PDF(Pubmed)
Abstract：
The Japanese Breast Cancer Society Clinical Practice Guidelines are published as timely guidance on clinical issues in breast cancer treatment in Japan. In the recent edition of these guidelines, we addressed a new clinical question 34 (CQ 34, systemic treatment part) \"Is trastuzumab deruxtecan recommended for patients with unresectable or metastatic HER2-low breast cancer?\" and a new future research question 7 (FRQ 7, pathological diagnosis part) \"How is HER2-low breast cancer diagnosed for the indication of trastuzumab deruxtecan?\". These questions address use of trastuzumab deruxtecan in patients with unresectable or metastatic HER2-low breast cancer who have previously received chemotherapy for metastatic disease. The strengths of evidence and recommendation were determined through a quantitative and qualitative systematic review using multiple outcomes, including efficacy and safety. We conclude that trastuzumab deruxtecan is recommended for this patient population (strength of recommendation: 1; strength of evidence: moderate; CQ34) and that HER2-low expression for the indication of trastuzumab deruxtecan should be diagnosed using companion diagnostics based on appropriate criteria (FRQ7).
摘要：
《日本乳腺癌协会临床实践指南》作为日本乳腺癌治疗临床问题的及时指南发布。在这些指南的最新版本中，我们解决了一个新的临床问题34（CQ34，系统治疗部分）\“曲妥珠单抗曲妥替康是推荐用于不可切除或转移性低HER2乳腺癌患者吗？”和一个新的未来研究问题7（FRQ7，病理诊断部分）\“如何诊断低HER2乳腺癌以曲妥珠单抗曲妥替康为适应症？”。这些问题涉及曲妥珠单抗deruxtecan在先前接受过转移性疾病化疗的不可切除或转移性低HER2乳腺癌患者中的应用。证据和建议的优势是通过使用多个结果的定量和定性系统评价来确定的。包括疗效和安全性。我们得出的结论是，曲妥珠单抗deruxtecan推荐用于该患者人群（推荐强度：1；证据强度：中度；CQ34），并且应使用基于适当标准的伴随诊断（FRQ7）来诊断曲妥珠单抗deruxtecan适应症的HER2低表达。
