| アブストラクト | 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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| 投稿者 | Da Silva, Angelique; Alexandre, Joachim; Bertoletti, Laurent; Laneelle, Damien; Biron, Flavie; Chretien, Basile; Minoc, Flavien; Janson, Melanie; Plane, Anne-Flore; Legallois, Damien; Dolladille, Charles |
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| 組織名 | Departments of Pharmacology and Medical Oncology, PICARO Cardio-oncology program,;Universite Caen Normandie, ANTICIPE UMR 1086, Centre Hospitalier Universitaire de;Caen, Caen, France.;Department of Pharmacology, PICARO Cardio-Oncology Program, Universite Caen;Normandie, ANTICIPE UMR 1086, Centre Hospitalier Universitaire de Caen, Caen,;France.;Service de Medecine Vasculaire et Therapeutique, Centre Hospitalier Universitaire;de St-Etienne, Saint-Etienne, France.;INSERM, UMR 1059, Equipe Dysfonction Vasculaire et Hemostase, Universite;Jean-Monnet, Saint-Etienne, France.;INSERM, Clinical Investigation Center-1408, Centre Hospitalier Universitaire;Saint-Etienne, Saint-Etienne, France.;Vascular Medicine Department, Centre Hospitalier Universitaire de Caen Normandie,;Caen, France.;INSERM UMRS-1075, COMETE, GIP Cyceron, Universite de Caen Normandie, Caen,;Division of Biostatistics, Department of Advanced Medicine, Nagoya University;Hospital, Nagoya, Japan.;Medical Oncology Department, Centre Hospitalier Universitaire de Caen Normandie,;Medical Oncology Department, Centre Francois Baclesse, Caen, France.;Cardiology Department, Centre Hospitalier Universitaire de Caen Normandie, Caen,;Department of Cardiology, PICARO Cardio-Oncology Program, Universite Caen;Department of Pharmacology, Pharmaco-Epidemiology Unit, PICARO Cardio-Oncology;Program, Universite Caen Normandie, ANTICIPE UMR 1086, Centre Hospitalier;Universitaire de Caen, Caen, France. |
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