Sergio Cifuentes, Medical Oncologist at Las Américas Auna Clinic, shared a post on X:
“AMALEE Trial – Ribociclib 400 mg vs 600 mg.
Could a lower starting dose reduce toxicity without compromising efficacy in HR+/HER2– advanced breast cancer? Let’s look at the data.
Key Results:
- ORR difference: −7.2% (non-inferiority not met).
- Median PFS: 26.9 vs 25.1 mo (similar).
- DOR: 26.5 vs 28.8 mo.
- Time to response: longer with 400 mg (13.1 vs 9.0 mo).
Safety:
- Grade 3–4 neutropenia: 41% vs 58.5%.
- QTc prolongation: 12.5 vs 19.7 ms.
- Dose reductions: 15.4% vs 36.9%.
Conclusion: Lower dose improved safety but did not meet non-inferiority for ORR. 600 mg remains standard starting dose.”
Title: 600- vs 400-mg First-Line Ribociclib in Hormone Receptor–Positive/ERBB2-Negative Advanced Breast Cancer
Authors: Fatima Cardoso, William Jacot, Sherko Kuemmel, Sudeep Gupta, Felipe Cruz, Rama Balaraman, Ana Ferreira, Tytti Ahola, Yana Chapko, Lyudmila Zhukova, Wendy Chiang, Zheng Li, Yan Ji, Nadia Kaakiou, Natalia Bolotova, Joseph A. Sparano
Read The Full Article at JAMA Oncology.
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