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Peer-reviewedCC BY-NC-NDBlood vessels, thrombosis & hemostasis

Antineoplastic therapies associated with venous thromboembolism: disproportionality analysis of the WHO database

  • Angélique Da Silva1
  • Joachim Alexandre2
  • Laurent Bertoletti3
  • Damien Laneelle4
  • Flavie Biron4
  • Basile Chrétien5
  • Flavien Minoc6
  • Mélanie Janson7
  • Anne-Flore Plane8
  • Damien Legallois9
  • Charles Dolladille10
10 affiliations
  1. 1Departments of Pharmacology and Medical Oncology, PICARO Cardio-oncology program, Université Caen Normandie, ANTICIPE UMR 1086, Centre Hospitalier Universitaire de Caen, Caen, France
  2. 2Department of Pharmacology, PICARO Cardio-Oncology Program, Université Caen Normandie, ANTICIPE UMR 1086, Centre Hospitalier Universitaire de Caen, Caen, France
  3. 3Service de Médecine Vasculaire et Thérapeutique, Centre Hospitalier Universitaire de St-Etienne, Saint-Etienne, France
  4. 4Vascular Medicine Department, Centre Hospitalier Universitaire de Caen Normandie, Caen, France
  5. 5Division of Biostatistics, Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan
  6. 6Medical Oncology Department, Centre Hospitalier Universitaire de Caen Normandie, Caen, France
  7. 7Medical Oncology Department, Centre François Baclesse, Caen, France
  8. 8Cardiology Department, Centre Hospitalier Universitaire de Caen Normandie, Caen, France
  9. 9Department of Cardiology, PICARO Cardio-Oncology Program, Université Caen Normandie, ANTICIPE UMR 1086, Centre Hospitalier Universitaire de Caen, Caen, France
  10. 10Department of Pharmacology, Pharmaco-Epidemiology Unit, PICARO Cardio-Oncology Program, Université Caen Normandie, ANTICIPE UMR 1086, Centre Hospitalier Universitaire de Caen, Caen, France
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Abstract

The risk of venous thromboembolic events (VTE) is elevated in patients with active cancer. Recent antineoplastic therapies, including immunotherapies and targeted therapies, may further increase VTE risk, although evidence is limited. In March 2024, we conducted a disproportionality analysis using reporting odds ratios (Reporting-OR) in VigiBase, the World Health Organization's (WHO's) pharmacovigilance database, to assess the association between 280 antineoplastic therapies approved by the US Food and Drug Administration and/or the European Medicines Agency and VTE (symptomatic or not), defined as deep vein thrombosis and/or pulmonary embolism. Reporting-OR were adjusted (aReporting-OR) for case characteristics, including primary tumor site and metastatic status. A total of 37 803 VTE reports associated with at least 1 antineoplastic therapy were identified. We identified 19 antineoplastic therapies significantly associated with an increased reporting of VTE, with nintedanib emerging as a newly recognized association. The strongest associations were observed for lenalidomide (aReporting-OR, 3.64; 95% confidence interval [CI], 3.47-3.82), bevacizumab (aReporting-OR, 3.64; 95% CI, 3.43-3.86), and cyproterone (aReporting-OR, 3.52; 95% CI, 2.55-4.87). The median time to VTE onset was 64 days (interquartile range, 27-143), with 81% of VTE events occurring within the first 6 months after antineoplastic therapy initiation. Future studies should include antineoplastic therapies in VTE risk assessments and evaluate the management of VTE when recurrences occur while under treatment. This trial was registered at www.clinicaltrials.gov as NCT04696250.

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Cite

BibTeXRIS
BibTeX
@article{silva2026antineoplastic,
  title = {{Antineoplastic therapies associated with venous thromboembolism: disproportionality analysis of the WHO database}},
  author = {Angélique Da Silva and Joachim Alexandre and Laurent Bertoletti and Damien Laneelle and Flavie Biron and Basile Chrétien and Flavien Minoc and Mélanie Janson and Anne-Flore Plane and Damien Legallois and Charles Dolladille},
  journal = {Blood vessels, thrombosis \& hemostasis},
  year = {2026},
  month = sep,
  doi = {10.1016/j.bvth.2026.100212},
  url = {https://europepmc.org/article/PMC/PMC13717868},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Antineoplastic therapies associated with venous thromboembolism: disproportionality analysis of the WHO database
AU  - Angélique Da Silva
AU  - Joachim Alexandre
AU  - Laurent Bertoletti
AU  - Damien Laneelle
AU  - Flavie Biron
AU  - Basile Chrétien
AU  - Flavien Minoc
AU  - Mélanie Janson
AU  - Anne-Flore Plane
AU  - Damien Legallois
AU  - Charles Dolladille
PY  - 2026
DA  - 2026/09/04
JO  - Blood vessels, thrombosis & hemostasis
DO  - 10.1016/j.bvth.2026.100212
UR  - https://europepmc.org/article/PMC/PMC13717868
AB  - The risk of venous thromboembolic events (VTE) is elevated in patients with active cancer. Recent antineoplastic therapies, including immunotherapies and targeted therapies, may further increase VTE risk, although evidence is limited. In March 2024, we conducted a disproportionality analysis using reporting odds ratios (Reporting-OR) in VigiBase, the World Health Organization's (WHO's) pharmacovigilance database, to assess the association between 280 antineoplastic therapies approved by the US Food and Drug Administration and/or the European Medicines Agency and VTE (symptomatic or not), defined as deep vein thrombosis and/or pulmonary embolism. Reporting-OR were adjusted (aReporting-OR) for case characteristics, including primary tumor site and metastatic status. A total of 37 803 VTE reports associated with at least 1 antineoplastic therapy were identified. We identified 19 antineoplastic therapies significantly associated with an increased reporting of VTE, with nintedanib emerging as a newly recognized association. The strongest associations were observed for lenalidomide (aReporting-OR, 3.64; 95% confidence interval [CI], 3.47-3.82), bevacizumab (aReporting-OR, 3.64; 95% CI, 3.43-3.86), and cyproterone (aReporting-OR, 3.52; 95% CI, 2.55-4.87). The median time to VTE onset was 64 days (interquartile range, 27-143), with 81% of VTE events occurring within the first 6 months after antineoplastic therapy initiation. Future studies should include antineoplastic therapies in VTE risk assessments and evaluate the management of VTE when recurrences occur while under treatment. This trial was registered at www.clinicaltrials.gov as NCT04696250.
SN  - 2950-3272
ER  -