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Surgical Resection andAblative Therapies
for Hepatocellular Carcinoma
Kim M. Olthoff, MDAssociate Professor of Surgery
Liver Transplantation and Hepatobiliary SurgeryUniversity of Pennsylvania
Philadelphia, Pennsylvania, USA PennCancer Center
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University of Pennsylvania Medical CenterPenn Transplant Center and Cancer
CenterFirst School of Medicine in United States
First Teaching Hospital in the US2nd Nationally in NIH grand dollars
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Hepatobiliary Tumor ConferenceWeekly multidisciplinary case presentations
• Weekly discussion of all patients with possible hepatobiliary tumors Review history and
imaging Determine options for
treatment
• Review of all pathology Determine adjuvant
therapy
• Follow-up on cases• Potential clinical trials
• Transplant and Hepatobiliary surgeons
• Surgical oncology• GI surgeons• Oncologists• Radiologists• Interventional
radiologists• Nuclear Medicine• Hepatologists
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Background:Hepatocellular carcinoma (HCC)
• One of the most common fatal tumors worldwide 80-90% of primary malignant tumors
• Mostly associated with cirrhosis Rising incidence in US due to Hepatitis C Seen after 20 - 30 years after HCV infection
• In the year 2000 - an estimated 8,000-10,000 deaths in US from HCV
• Mortality rate expected to double or triple by 2015 Much of this mortality due to development of HCC
• Younger population, increasing mortality• 2-8% annual incidence of HCC in HCV cirrhosis• 5 year cumulative incidence 15-20%
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Background:Natural history of HCC in cirrhosis
• Prognosis – not dependent only on tumor stage If “Resectable”
• may exceed 70% 5 yr Untreated intermediate/advanced
• 10-50% 3 yr survival Severity of disease determines
outcome• Child’s A - 82% at 2 years• Child’s B/C - 36% at 2 yrs• Child’s C, large tumors
• no survivors > 6 months
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Tumor surveillanceDefining high risk populations
• Cohort studies Male Advanced age HCV positivity/cirrhosis Functional impairment High AFP
• Other parameters Proliferation rate Irregular regeneration Dysplasia Viral genotype
• Columbo et al NEJM 1991• Tsukuma et al NEJM 1993• Liver Cancer Study Group
Cancer 1994• Bolondi et al Gut 2001• Degos et al Gut 2000• Chen et al Int J Cancer 2002• Esnaola et al Ann Surg
2003
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Tumor surveillance HCC and Alpha Feto-protein (AFP)
• Prognosis of HCC with treatment AFP <15 associated
with better outcome• Fong 1999
AFP > 400 associated with poorer outcome
• CLIP Investigators, 2000
• Prognosis of HCC Rx with OLT Pre-operative AFP not
independently associated with survival
• Iwatsuki 2000,• Shumihito 2001
AFP > 1000 RR=2.96, P=0.04
• Yao, 2001 AFP > 700
• Shetty, 2004
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Tumor surveillance Defining high and low risk populations
Velazquez et al Hepatology March 2003
463 patientsAge 40-65Childs A or B
High risk:Males > 55HCVPT < 75%Plt < 75%
30%
2.3%
UTZ and AFP Q 3-6 mos
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Treatment of HCC “Curative” Treatment Options
• Surgical resection is only proven curative treatment
• Spectrum of therapy• Surgical Options:
Resection OLT
• Nonsurgical “Curative” Options: Ablative therapies
• Percutaneous Ethanol Infusion
• Radiofrequency Ablation• Acetic acid Infusion
• Which is best? Surgery vs. ablation?
