Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Guideline
. 2021 Dec 20;39(36):4073-4126.
doi: 10.1200/JCO.21.01440. Epub 2021 Nov 1.

Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update

Bryan J Schneider  1 , Jarushka Naidoo  2   3 , Bianca D Santomasso  4 , Christina Lacchetti  5 , Sherry Adkins  6 , Milan Anadkat  7 , Michael B Atkins  8 , Kelly J Brassil  6 , Jeffrey M Caterino  9 , Ian Chau  10 , Marianne J Davies  11 , Marc S Ernstoff  12 , Leslie Fecher  1 , Monalisa Ghosh  13 , Ishmael Jaiyesimi  14 , Jennifer S Mammen  15 , Aung Naing  6 , Loretta J Nastoupil  6 , Tanyanika Phillips  16 , Laura D Porter  17 , Cristina A Reichner  18 , Carole Seigel  19 , Jung-Min Song  20 , Alexander Spira  21 , Maria Suarez-Almazor  6 , Umang Swami  22 , John A Thompson  23 , Praveen Vikas  24 , Yinghong Wang  6 , Jeffrey S Weber  25 , Pauline Funchain  20 , Kathryn Bollin  26
Affiliations
Guideline

Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update

Bryan J Schneider et al. J Clin Oncol. .

Erratum in

  • Erratum.
    [No authors listed] [No authors listed] J Clin Oncol. 2022 Jan 20;40(3):315. doi: 10.1200/JCO.21.02786. J Clin Oncol. 2022. PMID: 35030312 No abstract available.

Abstract

Purpose: To increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events (irAEs) in patients treated with immune checkpoint inhibitor (ICPi) therapy.

Methods: A multidisciplinary panel of medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, neurology, hematology, emergency medicine, nursing, trialists, and advocacy experts was convened to update the guideline. Guideline development involved a systematic literature review and an informal consensus process. The systematic review focused on evidence published from 2017 through 2021.

Results: A total of 175 studies met the eligibility criteria of the systematic review and were pertinent to the development of the recommendations. Because of the paucity of high-quality evidence, recommendations are based on expert consensus.

Recommendations: Recommendations for specific organ system-based toxicity diagnosis and management are presented. While management varies according to the organ system affected, in general, ICPi therapy should be continued with close monitoring for grade 1 toxicities, except for some neurologic, hematologic, and cardiac toxicities. ICPi therapy may be suspended for most grade 2 toxicities, with consideration of resuming when symptoms revert ≤ grade 1. Corticosteroids may be administered. Grade 3 toxicities generally warrant suspension of ICPis and the initiation of high-dose corticosteroids. Corticosteroids should be tapered over the course of at least 4-6 weeks. Some refractory cases may require other immunosuppressive therapy. In general, permanent discontinuation of ICPis is recommended with grade 4 toxicities, except for endocrinopathies that have been controlled by hormone replacement. Additional information is available at www.asco.org/supportive-care-guidelines.

