A Multidisciplinary Toxicity Team for Cancer Immunotherapy–Related Adverse Events Jarushka Naidoo.pdf

该【A Multidisciplinary Toxicity Team for Cancer Immunotherapy–Related Adverse Events Jarushka Naidoo 】是由【周瑞】上传分享，文档一共【13】页，该文档可以免费在线阅读，需要了解更多关于【A Multidisciplinary Toxicity Team for Cancer Immunotherapy–Related Adverse Events Jarushka Naidoo 】的内容，可以使用淘豆网的站内搜索功能，选择自己适合的文档，以下文字是截取该文章内的部分文字，如需要获得完整电子版，请下载此文档到您的设备，方便您编辑和打印。:..ORIGINALRESEARCHAMultidisciplinaryToxicityTeamforCancerImmunotherapy–RelatedAdverseEventsJarushkaNaidoo,MBBCha;JiajiaZhang,MD,PhDa;,MDa;,MBBCha;KarthikSuresh,MDb;,MDc;SeemaMehta,MDd;,MDe;,MDf;,MDf;,MD,PhDg;RosanneRouf,MDh;,MD,PhDi,j;SatishShanbhag,MDa;JoanneRiemer,RN,BSNa;,MDk;,MD,PhDa;,MDk;,MD,MHSa;,MD,MHSkBackgroundABSTRACTMultidisciplinarytumorboardsareamechanisminwhichBackground:Immunecheckpointinhibitors(ICIs)maycauseimmune-oncologistsandsubspecialistsdiscusschallengingcasestorelatedadverseevents(irAEs).Methodstoobtainreal-timemultidisci--diagnosisandpositivelyin?uencemanagementacrossrelatedtoxicity(IR-tox)–5Morerecently,specializedmoleculartu-wouldbefeasibletoimplement,beusedbyoncologyproviders,:PatientstreatedwithICIsandreferredtotheIR-toxteaminAugust2017throughMarch2018wereidenti??eldofcancerimmunotherapy,emerging-immune-relatedtoxicitiesrequiremultidisciplinaryman-?nedasthepro-,immuneportionofreferringproviderswhousedtheteam’mendations,checkpointinhibitors(ICIs)cancausepatientstode-,treatment,-speci?cimmune-:TheIR-toxevents(irAEs).7Similarly,patientsmayhaveotherprocesses,teamwasfoundtobefeasibleandused:117referralsfrom102patientssuchasinfectionorprogressivecancer,,mendationsEarlyevaluationanddiagnosisiscriticalandassociateswithwithin24hours,100%men-,9Diagnosisandmanagementdations,and74%changedpatientmanagementbasedonIR-(n5106;ofselectedirAEsmaybechallengingandoftenrequires91%)andsuitabilitytotreatwithICIs(n511;10%).Inreferredpa-theinputofatleastonenon-oncologyspecialistfortients,medianagewas64years,54%weremen,13%hadpriorau-speci?cphysicalexamination,interpretationoflab-toimmunity,and46%pletionofadiagnostic(54%).monlyreferredtoxicitieswerepneumonitis(23%),uidanceonimmunosuppressionforarthritis(16%),anddermatitis(15%);15%-,high-riskpatientscombinationICIs(oddsratio[OR],;)orwithmultisystemwithpreexistingautoimmunediseases,an/toxicities(OR,;).TheIR-toxteamprovidedanewmulti-bonemarrowtransplants,?eseducationalandserviceneeds,physiciansandnursesarecentraltothisconsultation,:AvirtualmultidisciplinarytoxicityteamforirAEswasafeasibleandusedservice,andfacilitatedtoxicityidenti?-KimmelInstituteforCancerImmunotherapy,SidneyKimmelbw2019;17(6):712–prehensiveCancerCenteratJohnsHopkins;DepartmentofMedicine,DivisionofPulmonaryandCriticalCareMedicine,cDepartmentofdoi:/.,DivisionofEndocrinology,Diabetes&Metabolism,dDepartmentofMedicine,DivisionofInfectiousDiseases,eDepartmentofMedicine,DivisionofDermatology,fDepartmentofMedicine,DivisionofGastroenterology,gDepartmentofMedicine,DivisionofNeurology,hDepartmentofMedicine,DivisionofCardiology,iDepartmentofMedicine,DivisionofOphthalmology,jDepartmentofEpidemiology,andkDepartmentofMedicine,,JohnsHopkinsUniversitySchoolofMedicine,Baltimore,?