Neratinib for breast cancer: a meta-analysis of 23 trials

  • Tao Z & al.
  • Clin Drug Investig
  • 28 Oct 2018

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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  • Neratinib, a pan-human epidermal growth factor receptor (HER) tyrosine kinase inhibitor, was approved by the FDA in 2017 to reduce the risk for recurrence after early HER2+ breast cancer.
  • Across 23 prospective trials, the most common adverse event (AE) was diarrhea, which can be ameliorated by prophylactic loperamide.
  • Neratinib monotherapy is promising, but neratinib plus other therapies has a higher response rate.

Why this matters

  • Neratinib is an important treatment option for HER2+ breast cancer.

Study design

  • Systematic review of safety and efficacy (23 studies; n=4896) and meta-analysis of safety outcomes after a literature search of PubMed, EMBASE, and Web of Science.
  • Funding: None.

Key results

  • Safety meta-analysis found that the most frequent all-grade AEs with neratinib monotherapy were diarrhea (83.9%), nausea (37.9%), and abdominal pain (28.4%; all P=.000).
    • The most frequent grade 3/4 AEs were diarrhea (25.1%; P=.000), dyspnea (5.6%; P=.001), and abnormalities in liver enzymes (4.2%; P=.000).
  • Prophylactic loperamide nonsignificantly reduced the frequency of all-grade diarrhea (61.3% vs 91.3% without loperamide; P=.116) but significantly reduced grade 3/4 diarrhea (22.4% vs 28.0%; P<.001>
  • Neratinib monotherapy had promising objective response rates and PFS in HER2+ BC (4 studies), but they were less promising in HER2-mutated BC.
  • Neratinib combined with other therapies had better response rates than neratinib monotherapy.


  • Most included studies were single-arm.

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