Journal of the National Cancer Institute · 2026
Recurrence risk in HR-positive/HER2-negative early breast cancer: real-world US electronic health records study.
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Tarantino Paolo, Curigliano Giuseppe, Hamilton Erika, Kim Julia, Graff Stephanie L, Neven Patrick, Schlam Ilana, Harbeck Nadia, Cardoso Fatima, Akdere Murat, Santarsiero Liz, Ye Fen, Angehrn Zuzanna, Jhaveri Komal
Аннотация
BACKGROUND: The NATALEE and monarchE trials showed significant invasive disease-free survival benefits with the addition of a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) to endocrine therapy (ET) in patients with hormone receptor-positive, HER2-negative (HR+/HER2-) early breast cancer (EBC). This study evaluates outcomes in real-world patients prior to widespread availability of adjuvant CDK4/6is, depending on nodal status, including N0 disease with and without high-risk features.
METHODS: Anonymized data from the Flatiron Health US electronic health record database (2011 to 2023) were analyzed. Adults with American Joint Committee on Cancer anatomic stage I-III HR+/HER2- EBC who underwent surgery and adjuvant ET were included. Overall and distant recurrence and all-cause mortality risks were assessed descriptively across nodal subgroups using Cox proportional hazards models. Recurrence-free survival, distant recurrence-free survival (DRFS), and overall survival were evaluated using Kaplan-Meier methods in the NATALEE- and monarchE-eligible populations.
RESULTS: Among 7481 analyzed patients, 5387 (72.0%) had N0 disease, including 604 (11.2%) with high-risk features and 4783 (88.8%) without. Additionally, 1626 (21.7%) had N1 and 468 (6.3%) had N2-N3 disease. At a potential median follow-up of 78.0 months, the N0 high-risk subgroup showed overall and distant recurrence and mortality risks similar to those in the N1 subgroup. Overall, 2534 patients (33.9%) were NATALEE-eligible, and 1157 (15.5%) were monarchE-eligible. Both populations showed relatively high 5-year distant recurrence rates (DRFS, 83.1% and 74.6%, respectively).
CONCLUSIONS: This contemporary real-world analysis highlights a meaningful recurrence risk in the broader HR+/HER2- EBC population, irrespective of nodal status, and emphasizes the need for effective treatment strategies.
METHODS: Anonymized data from the Flatiron Health US electronic health record database (2011 to 2023) were analyzed. Adults with American Joint Committee on Cancer anatomic stage I-III HR+/HER2- EBC who underwent surgery and adjuvant ET were included. Overall and distant recurrence and all-cause mortality risks were assessed descriptively across nodal subgroups using Cox proportional hazards models. Recurrence-free survival, distant recurrence-free survival (DRFS), and overall survival were evaluated using Kaplan-Meier methods in the NATALEE- and monarchE-eligible populations.
RESULTS: Among 7481 analyzed patients, 5387 (72.0%) had N0 disease, including 604 (11.2%) with high-risk features and 4783 (88.8%) without. Additionally, 1626 (21.7%) had N1 and 468 (6.3%) had N2-N3 disease. At a potential median follow-up of 78.0 months, the N0 high-risk subgroup showed overall and distant recurrence and mortality risks similar to those in the N1 subgroup. Overall, 2534 patients (33.9%) were NATALEE-eligible, and 1157 (15.5%) were monarchE-eligible. Both populations showed relatively high 5-year distant recurrence rates (DRFS, 83.1% and 74.6%, respectively).
CONCLUSIONS: This contemporary real-world analysis highlights a meaningful recurrence risk in the broader HR+/HER2- EBC population, irrespective of nodal status, and emphasizes the need for effective treatment strategies.