—work|Volume17Number6|June2019:..Immune-RelatedToxicityTeamORIGINALRESEARCHaddressICIdiscontinuationorsuitabilityforfutureim-.-teamwasassessedastheproportionofreferringprovidersmendsamultidisciplinaryapproachbutlackspracticalwhousedtheteam’mendations,-,uratunpredictabletimesInclusionandExclusionCriteria,DataCollectionwhenspecialistsarenotavailable,andtheneedforex-PatientswereincludediftheywerereferredtotheIR-toxpre-mendationsarenotcon?(JHH).ThisstudyaimedtoformalizethemultidisciplinaryIncludedpatientshadapathologicallycon?rmedsolidcollaborationsbetweenoncologyandmedicinesub-tumororhematologicmalignancyandwereeitherre-,hadreceived,orwereduetoreceiveanICIasoncologyandmedicalsubspecialistswithexpertiseinstandard-of--timeexcludediftheywerenottreatedatJHHandhadnotinputonirAEsviaanelectronicplatform,,referral,feasibilityanduseofthisimmune-relatedtoxicity(IR-tox)irAEmanagement,,IR-toxteammeetings,orextractedfromtheelectronicmedicalrecordandcol-lectedinanIRB-approveddatabase(IRB00144013).Pa-PatientsandMethodspetingIR-ToxTeamOperationsdiagnoseswereexcluded,multidisciplinaryconsensuswasTheIR-toxteamwasproposedasacollaborationbe-reached,andtheyhadeitherpathologicevidenceofirAEtweenmedicaloncology(.,Co-Chair)andmedicineorshowedclinicalimprovementwithcorticosteroid/subspecialists(.,Co-Chair).ThismultidisciplinaryirAE-?rmedirAEsweregradedordingtoCTCAE,,includingmedicaloncologists(n58),on-uncon?rmedirAEsincludedthoseforwhomanalterna-cologynurses(n54),andsubspecialistsfromrheu-tivediagnosiswascon?rmedorforwhomnomultidis-matology(n54),pulmonology(n53),?areofaknown(n53),neurology(n52),endocrinology(n52),derma-(n52),ophthalmology(n52),cardiology(n51),whodevelopedirAEsinvolving$2organs/systemswereinfectiousdiseases(n51),andhematology(n51).de?-an/bonemarrowproviders(faculty,fellows,nurses)whoadministerICIstransplantswerede?nedashavingpriorautoimmunitytopatientsinatertiarycancercentertoelectronicallyorhigh--.-Anelectronicreferraltemplatewasprovided(supple-,).Patientreferralinformationincludeddemographics,tu-PostpilotSurveymortype,immunotherapyregimen,clinicalcourse,spe-Afterthe?rst8weeksofthepilotprogram,ananony-ci?creferralquestions,-toxteamdiscussedcasescancercenter,includingoncologyproviders,nurses,inrealtimeviaapassword-protectedelectronicmes-andalliedsta?,toassesstheuseandutilityoftheteam,,-typesofquestionsposedtotheteam,andfuturesug-mendationswassenttoreferringprovidersviaemail,gestions(supplementaleAppendix1).Providerswereandmayhavebeenaddedtothepatient’selectronicaskedabouttheirareaofpracticeinoncology,ICImedicalrecordatthediscretionofthereferringproviderprescribingpatterns,andexperienceinmanagingirAEs.