PMID- 11694784
OWN - NLM
STAT- MEDLINE
DCOM- 20011228
LR  - 20171101
IS  - 0030-2414 (Print)
IS  - 0030-2414 (Linking)
VI  - 61 Suppl 2
DP  - 2001
TI  - Testing for HER2 status.
PG  - 22-30
AB  - Incorporation of a new biological marker such as HER2 into routine clinical 
      practice requires proof that it provides reproducible information independent of, 
      and better than, conventional pathologic criteria, and that it influences 
      treatment decisions. In breast cancer, HER2 amplification/overexpression predicts 
      for a poor clinical outcome and an enhanced survival benefit from the 
      HER2-targeted therapy, Herceptin, and may predict for resistance to some 
      conventional therapies. Thus, HER2 is considered to be a clinically important 
      molecule and testing for HER2 abnormalities is already part of routine patient 
      assessment in many parts of the world. There is currently no gold standard for 
      HER2 testing. The main challenge is to standardize and technically validate HER2 
      testing methodologies. Immunohistochemistry (IHC) and fluorescence in situ 
      hybridization (FISH) are the most common HER2 tests used, and show a high level 
      of concordance. HER2 testing approaches based on the polymerase chain reaction 
      (PCR) are under extensive investigation and appear promising. A Canadian HER2 
      testing algorithm designed to increase the validity and reproducibility of HER2 
      testing has been compiled. HER2-positive cases are defined as those with >10% of 
      tumor cells with moderate/strong, complete membrane staining in the invasive 
      component, by IHC. Confirmatory HER2 testing using either FISH or quantitative 
      PCR is recommended for indeterminate cases. Additional studies are required to 
      calibrate HER2 testing results to clinical outcome.
CI  - Copyright 2001 S. Karger AG, Basel
FAU - Hanna, W
AU  - Hanna W
AD  - Sunnybrook and Women's College Health Sciences Centre, Toronto, Ont., Canada. 
      wedad.hanna@swchsc.on.ca
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Review
PL  - Switzerland
TA  - Oncology
JT  - Oncology
JID - 0135054
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (Neoplasm Proteins)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Algorithms
MH  - Biomarkers, Tumor/*analysis
MH  - Blotting, Northern
MH  - Blotting, Southern
MH  - Blotting, Western
MH  - Breast Neoplasms/*chemistry/genetics/mortality/pathology
MH  - Computer Systems
MH  - Enzyme-Linked Immunosorbent Assay
MH  - Female
MH  - Gene Amplification
MH  - Gene Expression
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Neoplasm Proteins/*analysis
MH  - Polymerase Chain Reaction
MH  - Prognosis
MH  - Receptor, ErbB-2/*analysis
MH  - Reference Standards
MH  - Reproducibility of Results
MH  - Retrospective Studies
MH  - Sensitivity and Specificity
MH  - Specimen Handling
RF  - 57
EDAT- 2001/11/06 10:00
MHDA- 2002/01/05 10:01
CRDT- 2001/11/06 10:00
PHST- 2001/11/06 10:00 [pubmed]
PHST- 2002/01/05 10:01 [medline]
PHST- 2001/11/06 10:00 [entrez]
AID - 55398 [pii]
AID - 10.1159/000055398 [doi]
PST - ppublish
SO  - Oncology. 2001;61 Suppl 2:22-30. doi: 10.1159/000055398.