Ming-Hei Tai, PharmD, BCOP’s Post

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Oncology Pharmacist

Did you know that 18 pathologists only had 26% concordance on whether a HER2 IHC stain was 0 or 1+?  This study, done back in 2022, collected 170 biopsies from Yale and sent the scanned slides to 18 different pathologists.  Of those 170 biopsies, 92 were read as IHC 0 by at least one of the 18 pathologists.  17 of 18 pathologists agreed on 24/92 of these cases (26%), meaning that you have a good chance of turning an IHC 0 patient into an IHC 1 patient simply by sending the biopsy slides to another pathologist.  That would qualify a breast cancer patient for fam-trastuzumab deruxtecan - no repeat biopsy needed! Differences in HER2 testing before and after fixation have also been noted in our national guidelines (https://lnkd.in/eA8qKshR).  This is why central HER2 testing is very important in studies that look at HER2-directed agents, especially in "low" and "ultralow" patients, because it eliminates variation between institutions. New HER2 testing methodologies are needed (and being studied), but then the question is, how would that impact fam-trastuzumab deruxtecan?  The current FDA approval may need to be re-validated for any new testing methodology, not to mention all the clinical trials that currently use HER2 IHC testing.  #breastcancer #enhertu https://lnkd.in/eJh5XeCA

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