(supplementaleFigure1B).Furtherdiscussionandrec-Providerswereunawaretheywouldbesurveyedbeforeommendationsbeyond24hourswereusedatthedis---toxteammetStatisticalAnalysismonthlytodiscussreferralsandidentifynewclinical,Patient,tumor,andtreatmentcharacteristics;referraleducational,;andthespectrumofsuspectedandcon?rmedirAEsde?|Volume17Number6|June2019713:..ORIGINALRESEARCHNaidooetalparedbyirAEgradeusingthePatientDemographicsandOncologicHistoryWilcoxonrank-sumtestforcontinuousvariablesandCONSORTdiagramsofreferralsandindividualpatientsPearsonchi--areprovidedinFigure1andsupplementaleFigure2,-obtainoddsratios(ORs)forthee?ectsoftreatment,sex,pectedirAE(n5106;91%)andsuitabilityforICIs(n511;smokingstatus,age,priorautoimmunity/high-riskcon-10%).Of106referralsforsuspectedirAEs,thesein-ditions,multisystemirAEs,,10(91%)wereforpre-immunotherapyreferral(.1referral/patient)(9%)-(StataCorpimmunotherapyreferrals,7hadpriorautoimmunecon-LP).Statisticaltestswere2-sidedwithaPvalue,.05ditions(rheumatoidarthritis,n53;in?ammatorybowelconsideredtoindicatestatisticalsigni?,n51;hrombocytopeniapurpura/Evanssyndrome,n51;myastheniagravis,n51;Sjogrensyn-¨drome,n51),1hadapriorhigh-gradeirAE(hepatitis),andResults2hadotherclinicalconditionswhereinsuitabilityforICIFeasibilityoftheIR-ToxTeamwasquestioned(ination,n51;splenectomy/DatawerecollectedfromAugust1,2017,throughMarchincreasedinfectionrisk,n51).Mostpatientswerere-30,-toxteamreceived122referralscon-ferredtotheteamonce(n587/102;85%)andsomewerecerning107patientsoveran8--referredtwice(n515/102;15%).tientswereexcluded(didnotreceiveICIs,n54;notPatient,treatment,andtumorfeaturesofreferredmanagedatJHH,n51).-64years(range,21–91years),54%ofpatientsweremaleferrals,theIR-menda-(n555),and13%hadpriorautoimmunity/high-(n513;9autoimmuneconditions,1solidTotalnumberofIR-toxteamreferralsa(N=117)ReasonforreferralSuspectedirAESuitabilityforimmunotherapy(n=106)(n=11)FirstreferralSecondreferralPre-immunotherapyImmunotherapy(n=92)(n=14)assessment(n=10)rechallenge(n=1)1suspectedirAE2suspectedirAEs1suspectedirAE2suspectedirAEs(n=81)(n=11,22suspectedirAEs)(n=13)(n=1,2suspectedirAEs)1con?rmedirAE2con?rmedirAEs1con?rmedirAE2con?rmedirAEs(n=61)(n=2,4irAEs)(n=9)(n=0)NotirAE/unknown1con?rmedirAEandNotirAE/unknown1con?rmedirAEand(n=20)1notirAE/unknown(n=4)1notirAE/unknown(n=4,8suspectedirAEs)(n=1,2suspectedirAEs)2notirAE/unknown2notirAE/unknown(n=5,10suspectedirAEs)(n=0)-:IR-tox,immune-relatedtoxicity;irAE,immune-??—work|Volume17Number6|June2019:..Immune-RelatedToxicityTeamORIGINALRESEARCHmelanoma/skinmalignancies(n517;17%).Patientsre-:DemographicsandceivedeitherICImonotherapy(n555;54%)bi-OncologicHistory(N5102)nations(n547;46%),eitherasstandard-of-care(n549;(%)49%)orinclinicaltrials(n552;51%).MostreferralswereMedianage(range),y64(21–91)receivedfromtheoutpatient(n565;63%)ratherthantheSexinpatientsetting(n537;36%).ThemediannumberofICIMale55()dosesreceivedbeforereferralwas3(range,0–40).Female47()SpectrumofirAEsReferredtotheIR-ToxTeamSmokingstatusanFormer/Current39()()118suspecte