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

Design and created by Guideline Central in participation with the American Society of Clinical Oncology.

Document Overview

Document Title: Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy

Authoring Society: American Society of Clinical Oncology

Document Publication Date: Nov 1, 2021

Page Last Reviewed/Updated: May 5, 2026

Document Type: Guideline

Country of Publication: United States

Full Text Freely Available: Yes

Full Text Guideline: ascopubs.org/doi/full/10.1200/JCO.21.01440

Source Citation: Schneider BJ, Naidoo J, Santomasso BD, Lacchetti C, Adkins S, Anadkat M, Atkins MB, Brassil KJ, Caterino JM, Chau I, Davies MJ, Ernstoff MS, Fecher L, Ghosh M, Jaiyesimi I, Mammen JS, Naing A, Nastoupil LJ, Phillips T, Porter LD, Reichner CA, Seigel C, Song JM, Spira A, Suarez-Almazor M, Swami U, Thompson JA, Vikas P, Wang Y, Weber JS, Funchain P, Bollin K. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update. J Clin Oncol. 2021 Dec 20;39(36): 4073-4126. doi: 10.1200/JCO.21.0.1440. Epub 2021 Nov 1. Erratum in: J Clin Oncol. 2022 Jan 20;40(3):315. PM ID: 34724392

Supplemental Implementation Resources

Document Scope, Criteria, and Use Cases

Document Objectives: 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.

Scope: Management, Prevention

Diseases/Conditions (MeSH)

D007167 - Immunotherapy

D064420 - Drug-Related Side Effects and Adverse Reactions

D000082082 - Immune Checkpoint Inhibitors

D007167 - Immunotherapy

D064420 - Drug-Related Side Effects and Adverse Reactions

D000082082 - Immune Checkpoint Inhibitors

Keywords: Cancer immunotherapy, ICPis, IRAEs, Immune Related Adverse Events, Keytruda, Opdivo, immune checkpoint inhibitor (ICI)

Target Patient Population: Adult patients with cancer receiving treatment with immune checkpoint blockade inhibitors alone

Target Provider Population: Health care practitioners, including oncologists, other medical subspecialists, emergency medicine, internal and family medicine practitioners, nurses, and pharmacists

Inclusion Criteria: Male, Female, Adolescent, Adult, Child, Older Adult

Health Care Settings: Ambulatory, Emergency Care, Hospital, Outpatient

Intended Users: Community Pharmacist, Health-Systems Pharmacist, Healthcare Business/Administration, Nurse, Nurse Practitioner, Physician, Physician Assistant

Recommendation Development Processes & Methodology

PICO Questions

How should clinicians manage immune-mediated adverse events (AEs) in adult patients with cancer treated with immune checkpoint blockade antibodies?
In addition, the guideline addresses how AEs related to steroid use can be prevented and managed.

Supplemental Methodology Resource: Data Supplement

Number of Source Documents: 288

Literature Search Start Date: Wednesday, August 30, 2017

Literature Search End Date: Tuesday, March 2, 2021

Includes peer/external review process?: Yes

Includes public comment process?: Yes

Methodologist involvement?: Yes

Patient involvement?: Yes

Includes multi-disciplinary group?: Yes

Includes systematic review?: Yes

Grades quality of strength of evidence?: Yes

Grades quality of strength of recommendation?: Yes

Discloses funding source?: Yes

Discloses conflicts of interest?: Yes

Includes benefits/harms analysis with recommendations?: Yes

Identifies study selection process?: Yes

Identifies study selection criteria?: Yes

Identifies methods used to evaluate and analyze the evidence?: Yes

Identifies key questions addressed by the systematic review?: Yes

Identifies search strategy?: Yes