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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低her2早期乳腺癌核心针活检的可靠性。

背景：核心针活检（CNB）诊断her2阳性乳腺癌的可靠性已经得到了很好的证实。然而，her2低的数据和与手术样本不一致的可能性是有限的。材料与方法：采用未加权Cohen kappa统计量（Kc）对连续776例treatment-naïve早期乳腺癌患者的CNB与手术样本的一致性进行评估。采用Logistic回归模型评估一致性与临床病理特征之间的关系。结果：CNB与手术标本her2阳性状态的一致性高达95%，Kc值为0.86，几乎完全一致。然而，123例HER2-0患者中有65例（53%）被重新分类为her1 +或2 + / ish阴性，374例（24%）her1 + /2 +患者中有89例（24%）在手术样本中为HER2-0。这导致Kc值为0.22，表明HER2-0与her2 -低乳腺癌的分类是公平一致的。肿瘤大小是影响不一致的重要因素，大于2 cm的肿瘤有两倍的误分类风险。结论：这些发现提示HER2状态应该重新检测，特别是对于最初诊断为HER2-0的大肿瘤，考虑到HER2低乳腺癌的新有效疗法，如抗体-药物偶联物。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.