Immune-related generalised oedema - A new category of adverse events with immune checkpoint inhibitors.

Autor: Velev M; Gustave Roussy - Paris-Saclay University, Département d'Innovation Thérapeutique et Essais Précoces, 94800 Villejuif, France., Baroudjian B; Assistance Publique - Hôpitaux de Paris, Saint-Louis Hospital, Dermatology Department, 75010 Paris, France., Pruvost R; Gustave Roussy - Paris-Saclay University, Département d'Innovation Thérapeutique et Essais Précoces, 94800 Villejuif, France., De Martin E; Assistance Publique - Hôpitaux de Paris, Paul-Brousse Hospital, Department of Hepatology, Centre Hépato-Biliaire, INSERM 1193, 94800 Villejuif, France., Laparra A; Gustave Roussy - Paris-Saclay University, Département d'Innovation Thérapeutique et Essais Précoces, 94800 Villejuif, France., Babai S; Assistance Publique - Hôpitaux de Paris, Henri Mondor Hospital, Department of Pharmacovigilance, 94000 Créteil, France., Teysseire S; Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud Pierre Bénite, Department of Dermatology, 69002 Lyon, France., Danlos FX; Gustave Roussy - Paris-Saclay University, Département d'Innovation Thérapeutique et Essais Précoces, 94800 Villejuif, France., Albiges L; Gustave Roussy - Paris-Saclay University, Department of Medical Oncology, 94800 Villejuif, France., Bernigaud C; Assistance Publique - Hôpitaux de Paris, Henri Mondor Hospital, Dermatology Department, 94000 Créteil, France., Benderra MA; Assistance Publique - Hôpitaux de Paris, Tenon Hospital, Department of Medical Oncology, 75020 Paris, France., Pradère P; Centre Chirurgical Marie Lannelongue, Le Plessis Robinson, France., Zaidan M; Assistance Publique - Hôpitaux de Paris, Paris-Saclay University, Bicêtre Hospital, Nephrology Department, 94270 Le Kremlin-Bicêtre, France., Decroisette C; Centre Hospitalier Annecy Genevois, Department of Medical Oncology, 74374 Pringy, France., Fallah F; Centre Hospitalier Argenteuil, Department of Medical Oncology, 95107 Argenteuil, France., Matergia G; Hôpital-Clinique Claude Bernard, Department of Medical Oncology, 57070 Metz, France., Lavaud P; Gustave Roussy - Paris-Saclay University, Department of Medical Oncology, 94800 Villejuif, France., Jantzem H; Centre Hospitalier Universitaire de Brest, Department of Pharmacovigilance, Centre Régional de Pharmacovigilance, 29609 Brest, France., Atzenhoffer M; Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud Pierre Bénite, Department of Clinical Pharmacology and Pharmacovigilance, 69002 Lyon, France., Buyse V; O.L.V. van Lourdes Ziekenhuis Waregem, Vijfseweg 150, 8790 Waregem, Belgium; Oncologie, Vijfseweg 150, B-8790 Waregem, Belgium., Ammari S; Gustave Roussy - Paris-Saclay University, Radiology Department, 94800 Villejuif, France., Robert C; Gustave Roussy - Paris-Saclay University, Department of Medical Oncology, 94800 Villejuif, France., Champiat S; Gustave Roussy - Paris-Saclay University, Département d'Innovation Thérapeutique et Essais Précoces, 94800 Villejuif, France., Messayke S; Gustave Roussy - Paris-Saclay University, Pharmacovigilance Unit, 94800 Villejuif, France., Marabelle A; Gustave Roussy - Paris-Saclay University, Département d'Innovation Thérapeutique et Essais Précoces, 94800 Villejuif, France., Guettier C; Assistance Publique - Hôpitaux de Paris, Paris-Saclay University, Bicêtre Hospital, Department of Pathology, UMR-S 1193, 94270 Le Kremlin Bicêtre, France., Lebbe C; Assistance Publique - Hôpitaux de Paris, University of Paris, Department of Dermatology, DMU ICARE, Saint Louis Hospital, INSERM U976 HIPI, Team 1, F-75010 Paris, France., Lambotte O; Assistance Publique - Hôpitaux de Paris, Paris-Saclay University, Bicêtre Hospital, Internal Medicine Department, 94270 Le Kremlin-Bicêtre, France., Michot JM; Gustave Roussy - Paris-Saclay University, Département d'Innovation Thérapeutique et Essais Précoces, 94800 Villejuif, France; Gustave Roussy, INSERM U1170, Université Paris-Saclay, Villejuif, France. Electronic address: jean-marie.michot@gustaveroussy.fr.
Jazyk: angličtina
Zdroj: European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2023 Jan; Vol. 179, pp. 28-47. Date of Electronic Publication: 2022 Nov 12.
DOI: 10.1016/j.ejca.2022.11.001
Abstrakt: Background: Generalised oedema was occasionally reported associated with immune checkpoint inhibitors (ICPIs). The purpose of this study is to investigate immune-related generalised oedema (ir-GE) drug related to ICPI, through frequency, clinical and pathological characteristics, and patient's outcome.
Patients and Methods: Objectives of the study were to report on ir-GE associated with ICPI to define frequency, associated signs and symptoms, pathological characteristics, severity, and response to corticosteroids. To be included in the study, adult patients had to have ir-GE related to ICPI with certain or likely link, without any other known causes of generalised oedema. The study design was observational, over the period 2014-2020, from pharmacovigilance databases in France, including the prospective Registre des Effets Indésirables Sévères des Anticorps Monoclonaux Immunomodulateurs en Cancérologie (REISAMIC) registry. Calculation of the frequency of ir-GE was restricted to the prospective REISAMIC registry.
Results: Over 6633 screened patients, 20 had ir-GE confirmed drug related to ICPI. Based on the prospective REISAMIC registry, the frequency of ir-GE was 0.19% of ICPI-treated patients (3 cases out of 1598 screened patients). The 20 patients with ir-GE had a median (range) age of 62 (26-81) years, most frequent tumour types were melanoma (n = 9; 45%) and lung cancer (n = 6; 30%). The most frequent localisations of oedema were peripheral (n = 17; 85%), pleural (n = 13; 65%), and peritoneal (n = 10; 50%). Polyserositis was observed in 11 (55%) patients. The median (range) weight gain per patient was 9 (2-30) kg. Associated signs and symptoms met criteria for capillary leak syndrome (n = 4; 20%), sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) (n = 3; 15%), or subcutaneous autoimmune syndrome (n = 2; 10%). Corticosteroids were administered to 15 patients; of them, 10 (67%) improved clinically after corticosteroids. Based on CTCAEV5.0, the highest severity of ir-GE was grade ≥4 in 11 (55%) patients and four (20%) patients died due to ir-GE.
Conclusions: Generalised immune system-related oedema is a new category of adverse event with immune checkpoint inhibitors and is often associated with a life-threatening condition. The pathophysiology may in some cases be related to endothelial dysfunctions, such as SOS/VOD or capillary leak syndrome.
(Copyright © 2022 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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