Top Banner
2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors Barbara S. Apgar MD, MS Professor Emerita of Family Medicine Michigan Medicine University of Michigan Ann Arbor, Michigan
107

2019 ASCCP Risk-Based Management Consensus ...

Mar 08, 2023

Download

Documents

Khang Minh
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Page 1: 2019 ASCCP Risk-Based Management Consensus ...

2019ASCCPRisk-BasedManagementConsensusGuidelinesforAbnormalCervicalCancerScreeningTestsand

CancerPrecursors

BarbaraS.ApgarMD,MS

ProfessorEmeritaofFamilyMedicineMichiganMedicine

UniversityofMichiganAnnArbor,Michigan

Page 2: 2019 ASCCP Risk-Based Management Consensus ...

Disclosures

• ASCCPCasesoftheMonthCommitteeChair(current)• ASCCPBoardofDirectors,GuidelinesCommittees,DirectorofComprehensiveColposcopyCourses(former)

• NofinancialcompensationfromASCCPapp

•  Images:ApgarB,BrotzmanG,SpitzerM.IntegratedTextandAtlas,2004,2008.ElsevierPublishing.

•  Slides:CompilationofASCCPslides/algorithmsandpersonalcollection• AllslidedataarefromPetersRetalunlessotherwisespecified

Page 3: 2019 ASCCP Risk-Based Management Consensus ...

Objec&ves

• Understandthedifferencesbetweenthe2012and2019ASCCPguidelines

• Reviewthescien=ficevidenceusedtoconstructthe2019guidelines.

• Summarizetheprinciplesofthe2019guidelines.• UnderstandhowtointerprettheresultsontheASCCPapp.

Page 4: 2019 ASCCP Risk-Based Management Consensus ...

Equalmanagementforequalrisk

Managementisbasedonrisk,notresults

Page 5: 2019 ASCCP Risk-Based Management Consensus ...
Page 6: 2019 ASCCP Risk-Based Management Consensus ...

Na=onalCancerIns=tuteandASCCPcollaboratedonaformalconsensusguidelineprocessin2001,2006,2012andnowin2019.TheroleofNCIepidemiologistsandsta=s=cianswhospecializeincervicalscreeningistoprovideepidemiologicevidenceregardingtestperformancebasedonNCIandotherresearch.TheroleofASCCPistoconveneandconductconsensusconferencesbringingtogetherorganiza=onsand“stakeholders”tocreatetheguidelines.Goalwastoproduceconsensusrecommenda=onsbasedonrisk,toachievealongshelf-lifeforthe2019versionbeforeanotherconsensusconferenceisneededdespitenewcompe=ngtestsandstrategies.18–monthcollabora=veeffortfor2019guidelines.

Page 7: 2019 ASCCP Risk-Based Management Consensus ...

NCI sta&s&cians had input from many sources

• Therisk-basedapproachprovedadequateformostclinicalscenariosexceptforwomeninspecialpopula=onsandtopicsbesthandledbyconven=onalmanagementalgorithms,guidedbyexpertopinion.

• Risk-basedapproachwastranslatedinto“management”throughuseofclinicalac'onthresholdsthatweredeterminedbytheconsensusgrouprepresen=ngthe19organiza=ons.

• Determinedtrade-offsinbenefitsandharms.

Page 8: 2019 ASCCP Risk-Based Management Consensus ...

The new risk-based management

consensus guidelines use RISK and CLINICAL ACTION THRESHOLDS to determine the appropriate

course of management of cervical cancer screening abnormali&es.

Page 9: 2019 ASCCP Risk-Based Management Consensus ...

NCIHPVepidemiologistsandsta=s=cianses=matedtherisksofCIN3+byHPVtests,cytology,pastscreeningtestsand

colposcopicbiopsyresults.

Tables of risk es&mates were generated from a prospec&ve longitudinal cohort of > 1.5 million pa&ents followed for over a

decade at Kaiser Permanente Northern California (KPNC)

Allowedobserva=onofdetaileddataandfollow-upofCIN2andCIN3,AISandcancer.

Page 10: 2019 ASCCP Risk-Based Management Consensus ...

RISKTABLE:Follow-upofHPV-nega=veASC-US

EnegenDetal.Riskes=matessuppor=ngthe2019ASCCPrisk–basedmanagementconsensusguidelines.JLowGenitTractDis2020;24:132.

Page 11: 2019 ASCCP Risk-Based Management Consensus ...

Adherence to cervical cancer guidelines

•  Significantdifferencebetweenclinician’sdecisionsandactualguidelinestheybelievedtheywerefollowing.

• Confusionandoverloadmaycontributetononadherencebyclinicians.•  Skepticismofutilityofguidelines.

• Mayreverttooverscreeningto“playitsafe”.• Maybelievethatguidelinesareriskyandinappropriate.• Needtoexplainguidelinestoskepticalpatientsevenifbelieveguidelinesareauthoritative

• Maybelievebenefitsandharmsarenotbalanced.

Page 12: 2019 ASCCP Risk-Based Management Consensus ...

