Abstract
BackgroundTo explore the association between serum human epidermal growth factor receptor 2 (HER 2) extracellular domain (ECD) levels and tissue HER 2 status in metastatic gastric cancer.Patients and MethodsHER 2 status was retrospectively analyzed in 219 advanced gastric or gastroesophageal junction (GEJ) patients. Serum HER 2 ECD was measured by chemiluminescent assay and tissue HER 2 was assessed by fluorescent in situ hybridisation (FISH) and immunohistochemistry (IHC) assay.ResultsSignificant associations were found between serum HER 2 ECD levels and tissue HER 2 status. Twenty-four patients had HER 2 ECD levels >16.35 ng/mL, which has a sensitivity of 51.4% and a specificity of 97.3% to predict tissue HER 2 status. When the cut-off value was increased to 22 ng/mL, then all 12 patients with serum HER 2 ECD levels>22 ng/mL were tissue HER 2 positive, corresponding to a specificity of 100% and a sensitivity of 32.4%. High serum HER 2 ECD levels were strongly associated with the intestinal histological type (Lauren’s classification), liver metastasis, multiple metastasis (>2) and increased LDH levels, but not with overall survival.ConclusionsThe high specificity of the serum HER 2 ECD assay in predicting tissue HER 2 status suggests its potential as a surrogate marker of the HER 2 status in gastric cancer.
Highlights
Human epidermal growth factor receptor 2 (HER 2) is a 185kDa transmembrane protein encoded by HER2/neu or the cerbB-2 proto-oncogene on chromosome 17q21
On the basis of these trial results, it is recommended that patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma should be tested for tissue human epidermal growth factor receptor 2 (HER 2) status by immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH) in order to guide antiHER 2 therapy
High serum HER 2 extracellular domain (ECD) levels were strongly associated with the intestinal histological type (P = 0.003), liver metastasis (P,0.001), multiple metastases (.2) (P = 0.012) and an increased LDH level (P,0.001)
Summary
Human epidermal growth factor receptor 2 (HER 2) is a 185kDa transmembrane protein encoded by HER2/neu or the cerbB-2 proto-oncogene on chromosome 17q21. On the basis of these trial results, it is recommended that patients with advanced gastric and GEJ adenocarcinoma should be tested for tissue HER 2 status by immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH) in order to guide antiHER 2 therapy Both assays have their own limitations: 1) Each technique requires a high-quality tissue sample, which sometimes may not be available; (2) There is a lack of ‘‘real-time’’ monitoring during anti-HER 2 therapy; (3) Discordance between IHC and the FISH results may occur due to interlaboratory variability, tumour heterogeneity, antigen loss during tissue storage and processing, non-standardized procedures, subjective observations, and discrepancies of HER2 protein expression and gene amplification. To explore the association between serum human epidermal growth factor receptor 2 (HER 2) extracellular domain (ECD) levels and tissue HER 2 status in metastatic gastric cancer
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