Yang Xiaofang, Xu Mengdan, Xia Yu, Ba Zhaofen, Han Chunmiao, Wang Yipu, Qu Jinwen, Wang Yu, Zhou Yehui, Wang Rong, Lan Jing
Jiangsu MicroDiag Biomedical Technology Co., Ltd., Suzhou, China.
Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Transl Cancer Res. 2025 May 30;14(5):3186-3200. doi: 10.21037/tcr-2025-825. Epub 2025 May 27.
Exosomes derived from liquid biopsy can serve as excellent biomarkers in clinical practices. Human epidermal growth factor receptor 2 (HER2) has been shown to be associated with tumor stage, clinical therapy, and prognosis. However, the clinical value of exosomal HER2 for breast cancer remains unclear. The study aimed to investigate the potential of exosomal HER2 in breast cancer diagnosis, explore its role in guiding clinicians in the selection of treatment options, and find out whether changes in exosomal HER2 levels could be used to evaluate the efficacy of neoadjuvant chemotherapy.
The HER2 protein was detected by magnetic particle-based chemiluminescence immunoassay. The study enrolled 51 patients with breast cancer and 36 patients with benign breast disease to evaluate the diagnostic value of exosomal HER2. Additionally, a receiver operating characteristic (ROC) curve was drawn for HER2 immunohistochemistry (IHC) to determine the concordance between exosomal HER2 and HER2 IHC. Furthermore, the exosomal HER2 levels during neoadjuvant therapy were measured to assess the efficacy of neoadjuvant therapy.
Exosomal HER2 concentration in patients with breast cancer was significantly higher than that in patients with benign breast disease. The optimal cutoff value of exosomal HER2 for diagnosing breast cancer was 772.7 pg/mL, with a sensitivity of 45.1% and a specificity of 97.22%. With 743 pg/mL as the cutoff value, the concordance between exosomal HER2 levels and HER2 IHC was 74.51%, with a sensitivity of 81.25% and a specificity of 71.43%. Exosomal HER2 could be detected in patients receiving neoadjuvant therapy, and some patients (5/8) exhibited a proportional relationship between exosomal HER2 levels and clinical tumor size changes.
Plasma-derived exosomal HER2 might serve as a promising biomarker for distinguishing breast cancer from benign breast disease, screening patients who could benefit from HER2-targeted therapy, and monitoring neoadjuvant therapy.
液体活检来源的外泌体可作为临床实践中出色的生物标志物。人表皮生长因子受体2（HER2）已被证明与肿瘤分期、临床治疗及预后相关。然而，外泌体HER2在乳腺癌中的临床价值仍不明确。本研究旨在探讨外泌体HER2在乳腺癌诊断中的潜力，探索其在指导临床医生选择治疗方案中的作用，并查明外泌体HER2水平的变化是否可用于评估新辅助化疗的疗效。
采用基于磁颗粒的化学发光免疫分析法检测HER2蛋白。本研究纳入了51例乳腺癌患者和36例乳腺良性疾病患者，以评估外泌体HER2的诊断价值。此外，绘制HER2免疫组织化学（IHC）的受试者工作特征（ROC）曲线，以确定外泌体HER2与HER2 IHC之间的一致性。此外，测量新辅助治疗期间的外泌体HER2水平，以评估新辅助治疗的疗效。
乳腺癌患者的外泌体HER2浓度显著高于乳腺良性疾病患者。诊断乳腺癌的外泌体HER2最佳临界值为772.7 pg/mL，灵敏度为45.1%，特异性为97.22%。以外泌体HER2水平与HER2 IHC的一致性为74.51%，临界值为743 pg/mL，灵敏度为81.25%，特异性为71.43%。在接受新辅助治疗的患者中可检测到外泌体HER2，部分患者（5/8）的外泌体HER2水平与临床肿瘤大小变化呈比例关系。
血浆来源的外泌体HER2可能是一种有前景的生物标志物，可用于区分乳腺癌与乳腺良性疾病、筛选可能从HER2靶向治疗中获益的患者以及监测新辅助治疗。
