Mugur Grasu MD, PhDRadiology, Medical Imaging and Interventional Radiology – Fundeni Clinical
Institute
University of Medicine and Pharmacy - Carol Davila – Bucharest
� depends on a variety of factors:
� the size, number, distribution (unilobar vs. bilobar )
of tumors
� the relationship of the tumor to hepatic vasculature
� the status of distant metastases
� the severity of liver disease (Child-Pugh score)
� the suitability of the patient for liver transplantation
� the functional status of the patient
� local expertise
Memeo, R., de Blasi, V., Cherkaoui, Z. et al. J Gastrointest Canc (2016) 47: 239. doi:10.1007/s12029-016-9840-6
Portal pressure/
bilirubin
HCC
PEI/RFA Sorafenib
Stage 0
PST 0, Child–Pugh A
Very early stage (0)
1 HCC < 2 cm
Carcinoma in situ
Early stage (A)
1 HCC or 3 nodules
< 3 cm, PST 0
End stage (D)
Liver transplantation TACEResection
Target: 10%
OS < 3 months
Curative treatments (30%)
Median OS > 60 mo; 5-year survival (40–70%)Target: 20%
OS 20 mo (45-14)
Associated diseases
YesNo
3 nodules ≤ 3 cm
Increased
Normal
1 HCC
Stage D
PST > 2, Child–Pugh C
Intermediate stage (B)
Multinodular,
PST 0
Advanced stage (C)
Portal invasion,
N1, M1, PST 1–2
Stage A–C
PST 0–2, Child–Pugh A–B
Barcelona Clinic for Liver Cancer (BCLC)
staging system and treatment strategy
AASLD = American Association for the Study of Liver Diseases; PEI = percutaneous ethanol injection;
PST = Performance Status test; RFA = radiofrequency ablation.
Target: 40%
OS 11 mo (6-14)
Best supportive care
� BCLC – B class – multinodular, asymptomatic,
without an invasive pattern
� Untreated patients – median survival 16 mo
or 49% at 2 year
� 11 mo – worst scenario of untreated patients
(placebo arm of SHARP trial)
� TACE extends survival – median up to 19-20
mo
� Best responders to TACE 36-45 mo
� Ascites is the worst prognostic factor for this
subclass
Llovet, Lancet 2002 Lo, Hepatology 2002
Llovet JM, et al. Lancet. 2002;359:1734-9. Lo CM, et al. Hepatology. 2002;35:1164-71.
Treatment Patients 1 year 2 years 3 years
TACE 40 57 % 31 % 26 %
Control 39 32 % 11 % 3 %
Lo CM, et al. Hepatology. 2002;35:1164-71.
Intermediate stage HCC population:
indication and contraindications for TACE
� Treatment of
intermediate
stage (BCLC B)
HCC
� Decompensated cirrhosis
including:
� jaundice
� clinical encephalopathy
� refractory ascites
� hepatorenal syndrome
� Extensive tumor with massive
replacement of both entire
lobes
� Severely reduced portal vein
flow
� Technical contraindications to
hepatic intra-arterial treatment
� Renal insufficiency (creatinine ≥
2 mg/dL
IndicationAbsolute
contraindications
Relative contraindications
• Tumor size ≥ 10 cm
• Comorbiditiesinvolving compromised organ function
• Untreated varices at high risk of bleeding
• Bile-duct occlusion or incompetent papilla due to stent or surgery
Raoul JL, Sangro B, Forner A, Mazzaferro V, Piscaglia F, Bolondi L, et al. – Evolving strategies for the management of intermediate-stage hepatocellularcarcinoma: Available evidence and expert opinion on the use of transarterial chemoembolization. Cancer Treat Rev 2011;37:212–220.
� IMAGING - preferably within 4 weeks of the planned TACE (max 8 weeks), not only for the purpose of patient triage to proper therapy, but also to accurately evaluate response to the treatment.� MRI
� CT (at least 3 phases postcontrast)
� STAGING (thorax, abdomen and pelvis)
� BONE SCAN� BLOOD TESTS (bilirubin < 2 mg/dl !)� INFORMATION FOR THE PATIENT
� Palliative treatment
� 5-7% complications, 1-4% periprocedural death
� Femoral approach– 4-5F catheter
� Diagnostic angiograpphy
� Mesenteric artery evaluation
� Indirect portal vein evaluation
� Selective catheterization of lobar or
segmental hepatic artery
� Inject – Lipiodol and Doxorubicin
� EMBOLISATION
Hepatic angiography – Hepatic artery with origin from SMA
Right Hepatic angiography – HCC in segment VI
L
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D
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L
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P
T
A
K
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B
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F
O
R
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T
A
C
E
1 MONTH FOLLOW-UP
M, 64y –
Child-Pugh
A
HCC right
lobe
27 Jul 2016
M, 64y –
Child-Pugh
A
HCC right
lobe
27 Jul 2016
M, 64y –
Child-Pugh
A
HCC right
lobe
27 Jul 2016
M, 64y – Child-Pugh A HCC right lobe - 19 Jan 2017
Lencioni R. Personal communication.
