Reliability of core needle biopsy for HER2-low early-stage breast cancer.

IF 2.8 3区医学 Q2 ONCOLOGY

Clinical & Translational Oncology Pub Date : 2025-03-09 DOI:10.1007/s12094-025-03877-2

C M Ciniselli, P Verderio, V Duroni, P Baili, S Pizzamiglio, F G de Braud, S Folli, C Depretto, G Scaperrotta, M C De Santis, M G Carnevale, C De Marco, A Vingiani, G Pruneri, S Di Cosimo

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引用次数: 0

Abstract

Background: The reliability of core needle biopsy (CNB) for HER2-positive breast cancer is well established. However, data on HER2-low and the potential for inconsistencies with surgical samples are limited.

Materials and methods: Concordance between CNB and surgical samples was assessed using the unweighted Cohen kappa statistic (Kc) in a consecutive series of 776 treatment-naïve early-stage breast cancer patients. Logistic regression models were used to evaluate the association between concordance and clinico-pathological features.

Results: The agreement for HER2-positive status between CNB and surgical specimens was high at 95%, with a Kc value of 0.86 indicating almost perfect agreement. However, 65 of 123 (53%) cases initially classified as HER2-0 were reclassified as HER2 1 + or 2 + /ISH-negative, and 89 of 374 (24%) cases initially classified as HER2 1 + /2 + were HER2-0 in surgical samples. This resulted in a Kc value of 0.22, indicating fair agreement in classifying HER2-0 versus HER2-low breast cancer. Tumor size was a significant factor influencing discordance, with tumors larger than 2 cm having double the risk of misclassification.

Conclusion: These findings suggest that HER2 status should be retested, particularly for large tumors initially diagnosed as HER2-0, in light of new effective therapies for HER2-low breast cancer, such as antibody-drug conjugates.

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来源期刊

Clinical & Translational Oncology 医学-肿瘤学

CiteScore

6.20

自引率

2.90%

发文量

240

审稿时长

1 months

期刊介绍： Clinical and Translational Oncology is an international journal devoted to fostering interaction between experimental and clinical oncology. It covers all aspects of research on cancer, from the more basic discoveries dealing with both cell and molecular biology of tumour cells, to the most advanced clinical assays of conventional and new drugs. In addition, the journal has a strong commitment to facilitating the transfer of knowledge from the basic laboratory to the clinical practice, with the publication of educational series devoted to closing the gap between molecular and clinical oncologists. Molecular biology of tumours, identification of new targets for cancer therapy, and new technologies for research and treatment of cancer are the major themes covered by the educational series. Full research articles on a broad spectrum of subjects, including the molecular and cellular bases of disease, aetiology, pathophysiology, pathology, epidemiology, clinical features, and the diagnosis, prognosis and treatment of cancer, will be considered for publication.