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

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 profi...

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Main Authors: Frederick L Locke, Stephan A Grupp, Elizabeth J Shpall, Sattva S Neelapu, Michael R Bishop, Marcela V Maus, Jorg Dietrich, Daniel W Lee, Matthew J Frigault, Terry J Fry, Sara Alexander, Jennifer N Brudno, Colleen Callahan, Marco L Davila, Claudia Diamonte, Julie C Fitzgerald, Jennifer L Holter-Chakrabarty, Krishna V Komanduri, Shannon L Maude, Philip L McCarthy, Elena Mead, Tomas G Neilan, Bianca D Santomasso, David T Teachey, Cameron J Turtle, Tom Whitehead
Format: Article
Language:English
Published: BMJ Publishing Group 2020-10-01
Series:Journal for ImmunoTherapy of Cancer
Online Access:https://jitc.bmj.com/content/8/2/e001511.full
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author Frederick L Locke
Stephan A Grupp
Elizabeth J Shpall
Sattva S Neelapu
Michael R Bishop
Marcela V Maus
Jorg Dietrich
Daniel W Lee
Matthew J Frigault
Terry J Fry
Sara Alexander
Jennifer N Brudno
Colleen Callahan
Marco L Davila
Claudia Diamonte
Julie C Fitzgerald
Jennifer L Holter-Chakrabarty
Krishna V Komanduri
Shannon L Maude
Philip L McCarthy
Elena Mead
Tomas G Neilan
Bianca D Santomasso
David T Teachey
Cameron J Turtle
Tom Whitehead
author_facet Frederick L Locke
Stephan A Grupp
Elizabeth J Shpall
Sattva S Neelapu
Michael R Bishop
Marcela V Maus
Jorg Dietrich
Daniel W Lee
Matthew J Frigault
Terry J Fry
Sara Alexander
Jennifer N Brudno
Colleen Callahan
Marco L Davila
Claudia Diamonte
Julie C Fitzgerald
Jennifer L Holter-Chakrabarty
Krishna V Komanduri
Shannon L Maude
Philip L McCarthy
Elena Mead
Tomas G Neilan
Bianca D Santomasso
David T Teachey
Cameron J Turtle
Tom Whitehead
author_sort Frederick L Locke
collection DOAJ
description 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.
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spelling doaj-art-d61d44366994471cbc391339ac6fd8982024-11-09T17:35:08ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262020-10-018210.1136/jitc-2020-001511Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse eventsFrederick L Locke0Stephan A Grupp1Elizabeth J Shpall2Sattva S Neelapu3Michael R Bishop4Marcela V Maus5Jorg Dietrich6Daniel W Lee7Matthew J Frigault8Terry J Fry9Sara Alexander10Jennifer N Brudno11Colleen Callahan12Marco L Davila13Claudia Diamonte14Julie C Fitzgerald15Jennifer L Holter-Chakrabarty16Krishna V Komanduri17Shannon L Maude18Philip L McCarthy19Elena Mead20Tomas G Neilan21Bianca D Santomasso22David T Teachey23Cameron J Turtle24Tom Whitehead2515 Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, Florida, USADepartment of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA22 Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA19 Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA11 The David and Etta Jonas Center for Cellular Therapy, Chicago, Illinois, USACancer Center, Massachusetts General Hospital, Boston, Massachusetts, USANeuro-oncology/Neurology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USADepartment of Pediatrics, University of Virginia, Charlottesville, Virginia, USA2 Department of Medicine, Harvard Medical School, Boston, Massachusetts, USAUniversity of Colorado Denver Children`s Hospital Colorado Research Institute, Aurora, Colorado, USA2 Cancer Center, Massachusetts General Hospital, Boston, Massachusetts, USA4 Surgery Branch, National Cancer Institute, Bethesda, Maryland, USADivision of Oncology and Cancer Immunotherapy Program, The Children`s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA6 Blood and Marrow Transplantation and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, Florida, USA7 Cellular Therapeutics Center, Memorial Sloan Kettering Cancer Center, New York, New York, USA9 Department of Anesthesiology and Critical Care, Children’s Hospital of Philadelphia and University of Pennsylvania, Philadelphia, Pennsylvania, USA12 Department of Hematology/Oncology/Bone Marrow Transplant and Cellular Therapy, The University of Oklahoma Stephenson Cancer Center, Oklahoma City, Oklahoma, USA13 Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida, USA16 Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania, USA17 Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA18 Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA1 Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USADepartment of Neurology, Brain Tumor Center, Memorial Sloan Kettering Cancer Center, New York, NY, USA23 Cancer Center, Children’s Hospital of Philadelphia and University of Pennsylvania, Philadelphia, Pennsylvania, USAFred Hutchinson Cancer Research Center, Seattle, Washington, USA25 Emily Whitehead Foundation, Phillipsburg, Pennsylvania, USAImmune 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.https://jitc.bmj.com/content/8/2/e001511.full
spellingShingle Frederick L Locke
Stephan A Grupp
Elizabeth J Shpall
Sattva S Neelapu
Michael R Bishop
Marcela V Maus
Jorg Dietrich
Daniel W Lee
Matthew J Frigault
Terry J Fry
Sara Alexander
Jennifer N Brudno
Colleen Callahan
Marco L Davila
Claudia Diamonte
Julie C Fitzgerald
Jennifer L Holter-Chakrabarty
Krishna V Komanduri
Shannon L Maude
Philip L McCarthy
Elena Mead
Tomas G Neilan
Bianca D Santomasso
David T Teachey
Cameron J Turtle
Tom Whitehead
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events
Journal for ImmunoTherapy of Cancer
title Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events
title_full Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events
title_fullStr Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events
title_full_unstemmed Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events
title_short Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events
title_sort society for immunotherapy of cancer sitc clinical practice guideline on immune effector cell related adverse events
url https://jitc.bmj.com/content/8/2/e001511.full
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