Journal of clinical pathology · 2026
Concordance of conventional two-tier HER2 classification versus three-tier classification (including HER2-low status) in invasive breast carcinoma: a retrospective real-world analysis.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Juneja Archita, Sahay Ayushi, Padwale Pooja, Patil Asawari, Pai Trupti, Panjwani Poonam, Joshi Shalaka, Wadasadawala Tabassum, Popat Palak, Shet Tanuja M, Gupta Sudeep, Desai Sangeeta B
Аннотация
AIM: To compare changes in HER2 expression status on reassessment across multiple clinical groups using new three-tier versus traditional binary HER2 reporting schemas.
METHODS: Retrospective study of 1107 paired IBC samples wherein HER2 immunohistochemistry (IHC) and, where needed, in-situ hybridisation (ISH) were performed at least twice in four clinical groups: core needle biopsy (CNB)-upfront resection (n=277); CNB-post-chemotherapy resection (n=104); primary (CNB/resection)-recurrence (local/metastatic, n=702); initial and subsequent distant metastasis (n=24). Concordance was noted for HER2-positive (HER2-IHC 3+ or 2+ ISH-amplified), negative (HER2-IHC 0) and low (HER2-IHC 1+ and 2+ ISH-non-amplified) status, and compared with the concordance of binary HER2 status (positive/negative).
RESULTS: HER2 concordance dropped sharply to 69.7% (k=0.53, 95% CI 0.48 to 0.57) on reassessment after applying the three-tier schema, driven primarily by bidirectional shifts between HER2-negative (IHC 0) and HER2-low. Referral specimens showed poorer concordance than in-house tissue in both binary (p value <0.001, OR: 2.40, 95% CI 1.40 to 4.10) and ternary classification (p value <0.001, OR: 1.72, 95% CI 1.31 to 2.2), emphasising the effects of pre-analytical factors like fixation on HER2 interpretation.
CONCLUSIONS: The three-tier HER2-low classification schema demonstrates poor reproducibility on re-evaluation, with nearly one-third of cases discordant. This fluidity has significant therapeutic implications. We recommend HER2 re-evaluation with careful attention to the 0 versus 1+ distinction, especially in metastatic and post-treatment settings and when pre-analytical factors are suboptimal.
METHODS: Retrospective study of 1107 paired IBC samples wherein HER2 immunohistochemistry (IHC) and, where needed, in-situ hybridisation (ISH) were performed at least twice in four clinical groups: core needle biopsy (CNB)-upfront resection (n=277); CNB-post-chemotherapy resection (n=104); primary (CNB/resection)-recurrence (local/metastatic, n=702); initial and subsequent distant metastasis (n=24). Concordance was noted for HER2-positive (HER2-IHC 3+ or 2+ ISH-amplified), negative (HER2-IHC 0) and low (HER2-IHC 1+ and 2+ ISH-non-amplified) status, and compared with the concordance of binary HER2 status (positive/negative).
RESULTS: HER2 concordance dropped sharply to 69.7% (k=0.53, 95% CI 0.48 to 0.57) on reassessment after applying the three-tier schema, driven primarily by bidirectional shifts between HER2-negative (IHC 0) and HER2-low. Referral specimens showed poorer concordance than in-house tissue in both binary (p value <0.001, OR: 2.40, 95% CI 1.40 to 4.10) and ternary classification (p value <0.001, OR: 1.72, 95% CI 1.31 to 2.2), emphasising the effects of pre-analytical factors like fixation on HER2 interpretation.
CONCLUSIONS: The three-tier HER2-low classification schema demonstrates poor reproducibility on re-evaluation, with nearly one-third of cases discordant. This fluidity has significant therapeutic implications. We recommend HER2 re-evaluation with careful attention to the 0 versus 1+ distinction, especially in metastatic and post-treatment settings and when pre-analytical factors are suboptimal.