Benefits and risks of BCG maintenanc the

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1、BenefitsandrisksofBCGmaintenancetherapy:DonLamm,M.D.ProfessorofUrologyMayoClinic,ScottsdaleArizona,USAWhichregimenforwhichpatient?ProgressinBladderCancerIncidenceupfrom14.6/100,000in1973to16.5in1997(adjustedto1970population)Mortalitydownfrom4.2/100

2、,000in1973to3.2in1997;5yrsurvival53%in1950,82%1997Oneofonly5cancers(Testis-5.1;Bladder-1.3;Breast-0.3;Ovary-0.5;Thyroid-1.1)withincreasedincidenceandreducedmortalitySEER,2000Thiotepa:ControlledStudiesAuthornControlThio%pBurnand5197%58%39%0.001Byar

3、8660%47%13%0.016Nocks4264%65%-1%nsAsahi13441%40%1%nsSchulman20969%59%10%nsKoontz9366%39%27%0.02Zincke5871%30%41%0.002Prout9076%64%12%0.05MRC36737%40%-3%nsNetto3480%43%37%nsHirao9346%15%31%0.002Total125760.6%44%16,6%SummaryofControlledChemotherapyTria

4、lsAgentSeries/n%(range)p<0.05Thiotepa1257/1116.6%(-3-41)6/11Thiotepa1257/1116.2%(5-39)4/8Mitomycin1384/613.9%(1-42)3/6Ethoglucid226/120.0%1/1Epirubicin985/619.6%(9-26)3/6Total2297/3217.0%(-3-42)17/32ControlledBCGTrialsAuthorNo.No.RxBCGBEN.pLamm'8557

5、52%20%32%<0.001Herr'858695%42%53%<0.001Herr(CIS)'8649100%35%65%<0.001Yamamoto'904467%17%50%<0.05Pagano'9113383%26%57%<0.001Mekelos'934959%32%27%<0.02Krege'9622448%29%24%<0.05Total68772%28%44%LammDL:NEnglJMed.1991;325:1205Percentageofpatients012243648

6、6072Timeafterregistration,months100806040200BCGvs.Doxorubicin:TimetoTreatmentFailuren5-yearRFSBCGCIS6445%BCGTa,T16337%DoxorubicinTa,T16718%DoxorubicinCIS6817%BCGvs.MMCStudiesBohleA.,JUrolJan03BCGRec.MMCBCGPvalueAuthor/year4%vs34%+30<0.01Pagano'8728

7、%vs62%+34<0.001Finnblad'8961%vs80%+19nsLee'9247%vs42%-5nsWitjes'9464%vs42%-21Vegt'9546%vs43%-3nsVegt'9543%vs56%+9<0.01SWOG'9651%vs66%+15<0.01Malmstr.'9624%vs29%+5nsKrege'9638%vs62%+24<0.001Ayed'9832%vs54%+22<0.001Milan'0013%vs26%+13<0.01Nogueira'0136

8、.7%of781vs53.8%of771(+17%)inmaintenanceBCGstudies.6/6maintenanceBCGstudiessignificantvs1/5non-maint.0123455yearTumorRecurrenceCurveswithChemotherapyvsControlEORTC/MRCChemotherapyControl1009080706050403020100Time(Years)PercentTumorFreeImprovingBCGImm