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Abstract
Aim: We investigated whether serum concentrations of the HER2 extracellular domain (ECD) can be used as an alternative to test tissue HER2 status in metastatic gastric cancer. Materials & methods: A total of 133 cases of metastatic gastric cancer were included in present study. Serum HER2 ECD was measured by chemiluminescence immunoassay (CLIA). Receiver operating characteristic curve analysis was used to determine optimal serum HER2 ECD concentrations for differentiation between positive and negative HER2 status. Results: The median level of serum HER2 ECD was 9.6 ng/ml in metastatic gastric cancer patients. There was a significant relationship between serum and tissue levels of HER2 protein (p < 0.001). Area under the curve for serum HER2 ECD was 0.771 (95% CI: 0.682–0.860). Conclusion: Levels of serum HER2 ECD are highly correlated with tissue HER2 status in metastatic gastric cancer. Serum HER2 ECD assay can be considered as a potential alternative for tissue HER2 status.
Financial & competing interests disclosure
This work was supported by National Natural Science Foundation of China (No. 81172110), National High Technology Research and Development Program (No. 2012AA 02A 504), Beijing Municipal Science & Technology Commission Program (No. Z11110706730000), Beijing Natural Science Foundation (7142034) and China Postdoctoral Science Foundation (2013M530494). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.