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1、530RandomizedPhaseIIStudyofAtrasentanAloneorinCombinationWithZoledronicAcidinMenWithMetastaticProstateCancerM.DrorMichaelson,MD,PhD1BACKGROUND.MetastaticprostatecancerischaracterizedbythepresenceofDonaldS.Kaufman,1osteoblasticbonemetastases.Bonemetas
2、tasesaccountformostofthemorbidityMDPhilipKantoff,2fromthisdisease.InhibitionofosteoclastactivitywiththepotentbisphosphonateMDWilliamK.Oh,2zoledronicacidreducesskeletalcomplicationsanddecreasesserumlevelsofbio-MDMatthewR.Smith,1chemicalboneturnovermar
3、kerscomparedwithplacebo.Atrasentanisaninves-MD,PhDtigationalagentthatinhibitsendothelin-1receptor,resultingindecreased1DepartmentofHematology/Oncology,Massachu-osteoblastactivity.settsGeneralHospital,Boston,Massachusetts.METHODS.Theeffectsofatrasenta
4、naloneversuscombinationtherapywithatra-2sentanandzoledronicacidwereinvestigatedonboneturnovermarkersinmenDanaFarberCancerInstitute,Boston,Massa-chusetts.withbonemetastasesfromprostatecancer.Forty-fourmenwererandomizedtoreceiveeitheratrasentanaloneorc
5、ombinationtherapy,and33completedatleast12weeksoftreatmentandwereincludedintheprimaryanalysis.RESULTS.TreatmentwiththecombinationresultedinsignificantlylowerserumlevelsofN-telopeptide,amarkerofboneresorption,comparedwithtreatmentwithatrasentanalone.Th
6、erewasnodifferencebetweengroupsinserumlevelsofbone-specificalkalinephosphatase,amarkerofboneformation,at12weeks.Commonlyobservedadverseeffectswereedema,rhinitis,fatigue,andshortnessofbreath,mostofwhichwereNCICTC(version3.0)Grade1.NoGrade4or5treatment
7、-relatedtoxicitieswereobserved.Therewasminimalclinicalefficacy,withnoobjectiveresponsesandonly1prostate-specificantigen(PSA)response.CONCLUSIONS.Thereisnoevidenceforadditiveorsynergisticeffectsofcombina-tiontherapywithatrasentanandzoledronicacidonbon
8、eturnovermarkersinmenwithmetastaticprostatecancer.Cancer2006;107:530–5.Ó2006AmericanCancerSociety.KEYWORDS:bonemetastases,osteoporosis,bisphosphonates,alkalinephospha-tase,N-telopeptide.Metastaticprostatecancerisaleadingcauseofmorbidityandmortalityam
