title: Evaluation of HER2 gene status in breast cancer by chromogenic in situ hybridization: comparison with immunohistochemistry.
abstract: BACKGROUND
  The purpose of this study was to evaluate HER2 gene status in relation to chromosome 17 polysomy with the chromogenic in situ hybridization (CISH) technique and to compare the results with those of immunohistochemistry (IHC).
  
  
  RESULTS
  Sixty six cases of breast carcinoma with an immunohistochemical HER2 protein score of 1+, 2+ 3+ (HercepTest) were investigated. HER2 gene status was evaluated on paraffin sections with the CISH technique using a digoxigenin-labeled DNA probe. In HER2 positive cases with low level amplification (LLA), the copy number of chromosome 17 was determined. Thirty four tumors (51.5%) were negative and 32 (48.5%) were positive for HER2 gene amplification. Of these 10 tumors (15%) showed LLA and 22 tumors (33.5%) high level amplification (HLA). Nine of ten tumors with LLA had an equal or greater than two ratio of HER2 to chromosome 17 signals. The correlation of the results obtained by CISH and IHC showed that the concordance of the two methods was highest in the 3+ group (100%) and lower in 1+ group (89%), whereas a high degree of discordance was found in the 2+ group (69%).
  
  
  CONCLUSIONS
  CISH is an accurate and practical technique for the evaluation of both HER2 gene and chromosome 17 status and its application is considered necessary especially for the clarification of the 2+ results of IHC.
authors.affiliation: Department of Pathology, Elena Venizelou Hospital, Athens, Greece.
authors.forename: Sophia
authors.initials: S
authors.lastname: Kounelis
authors.forename: Nikiforos
authors.initials: N
authors.lastname: Kapranos
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Malamos
authors.forename: Efi
authors.initials: E
authors.lastname: Kouri-Bairaktari
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000235:genetics* / Q000378:metabolism; D044584:Carcinoma, Ductal / Q000235:genetics*; D002869:Chromosome Aberrations; D002886:Chromosomes, Human, Pair 17 / Q000235:genetics; D005260:Female; D005784:Gene Amplification; D018734:Genes, erbB-2 / Q000235:genetics*; D006801:Humans; D007150:Immunohistochemistry; D017404:In Situ Hybridization, Fluorescence; D008875:Middle Aged; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000096:biosynthesis
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases