Immune Effector Cell-Related Adverse Events Guideline

SITC Cancer Immunotherapy Guidelines are 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 and 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 is also in development.

SITC Immune Effector Cell-Related Adverse Events Guideline Expert Panel

Members

Sara Alexander, R.N., MS, CCNS — Massachusetts General Hospital

Michael R. Bishop, MD — The University of Chicago

Jennifer N. Brudno, MD — National Cancer Institute

Colleen Callahan, RN, MSN, CRNP — Children’s Hospital of Philadelphia

Marco L. Davila, MD, PhD — Moffitt Cancer Center

Claudia Diamonte, RN — Memorial Sloan Kettering Cancer Center

Jorg Dietrich, MD, PhD — Massachusetts General Hospital

Julie C. Fitzgerald, MD, PhD — Children’s Hospital of Philadelphia and University of Pennsylvania

Matthew J. Frigault, MD, MSc — Massachusetts General Hospital

Terry J. Fry, MD — Children's Hospital Colorado and University of Colorado Anschutz School of Medicine

Jennifer L. Holter-Chakrabarty, MD — University of Oklahoma, Stephenson Cancer Center (ASH Representative)

Krishna V. Komanduri, MD — University of Miami Health System

Daniel W. Lee, MD — University of Virginia Cancer Center

Frederick L. Locke, MD — Moffitt Cancer Center (ASTCT Representative)

Shannon L. Maude, MD, PhD — Children’s Hospital of Philadelphia and University of Pennsylvania

Philip L. McCarthy, MD — Roswell Park Comprehensive Cancer Center

Elena Mead, MD — Memorial Sloan Kettering Cancer Center

Sattva S. Neelapu, MD — The University of Texas MD Anderson Cancer Center

Tomas G. Neilan, MD, MPH — Massachusetts General Hospitall

Bianca D. Santomasso, MD, PhD — Memorial Sloan Kettering Cancer Center

Elizabeth Shpall, MD — The University of Texas MD Anderson Cancer Center (FACT representative)

David T. Teachey, MD — Children’s Hospital of Philadelphia and University of Pennsylvania

Cameron J. Turtle, MBBS, PhD, FRACP — Fred Hutchinson Cancer Research Center, University of Washington

Tom Whitehead — Emily Whitehead Foundation (Patient Advocate)

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.