CDK4/6 Inhibition Plus Aromatase Inhibition in Advanced Breast Cancer
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PALOMA-2 Phase III Trial Results
- June 20, 2016
Palbociclib (Ibrance, CDK4/6 inhibitor) combined with letrozole demonstrated superior efficacy versus letrozole monotherapy in first-line treatment of ER+/HER2- advanced breast cancer in postmenopausal women.
Key Efficacy Data
Progression-Free Survival:
- Palbociclib + Letrozole: 24.8 months
- Placebo + Letrozole: 14.5 months
- 42% risk reduction (p<0.000001)
Objective Response Rate:
- Combination: 85%
- Letrozole alone: 70% (p<0.0001)
Safety Profile
Common Grade 3-4 adverse events: neutropenia (6%), fatigue (28%), nausea (26%), arthralgia (34%), alopecia (16%)
Clinical Conclusion
Palbociclib plus letrozole combination represents an effective first-line standard for postmenopausal women with ER-positive advanced breast cancer.
Data Source
PALOMA-2: Phase III trial of palbociclib with letrozole versus letrozole alone in postmenopausal women with ER+/HER2– advanced breast cancer. ASCO 2016, Abstract 706.
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