Assessment of methods for tissue-based detection of the HER-2/neu alteration in human breast cancer: a direct comparison of fluorescence in situ hybridization and immunohistochemistry.
Author(s): Pauletti G, Dandekar S, Rong H, Ramos L, Peng H, Seshadri R, Slamon DJ
Publication: J Clin Oncol, 2000, Vol. 18, Page 3651-64
PubMed ID: 11054438 PubMed Review Paper? No
Purpose of Paper
Conclusion of Paper
Studies
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Study Purpose
The purpose of this study was to compare two IHC detection methods for HER-2/neu overexpression: the commercially available Herceptest, and the R60 antibody.
Summary of Findings:
Using specimens identified as having high and low HER-2/neu copy number via FISH, two methods of IHC detection were compared for accuracy and sensitivity. Although sensitivity was reduced for both IHC methods compared to FISH, HercepTest analysis resulted in a higher instance of both false negatives (5%) and false positives (25%) compared to IHC analysis with the R60 antibody. Antigen retrieval used in conjunction with HercepTest analysis failed to improve results.
Biospecimens
Preservative Types
- Formalin
Diagnoses:
- Neoplastic - Carcinoma
Platform:
Analyte Technology Platform Protein Immunohistochemistry Pre-analytical Factors:
Classification Pre-analytical Factor Value(s) Immunohistochemistry Specific Technology platform HercepTest
R60 antibody
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Study Purpose
This study was performed to compare the accuracy of HER-2/neu detection and predictive value of FISH and IHC for breast cancer patient survival.
Summary of Findings:
Of the 900 specimens evaluated, 21% possessed cells with an abnormal number of HER-2/neu gene copies as determined by FISH, while 17.6% of specimens exhibited HER-2/neu protein overexpression as determined by IHC with the R60 antibody, suggesting FISH has a higher sensitivity for detection of abnormal levels of HER-2/neu when using FFPE sections. The authors observed a discrepancy among detection methods in terms of their ability to predict patient survival: while patient survival was found to decrease with increasing HER-2/neu copy number per chromosome as determined by FISH, patient survival was only reduced in the highest protein expression group (+3) as determined by IHC with the R60 antibody, indicating FISH is a better predictor of patient prognosis.
Biospecimens
Preservative Types
- Formalin
Diagnoses:
- Neoplastic - Carcinoma
Platform:
Analyte Technology Platform DNA FISH Protein Immunohistochemistry Pre-analytical Factors:
Classification Pre-analytical Factor Value(s) Immunohistochemistry Specific Technology platform Immunohistochemistry with the R60 antibody
FISH