• Caveats Only 30% of patients
referred are surgical candidates
No good randomized controlled trials
Apples and oranges Limitation of center
expertise and treatment availability
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Treatment of HCC Limitations of Resection
• Majority of HCC associated with cirrhosis Reduced hepatic reserve
• No accurate way to measure Increased morbidity and
mortality• Mortality now 3-10%
Surgical margins may be compromised
• Multifocal tumors common 20 to 60% of small HCC
• Frequently underestimated
• Recurrence rates high 70-90% by 5 years
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Surgical Resection of HCCPredictors of Recurrence
• 164 patients resected for HCC (99-2001) 55% developed recurrence with median f/u of 26
months• Median time to recurrence - 24 mos
5 yr survival 40%, 25% RF survival• Predictors of recurrence – Univariate
Tumor > 5 cm Multifocality Cirrhosis (40% of patient population) Vascular invasion Tumor satellites
• Predictors of recurrence – Multivariate Vascular invasion
Cha et al JACS 2003MSKCC
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Treatment of HCC Surgical resection and HCC in cirrhosis
0102030405060708090
100
0 20 40 60 80
Months
Pro
babi
lity
(%
)
No Portal pressure, Bili <1
Portal pressure, Bili <1
Portal pressure, Bili 1
Llovet Hepatology 1999; 30:1434-40Patients selected by MazzaferoCriteria and Child’s A cirrhosis
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Surgical Resection of HCCWho are candidates?
• Best candidates Well-compensated liver disease Asymptomatic Single lesion Normal bilirubin No evidence of portal hypertension No medical comorbidities Limited resection Minimize operative time
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Surgical Resection of HCCComparison between USA, France and Japan
• Similar outcomes 31-41% 5 yr survival
• Larger tumors resected in US than in France or Japan 8 cm vs. 6 and 3.5 cm
• Less HCV in resection patients in US 20% vs. 38 and 74%
• Less cirrhotics resected in US 23% vs. 52 and 65%
US
JapanFrance
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Surgical Resection of HCCOperative Risks
• Potential complications Estimated 25-30% Bleeding from
coagulopathy and portal hypertension
Inadequate margins Liver failure Long LOS Hospital death Recurrent disease
• Strategies to decrease risk Liver anesthesiologist Minimize crystalloid Transfuse FFP/plts
early Keep CVP low Minimize OR time Minimize blood loss
• Pringle if necessary Careful post-op
management
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Port Placement for Lap. left lateral segmentectomy
lesion
X
X
12 mm - scope
X 12 mm - Stapler
5 mm - working
X5 mm - retractor
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Unresectable385 pts (70%)
Transplant Ineligible74 pts (80% )
Transplant Eligible36 pts (20% )
Resected180 pts (30% )
HCC Pts Evaluated1990-2001
611 pts
Surgical Resection of HCCOutcome in US Cancer Center
Cha et al Ann Surg 2003, 238.315Memorial Sloan Kettering
78% with cirrhosis
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Surgical Resection of HCCType of Resection in Transplant Eligible Patients
Trisegmentectomy
2 (6%)
Wedge/Single Segment
14 (39%)
Multiple Segments
12 (33%)
Lobectomy
8 (22%)
Cha et al Ann Surg 2003, 238.315Memorial Sloan Kettering
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Surgical Resection of HCCOverall Survival After Resection (N=180)
100806040200
1.0
.8
.6
.4
.2
0.0
Months after Resection
Sur
viva
l
Transplant EligibleN=36
Transplant IneligibleN=144
p=.009
69%
31%
Cha et al Ann Surg 2003, 238.315Memorial Sloan Kettering
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Surgical Resection of HCCRecurrence-Free Survival in Transplant Eligible Patients
Median follow-up of 35 mos
Recurrence in 20 of 36 pts
Months after Resection100806040200
Rec
urre
nce
Fre
e S
urvi
val
1.0
.8
.6
.4
.2
0.0
48%
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Treatment of HCC Surgical Resection vs. OLT Three year recurrence rates
Wong LL. Amer. J Surgery. 2002;183:309-16
20-70% 0-43%
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Treatment of HCC Surgical Resection vs. OLT
Five Year Survival
Wong LL. Amer. J Surgery. 2002;183:309-16
34-51% 60-69%
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Treatment of HCCAblative therapies
• Direct tissue ablation Thermal
• Radiofrequency Ablation (RFA)• Cryoablation• Microwave coagulation therapy (MCT)• Laser Induced Thermotherapy (LITT)
Chemical• EtOH• Acetic acid
• Chemoembolization• Radioembolization
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Ablative Therapy of HCCGoals of Ablation
• Equivalent to surgical resection in survival and local recurrence
• Bridge therapy to stabilize disease while awaiting transplant
• Palliation of unresectable, nontransplantable disease
• Conversion from unresectable to resectable
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Ablative Therapy of HCCPatient Selection for RFA
• Unresectable lesions Good
• < 3 lesions• < 3 cm.
