Establishment for Reference Range of Serum HER-2/neu in Korean Healthy Women

Purpose: HER-2/neu oncogene is known to play a part in the process of carcinogenesis, while the biological characteristics of HER-2/neu oncoprotein include regulating cell growth and increasing the reproductionability of a tumor. The extracelluar domain (ECD), whose molecular weight is between 95 and 105 kD among the HER-2/neu oncoprotein structures, is proteolyzed and separated from the cell surface by metalloproteases and goes into the blood stream where it starts circulation. Since monoclonal antibody was developed for the serum HER2/neu ECD, it’s now possible to measure HER-2/neu ECD in the serum with the immunoassay method. The measurement of serum HER-2/neu ECD is used for prognosis of metastatic breast cancer and for testing the treating effect of trastuzumab (Herceptin ), a target agent for the patients positive to the HER2/neu receptor. In Korea there is no report on the accurate reference range of serum HER-2/neu for healthy women. The purposes of this study were to measure the serum HER-2/neu ECD in healthy Korean women, analyze the reference range. Methods: The subjects of the study include 200 healthy Korean women with 50 from each in their twenties, thirties, forties, and fifties. As for methodology, the HER-2/neu in the serum separated from their blood was measured. The serum HER-2/neu level was measured quantitatively with the recently developed ADVIA Centaur automated immunoassay analyzer and ADVIA Centaur HER-2/neu assay reagent. With the measurement, you can use the sandwich immunoassay and direct chemilumines책임저자: 이민혁 140-743 서울시용산구한남동657-58번지 순천향대학교의과대학외과 Tel : 02-709-9499, FAX : 02-795-1682, E-mail : mhlee@hosp.sch.ac.kr 접수일: 2006년8월28일 게재승인일: 2006년11월10일 이논문은한국유방건강재단학술연구비지원에의해이루어진것임. 건강한한국여성에서의혈청 HER-2/neu 참고치설정