ArticleArchives of gynecology and obstetrics2026
The predictive role of Ki67 in pathological complete response (pCR) and invasive disease-free survival (IDFS) in HER2-positive breast cancer: a bi-centric retrospective cohort study of 244 cases.
Article in Archives of gynecology and obstetrics, 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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Abstract
purposeThe purpose of this study was to examine whether Ki67-scores have a predictive significance for pathological complete response (pCR) and invasive disease-free survival (IDFS) in HER2-positive breast cancer.
methodsThis retrospective, bi-centric cohort study focused on HER2-positive early breast cancer patients undergoing neoadjuvant chemotherapy from 2015 to 2023. Multivariable logistic regression was used to find independent association between various clinical parameters, including Ki67, and pCR. Ki67-values were categorized into three groups (low ≤ 15%, intermediate 15-35%, high > 35%). Kaplan-Meier estimator calculated differences in IDFS.
resultsThe study included 244 patients with known Ki67-expression. 147 patients (60.3%) achieved pCR. When categorized, 18 (7.4%) were Ki67 low, 114 (46.7%) Ki67 intermediate and 112 (45.9%) Ki67 high. No correlation between Ki67-score as continuous variable and pCR was observed (p = 0.25). HER2 immunohistochemistry (IHC) score 3 + significantly increased pCR compared to IHC score 2 + (63.2% vs. 45%, p = 0.031). Hormone receptor (HR)-positive tumors had a lower pCR rate (53.1% vs. 74.4%, p = 0.001) compared to HR-negative tumors. 5-year IDFS showed no difference between low Ki67 (88.9%; 95% CI 75.5-100%), intermediate Ki67 (82.0%; 95% CI 72.6-92.7%), and high Ki67 (80.9%, 95% CI 70.1-92.3%) subgroups (p = 0.7).
conclusionIn HER2-positive breast cancer, the Ki67-score showed no association with either pCR or IDFS, thereby questioning its clinical utility. Conversely the HER2 IHC-score and HR-status were predictive indicators for achieving pCR. Clinical decisions in patients with early HER2-positive breast cancer should not be influenced by Ki67-scores, especially not by using cut-offs.
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