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Title: A systematic review of adverse events in randomized trials assessing immune checkpoint inhibitors.
Austin Authors: Arnaud-Coffin, Patrick;Maillet, Denis;Gan, Hui K ;Stelmes, Jean-Jacques;You, Benoit;Dalle, Stephane;Péron, Julien
Affiliation: Department of Medicine, Melbourne University, Melbourne, Australia
ImmuCare (Immunology Cancer Research), Institut de Cancérologie des Hospices Civils de Lyon, Lyon, France
Lyon 1 University, EMR 3738, Faculté de Médecine Lyon-Sud, Oullins, France
Dermatology Department, Hospices Civils de Lyon, Pierre-Bénite, France
ImmuCare (Immunology Cancer Research), Institut de Cancérologie des Hospices Civils de Lyon, Lyon, France
Statistics unit, Hospices Civils de Lyon, Pierre-Bénite, France
CNRS, UMR 5558 Biometry and Evolutionary Biology Laboratory, Université Lyon 1, Villeurbanne, France
Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia
School of Cancer Medicine, La Trobe University, Heidelberg, Australia
Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite, France
Department of Radiation Oncology, University Hospital Zurich, Switzerland
Issue Date: 2019
Date: 2019-01-17
Publication information: International journal of cancer 2019; 145(3): 639-648
Abstract: The advent of immune checkpoint-inhibitors (CPI) has transformed treatment for several cancer types. This review was performed to assess the rate of adverse events (AEs) associated with the use of CPI, alone or in combinations. A review of AEs reporting quality was also performed. All publications of Randomized Clinical Trials (RCTs) assessing CPI published before December 2017 were included. To investigate the quality of AEs reporting, a set of items was defined based on the 2004 CONSORT harms extension statement. Rates of Grade 5, serious, and study-withdrawal related AEs were collected in each treatment category. Specific immune related AEs (irAEs) were also collected when available. Pooled estimates of adverse event rates were calculated by using generalized linear mixed model. A total of 35 RCTs including 16485 patients were included. The overall quality of AEs reporting was satisfactory, but items pertaining to methods of data collection and analysis were infrequently reported. Grade ≥ 3 AEs were reported for 14% (95% CI 12-16) of patients treated with PD(L)-1 inhibitors, 34% (95% CI 27-42) of patients treated with CTLA-4 inhibitors, 55% (95% CI 51-59) of patients on CPI combinations and 46% (95% CI 40-53) of patients on immunotherapy-chemotherapy combination. The profile of irAEs was different among the treatment categories. The use of CPI, especially in combination, is associated with significant rates of Grade ≥3 AEs. Healthcare planning should anticipate the expected high number of patients presenting with irAEs in the future. This article is protected by copyright. All rights reserved.
DOI: 10.1002/ijc.32132
ORCID: 0000-0002-1709-5152
Journal: International journal of cancer
PubMed URL: 30653255
Type: Journal Article
Subjects: Adverse event
immune checkpoint inhibitors
immune toxicity
quality control
systematic review
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