Correctlyaddressing<50%ofscreening-relatedques=onssignificantlymorelikelyamong:-  MDs>40years,prac=cing>20years-  workingsuburbanprivateprac=ce-  performing<20cervicalcytologytests/mo.PrimaryHPVtes=ngunderu=lizedandoverscreeningwithcytologyrampant.Consistentlyoverscreened<age21years,>age65(averageriskandadequatescreening)Cotes=ngtoosooninaverageriskpa=ent.

Page 13: 2019 ASCCP Risk-Based Management Consensus ...

Adherencetocervicalcancerguidelines

• Translatingevidence-basedinterventionsintoclinicalpracticeisincrediblycomplexandchallenging(84%ofcliniciansthoughtguidelinesunclear).

• Howtoimprove:

• Capitalizeuseoftechtoolstoincreaseadherence.• Decreasealgorithmuse(risk,notresults).

Page 14: 2019 ASCCP Risk-Based Management Consensus ...

Whywererevisionstothe2012guidelinesneeded?

• Revisionmotivatedbythecomplexityofthe2012guidelinesasnewtestsbecameavailable.

• Toomany“acceptable”choicestocontinueasbefore.• MANYmorealgorithmswouldberequiredfornewtestslikeextendedgenotypingandinfluenceofpast-historyoncurrentresults.

Page 15: 2019 ASCCP Risk-Based Management Consensus ...

Whywererevisionstothe2012guidelinesneeded?

• SufficientdatabecameavailableintheUSshowingthatincorporationoftherisk-basedapproachcouldprovidemoreappropriateandpersonalizedmanagementforthepatient.

• Basedoncurrentresultsandpasthistory.

• Newrecommendationsforcervicalcancerscreeningintroducedsince2012.

• PrimaryHPVtestingasascreeningoptionforpatients25yearsandolder.

Page 16: 2019 ASCCP Risk-Based Management Consensus ...

Whywererevisionstothe2012guidelinesneeded?

• 2012guidelinespresentedaconceptualbreakthroughinrisk-basedmanagement.

• Retainedacontinuedrelianceoncomplicatedalgorithmswithoutincorporatingpastscreeninghistory.

• 2019guidelinesreflectamorenuancedunderstandingofhowpriorresultsaffectrisk.

• MorevariablesavailableincludingthenaturalprogressionofHPV.

Page 17: 2019 ASCCP Risk-Based Management Consensus ...

Comparison of 2012 and 2019 guidelines

•  Changefromtestresults-basedalgorithms(2012)• “ColposcopyisrecommendedforpatientswithHPV-positiveASC-US,LSIL”.

• Changetorisk-basedguidelines(2019)

• “Colposcopyisrecommendedforanycombinationofhistoryandcurrenttestresultsyieldinga4.0%orgreaterprobabilityoffindingCIN3+.”

Page 18: 2019 ASCCP Risk-Based Management Consensus ...

2019guidelinesemphasizereductionofinvasiveprocedureswhilemaintaininghighstandardsofcancerprevention

• Colposcopicbiopsyconfirminglow-gradeornormalhistologyreducestheestimatedriskofhavingprecancer/cancerinthenext3years.

• AllowspatientswithHPV+ASC-USorLSILattheir1-yearfollow-upvisitaftercolposcopicbiopsyshowingnormalorlow-gradehistologytoreturnforrepeatHPV-basedtestingin1moreyear,ratherthanimmediatelyreturntocolposcopy.

Page 19: 2019 ASCCP Risk-Based Management Consensus ...

TREATwomenwithhighrisk

ofdevelopinginvasivedisease

OBSERVEwomenwhoarenotathighriskofdevelopinginvasive

diseaseand

protectthemfromover-treatment

Page 20: 2019 ASCCP Risk-Based Management Consensus ...

2012PrinciplesCarriedForward

• Timelydetectionandtreatmentofthehighestgradeofprecancers(CIN3/AIS)arethebenchmarkusedforallguidelines.

• Guidelinesapplytoallindividualswithacervix.

• Includestransgendermenwithacervix,includingthosewhohaveundergonesupracervicalhysterectomy.

Page 21: 2019 ASCCP Risk-Based Management Consensus ...

2012PrinciplesCarriedForward

Guidelinesapplytoasymptomaticpatientswhorequiremanagementofabnormalcervicalscreeningtestresults.

• Abnormaluterineorvaginalbleedingoravisiblyabnormal-appearingcervixrequireappropriatediagnostictestingtoR/Ocancer.

• Balancingbenefitsandrisks.• Guidelinesmaximizecervicalcancerpreventionandminimizeharmsfromovertreatmentandovertesting.

Page 22: 2019 ASCCP Risk-Based Management Consensus ...

Changesfrom2012GuidelinesPatientswithminorabnormalities

• Colposcopycanbedeferredforcertainpatients.

• PatientswithLSILorASC-UScytologycandefercolposcopyifresultswereprecededby:

•  negativescreeningwithHPV-basedtestingwithinthepast5years

•  colposcopywhereprecancerwasnotfoundinthepastyear.• Pasthistoryisimportant!

