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4 YEARS SURVIVAL OF 100 HCC PATIENTS TREATED WITH DC BEAD: A RETROSPECTIVE
ANALYSIS
Marta BurrelVascular Interventional Unit
Barcelona Clinic Liver Cancer Group Hospital Clínic. Barcelona, Spain.
Very early stage (0) Single< 2cm.
Carcinoma in situ
HCC
Portal pressure/ bilirubin
Okuda 3, PST >2, Child-Pugh C
Terminal stage (D)
Okuda 1-2, PST 0-2, Child-Pugh A-B
Stage A-C Stage D
Normal
Single 3 nodules <3cm
Associated diseasesIncreased
No Yes
Early stage ( A)Single or 3 nodules < 3cm, PS 0
Intermediate stage ( B)Multinodular, PS 0
Advanced stage (C)Portal invasion, N1,M1, PS 1-2
Stage 0
PST 0, Child-Pugh A
BCLC Classification and Treatment Schedule
Resection PEI/RF SorafenibTACE
Symptomatic treatment
Liver Transplantation (CLT / LDLT)
Curative Treatments: 50% - 75% at 5 years RCT: 40% - 50% at 3 yr vs 10% at 3yr
Forner et al. Semin Liver Dis. 2010 Feb;30(1):61-744
Lo et al. Hepatology 200235(5):1164-71 Llovet et al. Lancet 200218;359(9319):1734-9
Survival probability
TACE Control
1 year 82% 63% 2 years 63% 27%
35% objective response > 6 monthsIndependent prognostic factor
Survival probability
TACE Control
1 year 57% 32% 2 years 31% 11%
Lipiodol TACE improves survival in a selected group of HCC Lipiodol TACE improves survival in a selected group of HCC patientspatients
Favors treatment Favors control
Lin, Gastroenterology 1988 63
GETCH, NEJM 1995 159
Llovet, Lancet 2002 503
Pelletier, J Hepatol 1998 312
Bruix , Hepatology 1998 239
OVERALL 503
1010.10.01 1000.5 2
2p=0.017
Heterogeneity: Q:7.73 P=0.14
Random effects model (DerSimonian & Laird) OR (95% CI)
Author,Journal, year Cumulative (pts)
Lo, Hepatology 2002 391
2p=0.086
Median survival : ~ 20 months
Systematic Review of RCT for Unresectable HCCSystematic Review of RCT for Unresectable HCC
Llovet and Bruix. Hepatology 2002
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 24 m 92,5% 88,9%
12 m 24 m 30 m 97% 91% 88%
Cohort studies with TACE-DC BeadsCohort studies with TACE-DC Beads
. Improved Objective Response
. Better tolerance
Bland
Embolization
(n=41) Compensate cirrhosis Child-Pugh A –B
ECOG o-1Number of nodules
No difference in both groups
Ran
do
miz
atio
n
N=
87
TACE with DCB
(n=43)
Malagari et al.Cardiovasc Intervent Radiol. 2010 Jun;33(3):541-51. Epub 2009 Nov 24.
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)
Chemoembolization vs Bland EmbolizationChemoembolization vs Bland Embolization
Doxorubicin-Related Side Effects:Doxorubicin-Related Side Effects:
Precision V
End Point: Negative
Lammer et al. Cardiovasc Intervent Radiol (2010), 33(1):41-52
TACE - DC Beads: Randomised StudiesTACE - DC Beads: Randomised Studies
SURVIVAL DATA AFTER TACE IN PATIENTS SURVIVAL DATA AFTER TACE IN PATIENTS
WITH HEPATOCELLULAR CARCINOMA (HCC) IN 2010: WITH HEPATOCELLULAR CARCINOMA (HCC) IN 2010:
IMPACT ON CLINICAL PRACTICE AND RESEARCHIMPACT ON CLINICAL PRACTICE AND RESEARCH
OBJECTIVES
- Evaluate the survival of HCC patients treated with TACE-
DEB 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
Characteristic All (n=97)BCLC-A (n=46)
BCLC-B (n=51)
Age (years) 68,2 [34-81]68,2 [42-
80]67 [34-81]
Gender (male / female) 85/12 39/7 46/5
Etiology (VHC/Alcohol/others)
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 [0,4-
2,4]
Albumin (g/dL) 42 [29-64] 40,5 [31-
47]42 [29-64]
AFP (ng/ ml) 15,5
[1-78847]
11,5
[1-2422]
18,5
[1-78847]
Median whole cohort survival : 47.7 months (95%CI: 36.6-58.8)
Results: Survival
Survival (months)80,0060,0040,0020,000,00
1,0
0,8
0,6
0,4
0,2
0,0
Censurado
Función de supervivencia
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 B31.9 months for BCLC B
Results: Survival
Early (<1 month)• Abscess• Ischemic cholecystitis • Subcapsular hematoma• Severe pain • Pancreatitis • Hepatic artery dissection
111111
Late ( >1 month)• Hepatic artery dissection• Biliary dilatation• Abscess
112
Related death 1
n=10
Results: Complications
TACETACE
No objective responseNo objective response Objective responseObjective response
Treatable(i.e. additional small HCC)
Treatable(i.e. additional small HCC) Untreatable
(i.e. vascular invasion, M1)or
Liver failure/contraindication
Untreatable(i.e. vascular invasion, M1)
orLiver failure/contraindicationTACETACE
HCC progression controlledHCC progression controlled
2nd-line option2nd-line option
ProgressionProgression
Retreatment strategyRetreatment strategy
Prof Bruix.Personal communication
Evolutionary events after TACEThe untreatable progression concept
Evolutionary events after TACEThe untreatable progression concept
Causes of untreatable progression leading to Sorafenib administration
• Significant progression after TACE• Biliary dilatation related to tumor• Extrahepatic spread• Technically not feasible• Intolerance to previous TACE-DEB
10
3
5
3
1
n= 22
J Lammer et al. Cardiovasc Intervent Radiol. 2010 Feb;33(1):41-52.
Precision V: Potential patients with UTP
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
CONCLUSIONS