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Advanced Hepatocellular and
Renal Cell Carcinomas: Updated Data in
Specific Patient Populations
Based on presentations from the
44th Annual Meeting of the
American Society of Clinical Oncology (ASCO)
May 30-June 3, 2008
Chicago, Illinois
Responses to Sorafenib According to Resistance
IM-RES
(n=6)
IM/SU-RES
(n=23)
Overall
(n=29)
CR
0 (0%)
0 (0%)
0 (0%)
PR
1 (17%)
3 (13%)
4 (14%)
SD
3 (50%)
15 (65%)
18 (62%)
Disease control:
CR+PR+SD
4 (67%)
18 (78%)
22 (76%)
Adapted from Wiebe et al. ASCO 2008, abstract 10502.
Toxicities Developed After Sorafenib
Treatment (n=29)
Grade 3
(% patients)
Grade 4
(% patients)
Hypertension
24
-
Hand-foot
24
-
Rash
Diarrhea
Fatigue
Hemorrhage
Thrombosis
Perforation
17
10
7
7
3
3
-
Anemia
3
-
Adapted from Wiebe et al. ASCO 2008, abstract 10502.
Cardiac-related Grade ≥3 Adverse Events
≥65 years
(n=1131)
<65 years
(n=1361)
Hypertension
5
5
Cardiac ischemia
1
1
Hypotension
1
0.3
Cardiac arrhythmia
1
0.2
Adverse events (%)
Adapted from Bukowski et al. ASCO 2008, abstract 5045.
Cost-effectiveness Results
First-line treatment
Life-years gained
(discounted)
Total costs
(discounted)
Incermental LYG
Mean*
Standard deviation
Mean*
Standard deviation
Best
supportive care
1.06
0.10
$8,161
$1,408
0.53
Sorafenib
1.59
0.18
$41,782
$3,292
Incermental costs
$33,621
Incermental cost per LYG
$63,436
*Probabilistic mean
Adapted from Muzbek et al. ASCO 2008, abstract 6527.
RECIST Response by ECOG PS
Percentage of patients
PS 0
PS 1-2
sorafenib
(n=161)
Placebo
(n=164)
Sorafenib
(n=138)
Placebo
(n=139)
ORR (CR + PR)
2.5
0.6
2.2
0.7
SD
77.6
70.1
62.3
64.0
PD
13.7
25.6
23.2
22.3
Not assessable
6.2
3.7
12.3
13.0
DCR
46.6
36.0
39.9
26.6
Adapted from Raoul et al. ASCO 2008, abstract 4587.
SHARP: Baseline Patient Characteristics
MVI/EHS present
(n=421)
MVI/EHS absent
(n=181)
Characteristics
Sorafenib
(n=209)
Placebo
(n=90)
Sorafenib
(n=90)
Placebo
(n=91)
Median age (range), years
66 (21-84)
68 (21-82)
67 (21-89)
70 (39-86)
Male/female, %
ECOG PS, %
0
1-2
Region
(Europe/North/other), %
Etiology, %
Viral hepatitis
(HBV/HCV)
Alcohol/other
Child-Pugh class (A/B), %
BCLC stage (B/C), %
MVI (yes/no), %
EHS (yes/no), %
88/12
88/12
86/14
86/14
51
49
53
47
60
40
56
44
86/11/3
87/9/4
93/4/2
87/10/3
18/26
26/30
20/25
24/31
20/37
27/17
13/32
33/22
94/5
0/100
52/48
76/24
99/1
0/100
58/42
71/29
97/3
60/40
0/100
0/100
97/3
56/44
0/100
0/100
Adapted from Sherman et al. ASCO 2008, abstract 4584.
SHARP:
RECIST Response Stratified by MVI and/or EHS
Percentage of patients
MVI and/or EHS present
MVI and/or EHS absent
Sorafenib
(n=209)
Placebo
(n=212)
Sorafenib
(n=90)
Placebo
(n=91)
ORR (CR + PR)
2.4
0.9
2.2
0
SD
65.6
62.7
82.2
78.0
PD
21.5
27.4
10.0
16.5
Not assessable
10.5
9.0
5.6
5.5
DCR*
41.2
27.8
48.9
40.7
*Disease control rate is defined as the proportion of patients with a best response of CR,
PR or SD by RECIST that is maintained for ≥28 days following demonstration of that
response.
Adapted from Sherman et al. ASCO 2008, abstract 4584.