Antineoplastic agent-associated interstitial lung disease in breast, ovarian, and prostate cancers: a pharmacovigilance study using the FDA adverse event reporting system - Summary - MDSpire

Antineoplastic agent-associated interstitial lung disease in breast, ovarian, and prostate cancers: a pharmacovigilance study using the FDA adverse event reporting system

  • By

  • Keyuan Du

  • Chenglong Duan

  • Jiaqi Zhang

  • Jianing Zhang

  • Jinsui Du

  • Yi Pan

  • Zhihao Liu

  • Chenrong Zhang

  • Yuhan Zhang

  • Yibin Zhang

  • Xuan Zhang

  • Zhongxia Sheng

  • Bin Wang

  • Yu Ren

  • Lizhe Zhu

  • June 10, 2026

  • 0 min

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Objective:

To compare ILD reporting associations among antineoplastic agents used in breast, ovarian, and prostate cancers and provide clinical context from published literature regarding the significance of ILD.

Approach:
    Key Findings:
    • Trastuzumab deruxtecan (T-DXd) showed the highest adjusted reporting association for ILD according to the study's analysis.
    • Darolutamide and fulvestrant also exhibited elevated ILD reporting associations.
    • Older age and lower body weight were independently associated with ILD reporting.
    • Death-recorded ILD reports had a shorter median time-to-onset compared to non-death-recorded reports in certain weight subgroups.
    • Literature review identified 85 publications with 98 case-level records supporting FAERS findings.
    Interpretation:

    ILD reporting associations vary across antineoplastic agents for sex hormone-sensitive solid tumors.

    Limitations:
    • Findings are hypothesis-generating.
    • Study relies on FAERS data, which may have reporting biases.
    Conclusion:

    The study highlights the variability of ILD reporting associations across antineoplastic agents.

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