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Maternal and Neonatal Complications Associated with Breast Cancer Systemic Treatments-A VigiBase Disproportionality

Rayan Kabirian1,2, Floriane Jochum1, Elise Dumas3,1

  • 1Residual Tumor & Response to Treatment Laboratory, RT2Lab, INSERM, U932 Immunity and Cancer, Institut Curie, Université Paris Cité, Paris, France.

Clinical Pharmacology and Therapeutics
|July 29, 2026
PubMed

Insights

Pregnancy-associated breast cancer treatments show safety concerns. Anthracyclines and taxanes are linked to neonatal complications like hematologic disorders and IUGR, requiring further study.

Area of Science:

  • Oncology
  • Pharmacovigilance
  • Maternal-Fetal Medicine

Background:

  • Pregnancy-associated breast cancer (PrBC) poses unique treatment challenges.
  • Ensuring maternal-fetal safety of systemic anticancer therapies is paramount.
  • Limited data exists on specific risks associated with PrBC treatments.

Purpose of the Study:

  • To evaluate maternal-fetal outcomes associated with systemic breast cancer (BC) treatments during pregnancy.
  • To compare risks between cornerstone cytotoxic agents (anthracyclines, taxanes) and other BC therapies.
  • To identify potential trimester-specific risks.

Main Methods:

  • A case/non-case disproportionality analysis was conducted using the WHO global pharmacovigilance database (up to January 2024).
  • The study analyzed reports mentioning BC treatment during pregnancy.
  • Reporting odds ratios (ROR) were calculated for maternal-fetal complications.

Main Results:

  • Adverse maternal-fetal outcomes were reported in 55.8% of BC treatment cases versus 30.9% in other anticancer treatments.
  • Anthracyclines were associated with neonatal hematologic disorders (ROR=1.7) and intrauterine growth restriction (IUGR) (ROR=2.1).
  • Paclitaxel showed links to sensory defects (potentially platinum-mediated) and hyperbilirubinemia; docetaxel to neonatal neurologic disorders. First-trimester exposure suggested increased congenital malformation risks.

Conclusions:

  • Pharmacovigilance signals indicate specific maternal and neonatal risks associated with BC treatments during pregnancy.
  • Anthracyclines and taxanes warrant careful consideration due to observed adverse outcomes.
  • These hypothesis-generating findings necessitate confirmation through prospective studies and registries.

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