• Newdataindicatethatfollow-upinoneyearissafe.

Page 23: 2019 ASCCP Risk-Based Management Consensus ...

Changes from 2012 Guidelines Treatment

• ExcisionaltreatmentispreferredtoablativetreatmentforhistologicHSIL(CIN2or3)intheUS.• Excisionisalsorecommendedforadenocarcinomainsitu(AIS)

• ObservationispreferredforLSIL(CIN1)

Page 24: 2019 ASCCP Risk-Based Management Consensus ...

ManagementofwomenwithBiopsy-confirmedHistologicHSIL(CIN2and3)

2012EitherExcisionorAblationofT-zone

Isacceptable

2019DiagnosticExcisionalProcedureisPreferredAblationisacceptable

Page 25: 2019 ASCCP Risk-Based Management Consensus ...

Changes from 2012 Guidelines Treatment guidelines divided into pa&ents

younger than age 25 years or 25 years or older

•  2012guidelinesconsideredpatientsages21-24tobeaspecialpopulation.Term“youngwomen”isnolongerused(2019).

•  2019guidelinesrecognizethatpatientsofvariousagesareconcernedaboutthepotentialimpactoftreatmentonfuturepregnancyoutcomes.

• Appwillaskyouifpatientisconcernedaboutfuturepregnancy.

•  Shareddecision-makingiscriticalwhenpatientsconsidertreatmentofhistologicHSIL(CIN2)andabnormalitieswithalowlikelihoodofunderlyingCIN3+suchashistologicLSIL(CIN1).

Page 26: 2019 ASCCP Risk-Based Management Consensus ...

3years

Page 27: 2019 ASCCP Risk-Based Management Consensus ...

2019Guidelines:Patientsolderthan65years

• Approximately20%ofcervicalcancersoccurinpatients>65yrs.

• Samemanagementaspatientsaged25to65yearsifscreeningisperformedandabnormalitiesfound.

• Dataonprognosticvalueofspecificscreeningresultsislimitedinolderpatients.

Ifpatientisundergoingsurveillanceforabnormalresultsortreatmentforprecancer,stoppingsurveillanceisunacceptableifpatientishealthybut

acceptableiflimitedlifeexpectancy.

Page 28: 2019 ASCCP Risk-Based Management Consensus ...

2019Specialpopulations:Immunocompromised• HIV***

• Cervicalcancerscreeningguidelinessupportedbypublications.• Literatureislimitedforconditionsthatsuppresscell-mediatedimmunitybutwhichhavebeenassociatedwithvirallyinducedcancers,includingcervicalcancer.

• Solidorganorstemcelltransplant***• Systemiclupuserythematous•  Inflammatoryboweldisease• Rheumatologicdiseaserequiringimmunosuppressivetx

• Lackofdata(KPNC)precludesriskestimationforimmunosuppressed.

Page 29: 2019 ASCCP Risk-Based Management Consensus ...

RiskofCIN3+amongHIV+women

• HIV+womenhavehigherriskofCIN3+withlow-gradecytologicabnormalities.

• SexuallyactiveHIV+patientswithHPVhaveahighrateofprogressiontoprecancer.

• HighprevalenceofHPVbeforeage30years.• HigherratesofacquiringHPVandlowerratesofclearingit,thanHIV-negativewomen.

• HIV+womenare2.5timesmorelikelytohaveanHPVinfectionprogresstoHSILthanHIV-negativepatients.

LiuG,etal.HIV-posi=vewomenhavehigherriskofhumanpapillomavirusinfec=on,precancerouslesions,andcervicalcancer.AIDS.2018;32(6)HilaryKetal.CancerEpidemiolBiomarkersPreven=on2017;26(6):886.

Page 30: 2019 ASCCP Risk-Based Management Consensus ...

ImmunocompromisedwomenwithoutHIV

• UsethesamecervicalcancerscreeningandabnormalresultmanagementguidelinesdevelopedforwomenwithHIV.

• Screeningshouldbeginwithin1yearoffirstinsertionalsexualactivityandcontinuethroughoutpatient’slifetime.

• Annuallyfor3years.• Every3years(cytologyonly)untilageof30years• Continuingwithcytologyaloneorcotestingevery3yearsatage30.

Page 31: 2019 ASCCP Risk-Based Management Consensus ...

2019guidelinesforimmunocompromisedpatientsofanyage

• ColposcopyreferralrecommendedforallwomenwithcytologyresultsofHPV+ASC-US.

• ForallcytologyresultsofLSILorworse,refertocolposcopyregardlessofHPVtestsifdone.

Page 32: 2019 ASCCP Risk-Based Management Consensus ...

2012 and 2019 Guidelines: Pregnancy

• Pregnancywasconsideredaspecialpopulationwheremanagementoptionsweighedrisktomotherandfetusversusriskofmissingcancer(2012guidelines).

• Rateorriskofprogressiontocervicalcancerisnotdifferentinpregnancy.

