{
  "abstract": "Immune checkpoint inhibitors (ICIs) are an important class of cancer treatment. Endocrine immune-related adverse events (E-irAEs) account for a significant proportion of irAEs in ICI-treated patients. Diagnosing E-irAEs accurately and timely can be challenging in the absence of clear categorization and standardization across oncology, endocrinology and other specialties. While existing guidelines provide some broad directions to diagnosis and management, they lack clarity on irAE-specific symptom evaluation and work-up, as well as assessment of severity. These limitations can then impact triage, time-sensitive management and care escalation to specialists such as oncoendocrinologists. The objective of this study was to develop consensus-based statements on disease definitions for E-irAEs.A core working group of endocrinologists with expertise in the oncoendocrinology field drafted a survey with statements outlining the general approach to E-irAEs, disease definition and management approach of six specific diagnoses: ir-thyroiditis thyrotoxic phase, ir-thyroiditis hypothyroidism, ir-Graves’ disease, ir-hypophysitis, ir-adrenalitis and ir-type 1 diabetes mellitus. Severity grading tables were drafted for three disease categories—“thyroid”, “pituitary and adrenal”, and “diabetes mellitus”. A two-round modified Delphi process, using the RAND/University of California Los Angeles (RAND/UCLA) Appropriateness Method, was employed. In this process, a 25-member voting panel consisting of endocrinologists, oncologists and other specialists and healthcare providers with experience in management of ICI-treated patients and irAEs was recruited. The panel rated anonymously on usability, accuracy, appropriateness or agreement of 41 items on a 9-point scale in Survey 1, after which a meeting was convened. Statements were modified based on voting results from Survey 1 and Meeting 1, and the process was repeated in Survey 2 and Meeting 2. At the end of this process, consensus was achieved for all statements.Our study findings address the gap in standardized nomenclature, clinical, laboratory and radiological evaluations, and management principles of E-irAEs. With consensus achieved from a panel of experts from a variety of disciplines, we anticipate that the statements can form the basis for standardization of the diagnostic process and improvement of patient care.",
  "authors": [
    {
      "affiliations": [
        "Department of Endocrinology, Singapore General Hospital, Singapore"
      ],
      "name": "Ling Zhu"
    },
    {
      "affiliations": [
        "Memorial Sloan Kettering Cancer Center, New York, New York, USA"
      ],
      "name": "Yee-Ming M Cheung"
    },
    {
      "affiliations": [
        "Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Cherie Chiang"
    },
    {
      "affiliations": [
        "Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Emily J Gallagher"
    },
    {
      "affiliations": [
        "Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, USA"
      ],
      "name": "Ole-Petter R Hamnvik"
    },
    {
      "affiliations": [
        "Division of Endocrinology, Diabetes and Metabolism, Johns Hopkins Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Jennifer Mammen"
    },
    {
      "affiliations": [
        "Medicine, Endocrinology, UCSF, San Francisco, California, USA"
      ],
      "name": "Zoe Quandt"
    },
    {
      "affiliations": [
        "Project Data Sphere LLC, Cary, North Carolina, USA"
      ],
      "name": "Renisha Jones"
    },
    {
      "affiliations": [
        "Project Data Sphere LLC, Morrisville, North Carolina, USA"
      ],
      "name": "Jon McDunn"
    },
    {
      "affiliations": [
        "Division of Endocrinology, Metabolism and Lipid Research, Washington University in St Louis School of Medicine, St Louis, Missouri, USA"
      ],
      "name": "Huda Al-Bahadili"
    },
    {
      "affiliations": [
        "Division of Endocrinology and Diabetes, USC Keck School of Medicine, Los Angeles, California, USA"
      ],
      "name": "Trevor Angell"
    },
    {
      "affiliations": [
        "Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA"
      ],
      "name": "Irina Bancos"
    },
    {
      "affiliations": [
        "Stanford University School of Medicine, Stanford, California, USA"
      ],
      "name": "Allison Betof Warner"
    },
    {
      "affiliations": [
        "Duke Cancer Institute, Durham, North Carolina, USA"
      ],
      "name": "Susan Blackwell"
    },
    {
      "affiliations": [
        "Department of Rheumatologic and Immunologic Disease, Cleveland Clinic, Cleveland, Ohio, USA"
      ],
      "name": "Cassandra Calabrese"
    },
    {
      "affiliations": [
        "The University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA"
      ],
      "name": "Tracey A Cho"
    },
    {
      "affiliations": [
        "Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts, USA"
      ],
      "name": "Michael Dougan"
    },
    {
      "affiliations": [
        "Johns Hopkins Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Michelle Ferreira"
    },
    {
      "affiliations": [
        "Stanford University School of Medicine, Stanford, California, USA"
      ],
      "name": "Pauline Funchain"
    },
    {
      "affiliations": [
        "Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA"
      ],
      "name": "Justine Herndon"
    },
    {
      "affiliations": [
        "Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA"
      ],
      "name": "Douglas B Johnson"
    },
    {
      "affiliations": [
        "Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA"
      ],
      "name": "Randol Kennedy"
    },
    {
      "affiliations": [
        "Department of Dermatology, Duke University School of Medicine, Durham, North Carolina, USA"
      ],
      "name": "Meenal Kheterpal"
    },
    {
      "affiliations": [
        "Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA"
      ],
      "name": "Michel Khouri"
    },
    {
      "affiliations": [
        "Division of Endocrinology, Diabetes, and Metabolism, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA"
      ],
      "name": "Melissa G Lechner"
    },
    {
      "affiliations": [
        "Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia"
      ],
      "name": "Annette M Lim"
    },
    {
      "affiliations": [
        "Memorial Sloan Kettering Cancer Center, New York, New York, USA"
      ],
      "name": "Alina Markova"
    },
    {
      "affiliations": [
        "Division of Oncology, The Ohio State University, Columbus, Ohio, USA"
      ],
      "name": "Alexa Meara"
    },
    {
      "affiliations": [
        "Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA"
      ],
      "name": "Laura Overton"
    },
    {
      "affiliations": [
        "Yale University Department of Medical Oncology, New Haven, Connecticut, USA"
      ],
      "name": "Ana Luisa Perdigoto"
    },
    {
      "affiliations": [
        "Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia"
      ],
      "name": "Nirupa Sachithanandan"
    },
    {
      "affiliations": [
        "Dana-Farber Cancer Institute, Boston, Massachusetts, USA"
      ],
      "name": "Elad Sharon"
    },
    {
      "affiliations": [
        "Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia"
      ],
      "name": "Lavinia Spain"
    },
    {
      "affiliations": [
        "Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA"
      ],
      "name": "Katy Tsai"
    },
    {
      "affiliations": [
        "Johns Hopkins Medicine Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA"
      ],
      "name": "Mark Yarchoan"
    },
    {
      "affiliations": [
        "Harvard Medical School, Boston, Massachusetts, USA",
        "Massachusetts General Hospital, Boston, Massachusetts, USA"
      ],
      "name": "Kerry L Reynolds"
    },
    {
      "affiliations": [
        "Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA"
      ],
      "name": "Afreen Shariff"
    }
  ],
  "title": "Consensus-based disease definitions for endocrine immune-related adverse events of immune checkpoint inhibitors",
  "uid": "a3b7fa29-4c6f-5513-bed4-612ff46f2f86"
}
