SITC Immune Effector Cell-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 the recommendations are unbiased, transparent and balanced will aid oncologists in effective clinical decision-making concerning patient selection, toxicity management, response evaluation, and the sequencing or combination of therapies, among other topics.

As “living drugs,” the adverse events associated with immune effector cell (IEC) therapy differ markedly from those seen with other anti-cancer regimens. Although IEC-related adverse events are generally manageable with proper supportive care, the toxicities that do occur may have more rapid onset and can progress to life-threatening complications. Therefore, timely recognition and appropriate management of these toxicities are vital for safe use of IEC.

To provide expert guidance to practicing clinicians using IEC therapies and ensure the best outcomes for patients, the SITC established the Immune Effector Cell-related Adverse Expert Panel that included expert perspectives from physicians, nurses, patients, and patient advocates. The Expert Panel is currently developing recommendations for addressing some of the most commonly reported toxicities during treatment with FDA-approved CAR T cell therapies as well as other emerging IEC therapies, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and persistent cytopenias and resultant infections, among other key considerations for oncologists treating their patients with these agents. A companion guideline on the management of immune checkpoint inhibitor-related adverse events published on June 25, 2021 in the Journal for ImmunoTherapy of Cancer (JITC).

Published Guideline

Published December 16, 2020 in the Journal for ImmunoTherapy of Cancer (JITC) as "Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events"

SITC is a proponent for collaboration and harmonization of efforts between like-minded organizations whenever possible. SITC wishes to thank the American Society of Hematology (ASH), the American Society for Transplantation and Cellular Therapy (ASTCT) and the Foundation for the Accreditation of Cellular Therapy (FACT) at the University of Nebraska Medical Center for providing representatives to serve on SITC’s Immune Effector Cell-related Adverse Events Expert Panel to aid in the development of this clinical practice guideline.

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Webinar Series

SITC is pleased to offer companion educational resources in support of the published Immune Effector Cell-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 educational available features both webinars which are a longer-format recording that takes a deeper look at the guideline recommendations as well as mini-modules which are brief videos 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 Effector Cell-related Adverse Events- SITC CPG Webinar
- Leading experts in cancer immunotherapy presented an overview of the publication "Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events" during a live webinar.

Practical Management Pearls for Immune Effector Cell-related Adverse Events- SITC CPG Webinar
- This advanced webinar explains 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 Effector Cell-related Adverse Events- SITC CPG Webinar
- This high-level webinar will include case studies that illustrate execution of guideline recommendations, as well as discussion on difficult topics related to case management, as outlined in the Immune Effector Cell-related Adverse Events CPG.

Mini-Modules:

CRS and HLH
- A thorough explanation of the pathophisiology of Cytokine Relase Syndrome from Sattva S. Neelapu, MD - MD Anderson Cancer Center, begins this module. Practical pearls on Cytokine Release Syndrom risk factors and a discussion of overlapping pathology with hemophagocytic lymphohistiocytosis (HLH) are also offered.
ICANS
- This module includes a description of the risk factors and recommended monitoring for immune effector cell associated neurotoxicity syndrome from Jorg Dietrich, MD, PhD - Massachusetts General Hospital. Learners will also be provided with recommendations on management of neurotoxicity.
Product-specific Toxicity
- In this module, Michael R. Bishop, MD - University of Chicago, exlains the differential time to onset and severity of adverse events associated with specific CAR T cell products. The product-specific toxicity profiles inform recommendations for patient management.

SITC Immune Effector Cell-related Adverse Events Guideline

Published Guideline

Webinar Series

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