• 2019guidelinesdonotlistpregnancyasaspecialpopulation.• Datainpregnancyarelimited.

• Norandomized-controlledtrials.

Page 33: 2019 ASCCP Risk-Based Management Consensus ...

2019 Guidelines: Pregnancy

• ManagementofabnormalscreeningresultsusesameClinicalActionThresholdsforsurveillanceandcolposcopy/treatmentestablishedfornon-pregnantwomen.

• EMB,ECCandtreatmentwithoutbiopsyareunacceptable.Ectocervicalbiopsiesappeartobesafe.

• Colposcopyperformedbyanexperiencedclinicianpreferred.• Colposcopyexperienceisknowntoaffecttheabilitytodistinguishcancersfrompregnancy-relatedchanges.

Page 34: 2019 ASCCP Risk-Based Management Consensus ...

Extensivesquamousmetaplasiainpregnancy

canresembleCINorcancer

Apgar,Brotzman,Spitzer

Page 35: 2019 ASCCP Risk-Based Management Consensus ...

2019 Guidelines: Pregnancy •  2019guidelinesallowdeferralofcolposcopyforminorabnormalitiesinwomenwithpriornegativeHPVtestingorcolposcopy.

•  IfHSIL(CIN2or3)isdiagnosedatthefirstcolposcopy,surveillance(colposcopyandcytology/HPVdependingonage)ispreferredevery12-24weeks.

• Repeatbiopsyisrecommendedifinvasionissuspectedortheappearanceofthelesionworsens.

• Deferringcolposcopytothepostpartumperiodisacceptable.•  Notearlierthan4weeksafterdelivery.

Page 36: 2019 ASCCP Risk-Based Management Consensus ...

DiagnosticexcisionfordiagnosisortreatmentofHSIL(CIN2,3)shouldbedeferreduntilafterdeliveryunlessinvasivediseaseisdetectedorissuspected.

Excludeinvasionbycolposcopyandbiopsy.

Strongsuspicionofinvasionrequiresadiagnostic

excisiontoexcludeinvasionanddeterminedepthofinvasion.

Page 37: 2019 ASCCP Risk-Based Management Consensus ...

2019GuidingPrinciple#1

•  ThelongeranHPVinfectionhasbeenpresent,the

highertheriskofpre-cancerandcancer.

•  Timematters.•  Typematters(HPV16mostdangerous).

RiskisgreatlyreducedifpriorscreeningroundwasHPV-negative.

Page 38: 2019 ASCCP Risk-Based Management Consensus ...

WhatisHPV-basedtesting?PrimaryHPVtestingorcotesting

• MostHPVDNAassaysapprovedforadjuncttestingwithcytology.

•  subsetofassaysapprovedforHPVtestingalone,withoutcytology.

• UseofprimaryHPVscreeningwilllikelyincreaseinthefuture.

• Notalllabsequippedforitnow.• HPV16/18+testshavehighestriskofCIN3andoccultcancers.

• Additionaldiagnosticproceduresrecommendedforall+tests.

Page 39: 2019 ASCCP Risk-Based Management Consensus ...

PrimaryHPVscreening

FDA-approvedforpatients25yearsandolder

Page 40: 2019 ASCCP Risk-Based Management Consensus ...

Primary HPV tes&ng and reflex tes&ng

• ReflexcytologyrecommendedforallHPV+primaryscreeningresults,regardlessofHPVgenotype.

•  Ifreflextes=ngnotfeasible,pa=entsshouldgodirectlytocolpo.• Collectcytologyatcolposcopytoprovidefurtherinfoforrisk-basedmanagement.

• Combiningahighspecificitytest(HSILcytology)withahighsensi=vitytest(HPVtest)allowsmoreprecise,risk-basedmanagement.

• Expeditedtreatmentonlypossibleifcytologyisperformed.

Page 41: 2019 ASCCP Risk-Based Management Consensus ...

2019 guidelines prefer HPV tes&ng for follow- up

• SurveillancewithcytologyaloneisacceptableonlyifHPV-basedtes=ngisnotavailable.

• Cytologyislesssensi=vethanHPVtes=ngfordetec=onofprecancerandhastobeperformedmoreolen.

• Cytologyisrecommendedat6-monthintervalswhenHPV-basedtes=ngisrecommendedannually.

• Cytologyisrecommendedannuallywhen3-yearintervalsarerecommendedforHPV-basedtes=ng.

Page 42: 2019 ASCCP Risk-Based Management Consensus ...

SurveillancewithHPV-basedtestingafterTreatmentCIN2or3

• Con=nueHPV-basedtes=ngat3-yearintervalsforatleast25years.• Con=nuedsurveillanceat3-yearintervalsbeyond25yearsisacceptableifpa=ent’slifeexpectancyandabilitytobescreenedarenotcompromised.

• 2012guidelinesrecommendedreturnto5-yearintervalsanddidnotspecifywhenscreeningshouldstop.

• Newevidenceindicatesthatriskremainselevatedforatleast25years

•  Noevidencethattreatedpa=entseverreturntorisklevelscompa=blewith5-yearintervals.