PubMed Disclaimer

Conflict of interest statement

Reprint Requests: Bryan J. SchneiderResearch Funding: Merck Jarushka NaidooHonoraria: Bristol Myers Squibb, AstraZeneca/MedImmune, Merck, Daiichi Sankyo/Lilly, TakedaConsulting or Advisory Role: Bristol Myers Squibb, AstraZeneca/MedImmune, Roche/Genentech, Daiichi Sankyo/Lilly, Takeda, Pfizer, Kaleido BiosciencesResearch Funding: Merck, AstraZeneca, Roche/GenentechTravel, Accommodations, Expenses: Bristol Myers Squibb, AstraZeneca/MedImmune Bianca D. SantomassoConsulting or Advisory Role: Celgene, Janssen, Legend Biotech, Incyte, In8BioResearch Funding: ADC Therapeutics Sherry AdkinsConsulting or Advisory Role: CelgeneTravel, Accommodations, Expenses: Celgene Milan AnadkatStock and Other Ownership Interests: Anthem, Humana, Perrigo, Walgreens Boots Alliance, Abbott Laboratories, Merck, AbbVie, Amgen, Bristol Myers Squibb, Celgene, CVS Health, Gilead Sciences, Incyte, Johnson & Johnson, Lilly, Medtronic, Mylan, Pfizer, Procter & Gamble, United Health Group, Regeneron, Roche, Moderna Therapeutics (I), Dexcom, Quest DiagnosticsHonoraria: Adgero Biopharmaceuticals, Boehringer Ingelheim, Novocure, AbbVie, UCB, InnovadermConsulting or Advisory Role: Adgero Biopharmaceuticals, Boehringer Ingelheim, Novocure, Kintara TherapeuticsResearch Funding: AnaptysBio, Boehringer Ingelheim, Biogen, InflamRx, Lutris, Novartis, OnQuality Pharmaceuticals, Veloce Pharmaceuticals, XBiotech, UCB, AbbVie, Lilly Michael B. AtkinsStock and Other Ownership Interests: Werewolf Pharma, PyxisConsulting or Advisory Role: Genentech, Novartis, Bristol Myers Squibb, Merck, Exelixis, Eisai, Agenus, Arrowhead Pharmaceuticals, Werewolf Pharma, Surface Oncology, Iovance Biotherapeutics, Pyxis, Pneuma Respiratory, Leads Biolabs, Fathom Biotechnology, AVEO, Cota Healthcare, Neoleukin Therapeutics, Adagene, Idera, Ellipses Pharma, AstraZeneca, PACT Pharma, Seattle Genetics, Pfizer, ScholarRock, Asher Bio, Calithera Biosciences, Takeda, SanofiResearch Funding: Bristol Myers Squibb Kelly J. BrassilEmployment: Pack HealthHonoraria: Oncology Nursing Society, WebMD, M Consulting, i3 HealthResearch Funding: AbbVie, Daiichi Sankyo, Astellas Pharma, Genentech, Sanofi, GlaxoSmithKlineTravel, Accommodations, Expenses: Pack Health Jeffrey M. CaterinoStock and Other Ownership Interests: Motive Medical IntelligenceConsulting or Advisory Role: Wellstat TherapeuticsResearch Funding: Stago, Entegrion, JDP Therapeutics, AstraZeneca Ian ChauHonoraria: Lilly, Eisai, ServierConsulting or Advisory Role: Lilly, Bristol Myers Squibb, MSD Oncology, Merck Serono, Roche/Genentech, AstraZeneca, Pierre Fabre, Boehringer Ingelheim, Incyte, OncXerna Therapeutics, Astellas Pharma, GlaxoSmithKline, Eisai, SotioResearch Funding: Janssen-Cilag, LillyTravel, Accommodations, Expenses: MSD, Merck Serono, Lilly, Bristol Myers Squibb, Eisai Marianne J. DaviesSpeakers' Bureau: AstraZeneca, Genentech/Roche, Merck, Bristol Myers Squibb Marc S. ErnstoffStock and Other Ownership Interests: GE Healthcare, Bristol Myers SquibbResearch Funding: Alkermes, EMD SeronoTravel, Accommodations, Expenses: ImmuNext, AlkermesOther Relationship: Bristol Myers Squibb Leslie FecherConsulting or Advisory Role: Via Oncology, Hoosier Cancer Research Network, ElsevierResearch Funding: Merck, Incyte, Bristol Myers Squibb, Pfizer/EMD Serono, Array BioPharma, Kartos TherapeuticsOther Relationship: Array BioPharmaUncompensated Relationships: NCCN, American Association of Clinical Endocrinology, ASCO Monalisa GhoshResearch Funding: Novartis, Celgene Jennifer S. MammenStock and Other Ownership Interests: Johnson & Johnson, Bristol-Myers SquibbConsulting or Advisory Role: Five Prime Therapeutics Aung NaingConsulting or Advisory Role: Novartis, CytomX Therapeutics, OncoSec, STCube Pharmaceuticals Inc, Kymab, Takeda (I), CSL Behring (I), Horizon Pharma (I), Genome & CompanyResearch Funding: NCI, EMD Serono, MedImmune, Atterocor, Amplimmune, ARMO BioSciences, Karyopharm