Transcript Diapositiva 1

4 YEARS SURVIVAL OF 100 HCC PATIENTS TREATED
WITH DC BEAD: A RETROSPECTIVE ANALYSIS
Marta Burrel
Vascular Interventional Unit
Barcelona Clinic Liver Cancer Group
Hospital Clínic. Barcelona, Spain.
BCLC Classification and Treatment Schedule
HCC
Stage 0
Stage D
Stage A-C
PST 0, Child-Pugh A
Very early stage (0)
Okuda 1-2, PST 0-2, Child-Pugh A-B
Early stage ( A)
Single< 2cm. Single or 3 nodules < 3cm, PS 0
Carcinoma in situ
Single
Intermediate stage ( B)
Multinodular, PS 0
Okuda 3, PST >2, Child-Pugh C
Terminal
Portal invasion, N1,M1, PS 1-2 stage (D)
Advanced stage (C)
3 nodules <3cm
Portal pressure/ bilirubin
Associated diseases
Increased
Normal
Resection
No
Liver Transplantation
(CLT / LDLT)
Yes
PEI/RF
Curative Treatments: 50% - 75% at 5 years
TACE
Sorafenib
RCT: 40% - 50% at 3 yr
vs 10% at 3yr
Symptomatic treatment
Forner et al. Semin Liver Dis. 2010 Feb;30(1):61-744
Lipiodol TACE improves survival in a selected group of HCC patients
Survival probability
1 year
2 years
Survival probability
TACE
Control
57%
31%
32%
11%
TACE
1 year
2 years
82%
63%
Control
63%
27%
35% objective response > 6 months
Independent prognostic factor
Lo et al. Hepatology 200235(5):1164-71
Llovet et al. Lancet 200218;359(9319):1734-9
Systematic Review of RCT for Unresectable HCC
Random effects model (DerSimonian & Laird) OR (95% CI)
0.01
Author,Journal, year
0.1
0.5
1
2
10
100
Cumulative (pts)
Lin, Gastroenterology 1988
63
GETCH, NEJM 1995
159
Bruix , Hepatology 1998
239
Pelletier, J Hepatol 1998
312
Lo, Hepatology 2002
391
Llovet, Lancet 2002
503
OVERALL
2p=0.086
503
2p=0.017
Heterogeneity: Q:7.73 P=0.14
Median survival : ~ 20 months
Llovet and Bruix. Hepatology 2002
Favors treatment
Favors control
Cohort studies with TACE-DC Beads
. Improved Objective Response
. Better tolerance
Varela 2007
J Hepatology
Poon 2007
Clin Gastroenterol
Hepatology
Malagari 2008
CVIR
# patients
27
35
62
Tumor size (mm)
46 (8-150)
76 (25-220)
56 (30-90)
Tumor response
RC 29%
RP 75%
RO (IT) 66,6%
RC 14,3%
RO 42,9%
RC 12,2%
RO 80,7%
Survival
12 m
92,5%
24 m
88,9%
12 m 24 m 30 m
97% 91% 88%
Chemoembolization vs Bland Embolization
Compensate cirrhosis
Child-Pugh A –B
ECOG o-1
Number of nodules
Randomization
N=87
Bland
No difference in both groups
Embolization
(n=41)
TACE with DCB
(n=43)
TACE-DEB better than Bland Embolization
• Local response. Overall Response (p=0.04)
• Fewer recurrence. At 9 months (p=0.002)
• Longer TTP (p=0.008)
Malagari et al.Cardiovasc Intervent Radiol. 2010 Jun;33(3):541-51. Epub 2009 Nov 24.
TACE - DC Beads: Randomised Studies
Precision V
End Point: Negative
Doxorubicin-Related Side Effects:
Lammer et al. Cardiovasc Intervent Radiol (2010), 33(1):41-52
SURVIVAL DATA AFTER TACE IN PATIENTS
WITH HEPATOCELLULAR CARCINOMA (HCC) IN 2010:
IMPACT ON CLINICAL PRACTICE AND RESEARCH
OBJECTIVES
- Evaluate the survival of HCC patients treated with TACEDEB following a strict selection (preserved liver function,
absence of cancer related symptoms, extrahepatic spread or
vascular invasion)
- Evaluate causes of untreatable progression (UTP)
PATIENTS AND METHOD
HCC patients treated by TACE-DEB between February 2004
and March 2010
Retrospective review of:
- baseline characteristics
- development of treatment related adverse events
- overall survival
RESULTS
- 97 patients evaluated
- Median follow up 24.4 months (2.6-79.6)
- At the time of evaluation
31 patients had died
2 received transplantation
22 had received Sorafenib because of progression not
amenable for TACE
Results: Characteristics of patients
All (n=97)
BCLC-A
(n=46)
BCLC-B
(n=51)
68,2 [34-81]
68,2 [4280]
67 [34-81]
85/12
39/7
46/5
58/23/4/12
27/11/6/ 2
31/13/3/4
Child-Pugh (A/B/C)
93/4
45/1
48/3
BCLC stage (A/B)
46/51
46/0
0/51
Bilirrubin (mg/dl)
1 [0,4-2,8]
1 [0,4-2,8]
0,85 [0,42,4]
Albumin (g/dL)
42 [29-64]
40,5 [3147]
42 [29-64]
AFP (ng/ ml)
15,5
[1-78847]
11,5
[1-2422]
18,5
[1-78847]
Characteristic
Age (years)
Gender (male / female)
Etiology
(VHC/Alcohol/others)
Results: Survival
Median whole cohort survival :
47.7 months (95%CI: 36.6-58.8)
Función de
supervivencia
Censurado
1,0
0,8
0,6
0,4
0,2
0,0
0,00
20,00
40,00
Survival (months)
60,00
80,00
Results: Survival
OS 54.2 months for stage A
OS 40.2 months for stage B
Survival after censoring follow-up at the time of transplant or Sorafenib
40.2 months for BCLC A
31.9 months for BCLC B
Results: Complications
n=10
Early (<1 month)
• Abscess
• Ischemic cholecystitis
• Subcapsular hematoma
• Severe pain
• Pancreatitis
• Hepatic artery dissection
1
1
1
1
1
1
Late ( >1 month)
• Hepatic artery dissection
• Biliary dilatation
• Abscess
1
1
2
Related death
1
Evolutionary events after TACE
The untreatable progression concept
TACE
No objective response
2nd-line option
Objective response
Retreatment strategy
Progression
Treatable
(i.e. additional small HCC)
TACE
Untreatable
(i.e. vascular invasion, M1)
or
Liver failure/contraindication
HCC progression controlled
Prof Bruix.Personal communication
Causes of untreatable progression leading to Sorafenib
administration
n= 22
• Significant progression after TACE
• Biliary dilatation related to tumor
• Extrahepatic spread
• Technically not feasible
• Intolerance to previous TACE-DEB
10
3
5
3
1
Precision V: Potential patients with UTP
J Lammer et al. Cardiovasc Intervent Radiol. 2010 Feb;33(1):41-52.
CONCLUSIONS
1. Current survival of non-ressectable HCC patients within
stages A and B is 47,7 months
2. Current survival of BCLC B patients is 40,2 months
3. These new data update the previous survival results
obtained from Lipiodol-TACE, which impacts in clinical
practice and research purposes