Page 43: 2019 ASCCP Risk-Based Management Consensus ...
Page 44: 2019 ASCCP Risk-Based Management Consensus ...

2019guidelinesalignmanagementrecommendationswithcurrentunderstandingofHPVnaturalhistory

• CurrentHPVtestresults(themostimportantpredictionfactorofCIN3+)arenecessaryformanagement.

◆ IfoncogenicHPVispersistent,theriskofcervicalcancerisincreasedsubstantially.◆ Longerpersistence=greaterrisk.

Page 45: 2019 ASCCP Risk-Based Management Consensus ...

FindingcarcinogenicHPVtypesdoesnot

provideadiagnosisofCIN3orcancer

ItidentifiesagroupofwomeninwhomCIN3+ismorelikely

WomentestingnegativeforoncogenicHPVhaveextremelylowriskofdevelopingcervicalcancer

over5years(KPNC)

Page 46: 2019 ASCCP Risk-Based Management Consensus ...

ProgressiontoCervicalCancer

HSIL,HPVtype16,persistentfor10years

Apgar, Brotzman, Spitzer

Page 47: 2019 ASCCP Risk-Based Management Consensus ...

◆ Natural history of HSIL (CIN 3) implies that it can

progress to cancerCervical HPV persistence is the known necessary event for the

development of cervical cancer HPVinfectionHSIL(CIN3) Cancer

Apgar, Brotzman, Spitzer

Page 48: 2019 ASCCP Risk-Based Management Consensus ...

ΗΠς ανδ περσιστενχε: µετα-αναλψσισ• AssociationsbetweenHPVpersistenceandCIN2+werestrongerwhenpersistence>12months.

• HPVpersistencestronglyandpositivelyassociatedwithallgradesofCIN.

• AssociationsstrongerforCIN2/3+thanCIN1.• Emphasizedimportanceofpersistenceasaclinicalmarker.

• Long-termHPVpositivityclearlyassociatedwithneoplastictransformation.

KoshiolJetal.AmJEpidemiol2008;168:123-137.

Page 49: 2019 ASCCP Risk-Based Management Consensus ...

2019GuidingPrinciple#2Personalizedrisk-basedmanagementispossible

• Recommendationsof1,3,5yearsurveillance,colposcopyortreatmentcorrespondtoarangeofriskforCIN3+calleda“ariskstratum”.• determinedbycurrentresultsandpasthistory.

• Thelowerthresholdofeachriskstratum,calledtheClinicalActionThreshold,definesthelevelatwhichthemanagementchangestoanotherlevel.

Page 50: 2019 ASCCP Risk-Based Management Consensus ...
Page 51: 2019 ASCCP Risk-Based Management Consensus ...

2019Guidelinesbasedonapatient’sriskofCIN3+ratherthanaspecificcombinationoftestresults

• Estimatingriskallowsmorepersonalizedrecommendationsandstreamlinedincorporationofnewscreeninganddiagnostictechnologiesintoclinicalpractice.

• Managementofabnormaltestresultsshiftsfromalgorithmstoelectronicdecisionaids(ASCCPapp).

Page 52: 2019 ASCCP Risk-Based Management Consensus ...

Howtherisk-basedmethodwillworkfortheclinician5differentclinicalscenarios

Newabnormalscreeningresult(itallstartshere!)

Managementofafollow-uptestresultata1,or3or5-yearsurveillancereturnvisit

Interpretationofacolposcopicbiopsydiagnosis

Follow-upofpostcolposcopysurveillanceofpatientsnotinitiallyfoundtoneedtreatment(e.g.,abiopsyof<CIN2)

Posttreatmentfollow-up

Page 53: 2019 ASCCP Risk-Based Management Consensus ...

Clinical Ac&on Thresholds • Clinicalac=onsaleranabnormalscreeningresultareiden=fied

Expeditedtreatmentwithoutbiopsyispreferred.Treatmentorcolposcopicbiopsiesacceptable.Colposcopicbiopsiesarerecommended.Colposcopynotneededbutsurveillanceatshortenedintervalsisrecommended.

1and3yearsmaintainedasthe2levelsofconcerntoreducetherisksof“intervalcancers”occurringbeforethenexttes=ngvisit.

Con=nuescreeningatthe5-yearinterval.

Page 54: 2019 ASCCP Risk-Based Management Consensus ...

Pa&ent will likely aYend >1 management visit aZer ini&al abnormal screening results

• Mostvisitswillinvolvecommon,benignandminorcytologicabnormali5es.

1.Thecommonini=alvisitsthataremainlyminorabnormali=esarehandledbyuseofrisktablesandclinicalac=onthresholds.

• Postcolposcopymanagementdecisionsareabout½asfrequentasini=almanagementvisits.

2.Treatmentandposoreatmentvisitsareuncommon(1/10thasfrequentasini=almanagementvisits)butareimportantforpreven=ngcancer.

Page 55: 2019 ASCCP Risk-Based Management Consensus ...

