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Co-reported respiratory adverse events in trastuzumab deruxtecan-associated interstitial lung disease: A pharmacovigilance analysis of the FAERS database - PubMed

3 hours ago
  • #interstitial lung disease
  • #trastuzumab deruxtecan
  • #pharmacovigilance
  • Trastuzumab deruxtecan (T-DXd) is linked to interstitial lung disease (ILD) and pneumonitis, but co-reported respiratory adverse events patterns are not well characterized.
  • FAERS database analysis (2015-2025) identified 759 ILD and 289 pneumonitis cases involving T-DXd, using hierarchical clustering to examine co-reporting patterns.
  • ILD clustered with dyspnea and cough in breast cancer, while in gastric/GEJ cancer, it co-reported with pneumonia, suggesting overlap with infectious presentations.
  • Lung cancer reports showed heterogeneous respiratory co-reporting, with less consistent clustering of ILD with specific symptoms.
  • ILD was a central node in the respiratory adverse event network, and clusters were stable across bootstrap analyses, indicating non-random patterns.
  • Co-reported respiratory event patterns differ by tumor type, which may help clinicians interpret ILD reports in real-world practice.