Work

Reconciling Sentinel Node Omission with CDK4/6 Inhibitor Eligibility in HR+/HER2- Early Breast Cancer: A Real-World Cohort Analysis

Year: 2025

Type: article

Abstract: Purpose Omission of sentinel lymph node biopsy (SLNB) in selected hormone receptor-positive (HR+), HER2-negative (HER2−) early breast cancer patients has demonstrated safety in prospective trials. However, accurate axillary staging remains important for identifying candidates for adjuvant CDK4/6 inhibitor therapy. We quantified the impact of SLNB omission on CDK4/6 eligibility and explored predictors of occult nodal disease in a real-world cohort. Methods We retrospectively analyzed 948 patients treated 2014-2022 at Tübingen University Hospital who met criteria proposed for potential SLNB omission: age ≥50 years, cT1 cN0, HR+/HER2−, grade 1-2 tumors treated with breast-conserving surgery and whole-breast irradiation. We assessed the prevalence of occult nodal metastases and potential eligibility for adjuvant abemaciclib (monarchE-criteria) or ribociclib (NATALEE-criteria) based on final pathology and fitted multivariable logistic models. Results Among 948 patients meeting SLNB omission criteria, 143 (15.1%) harbored occult nodal disease. Of these node-positive patients, 17 fulfilled the criteria for abemaciclib eligibility. For ribociclib, 105 node-positive patients were eligible. On multivariable analysis, multifocality (OR=2.3; p≤0.001) and cT1c tumor stage (OR=1.76; p=0.008) predicted axillary upstaging; invasive lobular carcinoma (ILC) showed higher crude upstaging than IDC/NST (22.6% vs 14.0%) but did not retain independent significance after adjustment. Conclusions Omitting sentinel node biopsy in selected patients leads to under-detection of nodal metastasis in a relevant proportion of patients, particularly with cT1c tumors, multi-focal tumors and ILC. As these patients may benefit from more intensive adjuvant treatment, omission of sentinel-node biopsy should be part of decision-making. Future trials should investigate the impact of adjuvant treatment for patients with occult lymph node metastases. Microabstract In a real-world cohort of 948 HR+/HER2− early breast cancer patients eligible for sentinel lymph node biopsy (SLNB) omission, 15% harbored occult nodal disease. Focality, tumor size, and invasive lobular carcinoma increased the risk of axillary upstaging. As SLNB omission may miss patients eligible for adjuvant CDK4/6 inhibitor therapy, omission decisions should be individualized and integrated into shared decision-making.

Source: Clinical Breast Cancer

DOI: 10.1016/j.clbc.2025.10.003