Pertuzumab (brand name, Perjeta) is a monoclonal antibody used in the treatment of breast cancer. Pertuzumab was designed to target an epidermal growth factor receptor encoded by the gene, commonly referred to as the gene. The gene is overexpressed in 15–20% of breast cancers and is also overexpressed in some cases of other cancer types (gastric, colon, head, and neck). Historically, “HER2-positive” tumors are associated with a faster rate of growth and a poorer prognosis than other breast cancer subtypes. The use of pertuzumab in treatment regimens improves outcomes, with limited adverse effects that include cardiac toxicity. Pertuzumab is used with other drugs as an advanced breast cancer treatment, a neoadjuvant treatment, and an adjuvant treatment for HER2-positive breast cancer. In the advanced/metastatic setting, pertuzumab added to trastuzumab and a taxane is used to increase long-term progression-free and overall survival when administered in the first line setting. As neoadjuvant treatment, pertuzumab is given with trastuzumab and chemotherapy before surgery in individuals with early breast cancer to increase pathologic complete response rates. And as an adjuvant treatment, pertuzumab is given with trastuzumab and chemotherapy to reduce the risk of cancer reoccurrence in individuals with early breast cancer (Table 1). The 2020 FDA-approved drug label states that pertuzumab should only be used to treat individuals with tumors that have either HER2 protein overexpression or gene amplification, as determined by an accurate and validated FDA-approved assay. This is because these are the only individuals studied for whom benefit has been shown (1). The most recent update (2018) American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines continue to state that all newly diagnosed individuals with breast cancer must have an HER2 test performed. Individuals who then develop metastatic disease must have an HER2 test performed in a metastatic site, if a tissue sample is available (2).
帕妥珠单抗(商品名:帕捷特)是一种用于治疗乳腺癌的单克隆抗体。帕妥珠单抗旨在靶向由该基因编码的表皮生长因子受体,该基因通常被称为该基因。该基因在15%至20%的乳腺癌中过度表达,在其他一些癌症类型(胃癌、结肠癌、头颈癌)的某些病例中也过度表达。从历史上看,“HER2阳性”肿瘤与其他乳腺癌亚型相比,生长速度更快,预后更差。在治疗方案中使用帕妥珠单抗可改善治疗效果,不良反应有限,包括心脏毒性。帕妥珠单抗与其他药物联合用于晚期乳腺癌治疗、新辅助治疗以及HER2阳性乳腺癌的辅助治疗。在晚期/转移性情况下,将帕妥珠单抗添加到曲妥珠单抗和紫杉烷中,用于一线治疗时可提高长期无进展生存期和总生存期。作为新辅助治疗,在早期乳腺癌患者手术前,将帕妥珠单抗与曲妥珠单抗及化疗联合使用,以提高病理完全缓解率。作为辅助治疗,将帕妥珠单抗与曲妥珠单抗及化疗联合使用,以降低早期乳腺癌患者癌症复发的风险(表1)。2020年美国食品药品监督管理局(FDA)批准的药品标签指出,帕妥珠单抗仅应用于治疗经准确且经过验证的FDA批准检测方法确定为HER2蛋白过度表达或该基因扩增的肿瘤患者。这是因为这些是仅有的经研究显示有获益的患者(1)。美国临床肿瘤学会(ASCO)/美国病理学家学会(CAP)2018年的最新指南继续指出,所有新诊断的乳腺癌患者都必须进行HER2检测。如果有组织样本,随后发生转移性疾病的患者必须在转移部位进行HER2检测(2)。