A Phase II Trial of the Epothilone B Analog Ixabepilone (BMS-247550) in Patients with Metastatic Melanoma 英文参考文献.docVIP

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A Phase II Trial of the Epothilone B Analog Ixabepilone (BMS-247550) in Patients with Metastatic Melanoma 英文参考文献.doc

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A Phase II Trial of the Epothilone B Analog Ixabepilone (BMS-247550) in Patients with Metastatic Melanoma 英文参考文献

APhaseIITrialoftheEpothiloneBAnalogIxabepilone (BMS-247550)inPatientswithMetastaticMelanoma PatrickA.Ott1,AnneHamilton2,3,AmandaJones1,NaomiHaas4,TsiporahShore5,SandraLiddell2,PaulJ. Christos6,L.AustinDoyle7,MichaelMillward8,FrancoM.Muggia1,AnnaC.Pavlick1* 1DepartmentofMedicalOncology,NewYorkUniversityCancerInstitute,NewYork,NewYork,UnitedStatesofAmerica,2RoyalPrinceAlfredHospital,SydneyCancer Centre,Sydney,Australia,3SydneyMelanomaUnitandUniversityofSydney,Sydney,Australia,4DivisionofHematology/Oncology,AbramsonCancerCenter,University of Pennsylvania, Philadelphia, Pennsylvania, United States of America, 5Division of Hematology/Oncology, Weill Cornell Medical College and New York Presbyterian Hospital,NewYork,NewYork,UnitedStatesofAmerica,6DivisionofBiostatisticsandEpidemiology,WeillCornellMedicalCollege,NewYork,NewYork,UnitedStatesof America,7InvestigationalDrugBranch,NationalCancerInstitute,Bethesda,Maryland,UnitedStatesofAmerica,8DepartmentofMedicalOncology,CharlesGairdner HospitalandUniversityofWesternAustralia,Perth,Australia Abstract Background:Ixabepilone(BMS-247550),anepothiloneBanalog,isamicrotubulestabilizingagentwhichhasshownactivity inseveraldifferenttumortypesandpreclinicalmodelsinmelanoma.Inanopenlabel,one-arm,multi-centerphaseIItrial the efficacy and toxicity of this epothilone was investigated in two different cohorts: chemotherapy-na?¨ve (previously untreated)andpreviouslytreatedpatientswithmetastaticmelanoma. Methodology/Principal Findings: Eligible patients had histologically-confirmed stage IV melanoma, with an ECOG performancestatusof0to2.Ixabepilonewasadministeredatadoseof20mg/m2ondays1,8,and15duringeach28-day cycle. The primary endpoint was response rate (RR); secondary endpoints were time to progression (TTP) and toxicity. Twenty-fourpatientswereenrolledand23wereevaluableforresponse.Initialserumlactatedehydrogenase(LDH)levels wereelevatedin6/11(55%)ofthepreviouslytreatedandin5/13(38%)ofthepreviouslyuntreatedpatients.Nocomplete orpartialres