RT Journal Article SR Electronic T1 Managing toxicities associated with immune checkpoint inhibitors: consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group JF Journal for ImmunoTherapy of Cancer JO J Immunother Cancer FD BMJ Publishing Group Ltd SP 95 DO 10.1186/s40425-017-0300-z VO 5 IS 1 A1 I. Puzanov A1 A. Diab A1 K. Abdallah A1 C. O. Bingham III A1 C. Brogdon A1 R. Dadu A1 L. Hamad A1 S. Kim A1 M. E. Lacouture A1 N. R. LeBoeuf A1 D. Lenihan A1 C. Onofrei A1 V. Shannon A1 R. Sharma A1 A. W. Silk A1 D. Skondra A1 M. E. Suarez-Almazor A1 Y. Wang A1 K. Wiley A1 H. L. Kaufman A1 M. S. Ernstoff A1 on behalf of the Society for Immunotherapy of Cancer Toxicity Management Working Group A1 Jeff Anderson A1 Deborah Arrindell A1 Stephanie Andrews A1 Joan Ballesteros A1 Janie Boyer A1 Daniel Chen A1 David Chonzi A1 Ion Cotarla A1 Renato Cunha A1 Marianne Davies A1 Michelle Dawson A1 Adam Dicker A1 Lisa Eifler A1 Andrew Ferguson A1 Cristiano Ferlini A1 Stanley Frankel A1 William Go A1 Celestine Gochett A1 Jenna Goldberg A1 Priscila Goncalves A1 Trishna Goswami A1 Nancy Gregory A1 James L. Gulley A1 Vinny Hayreh A1 Nicole Helie A1 William Holmes A1 Jer-Yuan Hsu A1 Ramy Ibrahim A1 Cecilia Larocca A1 Kimberly Lehman A1 Sergio Ley-Acosta A1 Olivier Lambotte A1 Jason Luke A1 Joan McClure A1 Elisabete Michelon A1 Mary Nakamura A1 Kiran Patel A1 Bilal Piperdi A1 Zeshaan Rasheed A1 Dan Reshef A1 Joanne Riemer A1 Caroline Robert A1 Makan Sarkeshik A1 Ann Saylors A1 Judy Schreiber A1 Kim Shafer-Weaver A1 William Sharfman A1 Elad Sharon A1 Richard Sherry A1 Cyndy Simonson A1 Cherry Thomas A1 John A. Thompson A1 Elizabeth Trehu A1 Dina Tresnan A1 Michelle Turner A1 Darshan Wariabharaj A1 Ian Waxman A1 Lauren Wood A1 Lin Zhang A1 Pan Zheng YR 2017 UL http://jitc.bmj.com/content/5/1/95.abstract AB Cancer immunotherapy has transformed the treatment of cancer. However, increasing use of immune-based therapies, including the widely used class of agents known as immune checkpoint inhibitors, has exposed a discrete group of immune-related adverse events (irAEs). Many of these are driven by the same immunologic mechanisms responsible for the drugs’ therapeutic effects, namely blockade of inhibitory mechanisms that suppress the immune system and protect body tissues from an unconstrained acute or chronic immune response. Skin, gut, endocrine, lung and musculoskeletal irAEs are relatively common, whereas cardiovascular, hematologic, renal, neurologic and ophthalmologic irAEs occur much less frequently. The majority of irAEs are mild to moderate in severity; however, serious and occasionally life-threatening irAEs are reported in the literature, and treatment-related deaths occur in up to 2% of patients, varying by ICI. Immunotherapy-related irAEs typically have a delayed onset and prolonged duration compared to adverse events from chemotherapy, and effective management depends on early recognition and prompt intervention with immune suppression and/or immunomodulatory strategies. There is an urgent need for multidisciplinary guidance reflecting broad-based perspectives on how to recognize, report and manage organ-specific toxicities until evidence-based data are available to inform clinical decision-making. The Society for Immunotherapy of Cancer (SITC) established a multidisciplinary Toxicity Management Working Group, which met for a full-day workshop to develop recommendations to standardize management of irAEs. Here we present their consensus