Managementafteranabnormalscreeningresult

• Recommendationsforcolposcopy,treatmentorsurveillancewillbebasedonthepatient’sriskofCIN3+asdeterminedby:

•  Currentresults•  Pasthistory(includingunknownhistory)

• CurrentHPVtestresults(themostimportantpredictionfactorforCIN3+)arenecessaryformanagement.

• Thesamecurrenttestresultsmayyielddifferentmanagementrecommendationsdependingonthepasttestresults.

Page 56: 2019 ASCCP Risk-Based Management Consensus ...

2019Guidelines:CurrentResultsandHistory

• 2centralquestionsunderlieriskestimates.

• Whatarethecurrentresults?• Resultsforwhichtheclinicianisseekingguidance:anHPVtestorcotestresultoracolposcopy/biopsyresult.

• Whatpastresults(notedunderhistory)affecttheriskestimateforthecurrentresults?

• DocumentednegativecytologyprovidesrelativelylessreductioninriskcomparedwithanegativeHPVorcotestashistory.

Page 57: 2019 ASCCP Risk-Based Management Consensus ...

Iden&fy risk of CIN 3+ for each pa&ent Egermenetal.Riskestimatessupportingthe2019ASCCPrisk-basedmanagementconsensus

guidelines.JLowGenitTractDis2020;24:132-143.

• Mostpa=entscanbemanagedbyiden=fyingtheirrisklevelandlinkingittoarecommendedclinicalac1on.

• Returntorou=nescreening.• Surveillancewithrepeattes=ngat1,3or5yearintervals.• Colposcopy.• Treatment.

• Thisinforma=onisaccessibleviasmartphoneapp(purchase)orwebthroughhop://www.asccp.org(nocost)

Page 58: 2019 ASCCP Risk-Based Management Consensus ...

Management Surveillanceinterval

ClinicalActions

Page 59: 2019 ASCCP Risk-Based Management Consensus ...
Page 60: 2019 ASCCP Risk-Based Management Consensus ...

How is the pa&ent’s risk determined?

• Managementbasedonapatient’sriskofCIN3+.• 2019guidelinesmakerecommendationsbasedon:

• ImmediateCIN3+riskistheprobabilityofpatientcurrentlyhavingCIN3+.

• 5-yearCIN3+riskistheprobabilityofdevelopingCIN3+overthenext5years.

• Extensivedataanalysisproducedriskestimatesforallcombinationsoftestsandrecentscreeninghistory.

Page 61: 2019 ASCCP Risk-Based Management Consensus ...

CIN3+chosenasthebestsurrogateforcancerrisk

•  CIN3+includesCIN3,AISandrarecasesofinvasivecancerfoundatscreening.

•  CIN3+chosenasendpointinsteadofcancer.•  CancerisuncommoninUS.• Riskissignificantlydecreasedbyprecursortreatment.

•  CIN3+choseninsteadofCIN2.•  Isamorepathologicallyreproduciblediagnosis.• HPVtypesinCIN3+lesionsapproximateclosertoinvasivecancerthanthelargerrangeoftypesinCIN2.

•  CIN2hasappreciableregressionratesinabsenceoftreatment.

Page 62: 2019 ASCCP Risk-Based Management Consensus ...

Howtodeterminethepatient’srisk?

• Firststep.• DeterminewhethertheimmediateriskofCIN3+is>4%or<4%.

• Secondstep.• Forimmediaterisks>4%,therecommendedcolposcopy/treatmentisdeterminedbytheimmediateCIN3+risk.

• Forimmediaterisks<4%,the5-yearriskisusedtodeterminetherecommendedfollow-upinterval.

Page 63: 2019 ASCCP Risk-Based Management Consensus ...

Whythe4%estimatedriskofCIN3+?

• TheClinicalActionThresholdofa4%immediateriskofCIN3+wasconsideredareasonablebalanceofbenefitsandharms.

• ValidationoftheThresholdincludedseveralstudypopulations:KPNC,NMHPVPapRegistry,CDCbreastandcervicalcancerearlydetectionprogram,BDOnclaritytrials.

• 4%thresholdfunctionedsimilarly.• Examinedclustersofpatientsindifferentresultgroups.

• High-graderesults• Low-graderesults• Combinationsforwhichcolpohasnotbeenperformed.

Page 64: 2019 ASCCP Risk-Based Management Consensus ...

management

4%

Page 65: 2019 ASCCP Risk-Based Management Consensus ...

Formanagement

Howpa=entriskisevaluatedforcurrentresultsandhistory

TheimmediateCIN3+riskisexamined

Treatmentor

Colposcopy

Determinewhetherpa=entsshouldreturnin1,3or5years

Page 66: 2019 ASCCP Risk-Based Management Consensus ...

Management Surveillanceinterval

Page 67: 2019 ASCCP Risk-Based Management Consensus ...

That important clinical ac&on threshold Consensus:Theclinicalac1onthresholdforreferraltocolposcopy

ortreatmentisa>4.0%immediateriskofCIN3+.

•  Op=onsbasedonimmediateriskofCIN3+>4.0%:• Expeditedtreatmentwithoutbiopsyispreferred.

