- An FDA analysis of 3 randomized controlled trials (RCTs) finds that CDK4/6 inhibitors for hormone receptor-positive, HER2-negative metastatic breast cancer (mBCa) are as efficacious in older women (≥75 years) vs women
Why this matters
- Clinicians should inform older patients of the benefits and risks of CDK4/6 inhibitors.
- FDA retrospective analysis of 1827 participants pooled from PALOMA-2, MONALEESA-2, and MONARCH-3 RCTs of CDK4/6 inhibitors in combination with an aromatase inhibitor (AI).
- Funding: FDA.
- Similar improvement in PFS with CDK4/6 inhibitors+AI vs AI alone in older women vs women
- Older women receiving CDK4/6 inhibitors have:
- Higher incidence of grade 3-4 adverse events (AEs; 88.8% vs 73.4% in
- Higher incidence of AEs leading to dose reduction and/or interruption (81.6% vs 71.1%, respectively).
- Higher incidence of AEs leading to discontinuation (32.0% vs 12.1%).
- Higher incidence of serious AEs (46.4% vs 22.8%).
- Poorer results on EQ-5D quality-of-life measures regardless of treatment group (CDK4/6+AI or AI alone), including mobility (HR, 1.30; 95% CI, 0.94-1.80), self-care (HR, 1.60; 95% CI, 1.13-2.30), and ability to perform usual activities (HR, 1.46; 95% CI, 1.08-1.97) compared with recipients
- Heterogeneity across studies.