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

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 .

Safety of Immune Checkpoint Inhibitor Resumption after Interruption for Immune-Related Adverse Events, a Narrative Review

“…Several general or organ-specific recommendations have been published to help to manage irAEs [ 17 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 ]. Generally, ICI should be continued with close monitoring for grade 1 irAEs, except for some neurologic, hematologic, and cardiac toxicities.…”

“…ICI dose adjustments are not recommended. Finally, the permanent discontinuation of ICI is recommended for grade 4 irAEs (except for endocrinopathies if controlled by hormone replacement) [ 17 ]. However, given the relatively limited knowledge of irAEs and the lack of robust available data (mostly heterogeneous, retrospective, and small-scale studies), these recommendations are currently based only on expert opinion with a low level of evidence (C).…”

“…Several recommendations have been published to help to manage irAEs [ 16 , 17 ]. Globally, grade 2/3 irAEs require corticosteroids and temporary ICI discontinuation, with the possibility of resuming when symptoms revert to grade ≤1, although permanent ICI discontinuation is recommended for grade 4 irAEs (except for endocrinopathies if controlled by hormone replacement).…”

Immune checkpoint inhibitors: immune-related adverse events, healthcare utilization, and costs among commercial and Medicare Advantage patients

“…There is still much to understand about irAEs and multiple societal guidelines for irAE and ICI usage such as ASCO, ESMO, and MASCC are available to guide clinicians [10][11][12]. For example, it not clear who is at highest risk for these toxicities, or why severe toxicities happen in certain populations.…”

Thyroid dysfunction induced by immune checkpoint inhibitors and tumor progression in neoadjuvant therapy for Non-Small Cell Lung Cancer: a case report and literature review

“…The clinical management of thyroid injury caused by ICIs should be determined by whether clinical symptoms occur, the type of thyroid dysfunction and the grade of thyroid dysfunction in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. [32]. The therapy regimens should be jointly formulated by endocrinologists and oncologists.…”