| Comparison of quantitative immunofluorescence with conventional methods for HER2/neu testing with respect to response to trastuzumab therapy in metastatic breast cancer. | |
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MedLine Citation:
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PMID: 18834223 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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CONTEXT: Selection for trastuzumab therapy depends on a companion diagnostic assessment of HER2 by either immunohistochemistry (IHC) for protein overexpression or fluorescence in situ hybridization (FISH) to detect gene amplification. Although many studies have compared IHC to FISH, few have compared the tests to the true gold standard, tumor response. OBJECTIVE: To compare HER2 testing by FISH and IHC along with a third immunofluorescence-based assay (automated quantitative analysis-tissue microarray [AQUA-TMA]) and to assess the value of each test for prediction of response to trastuzumab. DESIGN: Immunohistochemistry and FISH assays were done on both whole slides (IHC-WS and FISH-WS) and on TMAs (IHC-TMA and FISH-TMA). AQUA was only done on TMAs (AQUA-TMA). Response was assessed according to modified Response Evaluation Criteria in Solid Tumors. RESULTS: AQUA-TMA scores showed a significant linear relationship to both the FISH signal ratio and IHC scores on whole sections and TMAs. Assay assessment by outcome showed no association between response and FISH-WS ratio (P = .96), FISH-TMA (P = .55), IHC-WS (P = .75), or IHC-TMA (P = .06), but a significant relationship between AQUA score and categoric response was observed (P = .01). Assessed as a function of outcome using models of logistic regression, both AQUA-TMA and IHC-TMA were equally significant (P = .01). FISH-WS was the most sensitive assay, with a significantly higher true-positive fraction than all other tests except AQUA-TMA, although it was the least specific. IHC-TMA was the most specific assay. The lowest misclassification rate was achieved using AQUA-TMA (0.30). CONCLUSIONS: Both AQUA-TMA and IHC-TMA were substantially more predictive than the FISH or IHC-WS tests. Although these results are derived from a small retrospective series, they suggest that accurate measurement of protein expression and unbiased selection of tissue for measurement may be key factors in prediction of response. |
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Authors:
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Jennifer M Giltnane; Annette Molinaro; Huan Cheng; Andrew Robinson; Dmitry Turbin; Karen Gelmon; David Huntsman; David L Rimm |
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Publication Detail:
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Type: Comparative Study; Journal Article; Research Support, N.I.H., Extramural |
Journal Detail:
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Title: Archives of pathology & laboratory medicine Volume: 132 ISSN: 1543-2165 ISO Abbreviation: Arch. Pathol. Lab. Med. Publication Date: 2008 Oct |
Date Detail:
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Created Date: 2008-10-06 Completed Date: 2008-10-24 Revised Date: 2009-11-19 |
Medline Journal Info:
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Nlm Unique ID: 7607091 Medline TA: Arch Pathol Lab Med Country: United States |
Other Details:
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Languages: eng Pagination: 1635-47 Citation Subset: AIM; IM |
Affiliation:
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Departments of Pathology, Yale University School of Medicine, New Haven, Connecticut 06520-8023 , USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Antibodies, Monoclonal / therapeutic use* Antineoplastic Agents / therapeutic use* Breast Neoplasms / drug therapy*, metabolism*, secondary Cell Line Cricetinae Female Humans Immunohistochemistry / methods* In Situ Hybridization, Fluorescence / methods* Logistic Models Middle Aged Predictive Value of Tests Receptor, erbB-2 / metabolism* Retrospective Studies Sensitivity and Specificity Tissue Array Analysis Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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K22CA123146/CA/NCI NIH HHS; R33 CA 110511/CA/NCI NIH HHS; R33 CA106709/CA/NCI NIH HHS; S10 RR19895/RR/NCRR NIH HHS; TG 5T32GM07205/GM/NIGMS NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Monoclonal; 0/Antineoplastic Agents; 0/trastuzumab; EC 2.7.10.1/Receptor, erbB-2 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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