Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
American Society of Clinical Oncology, Alexandria, VA.
J Clin Oncol. 2023 Aug 1;41(22):3867-3872. doi: 10.1200/JCO.22.02864. Epub 2023 Jun 7.
PURPOSE: To update ASCO-College of American Pathologists (CAP) recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer. The Panel is aware that a new generation of antibody-drug conjugates (ADCs) targeting the HER2 protein is active against breast cancers that lack protein overexpression or gene amplification. METHODS: An Update Panel conducted a systematic literature review to identify signals for updating recommendations. RESULTS: The search identified 173 abstracts. Of five 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 ADCs. 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, while 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.
目的：更新美国临床肿瘤学会（ASCO）-美国病理学家学会（CAP）关于乳腺癌人表皮生长因子受体 2（HER2）检测的建议。专家组意识到，针对缺乏蛋白过表达或基因扩增的 HER2 蛋白的新一代抗体药物偶联物（ADC）对乳腺癌具有活性。
方法：一个更新专家组进行了系统的文献回顾，以确定更新建议的信号。
结果：搜索确定了 173 个摘要。在审查的五项潜在出版物中，没有一项构成修订现有建议的信号。
建议：确认 2018 年 ASCO-CAP 关于 HER2 检测的建议。
讨论：HER2 检测指南一直侧重于在乳腺癌中确定 HER2 蛋白过表达或基因扩增，以确定接受破坏 HER2 信号的治疗药物的患者。本次更新承认，当 HER2 不表达或扩增，但免疫组织化学（IHC）为 1+或 2+，原位杂交无扩增时，曲妥珠单抗 deruxtecan 具有新的适应证。关于 IHC 0 检测肿瘤的临床试验数据有限（排除在 DESTINY-Breast04 中），并且缺乏证据表明这些癌症的行为不同或对新型 HER2 ADC 没有类似的反应。尽管目前的数据不支持新的 IHC 0 与 1+的预测或预测反应阈值用于曲妥珠单抗 deruxtecan，但由于支持其新监管批准的试验入组标准，该阈值现在具有相关性。因此，虽然创建新的 HER2 表达结果类别（例如，HER2-Low，HER2-Ultra-Low）还为时过早，但现在区分 IHC 0 与 1+的最佳实践具有临床相关性。本次更新确认了先前的 HER2 报告建议，并提供了一个新的 HER2 检测报告注释，以突出 IHC 0 与 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。更多信息可在 www.asco.org/breast-cancer-guidelines 上获取。
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