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High concordance of protein (by IHC), gene (by FISH; HER2 only), and microarray readout (by TargetPrint) of ER, PgR, and HER2: results from the EORTC 10041/BIG 03-04 MINDACT trial
- Source :
- Annals of Oncology. 25:816-823
- Publication Year :
- 2014
- Publisher :
- Elsevier BV, 2014.
-
Abstract
- To investigate the correlation of TargetPrint with local and central immunohistochemistry/fluorescence in situ hybridization assessment of estrogen (ER), progesterone (PgR), and human epidermal growth factor receptor 2 (HER2) in the first 800 patients enrolled in the MINDACT trial.Data from local (N = 800) and central (N = 626) assessments of receptor status were collected and compared with TargetPrint results.For ER, the positive agreement (the percentage of central pathology positive assessments that were also TargetPrint/local laboratory positive) for TargetPrint in comparison to centralized assessment was 98% with a negative agreement (the percentage of central pathology negative assessments that were also TargetPrint/local laboratory negative) of 96%. For PgR, the positive agreement was 83% with a negative agreement of 92%. For HER2, the positive agreement was 75% with a negative agreement of 99%. Even though the local assessment showed higher positive agreement for PgR (89%) and higher positive agreement for HER2 (85%), the range of discordant local versus central assessments were as high as 6.7% for ER, 12.9% for PgR, and 4.3% for HER2.TargetPrint and local assessment of ER, PgR, and HER2 show high concordance with central assessment in the first 800 MINDACT patients. However, there are concerns about the higher discordance rates for some local sites. TargetPrint can improve the reliability of hormone receptor and HER2 testing for those centers with a lower rate of concordance with the reference laboratory, with the limitation of a positive agreement of 75% for HER2. TargetPrint consequently has important implications for treatment decisions in clinical practice and is a reliable alternative to local assessment for ER.NCT00433589.
- Subjects :
- Adult
Oncology
medicine.medical_specialty
Pathology
Microarray
Receptor, ErbB-2
medicine.drug_class
Concordance
Statistics as Topic
Breast Neoplasms
Biology
Breast cancer
Internal medicine
Biomarkers, Tumor
medicine
Humans
RNA, Messenger
skin and connective tissue diseases
Gene
In Situ Hybridization, Fluorescence
Aged
medicine.diagnostic_test
Microarray analysis techniques
Original Articles
Hematology
Middle Aged
Microarray Analysis
Prognosis
medicine.disease
Receptors, Estrogen
Estrogen
Protein Biosynthesis
Immunohistochemistry
Female
Receptors, Progesterone
hormones, hormone substitutes, and hormone antagonists
Fluorescence in situ hybridization
Subjects
Details
- ISSN :
- 09237534
- Volume :
- 25
- Database :
- OpenAIRE
- Journal :
- Annals of Oncology
- Accession number :
- edsair.doi.dedup.....3e1970635b9326984ca13ec2be1591b9