Safety of immune checkpoint inhibitor rechallenge after discontinuation for grade ≥2 immune-related adverse events in patients with cancer
| Autor: | Marion Allouchery, Ghada Miremont-Salamé, Franck Rouby, Mathieu Puyade, Celia Bertin, Thomas Lombard, Marion Sassier, Mickael Martin, Marie-Christine Perault-Pochat, Marina Atzenhoffer |
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| Přispěvatelé: | Centre hospitalier universitaire de Poitiers (CHU Poitiers), Ischémie Reperfusion en Transplantation d’Organes Mécanismes et Innovations Thérapeutiques ( IRTOMIT), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Centre régional de pharmacovigilance de Caen Basse-Normandie (CRPV), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Hôpital Henri Mondor, Hospices Civils de Lyon (HCL), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Laboratoire de neurosciences expérimentales et cliniques (LNEC), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Otten, Lisa |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions medicine.medical_treatment Immunology 03 medical and health sciences 0302 clinical medicine Immune system Internal medicine Neoplasms Pharmacovigilance medicine Immunology and Allergy Humans 030212 general & internal medicine Adverse effect Prospective cohort study Immune Checkpoint Inhibitors RC254-282 Aged Pharmacology business.industry Melanoma [SCCO.NEUR]Cognitive science/Neuroscience autoimmunity [SCCO.NEUR] Cognitive science/Neuroscience Cancer Correction Neoplasms. Tumors. Oncology. Including cancer and carcinogens Immunotherapy Middle Aged medicine.disease Discontinuation Oncology 030220 oncology & carcinogenesis Molecular Medicine Female immunotherapy business hormones hormone substitutes and hormone antagonists |
| Zdroj: | Journal for ImmunoTherapy of Cancer, Vol 8, Iss 2 (2020) Journal for Immunotherapy of Cancer Journal for Immunotherapy of Cancer, BMJ Publishing Group 2020, 8 (2), pp.e001622. ⟨10.1136/jitc-2020-001622⟩ |
| ISSN: | 2051-1426 |
| DOI: | 10.1136/jitc-2020-001622⟩ |
| Popis: | BackgroundSafety of rechallenge of immune checkpoint inhibitor (ICI) after grade ≥2 immune-related adverse events (irAEs) leading to ICI discontinuation remains unclear.MethodsAll adverse drug reactions involving at least one ICI reported up to December 31, 2019 were extracted from the French pharmacovigilance database. Patients were included if they experienced at least one grade ≥2 irAE resulting in ICI discontinuation, with subsequent ICI rechallenge. The primary outcome was the recurrence of at least one grade ≥2 irAE in these patients after ICI rechallenge.ResultsWe included 180 patients: 61.1% were men (median age of 66 years), 43.9% had melanoma and 78.9% were receiving anti-programmed cell death 1. First ICI discontinuation was related to 191 irAEs. After ICI rechallenge, 38.9% of the patients experienced at least one grade ≥2 irAE. Among them, 70.0% experienced the same irAE, 25.7% a distinct irAE, and 4.3% both the same and a distinct irAE. Lower recurrence rates of irAEs were associated with rechallenge with the same ICI treatment (p=0.02) or first endocrine irAEs (p=0.003). Gastrointestinal irAEs were more likely to recur (p=0.007). The median duration from ICI discontinuation to rechallenge and the severity of the initial irAE did not predict recurrent irAEs after ICI rechallenge (p=0.53 and p=0.40, respectively).ConclusionsIn this study, 61.1% of the patients who discontinued ICI treatment for grade ≥2 irAEs experienced no recurrent grade ≥2 irAEs after ICI rechallenge. Although ICI rechallenge appears to be safe under close monitoring, it should always be discussed balancing usefulness of rechallenge, patient comorbidities and risk of recurrence of first irAE(s). Due to inherent bias associated with pharmacovigilance studies, further prospective studies are needed to assess risk factors that may influence patient outcomes after ICI rechallenge. |
| Databáze: | OpenAIRE |
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