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Historical Article
The 2016-2019 ImmunoTOX assessment board report of collaborative management of immune-related adverse events, an observational clinical study.
- Jean-Marie Michot, Ariane Lappara, Jérôme Le Pavec, Audrey Simonaggio, Michael Collins, Eléonora De Martin, François-Xavier Danlos, Samy Ammari, Cécile Cauquil, EderhyStéphaneSAssistance Publique-Hôpitaux de Paris, Saint-Antoine Hospital, Service de cardiologie, Unite de cardio-oncologie, Pierre et Marie Curie University, Paris, France., Emmanuel Barreau, Rakiba Belkhir, Amandine Berdelou, Julien Lazarovici, Philippe Chanson, Hassan Izzedine, Andrei Seferian, Christine Le Pajolec, Capucine Baldini, Patricia Martin-Romano, Xavier Mariette, Caroline Robert, Benjamin Besse, Antoine Hollebecque, Andrea Varga, Salim Laghouati, Christine Mateus, Anne-Laure Voisin, Jean-Charles Soria, Christophe Massard, Aurélien Marabelle, ChampiatStéphaneSGustave Roussy, Université Paris-Saclay, Département des Innovations Thérapeutiques et Essais Précoces, Villejuif, France., and Olivier Lambotte.
- Gustave Roussy, Université Paris-Saclay, Département des Innovations Thérapeutiques et Essais Précoces, Villejuif, France. Electronic address: jean-marie.michot@gustaveroussy.fr.
- Eur. J. Cancer. 2020 May 1; 130: 39-50.
PurposeWe investigated the activities of an ImmunoTOX board, an academic, multidisciplinary group of oncologists and organ specialists that adopts a real-life, case-by-case approach in the management of patients with immune-related adverse events (irAEs).Experimental DesignThe ImmunoTOX assessment board was set up in 2016 at Gustave Roussy in France. It meets every 2 weeks to discuss the case-by-case management of patients presenting with irAEs. Here, we describe the ImmunoTOX board's activities between 2016 and 2019.ResultsOver study period, 398 requests (concerning 356 patients) were submitted to the ImmunoTOX board. Most of the requests concerned the putative causal link between immunotherapy and the irAE (n = 148, 37%), followed by possible retreatment after temporary withdrawal because of an adverse event (n = 109, 27%), the clinical management of complex situations (n = 100, 25%) and the initiation of immunotherapy in patients with pre-existing comorbidities (n = 41, 10%). The ImmunoTOX board discerned 273 irAEs. The five organ systems most frequently involved by irAEs were lung (n = 58, 21%), gastrointestinal tract (n = 36, 13%), liver or biliary tract (n = 33, 12%), musculoskeletal system (n = 27, 10%), and nervous system (n = 23, 8%). The time to occurrence was shorter for severe irAEs (grade III and VI) than for mild irAEs (grades I and II), with medians of 47 and 91 days, respectively (p = 0.0216).ConclusionThe main medical needs in the management of irAEs involved the lung organ. Severe irAEs were expected to occur earlier than mild irAEs. This real-life study can help to better estimate medical needs and therefore help to assess the management of irAEs.Copyright © 2020 Elsevier Ltd. All rights reserved.
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