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1、ResearchOriginalInvestigationEffectsofEstrogenReceptorandHumanEpidermalGrowthFactorReceptor-2LevelsontheEfficacyofTrastuzumabASecondaryAnalysisoftheHERATrialShereneLoi,MD,PhD;UraniaDafni,ScD;DimitrisKarlis,PhD;VarvaraPolydoropoulou,MSc;BrandonM.Young,BSc;ScooterWillis,PhD;BradleyLong,BSc;Evandrode
2、Azambuja,MD,PhD;ChristosSotiriou,MD,PhD;GiuseppeViale,MD;JosefRüschoff,MD;MartineJ.Piccart,MD,PhD;MitchDowsett,PhD;StefanMichiels,PhD;BrianLeyland-Jones,MDInvitedCommentaryIMPORTANCEAnumberofstudiessuggestthatresponsetoantihumanepidermalgrowthSupplementalcontentatfactorreceptor-2(currentlyknownasE
3、RBB2,butreferredtoasHER2inthisstudy)agentsjamaoncology.comdiffersbyestrogenreceptor(ER)levelstatus.Theclinicalrelevanceofthisisunknown.OBJECTIVETodeterminethemagnitudeoftrastuzumabbenefitaccordingtoquantitativelevelsofERandHER2intheHERceptinAdjuvant(HERA)trial.DESIGN,SETTING,ANDPARTICIPANTSTheHERA
4、trialwasaninternational,multicenter,randomizedtrialthatincluded5099patientswithearly-stageHER2-positivebreastcancer,randomizedbetween2001and2005toreceiveeithernotrastuzumabortrastuzumab,afteradjuvantchemotherapy.ThisisasecondaryanalysisoftheHERAstudy.LocalERimmunohistochemical(IHC)analyses,HER2flu
5、orescenceinsituhybridization(FISH)ratio,andcopynumberresultswereavailablefor3037patients(59.6%)randomizedtoobservationandtrastuzumab(1or2years)(cohort1).TranscriptlevelsofESR1andHER2geneswereavailablefor615patients(12.1%)(cohort2).INTERVENTIONSPatientswererandomizedtoreceiveeithernotrastuzumabor1y
6、earvs2yearsoftrastuzumab.Endocrinetherapywasgiventopatientswithhormonereceptor–positivediseaseasperlocalguidelines.MAINOUTCOMESANDMEASURESDisease-freesurvival(DFS)andoverallsurvival(OS)weretheprimaryandsecondaryendpointsintheintent-to-treatpopulation(ITT).Analysesadjustingforcrossover(censoredandi
7、nverseprobabilityweighted[IPW])werealsoperformed.Interactionsamongtreatment,ERstatus,andHER2amplificationusingpredefinedcutoffswereassessedinCoxproportionalhazardsregressionmodels.RESULTSMedianfollow-uptimewas8ye
