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1、Occurrence and lung cancer probability of new solid nodules at incidence screening with low-dose CT:analysis of data from the randomised,controlled NELSON trial2of39l Lung cancer is a leading cause of death worldwide.l US guidelines now recommend lung cancer screening with low-dose CT for high-risk
2、individuals.l So far,most research has focused on lung nodules detected during baseline screening.Introduction3of39Introductionl Reports of new nodules after baseline screening have been scarce and are inconsistent because of differences in definitions used.l Because these nodules developed within a
3、 short time-interval,Lung cancers found in incidence screening rounds tend to be more aggressive than those detected at baseline.4of39l Up to now,no study has focused on new solid nodules found during lung cancer screening.l We aimed to identify the occurrence of new solid nodules and their probabil
4、ity of being lung cancer at incidence screening rounds in the Dutch-Belgian Randomized Lung Cancer Screening Trial(NELSON).Introduction5of39Dutch Belgian randomised lung cancer screening trial(NELSON)Overall trial start date16/08/2003Overall trial end date31/12/20156of39l Organisation：Erasmus Medica
5、l Centre(Netherlands)l Participating centres:University Medical Centre Groningen,University Medical Centre Utrecht,Kennemer Gasthuis Haarlem(the Netherlands),and University Hospital Leuven(Belgium).Dutch Belgian randomised lung cancer screening trial(NELSON)7of39Dutch Belgian randomised lung cancer
6、screening trial(NELSON)studyaims：1.Toinvestigatewhetherscreeninginahigh-riskpopulationleadstoareductioninlungcancerdeathsofatleast25%;2.Toestimatetheimpactoflungcancerscreeningonhealth-relatedqualityoflifeandsmokingcessation3.Toestimatecost-effectivenessoflungcancerscreeningforsubgroups.8of39lPartic
7、ipant inclusion criteria1.Bornbetween1928and1956（50-75years）2.Smoked:2.1.Morethan15cigarettesperdayformorethan25years,or2.2.Morethan10cigarettesperdayformorethan30years3.Currentorformersmokerswhoquitsmokinglessthanorequalto10yearsagol Participant exclusion criteria1.Moderateorbadself-reportedhealthw
8、howereunabletoclimbtwoflightsofstairs2.Bodyweightgreaterthanorequalto140kg3.Currentorpastrenalcancer,melanomaorbreastcancer4.Lungcancer,diagnosedlessthanfiveyearsagoorgreaterthanorequaltofiveyearsbutstillundertreatment5.HadachestCTexaminationlessthanoneyearDutch Belgian randomised lung cancer screen
9、ing trial(NELSON)9of39lIntervention1.Screenarm:1.1.16-detectormulti-slicecomputedtomographyofthechestinyearone,twoandfourofthestudy1.2.Pulmonaryfunctiontest1.3.Bloodsampling1.4.Questionnaires1.5.Smokingcessationadviceforcurrentsmokers2.Controlarm:Smokingcessationadviceforcurrentsmokers.Dutch Belgian
10、 randomised lung cancer screening trial(NELSON)Methods-Study design and participants10 of39Intheongoing,multicentre,randomisedcontrolledNELSONtrial,betweenDec23,2003,andJuly6,2006.15822participantswereenrolledandrandomlyassignedtoreceiveeitherscreeningwithlow-doseCT(n=7915)ornoscreening(n=7907).7557
11、individualsunderwentbaseline;7295participantsunderwentsecondandthirdscreeningrounds.Methods-Study design and participants11 of39Thesecondscreeningroundtookplace1yearafterthebaselinescan(annualscreen).Thethirdscreeningroundtookplace2yearsafterthesecondscreeningscan(biannualscreen).Resultsofthefourths
12、creeninground,done55yearsafterbaseline(25yearscreeninginterval).Methods-Study design and participants12 of39Weincludedallparticipantswithsolidnon-calcifiednodules,registeredbytheNELSONradiologistsasneworsmallerthan15mm3(studydetectionlimit)atpreviousscreens.Methods-Procedures13 of39Nodulevolumewasge