• Treatmentorcolposcopicbiopsiesacceptable. • Colposcopicbiopsiesarerecommended.

Page 68: 2019 ASCCP Risk-Based Management Consensus ...

Es&mated risk of CIN 3+

• Ifthees=matedriskisfrom4-24%oriftes=ngresultsare+forHPVtypes16or18,colposcopywithbiopsyisrecommended.

• Iftheriskis25-59%,eithercolposcopywithbiopsyorexpeditedtreatmentisrecommended.

• Iftheriskis60%orhigher,expeditedtreatmentispreferred.

Page 69: 2019 ASCCP Risk-Based Management Consensus ...
Page 70: 2019 ASCCP Risk-Based Management Consensus ...

Expedited Treatment (ET) is defined as treatment without preceding colposcopic biopsy

• Fornon-pregnantpa=ents>25years,ETispreferredwhentheimmediateriskofCIN3+is>60%.

• Acceptableforthosewithrisksbetween25%and60%.

• ETispreferredfornon-pregnantpa=ents>25yearswithHPVtype16+HSILandneverorrarelyscreenedpa=entswithHPV+HSILcytologyregardlessofgenotype.

Page 71: 2019 ASCCP Risk-Based Management Consensus ...

Expedited Treatment

Shareddecision-makingshouldbeusedwhenETisconsidered,especiallyforpa=entswithconcerns

aboutthepoten=alimpactoftreatmentonpregnancy

outcomes.

Page 72: 2019 ASCCP Risk-Based Management Consensus ...

ThatimportantclinicalactionthresholdConsensus:Theclinicalactionthresholdforreferraltosurveillance

isa<4.0%immediateriskofCIN3+

• OptionsbasedonanimmediateriskofCIN3+<4%.• Lookatthe5-yearCIN3+risk

• FindthesurveillanceintervallevelandrepeatHPV-basedtestingin1,3or5years

Page 73: 2019 ASCCP Risk-Based Management Consensus ...

Below the threshold for colposcopy (4%) Es&mated 5-year risk of CIN 3+ Surveillance based on current results and past history

•  Ifthees=mated5-yearriskofCIN3+is>0.55%,repeatHPV-basedtes=ngin1year.

•  Ifthees=mated5-yearriskofCIN3+is0.15%orgreaterbutlessthan0.55%,repeatHPV-basedtes=ngtes=ngin3years.

•  Ifthees=mated5-yearriskofCIN3+is<0.15%,repeatHPV-basedtes=ngin5-years.

Page 74: 2019 ASCCP Risk-Based Management Consensus ...
Page 75: 2019 ASCCP Risk-Based Management Consensus ...

11/5/20, 11(56 AMMobile App - ASCCP

Page 1 of 2https://www.asccp.org/mobile-app

(0) View Cart [email protected] 0 My ASCCP

Search

Mobile App

The ASCCP Management Guidelines App& Web Application is Now Available

Streamline navigation of the ASCCP Risk Based Management Consensus Guidelines with the NEWASCCP Management Guidelines App

Evidence-based management guidelinesSimple navigationUncomplicated guidance

Need Help?

Quick Start Guide

Walk through the Appwith Cases

User Guide

asccp.orgwebsiteasccp.org/mobile-app

Page 76: 2019 ASCCP Risk-Based Management Consensus ...

How to use the ASCCP app Clinical Management Tab

•  1. Management of routine screening results: Management of HPV and/or cytology results obtained during routine cervical cancer screening.

•  2. Return visit during pre-colposcopy surveillance: management of HPV and/or cytology results obtained in patients where prior screening results did not result in colposcopy, but where risk was too high to return to routine screening.

•  3. Evaluation of a colposcopic biopsy: Management of biopsy results after colposcopy.

•  4. Management of results during post-colposcopy surveillance: Management of current HPV and/or cytology results for patients who previously were triaged to 1-year, 3-year, or 5-year follow-up after colposcopy.

•  5. Follow-up after treatment: Management of current HPV and/or cytology results for patients who have previously been treated for dysplasia.

Page 77: 2019 ASCCP Risk-Based Management Consensus ...
Page 78: 2019 ASCCP Risk-Based Management Consensus ...

How to use the ASCCP app Publica&ons and Defini&ons tab

• Publica=onstab-Thishasallthemainpapersthatwereusedinconjunc=onwiththedevelopmentoftheguidelines.Therearealsocytologyfigures,histologyfigures,datatables,andtheoldercytologyalgorithmsforreference.

• Defini=onstab-Defini=onsoftermsintheapp,asummaryofthechangesinthecurrentguidelinesfrompriorguidelines,andfrequentlyaskedques=ons.

Page 79: 2019 ASCCP Risk-Based Management Consensus ...

Sent from my iPhone

Page 80: 2019 ASCCP Risk-Based Management Consensus ...
Page 81: 2019 ASCCP Risk-Based Management Consensus ...
Page 82: 2019 ASCCP Risk-Based Management Consensus ...

