Efficacy of oral Etoposide in pretreated metastatic breast cancer. a multicenter phase 2 study

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1、EfficacyofOralEtoposideinPretreatedMetastaticBreastCancerAMulticenterPhase2StudyPengYuan,MD,LijunDi,MD,XiaohuiZhang,MD,MinYan,MD,DongguiWan,MD,LiLi,MD,YongqiangZhang,MD,JufenCai,MD,HongDai,MD,QiZhu,MD,RuoxiHong,MD,andBingheXu,MDINTRODUCTIONAbstract:Nostandardchemotherapyhasbeendefinedforme

2、tastaticignificantandworldwideprogressintheearlydetectionandbreastcancer(MBC)patientspretreatedwithanthracyclinesandtax-Scomprehensivetreatmentofbreastcancer(BC)hasbeenanes.Amulticenterphase2studywasconductedtoevaluatethesafetymadeinrecentyears.However,ithasbeenestimatedthat30%andefficacyo

3、foraletoposideinpatientswithMBC.ofthepatientsinitiallydiagnosedwithearly-stageBCwillEligiblepatientsweretreatedwithrepeatedcyclesoforaletoposideeventuallydevelopmetastaticbreastcancer(MBC).Inmost2(60mg/m/dondays1–10,followedby11daysofrest).Theprimarycases,MBCremainsanincurabledisease.Ther

4、efore,theendpointwasprogression-freesurvival(PFS).ThesecondaryendpointssystemictreatmentofMBCprolongssurvivalandenhanceswereobjectiveresponserate,clinicalbenefitrate(CBR),andtoxicityqualityoflife,butisnotcurative.profiles.AnthracyclinesandtaxanesarethepreferredcytotoxicSeventy-fivewomenwithM

5、BCwereenrolledat10centersindrugsforthetreatmentofMBC.Otheragents,includingChina.Seven(9.3%)patientsachievedpartialresponse(PR)and29capecitabine,gemcitabine,vinorelbine,andothers,arealso(38.7%)hadstabledisease(SD).Ninepatients(12%)hadSDfor>24availableastreatmentoptionsandcanbeusedincasesth

6、atweeksandtheCBRwas21.3%(16/75).ThemedianPFSwas4.5(range,werepretreatedwithatleastananthracyclineandataxane.1–51.3–7.7)months.Ofthe38patientswhoreceived3regimenspriortoForpatientswhohavefailed3chemotherapyregimens,therethisstudy,2(5.3%)hadPRand3(7.9%)hadSDfor>24weeks,withaarenostandardt

7、herapeuticschedules.MostguidelinessuggestCBRof13.2%.Thereportedgrade3/4adverseeventsincludedleu-bestsupportivetherapyorparticipationinclinicaltrials.kopenia(13.3%,n¼10),neutropenia(17.9%,n¼14),anemia(2.7%,Etoposideisasemisyntheticderivativeofpodophyllotoxinn¼2),vomi