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1、TheProstateComparisonofAbirateroneAcetateVersusKetoconazoleinPatientswithMetastaticCastrationResistantProstateCancerRefractorytoDocetaxel1233AvivitPeer,MayaGottfried,VictoriaSinibaldi,MichaelA.Carducci,345MarioA.Eisenberger,AvishaySella,RayaLeibowitz-Amit,
2、52RaananBerger,andDanielKeizman*1DepartmentofOncology,RambamMedicalCenter,Haifa,Israel2DepartmentofOncology,MeirMedicalCenter,KfarSaba,Israel3SidneyKimmelComprehensiveCancerCenteratJohnsHopkins,Baltimore,MD4DepartmentofOncology,AsafHarofeMedicalCenter,Zeri
3、f
4、n,Israel5DepartmentofOncology,ShebaMedicalCenter,TelHashomer,IsraelBACKGROUND.Abiraterone,apotentCYP17inhibitor,isstandardtreatmentindocetaxelrefractory,metastaticcastrateresistantprostatecancer(mCRPC).However,incountrieswhereabirateronehasnotbeenapprove
5、dyet,orforpatientswhocannotaffordit,ketoconazoleisusedasanalternativeCYP17inhibitor.AlthoughpreclinicaldatasuggeststhatketoconazoleisalesspotentinhibitorofCYP17,therearelimitedclinicaldatacomparingbothagents.Weaimedtocomparetheclinicaleffectivenessofabirat
6、eroneversusketoconazoleindocetaxelrefractorymCRPC.METHODS.RecordsfrommCRPCpatientstreatedwithketoconazole(internationalmulti-centerdatabase,n¼162)werereviewedretrospectively.Twenty-sixpatientstreatedpostdocetaxelwereindividuallymatchedbyclinicopathologicfa
7、ctorstopatientstreatedwithabiraterone(nationalmulticenterdatabase,n¼140).WecomparedthePSAresponse,biochemicalandradiologicalprogressionfreesurvival(PFS),andoverallsurvival(OS)betweenthegroups.PFSandOSweredeterminedbyCoxregression.RESULTS.Thegroupswerematch
8、edbyGleasonscore,pre-treatmentdiseaseextent,ECOGPS,pre-treatmentriskcategory(Keizman,Oncologist2012).Furthermore,theywerebalancedregardingotherknownconfoundingriskfactors.Inthegroupsofabirateroneversusketoconazole,PSAresponsewas46%versus19%(OR4.3,P¼0.04),m
9、edianbiochemicalPFS7versus2months(HR1.54,P¼0.02),medianradiologicalPFS8versus2.5months(HR1.8,P¼0.043),medianOS19versus11months(HR0.53,P¼0.79),andtreatmentinterruptiond/tsevereadverseevents8%(n¼2)versus31%(n¼8
