Title:SentinelLymphNodeBiopsyinBreastCancer

Agency:MedicalServicesAdvisoryCommittee(MSAC) DepartmentofHealthandAgeing

GPOBox9848CanberraACT2601Australia

Reference:MSACapplication1065AssessmentReport,Firstprinted:May2005

ISBN06428277377,ISSN14437120;

Aim

Todeterminewhethersentinellymphnodebiopsy(SLNB)forbreastcancercanidentifypatientsforwhom axillaryclearance(AC)isnotindicated(i.e.whoarelymphnodenegative),withoutincreasingaxillary recurrenceratesordecreasinglong-termsurvival.

Conclusionsandresults

DiagnosticaccuracyofSLNB

ArandomeffectsBayesianmeta-analysisfoundthepooledlocalisationratetobe94.1%(95%posterior interval93.3%to95.0%;192studies)andthepooledfalsenegativerate(calculatedasfalsenegativesover allnegatives)tobe4.7%(95%posteriorinterval4.0%to5.4%;130studies).Calculatedasfalsenegatives overallpositives,thefalsenegativerateis7.4%(95%posteriorinterval6.5%to8.5%).

Safety

Inonenon-randomisedstudy,theSLNBcomplicationratewassignificantlylowerthanforACandfor SLNBfollowedbyAC.TherewerestatisticallysignificantlyfewerwoundinfectionsforSLNBthanfor ACinoneoutoftwonon-randomisedstudies.Fourteencaseseriesstudiesreportedwhetherwomen reactedtothebluedye,rangingfrom0%to1.6%(median0%).

Effectiveness

SignificantlymoreACpatientsexperiencedlymphoedemathandidSLNBonlypatients;themedianacross sixstudieswas3.25%forSLNBand27.05%forAC,ariskdifferenceof23.8%.However,thisreduction

inmorbiditywillonlyapplyto70%to80%ofpatientsundergoingSLNB,sincetheremaining20%to30%

(withpositivenodes)willsubsequentlyneedAC.

InonerandomisedcontrolledtrialtherewerenoaxillaryrecurrencesineithertheSLNBgrouporthe SLNB+ACgroupafteramedianfollow-upof46months.In29caseseriesofSLNB,theaxillary recurrenceratedidnotexceed1%inpatientswhowerenodenegativeatthetimeofSLNB(follow-up rangedfrom8monthsto47months).Therewasinsufficientevidencetoassesstherelativeeffecton survivalofSLNB.IntwelveSLNBcaseseriesstudies,survivalafteratleast24monthswasgreaterthan

98%inallbuttwoofthesestudies.

Cost-effectivenessandcostimpact

Inacost-minimisationanalysisusingrecurrenceandsurvivalaseffectivenessoutcomes(SLNBandAC assumedtobeofsimilareffectiveness)thecostper100proceduresforSLNB(plusACinthesamesurgery whenrequired)rangedfrom$251,942to$514,277comparedtoarangeof$325,185to$499,600forAC alone.Thecostper100proceduresforSLNB(plusACinasubsequentsurgerywhenrequired)ranged

from$280,203to$590,097comparedtoarangeof$325,185to$499,600forACalone.

Usinglymphoedemaasthemeasureofeffectiveness,inacost-effectivenessanalysis,SLNBcostslessand ismoreeffectiveinthelowerendofthecostingrange.Atthehighendofthecostingrange,SLNB(with

ACinthesamesurgerywhenrequired)costs$8.63foronecaseoflymphoedemaavoidedand$53.20when

AC(ifrequired)isperformedinasubsequentsurgery.

Recommendation

Sentinelnodebiopsyappearstobesafeandeffectiveinidentifyingsentinellymphnodesresultinginthe reductionofcomplicationsduetoaxillarylymphnodedissection,inparticularlymphoedema. Longterm outcomesareuncertain. MSACrecommendsthatinterimfundingforsentinelnodebiopsyshouldbe providedpendingtheoutcomeoftrialsalreadyinprogressandshouldbereviewedinfiveyears.

Methods

MSACconductedasystemreviewofmedicalliteratureviaelectronicdatabasesandhealthtechnology websitespublishedbetween1966and2003. Thosecitationsthatmetpredefinedinclusioncriteriawere includedinthereviewofevidence.