1. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events
- Author
-
Matthew J. Frigault, Philip L. McCarthy, Jorg Dietrich, Shannon L. Maude, David T. Teachey, Stephan A. Grupp, Tom Whitehead, Sara Alexander, Sattva S. Neelapu, Terry J. Fry, Tomas G. Neilan, Marco L. Davila, Elena Mead, Jennifer N. Brudno, Jennifer Holter-Chakrabarty, Claudia Diamonte, Frederick L. Locke, Daniel W. Lee, Bianca Santomasso, Elizabeth J. Shpall, Julie C. Fitzgerald, Krishna V. Komanduri, Marcela V. Maus, Colleen Callahan, Michael R. Bishop, and Cameron J. Turtle
- Subjects
0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_treatment ,receptors ,Disease ,0302 clinical medicine ,Immunology and Allergy ,RC254-282 ,Cancer ,Pediatric ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Cytokine release syndrome ,5.1 Pharmaceuticals ,030220 oncology & carcinogenesis ,Molecular Medicine ,Immunotherapy ,immunotherapy ,Patient Safety ,Development of treatments and therapeutic interventions ,Biotechnology ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,Immunology ,Context (language use) ,Guidelines as Topic ,cell engineering ,adoptive ,Vaccine Related ,03 medical and health sciences ,Clinical Research ,Position Article and Guidelines ,Internal medicine ,medicine ,Humans ,Immunologic Factors ,Adverse effect ,Retrospective Studies ,Pharmacology ,business.industry ,Guideline ,medicine.disease ,Chimeric antigen receptor ,030104 developmental biology ,hematological neoplasms ,chimeric antigen ,Immunization ,business - Abstract
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.
- Published
- 2020