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ESMO open · 2026

Abemaciclib plus endocrine therapy in HR-positive, HER2-negative high-risk early breast cancer: efficacy in nodal subgroups.

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Cortes J, Johnston S R D, Martin M, Tolaney S M, Goetz M P, Rugo H S, Sohn J, Ozyilkan O, Abreu M H, Zaiss M, Vianna K M, Nielsen H M, Chan A, Kalofonos H, Morales S, Grimes B R, Amdur S, Neven P

Аннотация

BACKGROUND: In monarchE, 2 years of abemaciclib plus endocrine therapy (ET) significantly reduced the risk of recurrence and mortality in patients with node-positive, high-risk hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer. This analysis provides additional efficacy data based on nodal subgroups.

PATIENTS AND METHODS: Three nodal subgroups were analyzed in cohort 1, a population comprising 91% of the patients in monarchE: N1 high-risk (1-3 positive nodes with grade 3 tumors and/or tumor size ≥5 cm), N2 [4-9 positive axillary lymph node (ALN)], and N3 (≥10 positive ALN). Median follow-up was 76.8 months. Efficacy outcomes for invasive disease-free survival (IDFS) and distant recurrence-free survival (DRFS) using Kaplan-Meier methods and baseline characteristics are reported for nodal subgroups.

RESULTS: Kaplan-Meier analyses for IDFS and DRFS highlighted consistent and durable efficacy across nodal subgroups. Within the N1 high-risk group, 68.6% of tumors were grade 3; 57.6% of grade 3 tumors were <5 cm. In ET arm, recurrence risk in the N1 high-risk group was similar to N2.

CONCLUSIONS: The similar recurrence risk for patients in the N1 high-risk and N2 subgroups, and consistent efficacy across nodal subgroups, support addition of 2 years of adjuvant abemaciclib to ET to improve outcomes in patients meeting monarchE cohort 1 N1 high-risk, N2, or N3 criteria.

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

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