HR+ HER2- metastatic breast cancer: CDK4/6 inhibitors more toxic to older women

  • Howie LJ & al.
  • J Clin Oncol
  • 27 Sep 2019

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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

Limitations

  • Heterogeneity across studies.

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