BCa: neratinib-induced diarrhea common but short-lived in ExteNET

  • Mortimer J & al.
  • Breast Cancer Res
  • 27 Feb 2019

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

  • Neratinib-associated diarrhea is highly prevalent, with more serious grades affecting 40% of patients and lasting 5 days in women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBCa).

Why this matters

  • Antidiarrheal prophylaxis early in the course of neratinib treatment is warranted.

Study design

  • Safety analysis of multicenter, double-blind, placebo-controlled 12-month randomized phase 3 ExteNET trial (n=2816).
  • Funding: Wyeth, Pfizer, Puma Biotechnology Inc.

Key results

  • Grade 1 diarrhea was observed in 22.9% of the neratinib group vs 27.1% of the placebo group, grade 2 in 32.5% vs 6.7%, grade 3 in 39.8% vs 1.6%, and grade 4 in 0.1% vs 0%.
  • The neratinib group (vs placebo) had a median cumulative duration of diarrhea per patient:
    • Grade ≥3: 5 (interquartile range [IQR], 2-9) vs 2 (1-5) days;
    • Grade ≥2: 10 (5-27) vs 3 (2-7) days;
    • Any grade: 59 (14-164) vs 6 (2-34) days.
  • Neratinib-associated diarrhea occurred early during treatment irrespective of grade, with the incidence of grade 3 diarrhea decreasing from 28.6% in month 1 to 11.2% in month 2, and ≤6% after month 3.

Limitations

  • None identified.