Gao Yuan, Yin Lei, Duan Xiaojiang, Fu Zijian, Liu Qian, Chen Jinzhi, Xin Ling, Zhu Xiaojuan, Xiang Hongyu, Xu Ling, Ye Jingming, Liu Meng
Department of Nuclear Medicine, Peking University First Hospital, Beijing, China.
Thyroid and Breast Surgery, Peking University First Hospital, Beijing, China.
Eur J Nucl Med Mol Imaging. 2025 May 8. doi: 10.1007/s00259-025-07220-3.
Human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugates (ADCs) in breast cancer is progressing rapidly, asking for precise categorization of HER2 expression. Our aim was to explore the HER2-affibody uptake characteristics in breast cancer and to find potential biomarkers for differentiating HER2 status, in comparison with F-FDG PET/CT.
In this prospective study conducted from May 2024 to Jan 2025, participants with newly diagnosed breast cancer underwent both Ga-HER2-affibody and F-FDG PET/CT examinations. The relationship between PET parameters (such as maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean), tumor-to-background SUV ratio (TBR)) and HER2 expression statuses (HER2-zero, -low and -positive) was analyzed.
A total of 57 female participants (58 primary lesions) with newly diagnosed breast cancer were included. In the paired comparison of Ga-HER2-affibody and F-FDG PET/CT, HER2-TBR was higher than FDG-TBR in the HER2-low and HER2-positive group, respectively (P < 0.001). HER2-SUVmax and HER2-SUVmean exhibited differences across most comparisons, especially HER2-zero vs. -low (P < 0.05). HER2-SUVmean emerged as an independent predictor (P = 0.01; OR: 2.8) for differentiating HER2-low/positive and -zero, yielding an AUC of 0.91. Under detailed HER2 immunohistochemistry, HER2-SUVmax, -SUVmean and -TBR demonstrated intergroup differences (P < 0.05).
HER2-targeted PET/CT imaging demonstrated distinct advantages over F-FDG PET/CT imaging in characterizing the HER2 status of primary lesions. Parameters based on HER2-affibody differed significantly among different HER2 statuses, and might be potential imaging indicators for screening patients with HER2-low/positive who could benefit from HER2-targeted ADCs.
NCT06289517 (2024-03-04).
乳腺癌中靶向人表皮生长因子受体2（HER2）的抗体药物偶联物（ADC）发展迅速，这就需要对HER2表达进行精确分类。我们的目的是探讨HER2亲和体在乳腺癌中的摄取特征，并寻找与F-FDG PET/CT相比用于区分HER2状态的潜在生物标志物。
在2024年5月至2025年1月进行的这项前瞻性研究中，新诊断为乳腺癌的参与者同时接受了Ga-HER2亲和体和F-FDG PET/CT检查。分析了PET参数（如最大标准化摄取值（SUVmax）、平均标准化摄取值（SUVmean）、肿瘤与背景SUV比值（TBR））与HER2表达状态（HER2零表达、低表达和阳性）之间的关系。
共纳入57名新诊断为乳腺癌的女性参与者（58个原发性病灶）。在Ga-HER2亲和体与F-FDG PET/CT的配对比较中，HER2-TBR在HER2低表达和阳性组中分别高于FDG-TBR（P < 0.001）。HER2-SUVmax和HER2-SUVmean在大多数比较中表现出差异，尤其是HER2零表达与低表达之间（P < 0.05）。HER2-SUVmean成为区分HER2低表达/阳性与零表达的独立预测因子（P = 0.01；OR：2.8），曲线下面积为0.91。在详细的HER2免疫组化检查中，HER2-SUVmax、-SUVmean和-TBR显示出组间差异（P < 0.05）。
靶向HER2的PET/CT成像在表征原发性病灶的HER2状态方面比F-FDG PET/CT成像具有明显优势。基于HER2亲和体的参数在不同HER2状态之间存在显著差异，可能是筛选可能从靶向HER2的ADC中获益的HER2低表达/阳性患者的潜在成像指标。
NCT06289517（2024-03-04）。
