Advanced breast cancer: no PFS effect of high BMI after abemaciclib+ET

  • Franzoi MA & al.
  • J Natl Cancer Inst
  • 4 Aug 2020

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

  • High BMI does not adversely affect PFS after treatment with the CDK 4/6 inhibitor abemaciclib plus endocrine therapy (ET) vs placebo plus ET in patients with advanced breast cancer.

Why this matters

  • High BMI was predicted to have worse PFS based on findings in early breast cancer.
  • Patients with high BMI should be reassured by results.

Study design

  • Pooled analysis of 1138 patients in the Monarch 2 and 3 randomized controlled trials (RCTs).
  • Patients were categorized as underweight (BMI, 2), normal weight (BMI, 18.5-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2), or obese (BMI, ≥30 kg/m2).
  • Funding: None.

Key results

  • With abemaciclib+ET vs placebo+ET, PFS was prolonged regardless of BMI category.
  • Among normal/underweight patients vs those with overweight/obesity, overall response rate was higher in the abemaciclib+ET group:
    • 49.4% vs 41.6%.
    • OR, 0.73 (95% CI, 0.54-0.99).
  • Among normal/underweight patients vs those with overweight/obesity, neutropenia rates were higher in the abemaciclib+ET group:
    • 51.0% vs 40.4% (P=.004).
  • Weight loss of ≥5% was >3 times more common in the abemaciclib+ET vs placebo+ET group;
    • 27.1% vs 10.3%.
    • OR, 3.23 (P<.001>

Limitations

  • Results are considered exploratory and warrant further confirmation.