title: Evaluation of HER2/neu oncoprotein in serum & tissue samples of women with breast cancer.
abstract: OBJECTIVE
  The proto-oncogene HER2/neu has been extensively studied in breast cancer patients. Serum levels of HER2/neu by ELISA in breast cancer patients were compared with tissue HER2/neu expression and with other clinicopathological parameters with the aim to investigate whether the serum assay could replace the established tests (IHC/FISH) for HER-2 status.
  
  
  METHODS
  Blood and Tru-cut biopsy samples were collected for determining HER2/neu status in 64 breast cancer patients. The tissue specimens were processed routinely and immunohistochemistry (IHC) for HER2/ER/PR (oestrogen/progesterone receptors) performed. Fluorescence in-situ hybridization (FISH) was performed on all HER2/neu 2 positive cases. Sixty age matched healthy females and females with benign breast disease were taken as controls for ELISA.
  
  
  RESULTS
  Of the 64 breast cancer cases, 25 (39.1%) had elevated serum HER2/neu levels accompanied with increased tissue expression of HER2/neu receptors. On IHC, HER2/neu score was 3+ in 24 (37.5%) cases, 2+ in three (4.6%), 1+ in 18 (28.1%); while 19 cases (29.7%) showed no HER2/neu expression. o0 f the three 2+ cases on IHC, two showed amplification on FISH. Twenty one (32.8%) patients were ER positive and 17 (26.6%) were PR positive. There was a significant correlation (P<0.001) of serum HER2 concentration with tumour size, lymph node involvement, stage of disease and histological grade. Serum HER2/neu levels showed a negative correlation with ER status (P=0.047) but no correlation with PR status.
  
  
  CONCLUSIONS
  The results suggest that elevated serum HER2 level was associated with a clinicopathological aggressive phenotype of breast carcinoma and was related to tissue HER2 overexpression. Therefore, serum HER2 may be useful for monitoring the course of the disease and response to treatment.
authors.affiliation: Department of Pathology, Lady Hardinge Medical College and Associated Hospitals, New Delhi, India.
authors.forename: Shailaja
authors.initials: S
authors.lastname: Shukla
authors.affiliation: Department of Pathology, Lady Hardinge Medical College and Associated Hospitals, New Delhi, India.
authors.forename: Bhawana Komal
authors.initials: BK
authors.lastname: Singh
authors.affiliation: Department of Surgery, Lady Hardinge Medical College and Associated Hospitals, New Delhi, India.
authors.forename: Om Prakash
authors.initials: OP
authors.lastname: Pathania
authors.affiliation: Department of Pathology, Lady Hardinge Medical College and Associated Hospitals, New Delhi, India.
authors.forename: Manjula
authors.initials: M
authors.lastname: Jain
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000097:blood / Q000235:genetics* / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D015972:Gene Expression Regulation, Neoplastic; D006801:Humans; D007150:Immunohistochemistry; D017404:In Situ Hybridization, Fluorescence; D008875:Middle Aged; D009367:Neoplasm Staging; D015513:Oncogene Proteins / Q000096:biosynthesis / Q000235:genetics*; D000090063:Proto-Oncogene Mas; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000097:blood / Q000235:genetics*; D011960:Receptors, Estrogen / Q000097:blood; D011980:Receptors, Progesterone / Q000097:blood
chemical_list: D015513:Oncogene Proteins; D000090063:Proto-Oncogene Mas; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; C000715470:MAS1 protein, human; C508053:ERBB2 protein, human