PMID- 12177239
OWN - NLM
STAT- MEDLINE
DCOM- 20020830
LR  - 20230216
IS  - 0023-6837 (Print)
IS  - 0023-6837 (Linking)
VI  - 82
IP  - 8
DP  - 2002 Aug
TI  - Chromogenic in situ hybridization: a novel approach to a practical and sensitive 
      method for the detection of HER2 oncogene in archival human breast carcinoma.
PG  - 1007-14
AB  - The high incidence of HER2 overexpression on the cell surface of breast cancer 
      cells and the recognized prognostic and potentially predictive value of HER2 
      render this cell surface receptor a novel and important therapeutic target. 
      Although immunohistochemistry (IHC; HercepTest) and fluorescence in situ 
      hybridization (FISH; PathVysion and INFORM)-both approved by the Food and Drug 
      Administration-have emerged as the most viable assays for evaluation of HER2 
      status in routine clinical practice, there is still no consensus on which is the 
      best method for assessing HER2 status. Therefore, our specific objective was to 
      establish a chromogenic in situ hybridization (CISH) assay for the detection of 
      HER2 amplification on a cohort of 173 archival invasive breast carcinomas. 
      Results were compared with HercepTest, which is the most frequently used method 
      for detecting HER2 alteration. Additionally, HER2 gene copy number was 
      investigated using differential PCR (dPCR) as a testing system. HER2 
      overexpression was found by IHC in 24.3%; HER2 amplification was found by CISH in 
      19.1% and by dPCR in 9.2% of the tumors. The overall concordance rate was 95.9% 
      between CISH and IHC and 85.0% between dPCR and IHC. Kappa statistics revealed an 
      excellent agreement between IHC and CISH (kappa = 0.878), but only a moderate 
      agreement was found between IHC and dPCR (kappa = 0.482). Discrepant cases 
      between CISH and HercepTest and all IHC-positive cases (+2 and +3), a total of 42 
      cases, were analyzed with the FISH PathVysion (Vysis) assay. Among 25 
      HercepTest-positive cases (score +3), 2 showed no gene amplification by FISH or 
      CISH. Four of 13 tumors with weak HER2 overexpression (score +2) were negative 
      with both FISH and CISH. Concordance between CISH and FISH was 100% for the 38 
      cases analyzed. The current study showed that CISH represents a practical and 
      simple assay for evaluating HER2 gene amplification in archival material, 
      offering a promising alternative to IHC or FISH for the routine diagnostic 
      setting.
FAU - Dandachi, Nadia
AU  - Dandachi N
AD  - Institute of Pathology, Landeskliniken Salzburg, Salzburg, Austria. 
      n.dandachi@lks.at
FAU - Dietze, Otto
AU  - Dietze O
FAU - Hauser-Kronberger, Cornelia
AU  - Hauser-Kronberger C
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Lab Invest
JT  - Laboratory investigation; a journal of technical methods and pathology
JID - 0376617
RN  - 0 (Chromogenic Compounds)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Breast Neoplasms/*metabolism/pathology
MH  - Chromogenic Compounds
MH  - Female
MH  - Humans
MH  - In Situ Hybridization/*methods
MH  - Receptor, ErbB-2/*analysis
MH  - Sensitivity and Specificity
MH  - Tissue Embedding
EDAT- 2002/08/15 10:00
MHDA- 2002/08/31 10:01
CRDT- 2002/08/15 10:00
PHST- 2002/08/15 10:00 [pubmed]
PHST- 2002/08/31 10:01 [medline]
PHST- 2002/08/15 10:00 [entrez]
AID - S0023-6837(22)03681-9 [pii]
AID - 10.1097/01.lab.0000024360.48464.a4 [doi]
PST - ppublish
SO  - Lab Invest. 2002 Aug;82(8):1007-14. doi: 10.1097/01.lab.0000024360.48464.a4.