Extended• < 4 lesions• < 5 cm.
Heroic!• > 4 lesions• > 5 cm.
• Treatable under US/CT/MR guidance: Can you see it? Can you reach it?
• Adequate clotting function: Platelets >50K INR <1.5
• Adjacent structures Bowel, gallbladder,
diaphragm, vessels, bile ducts
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Treatment of HCCAblative therapy: RFA Mechanism
CoagulationNecrosis
Energy
Deposited
Local TissueInteractions
Heat Loss
= x
-Limitations for RFA:
• Lesions close to heat sink make treatment less effective• Charring and impedance can limit size• Proximity of bowel or diaphragm
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Ablative Therapy of HCCRFA: Technique
• Percutaneous, laparoscopic, or open Benefits and limitations of all approaches
• Multiple overlapping burns to cover entire tumor volume plus “surgical margin”
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Ablative Therapy of HCCRFA: Percutaneous Technique
• IV access for sedation/analgesia.
• No abx• 4 grounding pads• Localize lesion• Prep and local
anesthetic through capsule
• Puncture with RF probe to 5 mm from back wall of lesion
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Ablative Therapy of HCCRFA Modality Selection:Ultrasound
• Real-time guidance• Allows complex
angled approach• Visualization of
probe can be difficult• Steam obscures
margins and probe• Imaging is
inadequate endpoint for therapy
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Ablative Therapy of HCCRFA Modality Selection:CT
• Lesions must be conspicuous on non-contrast scans
• Access limited by gantry and axial imaging
• Not real-time imaging• Excellent visualization of
probe location• Not obscured by steam• Can do dynamic enhanced
scan to assess completion of ablation
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Ablative Therapy of HCCRFA Device Selection:RITA
• Radial array up to 7 cm
• Measures temperature and impedance at multiple tines.
• Endpoint is target temperature for a specified time.
• Rise in impedance prevented by reducing power to allow complete burn time.
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Ablative Therapy of HCCRFA Device Selection:Radiotherapeutics
• Radial array up to 4 cm
• Only measures impedance
• Burn endpoint is “rolloff” of current due to rising impedance in the coagulated tissue.
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OR procedure: s/p Lap. RFA R. lobe HCC
Pre-Op CT Scan 3/02
3 mos post-RFA scan
6 mos post-RFA scan
Stable RFA site, NED
6 months s/p Lap. RFA HCC
OLTx 9 mos post-RFA, no viable tumor at RFA site, incidental 1 cm left lobe HCC
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Ablative Therapies of HCCComplications of RFA
• Pain• Fever• Vasovagal/
Hypotension• Oversedation• Pleural Effusion
(0.6%)• Pneumothorax• Hemorrhage (0.5%)
• Ascites• Cholangitis Abscess• Hepatic Infarct• Biliary Stricture• Tract Tumor Seeding• Skin burns
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Ablative Therapies of HCCFollow-up of RFA
• Imaging must be “functional”
• Dynamic CT• Gad-enhanced
MRI Early arterial
enhancement Bright on T2
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Ablative Therapies of HCCFollow-up of RFA: Results
• “Complete” necrosis in 70-75%. HCC 80%-90%
• Local recurrence in 13%-60%.• Disease-free survival
1 year 56% 2 years 29% 3 years 14%
• 65% new/distant lesionsDodd GD III; Solbiati L; RSNA 2000
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Ablative Therapies of HCCFollow-up of RFA vs. PEI: HCC 5 cm
PEI RF• N 50 52
# lesions 73 69 # sessions 5.4 1.1
• 1,2 yr survival 77%,43% 86%,64%• Local failure 26% 6%• Complications 0 0
Lencioni et al. Radiology 2003; 228: 235-240
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Treatment of HCCExplant pathology post RFA: Methods
