| アブストラクト | Importance: Limited information is available on the safety of a rechallenge with an immune checkpoint inhibitor (ICI) after an immune-related adverse event (irAE). Objective: To identify the recurrence rate of the same irAE that prompted discontinuation of ICI therapy after an ICI rechallenge in patients with cancer and to identify the clinical features associated with such recurrences. Design, Setting, and Participants: This observational, cross-sectional, pharmacovigilance cohort study examined individual case safety reports from the World Health Organization database VigiBase, which contains case reports from more than 130 countries. Case reports were extracted from database inception (1967) to September 1, 2019. All consecutive ICI cases with at least 1 associated irAE were included. Main Outcomes and Measures: The primary outcome was the rate of recurrence of the initial irAE after an ICI rechallenge. Secondary outcomes included the factors associated with the recurrence after a rechallenge among informative rechallenges, the recurrence rate according to the ICI regimen (anti-programmed cell death 1 or anti-programmed cell death ligand 1 monotherapy, anti-cytotoxic T-lymphocyte antigen-4 monotherapy, or combination therapy), and the rate of occurrence of a different irAE after a rechallenge. Results: A total of 24 079 irAE cases associated with at least 1 ICI were identified. Among the irAEs, 452 of 6123 irAEs associated with ICI rechallenges (7.4%) were informative rechallenges. One hundred thirty recurrences (28.8%; 95% CI, 24.8-33.1) of the initial irAE were observed. In a rechallenge, colitis (reporting odds ratio [OR], 1.77; 95% CI, 1.14-2.75; P = .01), hepatitis (reporting OR, 3.38; 95% CI, 1.31-8.74; P = .01), and pneumonitis (reporting OR, 2.26; 95% CI, 1.18-4.32; P = .01) were associated with a higher recurrence rate, whereas adrenal events were associated with a lower recurrence rate (reporting OR, 0.33; 95% CI, 0.13-0.86; P = .03) compared with other irAEs. Conclusions and Relevance: This cohort study found a 28.8% recurrence rate of the same irAE associated with the discontinuation of ICI therapy after a rechallenge with the same ICI. Resuming ICI therapy could be considered for select patients, with appropriate monitoring and use of standard treatment algorithms to identify and treat toxic effects. |
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| 投稿者 | Dolladille, Charles; Ederhy, Stephane; Sassier, Marion; Cautela, Jennifer; Thuny, Franck; Cohen, Ariel A; Fedrizzi, Sophie; Chretien, Basile; Da-Silva, Angelique; Plane, Anne-Flore; Legallois, Damien; Milliez, Paul U; Lelong-Boulouard, Veronique; Alexandre, Joachim |
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| 組織名 | Normandie University, University of Caen Normandy, Centre Hospitalier;Universitaire (CHU) de Caen Normandie, PICARO Cardio-oncology Program, Department;of Pharmacology, EA 4650, Signalisation, Electrophysiologie et Imagerie des;Lesions d'Ischemie-Reperfusion Myocardique, Caen, France.;Hopitaux Universitaires Paris-Est, Assistance Publique-Hopitaux de Paris, Hopital;Saint Antoine, Service de Cardiologie, Unico, Unite de Cardio-Oncologie APHP.6,;GRC Groupe de Recherche Clinique en Cardio Oncologie, Inserm 856, Universite;Pierre et Marie Curie, Paris, France.;CHU de Caen Normandie, Department of Pharmacology, Caen, France.;Aix-Marseille Mediterranean University, Assistance Publique-Hopitaux de;Marseille, Marseille, France.;Cardio-Oncology Center, Unit of Heart Failure and Valvular Heart Diseases,;Department of Cardiology, Hopital Nord, Marseille, France.;Centre de Recherche Cardiovasculaire et Nutrition, Inserm 1263, Inra, Marseille,;France.;Groupe Mediterraneen de Cardio-Oncologie, Marseille, France.;Oncosafety Network of the Early Phases Cancer Trials Center, Marseille, France.;Centre Francois Baclesse Centre de Lutte Contre le Cancer (Cancer Centre), Caen,;CHU de Caen Normandie, PICARO Cardio-oncology Program, Department of Cardiology,;Caen, France.;Normandie University, UNICAEN, CHU de Caen Normandie, PICARO Cardio-oncology;Program, Department of Cardiology, EA 4650, Signalisation, Electrophysiologie et;Imagerie des Lesions d'Ischemie-Reperfusion Myocardique, Caen, France. |
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