东西方肝癌的分析比较.ppt

东西方肝癌的分析比较
第一页，共四十页。
Asian (n=342)
Non-Asian (n=1350)
Proportion surviving
Time (months)


IV
Spain
102
17M
%
%
0%*
0%*
HK
106
3M
%
%
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
第七页，共四十页。
Randomized trials - octreotide vs placebo
第八页，共四十页。
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
第九页，共四十页。
Phase III SHARP and Asia-Pacific Overall Survival
SorafenibMedian: months(95% CI: , )
Survival Probability
Months
Hazard ratio (sor/pla): (95% CI: , ) P=*
PlaceboMedian: months(95% CI: , )

0



0
20
2
4
6
8
10
12
14
16
18
Survival Probability
SorafenibMedian: months (95% CI: -)
PlaceboMedian: months (95% CI: -)
HR (S/P):
P=




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
第十页，共四十页。
Asia-Pacific Liver Cancer Study vs SHARP:Baseline Patient Characteristics
Asia-Pacific(N=226)
SHARP1(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
Macroscopic 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 .
第十一页，