Therapeutics, Incyte, Novartis, Regeneron, Merck, Bristol Myers Squibb, Pfizer, CytomX Therapeutics, Neon Therapeutics, Calithera Biosciences, TopAlliance BioSciences Inc, Healios, Lilly, Kymap, PsiOxus Therapeutics, Immune Deficiency Foundation (I), Arcus Biosciences, NeoImmuneTech, ImmuneOncia, Surface Oncology, Baxalta (I), Jeffrey Modell Foundation (I), Chao Physician-Scientist Awards (I)Travel, Accommodations, Expenses: ARMO BioSciences Loretta J. NastoupilHonoraria: Celgene, Gilead Sciences, Novartis, Bayer, Janssen Oncology, Pfizer, Gamida Cell, TG Therapeutics, Bristol Myers Squibb, ADC Therapeutics, Morphosys, Epizyme, GenmabResearch Funding: TG Therapeutics, Janssen Biotech, Celgene, Genentech/Roche, LAM Therapeutics, Epizyme, Novartis, IgM Biosciences, Caribou Biosciences, Gilead Sciences, Allogene Therapeutics, Takeda Tanyanika PhillipsTravel, Accommodations, Expenses: City of Hope Alexander SpiraLeadership: NEXT Oncology VirginiaStock and Other Ownership Interests: LillyHonoraria: CytomX Therapeutics, AstraZeneca/MedImmune, Merck, Takeda, Amgen, Janssen Oncology, Novartis, Bristol Myers Squibb, BayerConsulting or Advisory Role: Array BioPharma, Incyte, Amgen, Novartis, AstraZeneca/MedImmune, Mirati Therapeutics, Gritstone Oncology, Jazz Pharmaceuticals, Merck, Bristol Myers Squibb, Takeda, Janssen Research & DevelopmentResearch Funding: Roche, AstraZeneca, Boehringer Ingelheim, Astellas Pharma, MedImmune, Novartis, Newlink Genetics, Incyte, AbbVie, Ignyta, LAM Therapeutics, Trovagene, Takeda, Macrogenics, CytomX Therapeutics, Astex Pharmaceuticals, Bristol Myers Squibb, Loxo, Arch Therapeutics, Gritstone Oncology, Plexxikon, Amgen, Loxo, Daiichi Sankyo, ADC Therapeutics, Janssen Oncology, Mirati Therapeutics, Rubius Therapeutics Maria Suarez-AlmazorConsulting or Advisory Role: Agile Therapeutics, AMAG Pharmaceuticals, AbbVie/Genentech, Avenue Therapeutics, Gilead Sciences, ChemoCentryx, Celgene/Bristol Myers Squibb Umang SwamiConsulting or Advisory Role: Seattle Genetics John A. ThompsonConsulting or Advisory Role: Calithera Biosciences, Clinical Care Options/NCCN, BJ Bioscience, Alpine Immune Sciences, Neoleukin Therapeutics, Academy for Continued Healthcare Learning, Meeting Sites Pro, Regeneron, AVEO, Bristol Myers SquibbResearch Funding: Roche, Pfizer, Agensys, Five Prime Therapeutics, Trillium Therapeutics, Merck, Novartis, Xencor, Incyte Praveen VikasStock and Other Ownership Interests: Moderna Therapeutics, NovavaxResearch Funding: Sanofi Yinghong WangConsulting or Advisory Role: Tillotts Pharma, Azurrx Pharma Jeffrey S. WeberStock and Other Ownership Interests: CytomX Therapeutics, Biond, Protean Biodiagnostics, NeximmuneHonoraria: Bristol Myers Squibb, Merck, Genentech, AstraZeneca, Daiichi Sankyo, GlaxoSmithKline, Amgen, Roche, Celldex, CytomX Therapeutics, Novartis, Sellas Life Sciences, WindMIL, Takeda, Moderna Therapeutics, Jounce Therapeutics, Kirin Pharmaceuticals, Regeneron, Idera, OncosecConsulting or Advisory Role: Celldex, Bristol Myers Squibb, Merck, Genentech, Roche, Amgen, AstraZeneca, GlaxoSmithKline, Daiichi Sankyo, CytomX Therapeutics, Novartis, Sellas Life Sciences, WindMIL, Jounce Therapeutics, Moderna Therapeutics, Kirin Pharmaceuticals, Protean Biodiagnostics, Idera, OncosecResearch Funding: Bristol Myers Squibb, Merck, GlaxoSmithKline, Genentech, Astellas Pharma, Incyte, Roche, Novartis, NextCure, Moderna TherapeuticsPatents, Royalties, Other Intellectual Property: Named on a patent submitted by Moffitt Cancer Center for an IPILIMUMAB biomarker, named on a patent for 41BB induced TIL by Moffitt Cancer CenterTravel, Accommodations, Expenses: Bristol Myers Squibb, GlaxoSmithKline, Roche, Celldex, Amgen, Merck, AstraZeneca, Genentech, Novartis Pauline FunchainConsulting or Advisory Role: EisaiResearch Funding: Pfizer, Bristol Myers Squibb, Taiho OncologyNo other potential conflicts of interest were reported.

Publication types

MeSH terms

Substances

LinkOut - more resources