SITC Publishes Clinical Practice Guideline on Immune Effector Cell-related Adverse Events

    Dec. 18, 2020

    MILWAUKEE – The Society for Immunotherapy of Cancer (SITC), the world’s leading member-driven organization dedicated solely to cancer immunotherapy, is pleased to announce the publication of a clinical practice guideline for the management of cell therapy adverse events. Immune effector cell therapies include the three U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T cell products for treatment of blood-based cancers.

    The Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events,” was published in the Journal for ImmunoTherapy of Cancer (JITC) and is part of the society’s long running Cancer Immunotherapy Guidelines program. The guideline was developed by an expert panel of physicians representing multiple medical specialties, patient advocates, and nurses. It covers risk-assessment, identification and management for the most clinically significant side effects associated with immune effector cell therapies.

    “Immune effector cell therapies, especially the CAR T cell products, have increasingly become an integral component of cancer care for patients with hematologic (blood-based) malignancies,” said Stephan Grupp, MD, PhD, co-chair of the SITC Immune Effector Cell-Related Adverse Events Expert Panel. “It’s crucial for oncologists and hematologists to understand the toxicities that may arise after treatment with these agents, so that they may safely offer these potentially lifesaving therapies to patients.”

    Immune effector cells are made from a patient’s own cells or in some cases from cells taken from a donor, usually from the blood. When these immune effector cells are infused back into a patient, they become “living drugs” that expand and persist in the body to attack cancer cells. This is one reason why immune effector cell therapies can sometimes produce long-lasting disease control, with some patients remaining cancer free for years after treatment. However, the therapies may cause unique side effects which can be similar to severe infections.

    “Clinicians need to feel comfortable identifying the signs and symptoms of common adverse events such as cytokine release syndrome and neurotoxicity so that they can appropriately intervene,” said Marcela Maus, MD, PhD, co-chair of the SITC Immune Effector Cell-Related Adverse Events Expert Panel. “In many cases, the adverse events associated with immune effector cell therapies may be safely managed, but prompt recognition is crucial.”

    The SITC Cancer Immunotherapy Guidelines were developed by leading experts to help hematologists and oncologists determine when and how to best use immunotherapy to treat their patients. The published disease-state specific guidelines provide evidence- and expert consensus-based recommendations on selection of appropriate immunotherapy treatments, toxicity management, biomarkers, and considerations for patient quality of life. SITC has published clinical practice guidelines for acute leukemia, bladder carcinoma, cutaneous melanoma, head and neck squamous cell carcinoma, multiple myeloma, non-small cell lung cancer, prostate cancer and renal cell carcinoma. Additional guidelines in development will cover lymphoma, breast cancer, hepatocellular carcinoma, non-melanoma skin cancer and immune checkpoint inhibitor-related adverse events.

    “Cell therapy is one of the major advances in cancer treatment in the past decade, and it’s reasonable to expect more of these cell therapies to be developed, and to see their use extend beyond very specialized treatment centers. SITC recognized the growing importance and use of cell therapy and therefore developed this new clinical practice guideline to assist physicians with management of the unique side effects,” said SITC President Mario Sznol, MD. “This is the tenth manuscript published in SITC’s Cancer Immunotherapy Guidelines series, a critically important effort to educate physicians and other health care providers, and improve outcomes for cancer patients receiving FDA-approved immunotherapies.”

    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), the Foundation for the Accreditation of Cellular Therapy (FACT) at the University of Nebraska Medical Center, and the Emily Whitehead Foundation 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.

    In addition to the published manuscript, SITC is also offering several different opportunities to help clinicians understand and implement the guidelines into their practice, including the live webinars and on-demand modules hosted on the SITC website. In 2021, SITC will host a live, free webinar during which attendees will be able to learn more about the recommendations included in this clinical practice guideline and ask questions of expert faculty. Registration information will be available in the coming weeks.

    About SITC
    Established in 1984, the Society for Immunotherapy of Cancer (SITC) is a nonprofit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC is comprised of influential basic and translational scientists, practitioners, health care professionals, government leaders and industry professionals around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC aims to one day make the word “cure” a reality for cancer patients everywhere. Learn more about SITC, our educational offerings and other resources at and follow us on Twitter, LinkedIn, Facebook and YouTube.

    About JITC
    Journal for ImmunoTherapy of Cancer (JITC) is the official open access, peer-reviewed online journal of the Society for Immunotherapy of Cancer featuring an impact factor of 10.252. The journal publishes high-quality articles on all aspects of tumor immunology and cancer immunotherapy, on subjects across the basic science-translational-clinical spectrum. JITC publishes original research articles, literature reviews, position papers and practice guidelines, and case reports; invited commentaries may also be commissioned by the journal editors. These articles, freely accessible at, make JITC the leading forum for tumor immunology and cancer immunotherapy research. Follow JITC on Twitter @jitcancer.

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