资源描述
Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,*,按一下以編輯母片標題樣式,按一下以編輯母片,第二層,第三層,第四層,第五層,Comparative Analyses of Hepatocellular Carcinoma between East and West,Implication on the design of clinical trials,11,th,CSCO,Shanghai,2008,Ann-Lii Cheng M.D.,Ph.D.,Department of Oncology and Department of Internal Medicine,National Taiwan University Hospital;,Taipei,Taiwan,.,1,Geographic,and,ethnic,factors become important in the era of molecular targeted therapy for cancers,2024/11/20,2,Asian,(n=342),Non-Asian,(n=1350),Proportion surviving,Time(months),0.0,1.0,0.8,0.6,0.4,0.2,0,2,4,6,8,10,12,14,16,0,2,4,6,8,10,12,14,16,Gefitinib,Placebo,Importance of Ethnicity for MTA,the lessons of ISEL trial,2024/11/20,3,EGFR mutation rates in each subgroup,Study,Centre,No.of patients,AdenoCa,(+BAC)(%),M(%),F(%),Smokers(%),n-smokers(%),Taiwan,1,NTUH,62,49,25,61,29,56,Taiwan,2,VGH-T,37,67.4,52,72,44,69,Korea,3,Seoul NU,90,21,9,33,13,26,Japan,4,NCC Tokyo,66,61,53,69,35,68,Japan,5,Aichi CCH,59,64,44,70,42,71,HK,6,Chinese U,72,32,China,7,Pek UMCH,76,48.6,32.3,34.8,Italy,8*,U Chieti,375,10,6,30,7,25,Shih et al,IJC 2005,Chou et al,CCR 2005,Han et al,JCO 2005,Takano et al,JCO 2005,*,only AdenoCa,Mitsudomi et al,JCO 2005,Lung et al,PAACR 2005,Mu et al,CCR 2005,Machetti et al,JCO 2005,2024/11/20,4,Liver Cancer in the World,Ferlay J et al.IARC Press,2001.,Men(396,364)/Women(165,972),North,America(%),2.07/2.61,Central&South,America(%),2.09/4.33,Africa(%),6.90/8.69,Europe(%),8.21/10.45,Asia(%),81.54/74.13,Oceania(%),0.25/0.27,2024/11/20,5,Geographic differences in the results of clinical trials for advanced HCC,2024/11/20,6,Sorafenib,Median:46.3 weeks(10.7 mo),(95%CI:40.9,57.9),Survival Probability,Weeks,Hazard ratio(S/P):0.69,(95%CI:0.55,0.88),P,=0.00058*,PlaceboMedian:34.4 weeks(7.9 mo),(95%CI:29.4,39.4),1.00,0,0.75,0.50,0.25,0,80,8,16,24,32,40,48,56,64,72,0,274,241,205,161,108,67,38,12,0,Patients at risk,Sorafenib:,0,276,224,179,126,78,47,25,7,2,Placebo:,299,303,Phase III SHARP Trial,Overall survival(Intention-to-treat),Llovet J et al,N Engl J Med.2008 Jul 24;359(4):378-90,(7.9 mo),2024/11/20,7,Comparison of Tx(-)Control Arms,Pt,No,Median,OS,PVT,TNM,Stage IV,Okuda,Stage III,ECOG,III/IV,Spain,102,17M,23.5%,54.9%,0%*,0%*,HK,106,3M,60.0%,90.6%,14%,13%,*,Spanish trials excluded“End-stage disease”,Llovet JM,Hepatology 1999;29:62-7,Yeung YP,Am J Gastroenterol 2005;100:1995-2004,EAST,VS,WEST,2024/11/20,8,Randomized trials-octreotide vs placebo,2024/11/20,9,Study Schema,of,SHARP,and,AP,Studies,Sorafenib,400 mg bid,Placebo,Eligibility,Advanced HCC,ECOG 0-2,Child-Pugh A,No prior systemic therapy,Stratification,Macroscopic vascular invasion(portal vein)and/or extrahepatic spread,ECOG PS,Geographic area,R,A,N,D,O,M,I,Z,E,2024/11/20,10,Phase III SHARP and Asia-Pacific Overall Survival,Sorafenib,Median:10.7 months(95%CI:40.9,57.9),Survival Probability,Months,Hazard ratio(sor/pla):0.69,(95%CI:0.55,0.87),P,=0.00058*,Placebo,Median:7.9 months(95%CI:29.4,39.4),1.00,0,0.75,0.50,0.25,0,20,2,4,6,8,10,12,14,16,18,Survival Probability,Sorafenib,Median:6.5 months(95%CI:5.6-7.6),Placebo,Median:4.2 months(95%CI:3.7-5.5),HR(S/P):0.68,95%CI:0.50-0.93,P,=0.014,0.25,0.50,0.75,1.00,0,0,Months,2,4,8,10,12,14,16,20,22,6,18,Llovet JM,et al.,N Engl J Med,2008:359:378-90,Cheng,AL,et al.ASCO 2008,Abstract 4509.,SHARP,Asia-Pacific,11,Asia-Pacific Liver Cancer Study vs SHARP:Baseline Patient Characteristics,Asia-Pacific(N=226),SHARP,1,(N=602),Median age(range),years,51(23-86),67(21-89),Hepatitis virus status(HBV/HCV),%,73/8,18/28,Sex(Male),%,85,87,ECOG PS(0/1/2),%,26/69/5,54/38/8,Macrosc,opic,vascular invasion,%,35,38,Extrahepatic spread,%,69,51,BCLC Stage(B/C),%,4/96,17/82,No.of tumor sites,%,1,11,44,2,35,31,3,20,12,4,35,13,Sites of disease,%,Lung,50,21,Lymph node,32,26,1,Llovet J,et al.,N Engl J Med,2008:359:378-90,.,2024/11/20,12,Llovet JM et al.,Lancet.,2003;362:1907-1917.,End Stage,Advanced Stage,Intermediate Stage,Early Stage,Surgical Treatments,Local Ablation,New Agents,TACE,HCC,(30%),Potentially curative treatments,5-yr survival:50-70%,(50-60%),Randomized trials,median survival if untreated:6-16 mo,(10%),BSC,survival 2 or Child C,PVT(-),PVT(+),Single,2 or 3,3 cm,4,3 cm,ICG good*,ICG bad*,Resection,Ablation,Transplan-tation,TACE,Main PV(-),extra-hepatic spread(-),Main PV(+)or extra-hepatic spread(+),TACE,BSC,New agents,BSC,Bil.,2 mg/dl,Bil.2 mg/dl,Bil.,2 mg/dl,Bil.2 mg/dl,Early stage(single or 3 nodules,3 cm,PS 0),Intermediate stage(multi-nodular,PS 0),Advanced stage(portal invasion,N1,M1,PS 1-2,Terminal stage(PS 2,Child C),NTUH,practice,BCLC guideline,Resection,Ablation,Transplan-tation,TACE,New agents,BSC,Single,PH(-),Multiple,PH(+),2024/11/20,16,Makuuchi M.et al,Hepatology Research 2007,Japan Guideline,Embolization hepatic arterial infusion chemotherapy,2024/11/20,17,Geographic differences in the etiology of HCC,implication in the development of MTAs,2024/11/20,18,Etiology of HCC,Distinct Geographic D
展开阅读全文