| アブストラクト | BACKGROUND: Immune checkpoint inhibitor (ICI)-associated early cardiac adverse events (CAEs), mostly acute and fulminant myocarditis, have been well characterized and mainly occur during the first 90 days after ICI therapy initiation. ICI-associated late CAEs (occurring after the first 90 days of treatment) have not yet been described. METHODS: First, we compared characteristics of a cohort involving early (defined as a CAE time to onset (TTO) of <90 days after ICI therapy initiation) and late (defined as a CAE TTO of >/=90 days after ICI therapy initiation) ICI-associated CAE consecutive cases who were referred to three French cardio-oncology units. Second, ICI-associated CAE cases were searched in VigiBase, the WHO global individual case safety report database, and early and late ICI-associated CAEs were compared. RESULTS: In the cohort study, compared with early CAE cases (n=19, median TTO of 14 days), late ICI-associated CAE cases (n=19, median TTO of 304 days) exhibited significantly more left ventricular systolic dysfunction (LVSD) and heart failure (HF) and less frequent supraventricular arrhythmias. In VigiBase, compared with early cases (n=437, 73.3%, median TTO 21 days), the late ICI-associated CAE reports (n=159, 26.7%, median TTO 178 days) had significantly more frequent HF (21.1% vs 31.4%, respectively, p=0.01). Early and late ICI-associated CAE cases had similarly high mortality rates (40.0% vs 44.4% in the cohort and 30.0% vs 27.0% in VigiBase, respectively). CONCLUSIONS: Late CAEs could occur with ICI therapy and were mainly revealed to be HF with LVSD. TRIAL REGISTRATION NUMBERS: NCT03678337, NCT03882580, and NCT03492528. |
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| 投稿者 | Dolladille, Charles; Ederhy, Stephane; Allouche, Stephane; Dupas, Querntin; Gervais, Radj; Madelaine, Jeannick; Sassier, Marion; Plane, Anne-Flore; Comoz, Francois; Cohen, Ariel Aron; Thuny, Franck Roland; Cautela, Jennifer; Alexandre, Joachim |
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| 組織名 | CHU de Caen, PICARO Cardio-oncology Program, Department of Pharmacology, CHU de;Caen, Caen, France cdolladille@hotmail.com.;CHU de Caen, Department of Cardiology, CHU de Caen, Caen F-14000, France.;Department of Cardiology, Cardio-oncology Unit, Cardio-oncology Research G,;INSERM U 856, Thrombose, Atherothrombose et Pharmacologie Appliquee, Assistance;Publique - Hopitaux de Paris, Paris, France.;EA4650, Signalisation, Electrophysiologie et Imagerie des Lesions;d'Ischemie-reperfusion Myocardique, Universite de Caen Normandie, Caen,;Normandie, France.;Onco-pneumology, Centre Francois Baclesse Centre de Lutte Contre le Cancer, Caen,;France.;CHU de Caen, Onco-pneumology, CHU de Caen, Caen, France.;Caen, Caen, France.;CHU de Caen, Pathology, CHU de Caen, Caen, France.;Mediterranean University Cardio-oncology Center (MEDI-CO Center), Unit of Heart;Failure and Valvular Heart Diseases, Department of Cardiology, Hopital Nord,;Marseille, APHM, Marseille, Provence-Alpes-Cote d'Azu, France. |
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