recommendations on managing toxicities associated with immune checkpoint inhibitor therapy.Abbreviations:2-D echoTwo-dimensional echocardiogram/echocardiography6MWT6 min walk testAACRAmerican Association for Cancer ResearchACCCAssociation of Community Cancer CentersACPAAnti-citrullinated protein antibodiesACTHAdrenocorticotropic hormoneADCCAntibody-dependent cell-mediated cytotoxicityADLActivities of daily livingALTAlanine aminotransferaseANAAntinuclear antibodyAnti-CCPCyclic citrullinated peptide antibodyAnti-RFAnti-rheumatoid factor (anti-RF)Anti-TNFAnti-tumor necrosis factorASCOAmerican Society of Clinical OncologyASTAspartate aminotransferaseATGAnti-thymocyte globulinBALBronchoalveolar lavageBIDTwo times dailyBNPB-type natriuretic peptideBSABody surface areaCBCComplete blood countCKCreatine kinaseCMPComplete metabolic panelCMVCytomegalovirusCNSCentral Nervous SystemCOPCryptogenic organizing pneumoniaCOPDChronic obstructive pulmonary diseaseCRPC-reactive proteinCTComputed tomographyCTCAECommon Terminology Criteria for Adverse EventsCTLA-4Cytotoxic T lymphocyte-antigen-4DICDisseminated intravascular coagulationDLCODiffusing capacity of the lungs for carbon monoxideDMARDSDisease modifying anti-rheumatic drugsDRESSDrug rash with eosinophilia and systemic symptomsEBUSEndobronchial ultrasoundECGElectrocardiogramESRErythrocyte sedimentation rateFDAU.S. Food and Drug AdministrationFDG-PETFluorodeoxyglucose positron emission tomographyFNAFine needle aspirationFOBTFecal occult blood testFreeT4Free thyroxineFSHFollicle-stimulating hormoneFVCForced vital capacityGAD65Glutamic acid decarboxylaseGCAGiant cell arteritisGIGastrointestinalHbA1cGlycated hemoglobinHBcAbHepatitis B core antibodyHBsAbHepatitis B surface antibodyHBsAgHepatitis B surface antigenHCAbHepatitis C antibodyHgbHemoglobinHIVHuman immunodeficiency virusHPHypersensitivity pneumonitisHRTHormone Replacement TherapyHSVHerpes simplex virusIBDInflammatory bowel diseaseICIsImmune checkpoint inhibitorsICUIntensive care unitIFImmunofluorescenceIgEImmunoglobulin EIgG1Immunoglobulin G1IgG4Immunoglobulin G4irAEsImmune-related adverse eventsIVIGIntravenous immunoglobulinLHLuteinizing hormoneLLNLower limit of NormalmAbsMonoclonal antibodiesMCPMetacarpophalangealMedDRAMedical Dictionary for Regulatory ActivitiesMRIMagnetic resonance imagingNCCNNational Comprehensive Cancer NetworkNCINational Cancer InstituteNIHNational Institutes of HealthNSCLCNon-small cell lung carcinomaNSIPNonspecific interstitial pneumonitisNT pro-BNPN-terminal pro B-type natriuretic peptideONSOncology Nursing SocietyPASIpsoriasis area severity indexPCRPolymerase chain reactionPD-1Programmed cell death protein-1PD-L1Programmed cell death-ligand 1PFPulmonary fibrosisPFTsPulmonary function testsPIPProximal interphalangealPMRPolymyalgia rheumaticPRESPosterior Reversible Encephalopathy SyndromeQIDFour times dailyRARheumatoid arthritisRAIUSRadioactive iodine uptake scanSITCSociety for Immunotherapy of CancerSJS/TENStevens-Johnson Syndrome/toxic epidermal necrolysisSLESystemic lupus erythematosusT1DMType I DiabetesT3TriiodothyronineTBBxTransbronchial lung biopsyTcTechnetiumTh17.1T helper 17 cellsTLCTotal lung capacityTNFiTumor necrosis factor inhibitorTPOThyroid peroxidaseTRAbThyroid-stimulating hormone receptor antibodyTSHThyroid-stimulating hormoneTSIThyroid-stimulating immunoglobulinUIPUsual interstitial pneumonitisULNUpper Limit of NormalUVBShort wave ultraviolet BVZVVaricella zoster virusZn-T8Zinc transporter 8