Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/20256
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dc.contributor.authorArnaud-Coffin, Patrick-
dc.contributor.authorMaillet, Denis-
dc.contributor.authorGan, Hui K-
dc.contributor.authorStelmes, Jean-Jacques-
dc.contributor.authorYou, Benoit-
dc.contributor.authorDalle, Stephane-
dc.contributor.authorPéron, Julien-
dc.date2019-01-17-
dc.date.accessioned2019-02-04T23:34:14Z-
dc.date.available2019-02-04T23:34:14Z-
dc.date.issued2019-
dc.identifier.citationInternational journal of cancer 2019; 145(3): 639-648-
dc.identifier.urihttp://ahro.austin.org.au/austinjspui/handle/1/20256-
dc.description.abstractThe 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.-
dc.language.isoeng-
dc.subjectAdverse event-
dc.subjectimmune checkpoint inhibitors-
dc.subjectimmune toxicity-
dc.subjectquality control-
dc.subjectsystematic review-
dc.titleA systematic review of adverse events in randomized trials assessing immune checkpoint inhibitors.-
dc.typeJournal Article-
dc.identifier.journaltitleInternational journal of cancer-
dc.identifier.affiliationDepartment of Medicine, Melbourne University, Melbourne, Australiaen
dc.identifier.affiliationImmuCare (Immunology Cancer Research), Institut de Cancérologie des Hospices Civils de Lyon, Lyon, Franceen
dc.identifier.affiliationLyon 1 University, EMR 3738, Faculté de Médecine Lyon-Sud, Oullins, Franceen
dc.identifier.affiliationDermatology Department, Hospices Civils de Lyon, Pierre-Bénite, Franceen
dc.identifier.affiliationImmuCare (Immunology Cancer Research), Institut de Cancérologie des Hospices Civils de Lyon, Lyon, Franceen
dc.identifier.affiliationStatistics unit, Hospices Civils de Lyon, Pierre-Bénite, Franceen
dc.identifier.affiliationCNRS, UMR 5558 Biometry and Evolutionary Biology Laboratory, Université Lyon 1, Villeurbanne, Franceen
dc.identifier.affiliationOlivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationSchool of Cancer Medicine, La Trobe University, Heidelberg, Australiaen
dc.identifier.affiliationMedical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite, Franceen
dc.identifier.affiliationDepartment of Radiation Oncology, University Hospital Zurich, Switzerland-
dc.identifier.doi10.1002/ijc.32132-
dc.identifier.orcid0000-0002-1709-5152-
dc.identifier.pubmedid30653255-
dc.type.austinJournal Article-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.fulltextNo Fulltext-
item.cerifentitytypePublications-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
crisitem.author.deptMedical Oncology-
crisitem.author.deptOlivia Newton-John Cancer Wellness and Research Centre-
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Items in AHRO are protected by copyright, with all rights reserved, unless otherwise indicated.