Kong S-Y, Kang J H, Kwon Y, Kang H-S, Chung K-W, Kang S H, Lee D H, Ro J, Lee E S
Research Institute and Hospital, National Cancer Centre, Gyeonggi-do, Korea.
J Clin Pathol. 2006 Apr;59(4):373-6. doi: 10.1136/jcp.2005.029603. Epub 2006 Feb 3.
To evaluate whether serum HER-2/neu (HER-2) concentration is a valid index of HER-2 status in women with primary breast cancer, and to establish a normal reference range for serum HER-2 concentration in Korean women.
Serum HER-2 concentration was measured and immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH) carried out on tissue samples from 86 consecutive female patients. The results of the three datasets were compared. The cut off value of HER-2 concentration was determined from the mean +2SD values derived from the serum of 93 healthy volunteers.
The IHC and FISH data were significantly correlated (p<0.01), but neither showed significant correlation with the serum HER-2 data. The cut off value of serum HER-2 was 10.2 microg/l, and the serum HER-2 concentration of patients with primary breast cancer ranged from 5.0 to 17.5 microg/l. Only five patients had a serum HER-2 value above the cut off value.
Serum HER-2 concentration cannot be substituted for IHC or FISH to evaluate HER-2 status, nor can it be used as a diagnostic tumour marker in primary breast cancer, considering the low prevalence of serum HER-2 elevation.
评估血清HER-2/neu（HER-2）浓度是否为原发性乳腺癌女性患者HER-2状态的有效指标，并建立韩国女性血清HER-2浓度的正常参考范围。
对86例连续女性患者的组织样本进行血清HER-2浓度检测、免疫组织化学（IHC）和荧光原位杂交（FISH）。比较三个数据集的结果。HER-2浓度的临界值由93名健康志愿者血清的均值+2SD值确定。
IHC和FISH数据显著相关（p<0.01），但两者均与血清HER-2数据无显著相关性。血清HER-2的临界值为10.2μg/l，原发性乳腺癌患者的血清HER-2浓度范围为5.0至17.5μg/l。只有5例患者的血清HER-2值高于临界值。
考虑到血清HER-2升高的患病率较低，血清HER-2浓度不能替代IHC或FISH来评估HER-2状态，也不能用作原发性乳腺癌的诊断肿瘤标志物。
