Evidence map›Paper›PMID 42855725›Full record

ArticleDiagnostic and prognostic research2026

Accurate assessment of surgical HER2-low status based on core needle biopsy data of breast cancer.

Wen Li, Zixi Chen, Junyao Li, Tao Ding, Haike Lei, Rui Chen, Jialu Li

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Article in Diagnostic and prognostic research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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7 authors.

Wen Li *Department of Pathology, Chongqing University Cancer Hospital, Chongqing, China.
Zixi Chen *Division of Social Science, School of Humanities and Social Science, Hong Kong University of Science and Technology, Hong Kong, China.
Junyao LiFaculty of Innovation Engineering, Macau University of Science and Technology, Macau, China.
Tao DingDepartment of Statistical Science, University College London, London, UK.
Haike LeiChongqing Cancer Multi-omics Big Data Application Engineering Research Center, Chongqing University Cancer Hospital, Chongqing, China. tohaike@163.com.
Rui ChenDepartment of Pathology, Chongqing University Cancer Hospital, Chongqing, China. chenrui76@cqu.edu.cn.
Jialu LiMathematical Statistician Consultant, Hangzhou, China. jialu.lilee@gmail.com.ORCID https://orcid.org/0000-0002-6411-6876

Funding

the fund of China interdisciplinary research project of medicine and engineering 2021CDJYGRH-003
6 · The paper itself

Abstract

backgroundBreast cancer is a leading cause of cancer-related mortality among women globally. Accurate identification of HER2 status, particularly the HER2-low category, is crucial for effective treatment strategies, given the emergence of HER2-targeted therapies for this subgroup. However, discrepancies often arise between core needle biopsy (CNB) and surgical resection tissue (SRT) regarding more refined HER2 status.

methodsThis retrospective study included female patients with invasive breast cancer who underwent surgical resection between January 1, 2020, and December 31, 2024, at a single cancer center in China. We assessed the concordance of HER2 status, alongside other clinicopathological features on both CNB and SRT samples. We then developed a supervised binary modeling framework to predict SRT HER2 status (with metastasis) based on CNB data.

resultsAmong 1,919 patients analyzed, the concordance rate for HER2 classification was 97.0% in a binary system but dropped to 75.9% when using a 3-category system, with discordance noted particularly between HER2-zero and HER2-low categories. Logistic regression identified significant factors impacting concordance. The predictive model utilizing CNB HER2 classification achieved a mean AUC of 0.824, indicating substantial predictive capability for SRT HER2-low status. Integrating CNB clinicopathological variables further improved prediction accuracy (mean AUC from 0.691 to 0.771) for SRT HER2-low with metastasis in clinically relevant regions.

conclusionWhile CNB effectively determines binary HER2 status, establishing HER2-low categorization reveals discrepancies. Our findings highlight the importance of accurate preoperative HER2 assessment, supported by AI-based prediction models that enhance clinical decision-making in breast cancer management targeted toward HER2-low patients.

Indexed as

Artificial intelligenceBreast cancerCore needle biopsyHER2-low

Identifiers

PMID42855725

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