Gemcitabine治疗晚期非小细胞肺癌的临床研究

Gemcitabine1311123456:Gemcitabine(:)IIIIV(NSCLC):11:1997919985IIIIVNSCLC21,III11,IV101000mg/m2,1,8,15,2821:19971019987IIIIVNSCLC48,III19,IV291000mg/m2,1,8,15;100mg/m2,,28:11:19,6(PR),2(1015%)43115%[95%CI,914%45115%],,418%(1)III,1III611321:41,23(PR),18(4319%)45611%[95%CI,3918%7115%]481/3IIIIV,18175%(9)III39(24137%)819:NSCLC,NSCLC,,NSCLC:/;;:R73412;R730153:A:1000-467X(1999)03-0241-05Gemcitabineinthetreatmentofadvancednon2small2celllungcancerGUANZhong2zhen,CHENRu2qin,XUGuang2chuan,etal.MedicalOncologyDepartmentofCancerCenter,SunYat2senUniversityofMedicalSciences,Guangzhou510060,ChinaAbstractObjective:TheaimofthestudywastoevaluatetheclinicalefficacyandtoxicityofGemcitabinesingle2drugandgemcitabine2cisplatincombinationinadvancednon2small2celllungcancer(NSCLC).Methods:11gemcitabinesingle2drugstudy:Twenty2onepreviouslyuntreatedNSCLCpatientsenteredthetrialfromSeptember1997toMay19981gemcitabine1000mg/m2wasadministeredondays1,8and15ineach282daycycle.21Gemcitabine2Cisplatincombinationstudy:Forty2eightpreviouslyuntreatedNSCLCpatientsenteredthetrialfromOctober1997toJuly19981Gemcitabine1000mg/m2wasadministeredondays1,8and15andCisplatin100mg/m2,onday1ineach282daycycle.Results:11Gemc2itabinesingle2drugstudy:Of19assessablepatients,6achievedapartialresponse(PR),andamongthem2(1015%)wereconfirmedPR.Theoverallresponseratewas3116%(95%confidenceinterval[CI],914%to45115%).21patientscanbeevaluatedthetoxicity.AminorproportionofpatientsexperiencedmildG2Ireaction,leukopenia,thrombocytopeniaanddecreasedhemoglobinlevels.Only418%(1patienteach)ofthepatientsexperiencegradeIIIleukopeniaandnausea/vom2iting.OnepatientexperiencedgradeIIIinfection.Themediansurvivalofthewholegroupwas6113months.21Gemc2itabine2cisplatincombinationstudy:Of41assessablepatients,23achievedapartialresponse(PR),andamongthem18(4319%)wereconfirmedPR.Theoverallresponseratewas5611%(95%confidenceinterval[CI],3918%to7115%).48patientscanbeevaluatedfortoxicity.About1/3ofthepatientsexperiencedgradeIII2IVnausea/vomitingandleukope2niaanddecreasedhemoglobin.18175%(9patients)experiencedgradeIIIthrombocytopenia.Theothertoxicitywasmildandtolerable.39cycles(24137%)ofgemcitabineinjectionsweredose2reducedoromittedduetotoxicity.Themediansurvivalofthewholegroupwas819months.Conclusion:Thesingle2druggemcitabineinducedanobjectiveefficacyinad2vancedNSCLC,withmodestsideeffects.Thegemcitabine2cisqlatincombinationregimewaseffectiveandwelltoleratedinthetreatmentofadvancedNSCLC,itcouldbeconsideredasoneoftherecommendedstandardregime.Keywords:Gemcitabine/TherapeuticUse;NonSmallCellLungCancer(NSCLC);ClinicalTrial:1999-05-05;:1999205210:11(510060)21(,200030)31(,100021)41(,100036)51(,200030)61(510515);;,dFdCTP(),DNADNA,EliLilly,15,16Anderson71999183241©1994-2007ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.http://www.cnki.net332,(PR)20%,III-IV25%,12%,1997623A96029533-16360,,,5,,,,:20(21);40(48)(CDDP)1111(1)/IIIIV,;(2)();(3)(60Gy),,3;(4)(P.S)70;(5);(6)12;(7),;(8)(315109/L,100109/L,Hb910g/dL,,);(9),18;(10);(11)3,;(IUD,)112(1)()(2)(CNS),:115,ALT/AST3(ALTAST5;(3):1125;(4);(5),();(6):5;(7)1131,815,28311000mg/m23060(30)4,1141224,1(109/L)(109/L)%21511021511075507550100752WHO%02(3/)3(/)410075**2.#()115(1)III,(2),/242,.Gemcitabine©1994-2007ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.http://www.cnki.netP.S.,,,,,,(3),2(4):WHO,:CR,PR,SDPDCRPR(5)CRPR,4/,,CRPR,CRPR(Confirmed)SD,4PD,,(6),WHO,11611611:21,19,211,,1732,,11612:14,74377,60KPS701,8010,9010:5,14,1,1:():III11,IV10;10,11;38,21,9,4,4;,4,4,1111613:11,20,16,411614:135-HT31G-CSF/11615:19,6PR(3115%),2(1015%)41CR6(SD),7(PD)8,16;13,19(MedianSurvival)6113Kaplan2Meier11Kaplan2Meier11616:,418%III,33(n=21)0+(%)/1216182020132021118161821111818192120202020352017107932041320110050110100332106100000111000000001000010000000000000000000000000000041800000000418000041800000001999183243©1994-2007ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.http://www.cnki.net11617:21,,,19,,1000mg/m2,3,28,,,III3115%PR,1015%4PR(ConfirmedPR)2211212281,8,151000mg/m2,30601,Cisplatin100mg/m2,30120,,21321421521511:48,41,7,:1,1,;2,11,2,21512:35,133476,58KPS70,3090,210013,33,2III19,IV2921,26,96,44,9,11,10,1,3,12,18,15()21513:18,3,121,39,934132mg/m2DDP153,7,9915mg/m221514:22G-CSF,475-HT3,3721515:41,CR,23PR(5611%),4PR(ConfirmedPR)18,4319%95%2815%6013%,1741815(2)9(SD),9(PD)11,75267,37,,17()345,267Kaplan2Meier33,80%20022924118(4)23244,.Gemcitabine©1994-2007ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.http://www.cnki.net421516:4,1/3III-IV1,,DDP4+DDP(n=48)0+(%)/ALTASTALPBILIRUBIN7444245443844479682045343742384642462046324445404547474747474747454646944042418998164292412221332411111111322160030800141714111853101150301420000000000120200000141413810210000100000000000000004000000032410000001()0000100000000000003313061250000035143313351418175211041221100211021100211000000000000021517:,DDPGem2citabine,/41,23(5611%)PR,18(4319%)ConfirmedPR,369,21,DDP48:,,,3115%PR,1015%PR(ConfirmedPR)DDP48,,,5611%PR,4319%PR(ConfirmedPR),,Gemzar+DDP,,1