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too much, too little, too late to start again- assessing the efficacy of bisphosphonates in patients with bone metastases from breast cancer

too much, too little, too late to start again- assessing the efficacy of bisphosphonates in patients with bone metastases from breast cancer

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页数：21页

时间：2018-10-29

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1、TooMuch,TooLittle,TooLatetoStartAgain?AssessingtheEfficacyofBisphosphonatesinPatientswithBoneMetastasesfromBreastCancer　　LEARNINGOBJECTIVES　　Afterpletingthiscourse,thereaderetastasisinthesettingofadvancedbreastcancer.　　Describetheroleofbisphosphonatesinmanagingbonemetasta

2、sesinthesettingofbreastcancer.　　Discussclinicalendpointsusedtodetermineetastasescanbeadevastatingoccurrenceforanyanetastasescanresultinskeletal-relatedevents(SREs)suchaspathologicfracture,spinalcordpression,andhypercalcemia.Severaltrialshaveconfirmedtheabilityofbisphospho

3、natestoreduceordelaytheseskeletalplications,andtheyshouldnoen.　　TheanalysisofSREsisthetypicalprimaryendpointinbisphosphonatestudies.oststudiesdependonthenumberandtimingofSREstoparethetreatmentandplaceboarms.ThedefinitionofanSREdoesnotincludeendpointsthatareimportanttopati

4、ents:pain,immobility,analgesicuse,andnonhospitalcostssuchasthoseofphysiotherapy[5].Inaddition,manystudiesuseserialplainradiographsintheformofskeletalsurveystodetectasymptomaticfractures,therebydetectingSREsbutignoringpain.Painscores,analgesicconsumption,andqualityoflife(Q

5、oL)scoresareallsubjecttoobserverbiasandaredifficulttopareamongdifferentpatientpopulations.Toalloationofanalgesicandpalliativebenefitsofbisphosphonates,easurementandQoLinstrumentthatincludesdomainsthatareimportanttothepatient.Thispaperrevieeasuresusedinbisphosphonatetrials

6、anddiscussestheirlimitations.　　ENDPOINTSINBISPHOSPHONATETRIALS　　TheU.S.FoodandDrugAdministration’s"regularapproval"isbasedonendpointsthatdemonstratethatadrugprovidesalongerorbetterlifeorthatithasafavorableeffectonanestablishedsurrogate[14].Regulatoryapprovalsforcurrentlya

7、vailablebisphosphonatesostfrequentlyusedprimaryendpointsinbisphosphonatetrials(Table1)[2,8,1527],manydifferentSREscoresareavailable,makingparisonsamongtrialsdifficult.　　First-eventanalysesconsiderinformationforfirstSREsonly.Thistypeofanalysishasbeenusedastheprimaryendpoin

8、tinvariouszoledronicacidandpamidronatestudiesandincludestheproportionofpatientsetofirsteventasse

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