Garoufali A, Kyriakou F, Kountourakis P, Yioti I, Malliou S, Nikaki A, Kardara E, Frangos I, Koumna S, Baziotis N, Scorilas A, Ardavanis A
Nuclear Medicine Laboratory, 1st Department of Medical Oncology, St. Savvas Anticancer Hospital, and Biology Department, University of Athens, Athens, Greece.
J BUON. 2008 Jul-Sep;13(3):409-13.
The extracellular domain (ECD) of the HER2 receptor is proposed as a real-time marker of HER2-positive breast cancer (BC). In this study, ECD-HER2 levels were compared with standard clinical and pathological prognostic factors.
In 247 consecutive patients (116 with early or localized BC, 116 with advanced or metastatic BC, and 16 with benign mastopathies), serum ECD-HER2 levels were measured. In 116 advanced-disease patients ECD-HER2 status was also studied by immunohistochemistry (IHC) and compared with established clinical and pathological variables.
Mean serum ECD-HER2 value was 19.62 ng/ml (median 10.35, range 3-->250). Mean value in benign mastopathies was 9.04 ng/ml, 9.4 ng/ml in early disease and 34.5 ng/ml in advanced disease. No difference between benign mastopathies and early BC was observed, while significant difference between early and advanced BC (p<0.001) was noted. However, in advanced-disease patients a positive correlation of ECD-HER2 with IHC (p=0.002), disease grade (p=0.034) and level II axillary node involvement (p=0.011) was noted, as well as a significant negative correlation with estrogen receptor (ER) and progesterone receptor (PR) (p=0.035 and p=0.011, respectively).
ECD-HER2 is a reliable marker for breast cancer, as suggested from the existing literature; therefore, its integration in the initial workup and follow-up routine of breast cancer, particularly the HER2-positive, is proposed.
HER2受体的细胞外结构域（ECD）被认为是HER2阳性乳腺癌（BC）的实时标志物。在本研究中，将ECD-HER2水平与标准临床和病理预后因素进行了比较。
对247例连续患者（116例早期或局限性BC患者、116例晚期或转移性BC患者以及16例良性乳腺病患者）测定血清ECD-HER2水平。对116例晚期疾病患者，还通过免疫组织化学（IHC）研究了ECD-HER2状态，并与既定的临床和病理变量进行比较。
血清ECD-HER2平均值为19.62 ng/ml（中位数10.35，范围3→250）。良性乳腺病患者的平均值为9.04 ng/ml，早期疾病患者为9.4 ng/ml，晚期疾病患者为34.5 ng/ml。未观察到良性乳腺病与早期BC之间存在差异，而早期与晚期BC之间存在显著差异（p<0.001）。然而，在晚期疾病患者中，ECD-HER2与IHC（p=0.002）、疾病分级（p=0.034）和II级腋窝淋巴结受累（p=0.011）呈正相关，与雌激素受体（ER）和孕激素受体（PR）呈显著负相关（分别为p=0.035和p=0.011）。
正如现有文献所提示的，ECD-HER2是乳腺癌的可靠标志物；因此，建议将其纳入乳腺癌，尤其是HER2阳性乳腺癌的初始检查和随访常规中。
