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 Puzanov, I. A1 Diab, A. A1 Abdallah, K. A1 Bingham, C. O. A1 Brogdon, C. A1 Dadu, R. A1 Hamad, L. A1 Kim, S. A1 Lacouture, M. E. A1 LeBoeuf, N. R. A1 Lenihan, D. A1 Onofrei, C. A1 Shannon, V. A1 Sharma, R. A1 Silk, A. W. A1 Skondra, D. A1 Suarez-Almazor, M. E. A1 Wang, Y. A1 Wiley, K. A1 Kaufman, H. L. A1 Ernstoff, M. S. A1 on behalf of the Society for Immunotherapy of Cancer Toxicity Management Working Group A1 Anderson, Jeff A1 Arrindell, Deborah A1 Andrews, Stephanie A1 Ballesteros, Joan A1 Boyer, Janie A1 Chen, Daniel A1 Chonzi, David A1 Cotarla, Ion A1 Cunha, Renato A1 Davies, Marianne A1 Dawson, Michelle A1 Dicker, Adam A1 Eifler, Lisa A1 Ferguson, Andrew A1 Ferlini, Cristiano A1 Frankel, Stanley A1 Go, William A1 Gochett, Celestine A1 Goldberg, Jenna A1 Goncalves, Priscila A1 Goswami, Trishna A1 Gregory, Nancy A1 Gulley, James L. A1 Hayreh, Vinny A1 Helie, Nicole A1 Holmes, William A1 Hsu, Jer-Yuan A1 Ibrahim, Ramy A1 Larocca, Cecilia A1 Lehman, Kimberly A1 Ley-Acosta, Sergio A1 Lambotte, Olivier A1 Luke, Jason A1 McClure, Joan A1 Michelon, Elisabete A1 Nakamura, Mary A1 Patel, Kiran A1 Piperdi, Bilal A1 Rasheed, Zeshaan A1 Reshef, Dan A1 Riemer, Joanne A1 Robert, Caroline A1 Sarkeshik, Makan A1 Saylors, Ann A1 Schreiber, Judy A1 Shafer-Weaver, Kim A1 Sharfman, William A1 Sharon, Elad A1 Sherry, Richard A1 Simonson, Cyndy A1 Thomas, Cherry A1 Thompson, John A. A1 Trehu, Elizabeth A1 Tresnan, Dina A1 Turner, Michelle A1 Wariabharaj, Darshan A1 Waxman, Ian A1 Wood, Lauren A1 Zhang, Lin A1 Zheng, Pan 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