ELISA方法检测乳腺癌患者血清HER2的临床价值

Clinical value of serum HER2 which detected by ELISA method in breast cancer patients

目的：HER2基因扩增和HER2蛋白过表达是乳腺癌患者预后不良的分子标志，是临床指导靶向HER2治疗的标准。肿瘤细胞中HER2蛋白胞外域经蛋白酶裂解脱落入血，血清中HER2水平改变可以用于监测乳腺癌的进展和治疗疗效。本研究旨在分析血清HER2水平与乳腺癌组织HER2表达状态的相关性，并探讨血清HER2水平与临床病理因素的关系，以评价其潜在的临床应用价值。方法：分别采用ELISA和免疫组化方法检测70例乳腺癌患者血清HER2水平和肿瘤组织HER2表达状态，Spearmen秩相关分析二者的相关性，χ2检验分析血清HER2与临床病理因素的关系。结果：乳腺癌患者血清HER2水平和组织HER2表达呈正相关（r=0．686，P〈0．001）；肿瘤直径大于2cm患者血清HER2水平高于小于等于2cm患者（χ2=9．071，P=0．030）；临床II-III期患者血清HER2水平高于I期患者（χ2=9．001，P=0．030）；ER阴性患者血清HER2水平高于ER阳性患者（χ2=16．307，P〈0．0.001）：PR阴性患者血清HER2水平高于PR阳性患者（χ2=16．164，P〈0．001），而血清HER2水平在不同患者年龄、组织学分级和淋巴结状态等临床病理因素各组间无统计学差异。结论：乳腺癌患者血清HER2水平可以反应肿瘤组织HER2表达状态，其水平升高提示乳腺癌恶性程度高、预后差，是潜在的乳腺癌预后预测和疗效监测的血清学标志，

Objective ： Either amplification of HER2 oncogene or overexpression of HER2 protein is a molecular marker of poor prognosis in breast cancer, and provides a target for therapeutic approaches. The extracellular domain of HER2 can be cleaved and shed from breast cancer cells into blood circulation, and serum HER2 levels can be used to monitor the tumor progression and treatment effects. The purpose of this study is to analyze the correlation of serum HER2 levels and tissue HER2 status, explore the relationship of serum HER2 levels and clinicopathological features, and evaluate its potential clinical significance. Methods ： The serum HER2 levels and HER2 expression levels in breast tumor tissues of70 breast cancer patients were detected by ELISA and IHC, respectively. Spearman rank correlation analysis was used to analyze the correlation of serum HER2 levels and tissue HER2 status, and Chi-square test was used to analyze the relationship of serum HER2 levels and clinicopathological features.Results ： The serum HER2 levels was significantly correlated with HER2 status in breast cancer tissues （r = 0.686, P 〈 0.001）; the serum HER2 levels of patients with tumor larger than 2 cm is higher than patients with tumor smaller than 2 cm （χ2 = 9.071, P = 0.030）; the serum HER2 levels was higher in patients with negative ER or negative PR than in patients with positive ER （χ2 = 16.307, P 〈 0.001） or positive PR （χ2 = 16.164, P 〈 0.001）. No significant relationship was found between serum HER2 levels and other clinicopathological factors, such as age , Histological grade and lymph nodes. Conclusions ： The serum HER2 levels can reflect the HER2 status in breast cancer tissues. High serum HER2 levels suggest high degree of malignancy and poor prognosis of breast cancer patients, indicating serum HER2 is a potential serology marker for predicting prognosis and monitoring treatment effects of breast cancer. ]