ［ 1 ］ 。2006年我国《乳腺癌HER2检测指南》 ［ 2 ］ 的发布对提高乳腺癌HER2检测水平起到了积极作用。我国病理学专家和临床专家于2009年、2014年和2019年联合发布了《乳腺癌HER2检测指南》 ［ 3 , 4 , 5 ］ ，强调HER2检测的结果判读标准、技术路线、内外部质量控制等，对我国乳腺癌HER2检测的标准化发挥了重要促进作用。针对HER2阳性乳腺癌的治疗药物（曲妥珠单抗、帕妥珠单抗、奈拉替尼、吡咯替尼、T-DM1等）在临床上已取得良好疗效。
临床试验DESTINY-Breast04结果显示新型HER2抗体耦联药物Trastuzumab Deruxtecan（T-DXd）在HER2低表达，即免疫组织化学（immunohistochemistry，IHC）1+或IHC 2+且原位杂交阴性的不可切除/转移性乳腺癌中显示出良好的临床获益 ［ 6 ］ 。DESTINY-Breast06结果显示T-DXd为至少一线内分泌治疗进展后的激素受体+/HER2超低表达（IHC 0，存在细胞膜染色）晚期/转移性乳腺癌患者带来无进展生存期的显著改善。此外，研究显示HER2基因突变的实体瘤患者也可从T-DXd、pan-HER2抑制剂（奈拉替尼和吡咯替尼）等治疗中获益 ［ 7 , 8 ］ 。因此，HER2检测面临着一些新的问题和挑战，需要更加精确的检测技术和判读标准以便更好地指导临床治疗决策 ［ 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ］ 。
基于临床循证依据的更新和针对全国临床与病理医师的调查问卷数据，《乳腺癌HER2检测指南（2024版）》编写组经过充分讨论确定了10个主要相关问题，包括乳腺癌HER2推荐检测方法、检测流程、判读要求、质量控制和报告模式等。本指南以《乳腺癌HER2检测指南（2019版）》为基础，围绕主要的临床问题进行更新，旨在提高HER2检测的准确性和可重复性，为临床抗HER2靶向治疗策略提供指导。
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备注信息
A
杨文涛（复旦大学附属肿瘤医院病理科 复旦大学上海医学院肿瘤学系，上海 200032），Email： mocdef.3ab610002twgnay
B
刘月平（河北医科大学第四医院 河北省肿瘤医院病理科，石家庄 050011），Email： mocdef.3ab61amanna
C
梁智勇（中国医学科学院 北京协和医学院 北京协和医院病理科，北京 100730），Email： nc.defhcabmupyzgnail
D
步宏（四川大学华西医院病理科，成都 610041），Email： nc.defudabe.ucsubgnoh
E

执笔人：刘月平（河北医科大学第四医院 河北省肿瘤医院病理科，石家庄 050011）；杨文涛（复旦大学附属肿瘤医院病理科 复旦大学上海医学院肿瘤学系，上海 200032）

F
《乳腺癌HER2检测指南（2024版）》编写组. 乳腺癌HER2检测指南（2024版）[J]. 中华病理学杂志, 2024, 53(12): 1192-1202. DOI: 10.3760/cma.j.cn112151-20241009-00664.
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