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Medicine(Baltimore).May;94(17):e.

EfficacyoforalEtoposideinpretreatedmetastaticbreastcancer:amulticenterphase2study.

YuanP,DiL,ZhangX,YanM,WanD,LiL,ZhangY,CaiJ,DaiH,ZhuQ,HongR,XuB.

DepartmentofMedicalOncology,CancerInstituteandHospital,ChineseAcademyofMedicalSciencesandPekingUnionMedicalCollege.

PekingUniversityCancerHospital.

PekingUnionMedicalCollegeHospital,Beijing.

HenanCancerHospital,Zhengzhou.

China-JapanFriendshipHospital,Beijing.

FirstAffiliatedHospitalofDalianMedicalUniversity(LL),Dalian.

BeijingHospitaloftheMinistryofHealth.

ZhejiangCancerHospital.

BeijingChaoYangHospital,Beijing.

ShanghaiPutuoDistrictPeoplesHospital,Shanghai,China.

Nostandardchemotherapyhasbeendefinedformetastaticbreastcancer(MBC)patientspretreatedwithanthracyclinesandtaxanes.Amulticenterphase2studywasconductedtoevaluatethesafetyandefficacyoforaletoposideinpatientswithMBC.Eligiblepatientsweretreatedwithrepeatedcyclesoforaletoposide(60mg/m/dondays1-10,followedby11daysofrest).Theprimaryendpointwasprogression-freesurvival(PFS).Thesecondaryendpointswereobjectiveresponserate,clinicalbenefitrate(CBR),andtoxicityprofiles.Seventy-fivewomenwithMBCwereenrolledat10centersinChina.Seven(9.3%)patientsachievedpartialresponse(PR)and29(38.7%)hadstabledisease(SD).Ninepatients(12%)hadSDfor24weeksandtheCBRwas21.3%(16/75).ThemedianPFSwas4.5(range,1.3-7.7)months.Ofthe38patientswhoreceived≥3regimenspriortothisstudy,2(5.3%)hadPRand3(7.9%)hadSDfor24weeks,withaCBRof13.2%.Thereportedgrade3/4adverseeventsincludedleukopenia(13.3%,n=10),neutropenia(17.9%,n=14),anemia(2.7%,n=2),vomiting(2.6%,n=2),andalopecia(1.3%,n=1).OraletoposidewaseffectiveandwelltoleratedinChinesewomenwithpretreatedMBC.

PMID:

DOI:10./MD.0

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