A Global Ring Study: Concordance Between Ventana PATHWAY Anti-HER2/neu (4B5) Companion Diagnostic Assay and Comparators in Detecting HER2-Low Breast Cancer
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Le résumé fourni par la source
Trastuzumab deruxtecan showed improved efficacy compared with the treatment of the physician's choice in human epidermal growth factor receptor 2 (HER2)-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization-negative) metastatic breast cancer (BC) patients in the DESTINY-Breast04 and -06 phase 3 clinical trials. Both trials used the Ventana PATHWAY HER2/neu (4B5) IHC assay (PATHWAY 4B5) to select patients. The variety of HER2 IHC assays in clinical use complicates real-world differentiation between HER2-low and HER2 IHC 0. This study assessed concordance between PATHWAY 4B5 and comparator assays in identifying HER2-low samples. Fifty clinical BC samples from a cohort of 300 were stained using PATHWAY 4B5 and centrally scored, according to the American Society of Clinical Oncology-College of American Pathologists 2018 guidelines, as HER2 IHC 0, 1+, 2+, and 3+. Unstained samples were sent to participating laboratories in North and South America, Europe, and the Asia-Pacific regions that were actively scoring HER2 IHC for BC, had 2 independent pathologists, and did not routinely use PATHWAY 4B5 following the CDx protocol. Pathologists stained and scored the samples using their laboratory's routine protocols. Following virtual alignment on interpretation of HER2 IHC scoring guidelines (postalignment), pathologists were directed to rescore the samples. Pathologist scores were compared with centrally assessed scores; the primary endpoint was positive percentage agreement (PPA) and negative percentage agreement (NPA) for HER2-low versus HER2 IHC 0 based on postalignment scores. Overall, 129 pathologists from 68 laboratories submitted 6270 postalignment scores for analysis. PPA (agreement in identifying HER2-low) and NPA (agreement in identifying HER2 IHC 0) were 84.8% (95% CI, 83.6%-86.0%) and 69.2% (95% CI, 67.0%-71.2%), respectively. Across assay types, postalignment PPA ranged from 61.6% to 95.5% and postalignment NPA ranged from 36.9% to 81.7%. The variation in concordance rates observed between assays suggests assay choice may be important for the correct identification of patients with low levels of HER2-expression who may benefit from HER2-targeted therapies.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- A Global Ring Study: Concordance Between Ventana PATHWAY Anti-HER2/neu (4B5) Companion Diagnostic Assay and Comparators in Detecting HER2-Low Breast Cancer
- Date Crossref
- 01/11/2025
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Emory University Department of Pathology and Laboratory Medicine pays non établi dans la noticeUniversité ou école supérieure
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Royal Adelaide Hospital pays non établi dans la noticeÉtablissement de santé
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Universität Hamburg pays non établi dans la noticeUniversité ou école supérieure
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University Medical Center Hamburg-Eppendorf pays non établi dans la noticeÉtablissement de santé
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Vall d'Hebron Hospital Universitari pays non établi dans la noticeÉtablissement de santé
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Inserm pays non établi dans la noticeOrganisme public
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Université Clermont Auvergne Department of Pathology pays non établi dans la noticeUniversité ou école supérieure
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Centre Jean Perrin pays non établi dans la noticeÉtablissement de santé
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Imagerie Moléculaire et Stratégies Théranostiques pays non établi dans la noticeStructure de recherche
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Fudan University Shanghai Cancer Center Department of Pathology pays non établi dans la noticeÉtablissement de santé
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Scientific Services Afrique du Sud (code pays fourni par la source)Structure de recherche
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Daiichi Sankyo (Germany) pays non établi dans la noticeEntreprise
Department of Pathology and Laboratory Medicine — Emory University, Royal Adelaide Hospital et Universität Hamburg, avec 9 autres affiliations. Pays d’affiliation : Afrique du Sud.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.