人表皮生长因子受体2在乳腺癌中的检测。

IF 3.7 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Archives of pathology & laboratory medicine Pub Date : 2023-09-01 DOI:10.5858/arpa.2023-0950-SA
Antonio C Wolff, Mark R Somerfield, Mitchell Dowsett, M Elizabeth H Hammond, Daniel F Hayes, Lisa M McShane, Thomas J Saphner, Patricia A Spears, Kimberly H Allison
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引用次数: 8

摘要

目的。-:更新美国临床肿瘤学会-美国病理学家学会(ASCO-CAP)对乳腺癌中人表皮生长因子受体2 (HER2)检测的建议。一个更新小组意识到,针对HER2蛋白的新一代抗体-药物偶联物对缺乏蛋白过表达或基因扩增的乳腺癌具有活性。-:更新小组进行了系统的文献回顾,以确定更新建议的信号。-:检索出173篇摘要。在审查的5份潜在出版物中,没有一份构成修订现有建议的信号。-:确认2018年ASCO-CAP关于HER2检测的建议。-: HER2检测指南的重点是识别乳腺癌中HER2蛋白过表达或基因扩增,以确定患者是否需要破坏HER2信号传导的治疗。这一更新承认了曲妥珠单抗deruxtecan在HER2未过度表达或扩增,但免疫组织化学(IHC) 1+或2+未通过原位杂交扩增时的新适应症。检测IHC 0的肿瘤的临床试验数据有限(排除在DESTINY-Breast04之外),并且缺乏证据表明这些癌症对较新的HER2抗体-药物偶联物表现不同或没有相似的反应。尽管目前的数据不支持对曲妥珠单抗德鲁德康反应的新的IHC 0 vs 1+预后或预测阈值,但由于支持其新的监管批准的试验进入标准,该阈值现在是相关的。因此,尽管创建新的HER2表达结果分类(例如HER2- low, HER2- ultra - low)还为时过早,但区分IHC 0和1+的最佳实践现在具有临床相关性。该更新确认了先前的HER2报告建议,并提供了新的HER2检测报告评论,以强调IHC 0和1+结果的当前相关性,以及区分这些通常细微差异的最佳实践建议。更多信息请访问www.asco.org/breast-cancer-guidelines。
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Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer.

Purpose.—: To update the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer. An Update Panel is aware that a new generation of antibody-drug conjugates targeting the HER2 protein is active against breast cancers that lack protein overexpression or gene amplification.

Methods.—: The Update Panel conducted a systematic literature review to identify signals for updating recommendations.

Results.—: The search identified 173 abstracts. Of 5 potential publications reviewed, none constituted a signal for revising existing recommendations.

Recommendations.—: The 2018 ASCO-CAP recommendations for HER2 testing are affirmed.

Discussion.—: HER2 testing guidelines have focused on identifying HER2 protein overexpression or gene amplification in breast cancer to identify patients for therapies that disrupt HER2 signaling. This update acknowledges a new indication for trastuzumab deruxtecan when HER2 is not overexpressed or amplified but is immunohistochemistry (IHC) 1+ or 2+ without amplification by in situ hybridization. Clinical trial data on tumors that tested IHC 0 are limited (excluded from DESTINY-Breast04), and evidence is lacking that these cancers behave differently or do not respond similarly to newer HER2 antibody-drug conjugates. Although current data do not support a new IHC 0 versus 1+ prognostic or predictive threshold for response to trastuzumab deruxtecan, this threshold is now relevant because of the trial entry criteria that supported its new regulatory approval. Therefore, although it is premature to create new result categories of HER2 expression (eg, HER2-Low, HER2-Ultra-Low), best practices to distinguish IHC 0 from 1+ are now clinically relevant. This update affirms prior HER2 reporting recommendations and offers a new HER2 testing reporting comment to highlight the current relevance of IHC 0 versus 1+ results and best practice recommendations to distinguish these often subtle differences. Additional information is available at www.asco.org/breast-cancer-guidelines.

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来源期刊
CiteScore
9.20
自引率
2.20%
发文量
369
审稿时长
3-8 weeks
期刊介绍: Welcome to the website of the Archives of Pathology & Laboratory Medicine (APLM). This monthly, peer-reviewed journal of the College of American Pathologists offers global reach and highest measured readership among pathology journals. Published since 1926, ARCHIVES was voted in 2009 the only pathology journal among the top 100 most influential journals of the past 100 years by the BioMedical and Life Sciences Division of the Special Libraries Association. Online access to the full-text and PDF files of APLM articles is free.
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