Hong K, et al. Clin Cancer Res. 2006;12:2563-7.
www.biocompatibles.com.
From
Non-selective
treatment of the
entire liver
parenchyma
To
Selective treatment
(segmental
approaches with
microcatheters)
From
“Homemade” drug-
in-oil emulsions and
embolic agents
(“conventional”
TACE)
To
Drug-eluting bead
(calibrated embolic
microsphere)
TACE: an evolving technique toward
improving the treatment of HCC
M, 54y – Child-Pugh B – 4 HCCs - May 2016
M, 54y – Child-Pugh B – DEB-DOX – HCC sg. VII - May 2016
M, 54y – Child-Pugh B – DEB-DOX – HCC sg. VII - May 2016
M, 54y – Child-Pugh B – DEB-DOX – HCC sg. VII - May 2016
M, 54y – Child-Pugh B
6 weeks Follow-up after DEB-DOX – HCC sg. VII
Before DEBDOX After DEBDOX
M, 54y – Child-Pugh B – DEB-DOX II – HCC sg. IV - May 2016
Post TACE
Post TACE6 weeks
Post TACE3 months
Pre TACE
Pre TACE
M, 54y – Child-Pugh B
6 weeks Follow-up after DEB-DOX II – HCC sg. IV
Pre TACE Post TACE2 months
Pre TACE
Post TACE4 months
Pre TACE Post TACE
Segment ISegment IV
NO LESIONS
4 PROCEDURES
� An important limitation of conventional TACE
has been the inconsistency in the technique and
the treatment schedules.
� This limitation has greatly hampered the acceptance
of TACE as a standard oncology treatment.
� DEBDOX provides levels of consistency and
repeatability not available with conventional
TACE, and offers the opportunity to implement a
standardized approach to HCC treatment.
Consensus Meeting – European Conference on Interventional Oncology in Florence, Italy
Technical recommendations for the use of DEBDOX in HCC treatment.
� Intra-arterial administration of chemotherapy associated with� nausea
� vomiting
� bone marrow depression
� alopecia
� potential renal failure
� Post-embolization syndrome occurs in 60-80% of patients� consists of fever, abdominal pain, and a moderate degree of ileus
� fasting for 24 hours and i.v. rehydration are mandatory
� prophylactic antibiotics not routinely used (?!)
� usually self-limited in < 48 hours and patients can be discharged from hospital
� fever reflective of tumor necrosis
� minority of patients may develop severe infectious complications such as hepatic abscess or cholecystitis
� in a multicenter study including 201 European
patients (PRECISION V), use of DEBDOX
resulted in a marked and statistically
significant reduction in liver toxicity and
drug-related adverse events compared with
conventional TACE with lipiodol and
doxorubicin
SAE Comparison : Conventional TACE vs PRECISION TACE
� Water-in-oil emulsion of Doxorubicin (30-100
mg) and Lipiodol (10-15 ml.)
� 1 volume Doxo+contrast / 2 volume Lipiodol
� Selective / ultraselective embolization with
microcatheters (2.8-2.0F) – improves survival
� CBCT – add-on tool for a more targeted
procedure
� A set of 2 sequential TACE procedures are
usually performed 2-8 weeks apart
� CT – after 1 month - mRECIST
� Lipiodol UPTAKE
� Residual tumoral tissue
� MRI – after 3 months
� New lesions ?
� Residual tumoral tissue
Raoul JL, Sangro B, Forner A, Mazzaferro V, Piscaglia F, Bolondi L, et al. – Evolving strategies for the
management of intermediate-stage hepatocellular carcinoma: Available evidence and expert opinion on
the use of transarterial chemoembolization. Cancer Treat Rev 2011;37:212–220.
Schematic diagram showing variable mRECIST objective response, with stable disease by RECISTA radiologist’s guide to the modified Response Evaluation Criteria in Solid Tumours (mRECIST) assessment of therapy for hepatocellular carcinoma – ECR 2011 C2120
HCC in segment VIII
1 mo FU – partial response mRECIST 18 moFU – partial response RECIST
1 mo follow-up
HCC in segment VII
NO Arterial enhancement
mRECIST - CR
� 376 TACE 2016
� 207 DEB-TACE (TANDEM and PearLife)
� 123 cTACE hyperselective
� 46 lobar cTACE
� TACE is the GOLD standard of care for patients with
intermediate stage HCC – BCLC-B
� However, only a limited patient population derives
maximum benefit from TACE
� DEB-TACE – increases overall survival – 36-45 months
� is generally well tolerated and effective
� may offer a benefit to patients with more advanced
disease within the intermediate stage of HCC
compared with cTACE
� Guidelines and expert opinion articles indicate that not
all intermediate HCC patients are suitable candidates
for TACE
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