Incorporating microarray assessment of HER2 status in clinical practice supports individualised therapy in early-stage breast cancer

Abstract Accurate determination of human epidermal growth factor receptor-2 (HER2) status is essential for optimal selection of breast cancer patients for gene targeted therapy. The analytical performance of microarray analysis using TargetPrint for assessment of HER2 status was evaluated in 138 bre...

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Bibliographic Details
Published in:Breast (Edinburgh) 2015-04, Vol.24 (2), p.137-142
Main Authors: Grant, Kathleen A, Pienaar, Fredrieka M, Brundyn, Karen, Swart, Gillaume, Gericke, George S, Myburgh, Ettienne J, Wright, Colleen A, Apffelstaedt, Justus P, Kotze, Maritha J
Format: Article
Language:English
Subjects:
Adult
Algorithms
Analytical validation
Biomarkers, Tumor - metabolism
Breast cancer
Breast Neoplasms - metabolism
Breast Neoplasms - pathology
Breast Neoplasms - therapy
Carcinoma, Ductal, Breast - metabolism
Carcinoma, Ductal, Breast - pathology
Carcinoma, Ductal, Breast - therapy
Carcinoma, Lobular - metabolism
Carcinoma, Lobular - pathology
Carcinoma, Lobular - therapy
Female
Hematology, Oncology and Palliative Medicine
HER2 status
Humans
Immunohistochemistry
In Situ Hybridization
MammaPrint prescreen algorithm
Middle Aged
Neoplasm Staging
Precision Medicine
Quality assurance
Quality Assurance, Health Care
Receptor, ErbB-2 - metabolism
TargetPrint microarray
Tissue Array Analysis
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Summary:Abstract Accurate determination of human epidermal growth factor receptor-2 (HER2) status is essential for optimal selection of breast cancer patients for gene targeted therapy. The analytical performance of microarray analysis using TargetPrint for assessment of HER2 status was evaluated in 138 breast tumours, including 41 fresh and 97 formalin-fixed paraffin embedded (FFPE) specimens. Reflex testing using immunohistochemistry/in situ hybridization (IHC/ISH) in four discordant cases confirmed the TargetPrint results, achieving 100% agreement regardless of whether fresh tissue or FFPE specimens were used. One equivocal IHC/ISH case was classified as HER2-positive based on the microarray result. The proven clinical utility in resolving equivocal and borderline cases justifies modification of the testing algorithm under these circumstances, to obtain a definitive positive or negative test result with the use of microarrays. Determination of HER2 status across three assay platforms facilitated improved quality assurance and led to a higher level of confidence on which to base treatment decisions.
ISSN:0960-9776
1532-3080
DOI:10.1016/j.breast.2014.12.006