☆ 4.7 Article

Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial

LANCET ONCOLOGY (2023)

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A Standardized Investigational Ki-67 Immunohistochemistry Assay Used to Assess High-Risk Early Breast Cancer Patients in the monarchE Phase 3 Clinical Study Identifies a Population With Greater Risk of Disease Recurrence When Treated With Endocrine Therapy Alone

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Summary: The objective of this study was to develop a standardized Ki-67 immunohistochemistry method for precise assessment of patients with early breast cancer and to evaluate the prognostic value of Ki-67 expression in these patients. The results showed that patients with high Ki-67 expression had a higher risk of developing invasive disease within 2 years compared to those with low Ki-67 expression.

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Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study

H. S. Rugo et al.

Summary: The combination of abemaciclib and endocrine therapy as adjuvant treatment for early breast cancer shows significant improvement in invasive disease-free survival. Safety analysis reveals a higher incidence of grade >=3 adverse events and serious adverse events in the abemaciclib-treated group, but most adverse events are reversible and manageable with comedications and dose modifications.

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FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer

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Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study

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Summary: Adjuvant abemaciclib combined with endocrine therapy significantly improved invasive disease-free survival in patients with early breast cancer, with an acceptable safety profile. Ki-67 index was prognostic but did not affect the benefits of abemaciclib. The robust treatment benefit of abemaciclib extended beyond the planned 2-year treatment period.

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Summary: The PALLAS trial investigated whether adding 2 years of palbociclib to adjuvant endocrine therapy could improve invasive disease-free survival in early-stage hormone-receptor-positive, HER2-negative breast cancer patients, but the results showed no significant benefit. The trial was then discontinued based on the lack of efficacy observed during the planned second interim analysis.

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Palbociclib for Residual High-Risk Invasive HR-Positive and HER2-Negative Early Breast Cancer-The Penelope-B Trial

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Risk of recurrence among patients with HR-positive, HER2-negative, early breast cancer receiving adjuvant endocrine therapy: A systematic review and meta-analysis

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