Journal Article

Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events

Shpall, Elizabeth J, Dietrich, Jorg, Locke, Frederick L, Santomasso, Bianca D, Lee, Daniel W, Komanduri, Krishna V, Bishop, Michael R, Mead, Elena, Frigault, Matthew J, Maus, Marcela V, Turtle, Cameron J, Alexander, Sara, Neilan, Tomas G, Maude, Shannon L, Neelapu, Sattva S, McCarthy, Philip L, Callahan, Colleen, Whitehead, Tom, Holter-Chakrabarty, Jennifer L, Diamonte, Claudia, Teachey, David T, Grupp, Stephan A, Brudno, Jennifer N, Davila, Marco L, Fitzgerald, Julie C, Fry, Terry J

2020

Overview

Immune effector cell (IEC) therapies offer durable and sustained remissions in significant numbers of patients with hematological cancers. While these unique immunotherapies have improved outcomes for pediatric and adult patients in a number of disease states, as ‘living drugs,’ their toxicity profiles, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), differ markedly from conventional cancer therapeutics. At the time of article preparation, the US Food and Drug Administration (FDA) has approved tisagenlecleucel, axicabtagene ciloleucel, and brexucabtagene autoleucel, all of which are IEC therapies based on genetically modified T cells engineered to express chimeric antigen receptors (CARs), and additional products are expected to reach marketing authorization soon and to enter clinical development in due course. As IEC therapies, especially CAR T cell therapies, enter more widespread clinical use, there is a need for clear, cohesive recommendations on toxicity management, motivating the Society for Immunotherapy of Cancer (SITC) to convene an expert panel to develop a clinical practice guideline. The panel discussed the recognition and management of common toxicities in the context of IEC treatment, including baseline laboratory parameters for monitoring, timing to onset, and pharmacological interventions, ultimately forming evidence- and consensus-based recommendations to assist medical professionals in decision-making and to improve outcomes for patients.

• Publisher: BMJ Publishing Group Ltd,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Accreditation / adoptive / Antigens / Blood cancer / Cancer / Cancer therapies / cell engineering / chimeric antigen / Clinical medicine / Clinical practice guidelines / Clinical trials / Drug-Related Side Effects and Adverse Reactions - immunology / Evidence-based medicine / FDA approval / Guidelines as Topic / hematological neoplasms / Hematology / Humans / Immunologic Factors - immunology / Immunotherapy / Immunotherapy - methods / Lymphocytes / Lymphoma / Medicine / Non-pharmacological intervention / Patients / Position and Guidelines / Position article and guidelines / receptors / Retrospective Studies / Young adults