Miao Haitao, Sun Yuyun, Jin Yizi, Hu Xichun, Song Shaoli, Zhang Jian
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Front Oncol. 2022 May 30;12:894767. doi: 10.3389/fonc.2022.894767. eCollection 2022.
Breast cancer is a heterogeneous disease, and the human epidermal growth factor receptor 2 (HER2) expression may vary considerably between primary and metastatic lesions, or even within a single lesion. Repeated biopsies cannot always be performed. In this feasibility trial, we assessed whether a novel Ga-NOTA-MAL-MZHER2 (Ga-HER2) affibody PET/CT could determine the HER2 status of each lesion if there was a clinical need for it.
Ga-HER2 affibody PET/CT was performed in breast cancer patients if HER2 status remained unclear after standard examinations (including bone scan, F-FDG PET/CT, CT, and feasible biopsy). All available images for each patient were evaluated through an independent review of two committee-certified radiologists with nuclear medicine expertise. In case of discrepancy, adjudication by a third radiologist was performed as needed. All radiologists were blinded to the clinical information.
Twenty-four patients were enrolled. Ga-HER2 affibody PET/CT was requested by physicians due to the following reasons: 6 with multiple primary cancers, 13 with metastases not amenable to biopsy or repeated biopsy, 6 with inconsistent HER2 status between primary and metastatic lesions, and 4 with different HER2 status within different metastases. The final PET report revealed that the Ga-HER2 affibody tumor uptake was considered positive in 16 patients, negative in 7 patients, and equivocal in one patient. The heterogeneity of Ga-HER2 affibody uptake was observed, with a maximal 8.5-fold difference within one patient and a maximal 11-fold difference between patients. Ga-HER2 affibody PET/CT demonstrated a high diagnostic accuracy in differentiating HER2-enriched breast cancer, with a sensitivity of 91.7% and a specificity of 84.6%, regardless of prior lines of anti-HER2 therapies.
Ga-HER2 affibody PET/CT imaging could provide valuable information on HER2 expression of each tumor in the body of patients, which may help in personalized clinical decision-making. Its value is now under systemic assessment.
乳腺癌是一种异质性疾病，人表皮生长因子受体2（HER2）在原发性和转移性病变之间，甚至在单个病变内的表达可能有很大差异。并非总能进行重复活检。在这项可行性试验中，我们评估了一种新型的镓-氮杂环辛三烯-马来酰亚胺-ZHER2（Ga-HER2）亲和体PET/CT在临床有需要时能否确定每个病变的HER2状态。
如果在标准检查（包括骨扫描、F-FDG PET/CT、CT和可行的活检）后HER2状态仍不明确，则对乳腺癌患者进行Ga-HER2亲和体PET/CT检查。通过两名具有核医学专业知识的委员会认证放射科医生的独立审查，对每位患者的所有可用图像进行评估。如有分歧，根据需要由第三位放射科医生进行裁决。所有放射科医生均对临床信息不知情。
共纳入24例患者。医生因以下原因要求进行Ga-HER2亲和体PET/CT检查：6例患有多原发性癌，13例有不适合活检或重复活检的转移灶，6例原发性和转移性病变之间HER2状态不一致，4例不同转移灶内HER2状态不同。最终的PET报告显示，16例患者的Ga-HER2亲和体肿瘤摄取被认为是阳性，7例为阴性，1例为可疑。观察到Ga-HER2亲和体摄取的异质性，同一患者内最大差异为8.5倍，患者之间最大差异为11倍。无论之前的抗HER2治疗线数如何，Ga-HER2亲和体PET/CT在鉴别HER2富集型乳腺癌方面均显示出较高的诊断准确性，敏感性为91.7%，特异性为84.6%。
Ga-HER2亲和体PET/CT成像可为患者体内每个肿瘤的HER2表达提供有价值的信息，这可能有助于个性化临床决策。其价值目前正在进行系统评估。
