Jean-Marie Michot1, Ariane Lappara2, Jérôme Le Pavec3, Audrey Simonaggio4, Michael Collins5, Eléonora De Martin6, François-Xavier Danlos4, Samy Ammari7, Cécile Cauquil8, Stéphane Ederhy9, Emmanuel Barreau10, Rakiba Belkhir11, Amandine Berdelou12, Julien Lazarovici13, Philippe Chanson14, Hassan Izzedine15, Andrei Seferian16, Christine Le Pajolec17, Capucine Baldini4, Patricia Martin-Romano4, Xavier Mariette11, Caroline Robert12, Benjamin Besse12, Antoine Hollebecque4, Andrea Varga4, Salim Laghouati18, Christine Mateus12, Anne-Laure Voisin18, Jean-Charles Soria4, Christophe Massard4, Aurélien Marabelle4, Stéphane Champiat4, Olivier Lambotte19. 1. Gustave Roussy, Université Paris-Saclay, Département des Innovations Thérapeutiques et Essais Précoces, Villejuif, France. Electronic address: jean-marie.michot@gustaveroussy.fr. 2. Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, Service de Médecine Interne and Immunologie clinique, Le Kremlin-Bicêtre, France. 3. Hôpital Marie-Lannelongue, Department of Thoracic and Cardiovascular, and Transplantation Cardio-Pulmonary, Le Plessis-Robinson, France. 4. Gustave Roussy, Université Paris-Saclay, Département des Innovations Thérapeutiques et Essais Précoces, Villejuif, France. 5. Assistance Publique-Hôpitaux de Paris, Université Paris-Sud, Hôpitaux Universitaires Paris Sud, Gastroenterology Unit, Le Kremlin Bicêtre, France. 6. Assistance Publique-Hôpitaux de Paris, Hôpital Universitaire Paul Brousse, Centre Hépato-Biliaire, Villejuif, France. 7. Gustave Roussy, Université Paris-Saclay, Department of Diagnostic Radiology, Villejuif, France. 8. Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, Division of Adult Neurology, Le Kremlin Bicêtre, France. 9. Assistance Publique-Hôpitaux de Paris, Saint-Antoine Hospital, Service de cardiologie, Unite de cardio-oncologie, Pierre et Marie Curie University, Paris, France. 10. Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, Department of Ophthalmology, Le Kremlin Bicêtre, France. 11. Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, Department of Rheumatology, Le Kremlin Bicêtre, France. 12. Gustave Roussy, Université Paris-Saclay, Department of Cancer Medicine, Villejuif, France. 13. Gustave Roussy, Université Paris-Saclay, Department of Hematology, Villejuif, France. 14. Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, Unit of Endocrinology and Reproductive Health, Le Kremlin Bicêtre, France. 15. Peupliers Private Hospital, Nephrology Department, Paris, France. 16. Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, Service de Pneumologie, Centre de Référence de l'Hypertension Pulmonaire, Le Kremlin Bicêtre, France. 17. Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, Ear Nose and Throat Department, Le Kremlin Bicêtre, France. 18. Gustave Roussy, Université Paris-Saclay, Unité de Pharmacovigilance, Villejuif, France. 19. Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, Service de Médecine Interne and Immunologie clinique, Le Kremlin-Bicêtre, France; INSERM U1184, Immunology of Viral Infections and Autoimmune Diseases, Le Kremlin Bicêtre, France; Université Paris Sud, UMR 1184, Le Kremlin Bicêtre, France; CEA, DSV/iMETI, IDMIT, Fontenay-aux-Roses, France.
Abstract
PURPOSE: We 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 DESIGN: The 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. RESULTS: Over 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). CONCLUSION: The 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.
PURPOSE: We 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 DESIGN: The 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. RESULTS: Over 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). CONCLUSION: The 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.
Authors: Nanruoyi Zhou; Maria A Velez; Benjamin Bachrach; Jaklin Gukasyan; Charlene M Fares; Amy L Cummings; Jackson P Lind-Lebuffe; Wisdom O Akingbemi; Debory Y Li; Paige M Brodrick; Nawal M Yessuf; Sarah Rettinger; Tristan Grogan; Philippe Rochigneux; Jonathan W Goldman; Edward B Garon; Aaron Lisberg Journal: Lung Cancer Date: 2021-08-30 Impact factor: 5.705
Authors: Leyre Zubiri; Gabriel E Molina; Alexandra-Chloé Villani; Kerry L Reynolds; Meghan J Mooradian; Justine Cohen; Sienna M Durbin; Laura Petrillo; Genevieve M Boland; Dejan Juric; Michael Dougan; Molly F Thomas; Alex T Faje; Michelle Rengarajan; Amanda C Guidon; Steven T Chen; Daniel Okin; Benjamin D Medoff; Mazen Nasrallah; Minna J Kohler; Sara R Schoenfeld; Rebecca S Karp-Leaf; Meghan E Sise; Tomas G Neilan; Daniel A Zlotoff; Jocelyn R Farmer; Aditya Bardia; Ryan J Sullivan; Steven M Blum; Yevgeniy R Semenov Journal: J Immunother Cancer Date: 2021-09 Impact factor: 13.751