Evidence map›Paper›PMID 40888754›Full record

ArticleThe oncologist2025

Immuno-OncologyThe adverse event of interstitial lung disease in patients treated with antibody-drug conjugates.

Nan Fang, Xiang Wang, Zhiqing Xu, Hongyan Zhan, Yuqing Wang, Bin Zhao, Hui Huang, Mingbao Lin

Abstract read
In one paragraph

Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Nan FangDepartment of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100730, China.
Xiang WangDepartment of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100730, China.
Zhiqing XuDepartment of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100730, China.
Hongyan ZhanState Key Laboratory of Bioactive Substances and Functions of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China.
Yuqing WangState Key Laboratory of Bioactive Substances and Functions of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China.
Bin ZhaoDepartment of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100730, China.ORCID 0000-0001-8555-523X
Hui HuangDepartment of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.ORCID 0000-0001-7184-0005
Mingbao LinState Key Laboratory of Bioactive Substances and Functions of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China.

Funding

Chinese Pharmaceutical Association Hospital Pharmacy Department 2022-PUMCH-B-058Chinese Pharmaceutical Association Hospital Pharmacy Department CPA-Z05-ZC-2022-003
6 · The paper itself

Abstract

objectivesThere has been a yearly increase in the incidence of interstitial lung disease (ILD) adverse events associated with antibody-drug conjugates (ADCs), which is becoming a significant challenge for the clinical application of ADCs. We aim to conduct an exhaustive analysis of the clinical characteristics and outcomes of ADC-associated ILD in the real world.

methodsWe utilized the FDA Adverse Event Reporting System database spanning from January 2004 to September 2023 to evaluate the clinical characteristics, onset times, and outcomes of ADC-associated ILD adverse events in patients. Additionally, safety signals were generated using disproportionality and Bayesian analyses to evaluate the association between ADC and ILD.

resultsOut of the fifteen ADCs, ten were recorded to have caused ILD adverse events, accounting for a total of 643 reported cases. Eight ADCs exhibited statistically significant safety signals related to ILD in both disproportionality and Bayesian analyses. Trastuzumab deruxtecan recorded the highest reporting odds ratio (ROR) = 49.04 [95% confidence interval (CI) =44.41-54.17], proportional reporting ratio (PRR) = 43.90 (χ2 = 18 297.87), empirical Bayes geometric mean = 43.45 (95% one-sided CI, 39.98). 44.20% of adverse reactions were recognized within the first month of ADC treatment. The median time to onset for ILD related to gemtuzumab ozogamicin was notably the shortest at 4 days [interquartile range (IQR): 2-12 days], and it had the highest fatality proportion, standing at 57.14%.

conclusionsThis study analyzed demographic, temporal and outcome profiles of ADC-related ILD cases and identified high-risk signals. These findings help raise awareness and improve the monitoring of adverse events related to ADC. In the future, large-scale prospective studies are needed to further confirm and explore the underlying biological mechanisms.

Indexed as

ImmunoconjugatesLung Diseases, InterstitialAdverse Drug Reaction Reporting SystemsAgedBayes TheoremFemaleHumansMaleMiddle AgedImmunoconjugatesantibody-drug conjugatecancerdisproportionality analysisFAERSinterstitial lung disease

Identifiers

PMID40888754
PMCPMC12629535

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.