HR+/HER2- advanced breast cancer: efficacy of CDK4/6 inhibitors confirmed

  • Li J & al.
  • Breast Cancer Res Treat
  • 22 Jan 2020

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

  • A meta-analysis of randomized controlled trials (RCTs), including MONALEESA, MONARCH, and PALOMA, erases any doubt about the benefits of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors when combined with endocrine therapy (ET) for treatment of hormone receptor (HR)-positive/human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer (aBCa).
  • CDK4/6 inhibitor+ET showed superior OS, PFS, objective response rate (ORR), and clinical benefit rate (CBR) compared with ET alone.

Why this matters

  • CDK4/6 inhibitor combined with ET should be considered the preferred treatment option for HR+/HER2 aBCa.

Study design

  • A meta-analysis of 8 RCTs (N=4580) after search including PubMed, MEDLINE, Cochrane Central Register, and EMBASE.
  • Funding: None.

Key results

  • CDK4/6 inhibitor+ET vs ET alone was superior for:
    • PFS: HR, 0.55 (P<.00001>
    • OS: HR, 0.79 (P=.004).
    • ORR: risk ratio (RR), 1.47 (P<.00001>
    • CBR: RR, 1.20 (P<.00001>
  • The PFS benefit was evident as first-line (HR, 0.56; P<.00001 and second-line p therapy regardless of menopausal status presence visceral metastasis previous treatment with chemotherapy patient age ethnicity.>
  • Neutropenia was the most common grade 3/4 adverse event (RR, 31.95; 95% CI, 17.75-57.50).

Limitations

  • Heterogeneity across studies.