Rajadurai Pathmanathan, Ravindran Sarala, Lee Bang Rom, Md Pauzi Suria Hayati, Chiew Seow Fan, Teoh Kean Hooi, S Raja Gopal Navarasi, Md Yusof Mastura, Yip Cheng Har
Subang Jaya Medical Centre, Subang Jaya 47500, Malaysia.
Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Petaling Jaya 47500, Malaysia.
Cancers (Basel). 2024 Jun 25;16(13):2325. doi: 10.3390/cancers16132325.
Breast cancer is one of the most common cancers in Malaysia. Recently, a new nomenclature was introduced for breast cancers with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 1+, or 2+ with negative in situ hybridization (ISH), i.e., HER2-low breast cancer. In current clinical practice, these breast cancers are reported as HER2-negative. Clinical trials have shown that HER2-low breast cancer benefits from targeted therapy with anti-HER2 antibody-drug conjugates. Unfortunately, various challenges and obstacles are faced by local pathologists in HER2 testing, which may jeopardize the standard of care for patients with HER2-low breast cancer. This consensus guideline aims to elucidate standard practices pertaining to HER2 testing and HER2-low interpretation in Malaysia. Topics discussed among a panel of local experts include tissue sampling and handling, assay and antibody selection, result interpretation and reporting, and quality assurance. Practice recommendations made in this consensus guideline reflect current international guidelines and, where appropriate, adapted to the Malaysian landscape.
乳腺癌是马来西亚最常见的癌症之一。最近，针对人表皮生长因子受体2（HER2）免疫组化（IHC）为1+或2+且原位杂交（ISH）为阴性的乳腺癌引入了一种新的命名法，即HER2低表达乳腺癌。在当前的临床实践中，这些乳腺癌被报告为HER2阴性。临床试验表明，HER2低表达乳腺癌可从抗HER2抗体药物偶联物的靶向治疗中获益。不幸的是，当地病理学家在HER2检测中面临各种挑战和障碍，这可能会危及HER2低表达乳腺癌患者的治疗标准。本共识指南旨在阐明马来西亚有关HER2检测和HER2低表达解读的标准做法。一组当地专家讨论的主题包括组织采样与处理、检测方法与抗体选择、结果解读与报告以及质量保证。本共识指南中提出的实践建议反映了当前的国际指南，并在适当时根据马来西亚的情况进行了调整。
