SITC Immune Checkpoint Inhibitor-related Adverse Events Guideline

SITC's Cancer Immunotherapy Guidelines program is a collection of clinical practice guidelines (CPGs) developed by multi-disciplinary panels of experts who draw from their own practical experience as well as evidence in the published literature and clinical trial data to develop evidence- and consensus-based recommendations. SITC uses as a model the Institute of Medicine's 2011 "Standards for Developing Trustworthy Clinical Practice Guidelines" to ensure recommendations are unbiased, transparent, and balanced. 

This guidelines addresses some of the most commonly reported irAEs that arise during treatment with ICIs, including gastrointestinal, musculoskeletal, and dermatologic toxicities, among other key considerations for oncologists treating their patients with these agents.

A companion guideline on the management of immune effector cell-related adverse events published on December 16, 2020 in the Journal for ImmunoTherapy of Cancer (JITC)

Published Guideline 

READ GUIDELINE

"Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events" originally published in Journal for Immunotherapy of Cancer (JITC) on June 25, 2021 and has since been updated.

SITC continuously evaluates the field for practice-changing data and new FDA approvals. The Immune Checkpoint Inhibitor-related Adverse Events Guideline Expert Panel guides the development of updates within this CPG. Updates appear in the SITC CPG Mobile App and as annotated text accompanying the original publication in JITC.

Highlights of Updated Content: 

• Updated recommendation based on new data demonstrating increased risk for MACE in patients receiving ICIs plus VEGF TKIs
• Updated recommendation to add guidance for the management of patients with ICI-related hypophysitis and severe compressive symptoms
• Additional immune checkpoint inhibitor-related adverse event management algorithms, developed from the Expert Panel recommendations, are available in SITC’s CPG Mobile App, including:
  • ICI General Toxicity Management Algorithm
  • ICI Myositis, Myocarditis, and Myasthenia Gravis Overlapping Workup Table
  • ICI GI Toxicity Workup Algorithm
  • ICI Diarrhea and Colitis Management Algorithm
  • ICI Hepatitis Management Algorithm
  • ICI Myositis Management Algorithm
  • ICI Hypothyroidism, Hyperthyroidism, and Hypophysitis Workup and Management Algorithm
  • ICI Myasthenia Gravis Management Algorithm
  • ICI Pneumonitis Management Algorithm
  • ICI Myocarditis Management Algorithm
  • ICI Hematologic Toxicities Workup Table

SITC is a proponent of collaboration and harmonization of efforts between like-minded organizations whenever possible. SITC wishes to thank the American Society for Transplantation and Cellular Therapy (ASTCT) for providing a representative to serve on SITC’s Immune Checkpoint Inhibitor-related Adverse Events Expert Panel to aid in the development of this clinical practice guideline.

Download the app for quick access to the immune checkpoint inhibitor-related adverse events CPG with interactive tools and companion education resources.

Guideline Education

SITC is pleased to offer companion education resources in support of the published Immune Checkpoint Inhibitor-related Adverse Events CPG. These activities feature faculty comprised of the guideline expert panel and are designed to provide a deeper understanding of the recommendations in the SITC guidelines and how to apply them in various clinical scenarios. The education available features one-hour webinars that take a deeper look at the guideline recommendations as well as mini-modules on a specific topic within the guideline content. Below is a list of the available educational resources for this CPG, available free and on-demand. 

Webinars:

• Immune Checkpoint Inhibitor-related Adverse Events CPG Overview
  • Leading experts in cancer immunotherapy present an overview of the publication "Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events." 

• Practical Management Pearls for Immune Checkpoint Inhibitor-related Adverse Events
  • This one hour on-demand webinar features members of the guideline Expert Panel. These faculty members discuss how to appraise and classify organ-specific considerations for immunotherapy agents and toxicities, identify and manage clinically significant uncommon toxicities, and determine optimal sequencing of immunotherapies in relapsed and/or refractory disease.

• Case Studies in Immune Checkpoint Inhibitor-related Adverse Events- SITC CPG Webinar
  • This one hour on-demand webinar features members of the guideline Expert Panel. These faculty members discuss case studies that illustrate execution of SITC guideline recommendations, as well as discussion on difficult topics related to case management. 

Mini-Modules:

• Autoimmune Disease
  • Features a case presentation of a patient with newly diagnosed metastatic non-squamous, non-small cell lung cancer who reports prior lupus. Includes essential considerations for treating patients with pre-existing autoimmunity. 

• Special Patient Populations
  • Features a discussion on immune-related adverse events in patients typically considered high-risk, specifically those with pre-exisiting autoimmune disease and transplant recipients.  Considerations for weighing risks versus benefits of checkpoint blockade in these patients are presented.

• Vaccines and Chronic irAEs
  • Discusses data on antibody responses after vaccination in patients treated with immunosuppressive agents and offers essential considerations for the management of chronic irAEs.