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

As reported in the Journal of Clinical Oncology by Julie R. Brahmer, MD, of the Johns Hopkins Kimmel Cancer Center, and colleagues, ASCO has released a clinical practice guideline on management of immune-related adverse events in patients receiving immune checkpoint inhibitor therapy. To develop the guideline, ASCO brought together a multidisciplinary, multiorganizational panel of experts in medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, nursing, clinical trials, and advocacy. The expert panel was co-chaired by Dr. Brahmer and John A. Thompson, MD, of the Seattle Cancer Care Alliance, the University of Washington, and Fred Hutchinson Cancer Research Center.

A systematic review of publications from 2000–2017 identified 204 relevant publications, with much of the evidence consisting of systematic reviews of observational data, consensus guidelines, case series, and case reports. As stated by the authors, due to the paucity of high-quality evidence on management of immune-related adverse events, recommendations are based on expert consensus.

The following summarizes/reproduces general recommendations to be followed irrespective of affected organs. The guideline provides detailed recommendations for organ-specific management—ie, skin, gastrointestinal, lung, endocrine, musculoskeletal, renal, nervous system, hematologic, cardiovascular, and ocular immune-related adverse events. All recommendations in the guideline are based on expert consensus, benefits outweigh harms, and moderate strength of recommendation.

General Recommendations

  • Patient and family caregivers should receive timely and up-to-date education about immunotherapies, their mechanism of action, and the clinical profile of possible immune-related adverse events prior to initiating therapy and throughout treatment and survivorship.
  • There should be a high level of suspicion that new symptoms are treatment related.
  • In general, immune checkpoint inhibitor therapy should be continued with close monitoring for grade 1 toxicities, with the exception of some neurologic, hematologic, and cardiac toxicities.
  • Hold immune checkpoint inhibitors for most grade 2 toxicities and consider resuming when symptoms and/or laboratory values revert to grade 1 or less. Corticosteroids (initial dose of 0.5–1 mg/kg/d of prednisone or equivalent) may be administered.
  • Hold immune checkpoint inhibitors for grade 3 toxicities and initiate high-dose corticosteroids (prednisone 1–2 mg/kg/d or methylprednisolone IV 1 to 2 mg/kg/d). Corticosteroids should be tapered over the course of at least 4 to 6 weeks. If symptoms do not improve with 48 to 72 hours of high-dose corticosteroid, infliximab may be offered for some toxicities.
  • When symptoms and/or laboratory values revert to grade 1 or less, rechallenge with immune checkpoint inhibitors may be offered; however, caution is advised, especially in those patients with early-onset immune-related adverse events. Dose adjustments are not recommended.
  • In general, grade 4 toxicities warrant permanent discontinuation of immune checkpoint inhibitors, with the exception of endocrinopathies that have been controlled by hormone replacement.

Additional information is available at and

The corresponding author of the Journal of Clinical Oncology article is ASCO.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.