13、neratedsemiautomaticallybysoftware.Thesemiautomatedvolumetricsoftware(LungCARE,versionSomaris/5VA70C-W,SiemensMedicalSolutions,Forchheim,Germany).Onthebasisofthethree-dimensionalnodulevolume,thissoftwarealsosimulatedlongestandperpendicularnodulediameterintheaxialplane.Methods-Procedures14 of39Forsub
14、sequentCTscans,noduleswereindividuallymatchedonpreviousscansbythesoftwaresmatchingalgorithm(dependingonconsistency,size,andlocation),andvisuallycheckedbytheradiologists.Methods-Procedures15 of39Atfirstdetection,solidnoduleswereassessedbasedonvolume.Becausenewnoduleswereconsideredfast-growing,theirfo
15、llow-upstrategydifferedfrombaselinenodules.Newnodulesmeasuring1550mm3withoutbenigncharacteristicswereconsideredindeterminate(follow-uplow-doseCTafter1year),newnodulesmeasuring50500mm3werealsoconsideredindeterminate(follow-uplow-doseCTwithin68weeks),andnewnodulesmeasuring500mm3ormorewereconsideredpos
16、itive(immediatereferraltopulmonologist).Methods-Procedures16 of39lAfterinitialdetection,subsequentevaluationofanodulewasbasedongrowthandvolumedoublingtime.lWecalculatedthemaximumvolumedoublingtimefornoduleswithanestimatedpercentagevolumechangeof25%ormore.17 of39Methods-ProceduresIn theory,the actual
17、 volume doubling time in the examined time interval might have been faster,but not slower,than the calculated maximum time.Methods-Procedures18 of39lFornoduleseventuallydiagnosedascancer,wesupplementeddatawithcancer-specificinformationobtainedatdiagnosis,suchashistologyandstage.lMalignancy was based
18、 on histology,and benignity was based on histology or stable size for at least 2 years.Methods-Statistical analysis19 of39NormalitytestingforcontinuousvariableswasdonewiththeKolmogorovSmirnovtest.ContinuousvariableswereanalysedwiththeMannWhitneyUtestandarepresentedasmediansandIQRs.WeusedFishersexact
19、testtoanalysenominalvariables.Methods-Statistical analysis20 of39Receiveroperatingcharacteristic(ROC)analysiswasdonefornodulevolumewitheventuallungcancerdiagnosisastheoutcometoevaluatetheirperformanceaspredictorsoflungcancerandtoestimatecutoffvalues.Wederivedcutoffvalueswithapredefinedoverallsensiti
20、vityof95%.Methods-Statistical analysis21 of39Wedevelopedariskpredictionmodeltoassesswhethertheestablishedrelationbetweenvolumeofanewsolidnoduleandlungcancerdiagnosisremainedsignificantindependentofotherriskfactors(ie,age,sex,pack-years,smokingstatus,timesincepreviousscan,solidnodulecountatbaseline,a
21、ndnoduleimagingandvolume).Results22 of39Weanalyseddataforparticipantswithatleastonesolidnon-calcifiednoduleatthesecondorthirdscreeninground.Inthetwoincidencescreeningrounds,theNELSONradiologistsregistered1222newsolidnodulesin787(11%)participants.23 of39Table1showscharacteristicsofincludedparticipant
22、s.Ahighernumberofpack-yearssmokedandalowernumberofsolidnodulesatbaselinescreeningsignificantlyincreasedtheprobabilityofanewsolidnodulebeinglungcancer.Increasedagewasnotsignificantlyassociatedwithlungcancer.Results24 of39In49(6%)participantswithnewsolidnodules,anewsolidnodulewaslungcancer.Oneparticip
23、antwasdiagnosedwithsynchronousdoubletumoursintwonewnodules.Intotal,50lungcancerswerefound,representing4%ofallnewsolidnodules.25 of39Table 2:New solid new nodules detected during second and third screening rounds(N=1222;1172 benign nodules and 50 lung cancer nodules).Results26 of39Nodule volume had a
