Discordant assessment of tumor biomarkers by histopathological and molecular assays in the EORTC randomized controlled 10041/BIG 03-04 MINDACT trial breast cancer : Intratumoral heterogeneity and DCIS or normal tissue components are unlikely to be the cause of discordance

Breast Cancer Research and Treatment
Giuseppe VialeFatima Cardoso

Abstract

Accurate identification of breast cancer patients most likely to benefit from adjuvant systemic therapies is crucial. Better understanding of differences between methods can lead to an improved ER, PgR, and HER-2 assessment. The purpose of this preplanned translational research is to investigate the correlation of central IHC/FISH assessments with microarray mRNA readouts of ER, PgR, and HER-2 status in the MINDACT trial and to determine if any discordance could be attributed to intratumoral heterogeneity or the DCIS and normal tissue components in the specimens. MINDACT is an international, prospective, randomized, phase III trial investigating the clinical utility of MammaPrint in selecting patients with early breast cancer for adjuvant chemotherapy (n = 6694 patients). Gene-expression data were obtained by TargetPrint; IHC and/or FISH were assessed centrally (n = 5788; 86 %). Macroscopic and microscopic evaluation of centrally submitted FFPE blocks identified 1427 cases for which the very same sample was submitted for gene-expression analysis. TargetPrint ER had a positive agreement of 98 %, and a negative agreement of 95 % with central pathology. Corresponding figures for PgR were 85 and 94 % and for HER-2 72 and 99 %. Agre...Continue Reading

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Citations

Aug 25, 2016·The New England Journal of Medicine·Fatima CardosoUNKNOWN MINDACT Investigators
Jan 14, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Kimberly H AllisonAntonio C Wolff
Nov 2, 2017·Oncotarget·Jyotsana SinghalSharad S Singhal
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Jan 28, 2021·Journal of Personalized Medicine·Jiande Wu, Chindo Hicks
Nov 11, 2017·Molecular & Cellular Proteomics : MCP·Vivian DelcourtIsabelle Fournier

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Methods Mentioned

BETA
biopsy

Clinical Trials Mentioned

NCT00433589

Software Mentioned

SAS
TargetPrint
MINDACT

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