PMID- 15659867
OWN - NLM
STAT- MEDLINE
DCOM- 20050308
LR  - 20091111
IS  - 0019-509X (Print)
IS  - 0019-509X (Linking)
VI  - 41
IP  - 4
DP  - 2004 Oct-Dec
TI  - FISH for HER-2/neu in breast cancer: standardization makes the difference!
PG  - 152-8
AB  - CONTEXT: Overexpression of HER-2/neu oncogene in breast cancer patients is 
      correlated with disease free survival (DFS) and overall survival (OS). The most 
      commonly used methods for the detection of HER-2/neu status are 
      immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). 
      However, therse is a lot of controversy with regard to the best method. Most of 
      the FISH studies chose arbitrary cut-off levels for positive results (10%) and 
      had no validation. AIM: In order to address these issues, we designed a pilot 
      study of 38 samples with known IHC status representing all 4 categories. SETTINGS 
      AND DESIGN: FISH was performed using Vysis Pathvysion probe. For validation, 5 
      cases of reduction mammoplasty were analyzed using same protocols. RESULTS: Our 
      results showed significant discordance between FISH and IHC. The rate of 
      discordance was much higher in the 0, 1+, and 2+ categories compared to published 
      literature. This could be due to the lower cut-off rates for positive 
      amplification established by validation in our study (5.7% vs 10%). Our analysis 
      showed that FISH positive and IHC negative patients have a poor prognosis in 
      terms of DFS and OS compared to FISH negative and IHC negative patients. Further, 
      our results also showed that IHC in comparison to FISH has a comparable 
      specificity (98%), but has a very low sensitivity (46%). CONCLUSION: Based on 
      these results, we consider FISH to be the gold standard for detecting HER-2/neu 
      status in breast cancer.
FAU - Gokhale, Sumita
AU  - Gokhale S
AD  - Department of Pathology, University of Texas Medical Branch, Galveston, TX, USA.
FAU - Gatalica, Zoran
AU  - Gatalica Z
FAU - Mohammad, Amin
AU  - Mohammad A
FAU - Rampy, A I
AU  - Rampy AI
FAU - Velagaleti Gopalrao, V N
AU  - Velagaleti Gopalrao VN
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - India
TA  - Indian J Cancer
JT  - Indian journal of cancer
JID - 0112040
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Breast Neoplasms/*diagnosis/genetics/mortality
MH  - Female
MH  - Gene Amplification
MH  - Genes, erbB-2/*genetics
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence/*standards
MH  - Middle Aged
MH  - Observer Variation
MH  - Pilot Projects
MH  - Reference Standards
MH  - Reproducibility of Results
MH  - Retrospective Studies
MH  - Sensitivity and Specificity
MH  - Survival Analysis
EDAT- 2005/01/22 09:00
MHDA- 2005/03/09 09:00
CRDT- 2005/01/22 09:00
PHST- 2005/01/22 09:00 [pubmed]
PHST- 2005/03/09 09:00 [medline]
PHST- 2005/01/22 09:00 [entrez]
PST - ppublish
SO  - Indian J Cancer. 2004 Oct-Dec;41(4):152-8.