ArticleCancers2026
Comprehensive Analysis and Prediction of HER2-Targeted Therapy Insensitivity Among HER2-Positive Breast Cancer Patients Undergoing Neoadjuvant Treatment.
Article in Cancers, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed.
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7 authors.
Funding
Abstract
purposeHER2-targeted therapy has been incorporated into the standard neoadjuvant treatment (NAT) regimen for HER2-positive early-stage breast cancer, yet a subset of patients have shown a limited pathological response. This study aimed to evaluate clinicopathological factors associated with NAT sensitivity and to develop a predictive model.
methodsThis retrospective study included 13,004 HER2-positive breast cancer patients from the National Cancer Database (2010-2022) who received neoadjuvant chemotherapy plus HER2-targeted therapy. Pathological complete response (pCR) was defined as no residual invasive carcinoma in the breast and axillary lymph nodes (ypT0/is, ypN0). NAT sensitivity was additionally defined using clinical-to-pathologic stage migration according to the AJCC 8th edition criteria. Baseline characteristics and overall survival (OS) were compared between NAT-sensitive and NAT-insensitive groups. A multivariable logistic regression model was developed based on age, clinical T stage, clinical N stage, histologic subtype, tumor grade, and hormone receptor (HR) status. Model performance was assessed using the area under the receiver operating characteristic curve and calibration curves.
resultsAmong the patients included, 3660 (28.1%) achieved pCR. Based on the predefined stage-based criteria, 10,451 (80.4%) were classified as NAT-sensitive and 2553 (19.6%) as NAT-insensitive. NAT-insensitive patients were older and more likely to present with clinical T1c and node-negative disease, whereas NAT-sensitive patients more frequently had higher clinical T and N stages. HR-positive and lower tumor grades were significantly associated with treatment insensitivity. NAT-insensitive patients demonstrated significantly worse OS compared with NAT-sensitive patients (
conclusionsNAT sensitivity in HER2-positive early-stage breast cancer exhibited substantial biological and clinical heterogeneity in real-world practice. A younger age, higher clinical stage, invasive ductal histology, higher tumor grade, and HR-negative status were associated with improved responses. A predictive model based on routinely available baseline variables demonstrated reasonable performance for estimating treatment sensitivity, supporting its potential utility for baseline risk stratification pending external validation.
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