Clinical guideline

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

JCO · 2021
Schneider BJ, Naidoo J, Santomasso BD, Lacchetti C, Adkins S, Anadkat M, et al. JCO. 2021. 39:4073-4126
Study type
Clinical guideline
Study name
ASCO irAE Guideline 2021
Design
Clinical practice guideline (update) based on a systematic literature review and an informal consensus process in a multidisciplinary panel
Source
JCO · 2021

In plain words

Immunotherapy medicines (immune checkpoint inhibitors) can cause the immune system to attack healthy organs as well. This guideline explains how doctors, depending on how severe the side effect is and which organ is affected, should continue or stop treatment or control the side effect with medicines such as corticosteroids. Tell your care team quickly about any new symptom during immunotherapy, and do not stop the medicine or lower the corticosteroid dose without talking to your doctor.

Key guideline recommendations

  1. For grade 1 toxicities, ICPi therapy should continue with close monitoring, except for some neurological, haematological and cardiac toxicities.

    Expert consensus
  2. ICPi therapy may be held for most grade 2 toxicities, with resumption considered when symptoms revert to grade 1 or less. Corticosteroids may be given.

    Expert consensus
  3. Grade 3 toxicities generally warrant holding ICPis and starting high-dose corticosteroids.

    Expert consensus
  4. Corticosteroids should be tapered over at least 4 to 6 weeks. Some refractory cases may require other immunosuppressive therapy.

    Expert consensus
  5. For grade 4 toxicities, permanent discontinuation of ICPis is generally recommended, except for endocrinopathies controlled with hormone replacement.

    Expert consensus

Study population

Patients treated with immune checkpoint inhibitors (ICPis) who develop immune-related adverse events (irAEs).

Endpoints

This guideline has no trial endpoint. Its aim is to increase awareness and provide strategies and guidance on the recommended management of irAEs in patients treated with ICPis.

Safety and side effects

This guideline focuses on the management of immune-related adverse events. Recommendations are given by toxicity grade and organ system involved; details of each adverse event are in the full guideline.

Clinical significance and place in guidelines

This guideline provides a practical framework for managing irAEs by toxicity grade: continue the ICPi with monitoring at grade 1, possibly hold at grade 2, hold and start high-dose corticosteroids at grade 3, and discontinue permanently at grade 4 (except endocrinopathies controlled with hormone replacement). The recommendations rest on expert consensus rather than high-quality evidence. Their adoption in other guidelines and local protocols should be checked separately.

Limitations

Because of a lack of high-quality evidence, the recommendations are based on expert consensus. The systematic review focused on evidence published from 2017 to 2021 and included 175 studies.

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.