24、 high discriminatory power(area under the receiver operating curve 0795 95%CI 07280862;p00001).27 of39Results28 of39Nodulessmallerthan27mm3hadalowprobabilityoflungcancer(two05%of417nodules;lungcancerprobability05%95%CI0019),noduleswithavolumeof27mm3upto206mm3hadanintermediateprobability(1731%of542no
25、dules;lungcancerprobability31%1950),andnodulesof206mm3orgreaterhadahighprobability(29169%of172nodules;lungcancerprobability169%120232).Avolumecutoffvalueof27mm3orgreaterhadmorethan95%sensitivityforlungcancer.29 of39Results30 of39Lessthanhalfofscreen-detectedlungcancersinnewsolidnoduleswere500mm3ormo
26、reatfirstnoduledetection.Histologically,mostlungcancerswereadenocarcinomas,squamous-cellcarcinomas,orsmall-celllungcarcinomas.Mostsmall-celllungcarcinomasandsquamous-cellcarcinomashadvolumesgreaterthan500mm3atfirstnoduledetection.However,fewadenocarcinomasinitiallypresentedwithvolumesof500mm3andmore
27、,whereasroughlytwo-fifthsweresmallerthan50mm3atfirstdetection.MostlungcancerswerediagnosedatstageI.Inabouthalfthelungcancercases,participantswerereferredimmediatelyafterfirstnewsolidnoduledetection.Adenocarcinomastendedtobereferredlater.Discussion31 of39Fewstudiesoflungcancerscreeninghavepublishedde
28、taileddataregardingnewnodulesatincidencescreeningrounds.Furthermore,toourknowledge,thisisthefirsttimenodulevolumecutoffvalueshavebeenestablishedasaguideforfurthermanagementofnewsolidnodules.1.Discussion32 of392.meredetectionofanewsolidnoduleduringincidencescreeningmightcarrythesamelungcancerprobabil
29、ityasasuspicioustestresultduringbaselinescreening(6%vs5%;p=025).Discussion33 of393.Atthesetinynodulesizes,growthdetectionbasedontwo-dimensionaldiameterevaluationisunreliable,favouringvolumetry.Discussion34 of39Agewasnotsignificantlyassociatedwithnewnodulelungcancer.Possibleexplanationscouldbethatthe
30、numberofcaseswastoolowtoshowthecorrelation,orperhapsfastnodulegrowthislessassociatedwithage,possiblyevenwithaconverserelation,witholderindividualshavinglessfast-growingnodules.4.Discussion35 of395.Themaximumvolumedoublingtimewassignificantlylowerinnewnodulelungcancersthaninbenignnewsolidnodules.Nota
31、bly,themedianmaximumvolumedoublingtimeofadenocarcinomas(191daysIQR146348)andsquamous-cellcarcinomas(133days105182)wassimilartopreviouslypublishedvolumedoublingtimeoffast-growingbaselinecancersintheNELSONtrialofthesamehistologicaltype(196daysIQR135250and142days91178,respectively).Discussion36 of396.C
32、omparedwiththeoverallscreeningresultsofthefirstthreerounds,newsolidnodulecancercomprised11(19%)of58cancersfoundinthesecondscreening;and34(44%)of77cancerseveninthethirdscreening;Thus,managementofnewsolidnoduleshasagreatimpactontheoutcomeofalungcancerscreeningprogramme.Discussion37 of397.limitationsWe
33、excludednodulessmallerthan15mm3,WecannotexcludethepossibilitythattheactualnumberofnewnodulesissomewhathigherthanwereportbasedontheNELSONmanagementsysteminformation.Weincludedonlysolidnodules,withexclusionofpart-solidandpureground-glassnodules.Calculationofamaximumvolumedoublingtimefornewnodulesisane
34、wandnotyetvalidatedapproach,andsoneedsfurtherinvestigation.Ratesofnewsolidnodulesandcancerdifferedbetweentheincidencescreeningrounds.Discussion38 of39Ourstudyshowsthatnewsolidnodulesaredetectedateachscreeningroundin57%ofindividualswhoundergoscreeningforlungcancerwithlow-doseCT.Thesenewnoduleshaveahighprobabilityofmalignancyevenatasmallsize.Thesefindingsshouldbeconsideredinfuturescreeningguidelines.Newsolidnodulesshouldbefollowedupmoreaggressivelythannodulesdetectedatbaselinescreening,forexamplebyusinglowervolumecutoffvalues(27mm3,27mm3to206mm3,206mm3)withasensitivityofmorethan95%.THANK YOU