What if you don’t want to use the ASCCP app?

EnegenDetal.Riskes=matessuppor=ngthe2019ASCCPrisk–basedmanagementconsensusguidelines.JLowGenitTractDis2020;24:132.

Page 83: 2019 ASCCP Risk-Based Management Consensus ...

Cases

• 32-year-oldpa=entpresentsforcervicalcancerscreening.Shedeniesanyabnormali=es.Shedeniescolposcopyorcervicaltreatmentinthepast.Hermedicalrecordsarenotavailablesoherprecisehistoryisunknown.ScreeningshowsHPV+ASC-US.Nogenotypingwasavailable.

• WhatisherimmediateriskofCIN3+?

Page 84: 2019 ASCCP Risk-Based Management Consensus ...
Page 85: 2019 ASCCP Risk-Based Management Consensus ...
Page 86: 2019 ASCCP Risk-Based Management Consensus ...
Page 87: 2019 ASCCP Risk-Based Management Consensus ...
Page 88: 2019 ASCCP Risk-Based Management Consensus ...
Page 89: 2019 ASCCP Risk-Based Management Consensus ...
Page 90: 2019 ASCCP Risk-Based Management Consensus ...
Page 91: 2019 ASCCP Risk-Based Management Consensus ...
Page 92: 2019 ASCCP Risk-Based Management Consensus ...
Page 93: 2019 ASCCP Risk-Based Management Consensus ...

35-year-old G0P0 presents for cervical cancer screening. Had abnormal

screening 5 years ago but was not treated. Using OCPs. Will start trying to

conceive in 3 months.

Page 94: 2019 ASCCP Risk-Based Management Consensus ...
Page 95: 2019 ASCCP Risk-Based Management Consensus ...
Page 96: 2019 ASCCP Risk-Based Management Consensus ...
Page 97: 2019 ASCCP Risk-Based Management Consensus ...
Page 98: 2019 ASCCP Risk-Based Management Consensus ...
Page 99: 2019 ASCCP Risk-Based Management Consensus ...
Page 100: 2019 ASCCP Risk-Based Management Consensus ...

2019 Guiding Principle #3 Guidelines will allow updates

•  Incorporatenewtestmethodsastheyarevalidated.

• AdjustfordecreasingCIN3+risksasmorepatientswhoreceivedHPVvaccinationreachscreeningage.

•  The2019guidelinesbuildaframeworkthatallowsincorporationofnewtechnologiesandmodifiedstrategieswithoutrequiringfullconsensusconferences.

• Revisionsmayrapidlyincorporatenewfindingsandbequicklydisseminatedtooptimizepatientcare.

Page 101: 2019 ASCCP Risk-Based Management Consensus ...

2019GuidingPrinciple#4

ColposcopypracticemustfollowguidancedetailedintheASCCPColposcopyStandards.

• Colposcopywithtargetedbiopsyremainstheprimarymethodofdetectingprecancersrequiringtreatment.

• Biopsiesshouldbetakenofalldiscreteacetowhiteareas,usually2-4biopsies/colposcopy.

• ASCCPStandardsemphasizetheneedforbiopsiesevenwhenthecolpoimpressionisnormalbutanydegreeofacetowhiteness,metaplasiaorotherabnormalityispresent.

KhanMJ,WernerCL,DarraghTM,etal.ASCCPColposcopyStandards:RoleofColposcopy.JLowerGenitTractDis2017;21:223-229.

Page 102: 2019 ASCCP Risk-Based Management Consensus ...

2019 Guiding Principle #4

Colposcopy prac&ce must follow guidance detailed in the ASCCP Colposcopy Standards.

42-year-oldwithASC-US,HPV16+SCJfullyvisible

Lesionnotfullyvisible

Page 103: 2019 ASCCP Risk-Based Management Consensus ...

2019GuidingPrinciple#4Colposcopyprac=cemustfollowguidancedetailedintheASCCPColposcopyStandards

50–year-oldwithHSILcytologyDidnotfollow-upforHSIL5years

agoCervixnotfullyvisibleSCJnotfullyvisible

Page 104: 2019 ASCCP Risk-Based Management Consensus ...

2019GuidingPrinciple#4Colposcopyprac=cemustfollowguidancedetailedintheASCCPColposcopyStandards

35-year-oldwithASC-HcytologyCervixnotfullyvisibleSCJnotfullyvisible

Page 105: 2019 ASCCP Risk-Based Management Consensus ...

38-year-oldwithLSILcytology,HPV+others

Persistentfor5yearsSCJfullyvisible

2019GuidingPrinciple#4Colposcopyprac=cemustfollowguidancedetailedintheASCCPColposcopyStandards

Page 106: 2019 ASCCP Risk-Based Management Consensus ...

Formanagement

Howpa=entriskisevaluatedforcurrentresultsandhistoryTheimmediateCIN3+riskisexamined

Treatmentor

Colposcopy

Determinewhetherpa=entsshouldreturnin1,3or5years

Page 107: 2019 ASCCP Risk-Based Management Consensus ...

Thanks!