ASCO Guidelines Abemaciclib with Endocrine Therapy in the Treatment of High-Risk Early Breast Cancer: ASCO Optimal Adjuvant Chemotherapy and Targeted Therapy Guideline Rapid Recommendation Update
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Dec 10, 2021 Dr. Sharon Giordano from MD Anderson Cancer Center shares her insights on the latest updates for using abemaciclib with endocrine therapy in high-risk early breast cancer. She discusses key findings from the MonarchE trial, highlighting its effectiveness in improving disease-free survival. The conversation touches on the updated guidelines for patient eligibility and the critical balance between treatment benefits and potential risks. Giordano emphasizes the need for tailored approaches in clinical practice to enhance patient outcomes.
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MONARCH-E Shows Early IDFS Benefit
- The MONARCH-E trial showed adding two years of adjuvant abemaciclib to endocrine therapy improved invasive disease-free survival with HR ~0.70.
- Overall survival data remain immature and do not yet show a benefit.
Who Should Be Offered Abemaciclib
- Offer two years of abemaciclib (150 mg twice daily) plus endocrine therapy for patients matching the FDA label with high-risk, node-positive, HR+ HER2- disease and Ki-67 ≥20%.
- Also consider the broader MONARCH-E intent-to-treat population as reasonable for offering abemaciclib based on trial data.
MONARCH-E High-Risk Definition
- MONARCH-E defined 'high risk' as ≥4 positive nodes or 1–3 nodes plus grade 3 tumor, tumor ≥5 cm, or Ki-67 ≥20%.
- This trial-based definition guided both FDA labeling and the guideline's population considerations.