Loading
Whether a breast cancer counts as HER2-low, and so qualifies for trastuzumab deruxtecan, turns on the least reproducible step of the HER2 stain, score 1+ versus 0. Cell-line microarrays with a known quantity of HER2 protein per cell, run alongside clinical slides, would anchor every laboratory to a physical standard.
T-DXd approval for HER2-low created a treatment decision at IHC 1+ versus 0, the least reproducible part of the HER2 scale, with inter-pathologist agreement reported as poor. Cell-line microarrays with quantified HER2 protein per cell, distributed as reference materials and run alongside clinical slides (as NordiQC and CAP do for proficiency testing), would anchor staining intensity and scoring to a physical standard, complemented by digital image analysis calibrated to the same materials.
Shares DESTINY-Breast06, AI quantification of HER2-low and HER2-ultralow, DESTINY-Breast04, HER2-low and HER2-ultralow.
Shares Publish each laboratory's biomarker proficiency results, Immunohistochemistry (IHC), Histopathology & immunohistochemistry, Biomarkers are not validated or standardised.
Shares DESTINY-Breast06, DESTINY-Breast06: trastuzumab deruxtecan before any chemotherapy in hormone-receptor-positive, HER2-low or ultralow breast cancer, HER2-low and HER2-ultralow, Trastuzumab deruxtecan.
Shares DESTINY-Breast04, HER2-low and HER2-ultralow, Digital pathology & AI, Immunohistochemistry (IHC).
Shares DESTINY-Breast04, HER2-low and HER2-ultralow, Digital pathology & AI, Immunohistochemistry (IHC).
Shares Publish each laboratory's biomarker proficiency results, Histopathology & immunohistochemistry, Biomarkers are not validated or standardised.
Shares AI quantification of HER2-low and HER2-ultralow, Digital pathology & AI, Histopathology & immunohistochemistry.
Shares HER2-low and HER2-ultralow, Immunohistochemistry (IHC), Histopathology & immunohistochemistry.