PMID- 12635131
OWN - NLM
STAT- MEDLINE
DCOM- 20030606
LR  - 20151119
IS  - 0022-3417 (Print)
IS  - 0022-3417 (Linking)
VI  - 199
IP  - 4
DP  - 2003 Apr
TI  - Correlation between immunohistochemistry (HercepTest) and fluorescence in situ 
      hybridization (FISH) for HER-2 in 426 breast carcinomas from 37 centres.
PG  - 418-23
AB  - Accurate diagnostic assessment of HER-2 is essential for the appropriate 
      application of the humanized anti-HER-2 monoclonal antibody trastuzumab 
      (Herceptin) to the treatment of patients with metastatic breast cancer. The 
      diagnostic test needs to be applicable to archival, fixed tissue removed at 
      excision, in many cases several years earlier. We compared the assessment of 
      HER-2 by immunohistochemistry (IHC; HercepTest) and fluorescence in situ 
      hybridization (FISH) in 426 breast carcinomas from patients being considered for 
      trastuzumab therapy. The tumours were tested in three reference centres having 
      been sent in from 37 hospitals. Only 2/270 (0.7%) IHC 0/1+ tumours were FISH 
      positive. Six of 102 (5.9%) IHC 3+ tumours were FISH negative. Five of the six 
      had between 1.75 and 2.0 HER-2 gene copies per chromosome 17 and the sixth had 
      multiple copies of chromosome 17. Thirteen per cent of tumours were IHC 2+ and 
      overall 48% of these were FISH positive but this proportion varied markedly 
      between the centres. Sixty IHC-stained slides selected to be enriched with 2+ 
      cases were circulated between the three laboratories and scored. There were 20 
      cases in which there was some discordance in scoring. Consideration of the FISH 
      score in these cases led to concordance in the designation of 
      positivity/negativity in 19 of these 20 cases. These data support an algorithm in 
      which FISH testing is restricted to IHC 2+ tumours in reference centres. The 
      results may not extrapolate to laboratories with less experience or using 
      different methodologies.
CI  - Copyright 2003 John Wiley & Sons, Ltd.
FAU - Dowsett, M
AU  - Dowsett M
AD  - Academic Department of Biochemistry, Royal Marsden NHS Trust, London, UK. 
      mitch@icr.ac.uk
FAU - Bartlett, J
AU  - Bartlett J
FAU - Ellis, I O
AU  - Ellis IO
FAU - Salter, J
AU  - Salter J
FAU - Hills, M
AU  - Hills M
FAU - Mallon, E
AU  - Mallon E
FAU - Watters, A D
AU  - Watters AD
FAU - Cooke, T
AU  - Cooke T
FAU - Paish, C
AU  - Paish C
FAU - Wencyk, P M
AU  - Wencyk PM
FAU - Pinder, S E
AU  - Pinder SE
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - J Pathol
JT  - The Journal of pathology
JID - 0204634
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (Neoplasm Proteins)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
CIN - J Pathol. 2003 Apr;199(4):411-7. PMID: 12635130
MH  - Algorithms
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/*therapeutic use
MH  - Biomarkers, Tumor/*metabolism
MH  - Breast Neoplasms/*metabolism/pathology
MH  - Female
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Neoplasm Metastasis
MH  - Neoplasm Proteins/analysis
MH  - Patient Selection
MH  - Receptor, ErbB-2/immunology/*metabolism
MH  - Reproducibility of Results
MH  - Trastuzumab
EDAT- 2003/03/14 04:00
MHDA- 2003/06/07 05:00
CRDT- 2003/03/14 04:00
PHST- 2003/03/14 04:00 [pubmed]
PHST- 2003/06/07 05:00 [medline]
PHST- 2003/03/14 04:00 [entrez]
AID - 10.1002/path.1313 [doi]
PST - ppublish
SO  - J Pathol. 2003 Apr;199(4):418-23. doi: 10.1002/path.1313.