• Patients listed for OLT at Penn Retrospective study, between 1996-2004 28 patients (40 HCC) had neoadjuvant image-
guided therapy 1-392 days prior to OLT
• Solitary lesions: (19 pts) 2.2-5.0 cm• Multifocal HCC (9 pts) 1.1-6.0 cm diameter• Exemption to UNOS criteria: 4 patients
Soulen et al 2004
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Pathology • Viable tumor was seen in 35/40 treated
nodules, but only 1 patient is completely free of tumor
• 11 of the treated HCC’s had either satellite nodules or microvascular invasion
• 3 patients had macroscopic extrahepatic extension or portal vein tumor thrombus, from 2 treated HCC’s and from 1 new lesion
Treatment of HCCExplant pathology post RFA: Methods
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• 35 of the 40 treated HCC had residual viable tumor (87.5%)
• 27/28 patients had viable tumor anywhere in the explanted liver at the moment of OLT (total of 55 nodules)
• In 6/18 patients, imaging studies were false negative for treated and occult tumors
• Recurrence-free post transplant survival is 85% with a follow-up of 1-61 months (mean 15 mos)
Treatment of HCCExplant pathology post RFA: Results
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• Although image-guided therapy is proven to be effective to provide local control of HCC, viable local or remote tumor is identified on explanted liver in the majority of patients
• Contrast enhanced follow-up CT and MRI tend to underestimate the amount of viable tumor in the treated lesions and miss additional sites of disease.
Treatment of HCCExplant pathology post RFA: Conclusions
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Ablative Therapy of HCCChemoembolization
• Liver has a dual blood supply
• Portal vein: 75-80%
• Hepatic artery: 20-25%
• HCC and Metastases have ~ 90% of blood supply from HA
Breedis and Young, Am J Pathol 1954; 30: 969-985.
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Ablative Therapy of HCCChemoembolization
• No standards: Patient selection Number and type of embolics Number and type of drugs Volume of liver treated Frequency and end-point of treatment Measurement of response
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Ablative Therapy of HCCChemoembolization: Eligibity at Penn
• Tissue diagnosis unless AFP>400
• Unresectable disease
• No active extrahepatic disease
• No biliary obstruction
• No contraindication to angiography
• No contraindication to HA embolization hepatic failure risk >50% tumor LDH>425 AST>100 AND bili>2
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ChemoembolizationCAM-Oil-Particle
100 mg Cisplatin
50 mg Adriamycin in 8.5 cc Contrast
10 mg Mitomycin-C 1.5 cc H2O
emulsified with
0.1 cc/kg Ethiodol plus 150-250 µ PVA
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Ablative Therapy of HCCChemoembolization RCTs: Barcelona Study
• 112 Patients with HCC
• Majority had Hepatitis C
• Stratified by tumor burden and Okuda stage
• Patients randomized to CE, bland embolization, or supportive care
• CE had 2 year survival of 63% vs. 50% with bland embo and 27% with no therapy
Llovet et al. Lancet 2002; 359: 1734-39.
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Ablative Therapy of HCCChemoembolization RCTs: Hong Kong Study
• 80 Patients with HCC• 80% HBSAg positive• Equal proportions of
Okuda I/II• Randomized to CE or
supportive care• CE performed with
cisplatin/lipiodol/Gelfoam sponge
• 2 year survival 31% vs. 11%
Lo, Hepatology 2002; 35: 1164-71.
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Ablative Therapy of HCCOther Ablative Techniques
• Laser-induced thermotherapy (LITT)
• Microwave coagulation therapy (MCT)
• Chemical PEI
• Safe, inexpensive, easy to perform. Minimal side effects
Acetic acid• Diffuses into liver better• Must be small lesions < 3
cm• One study showing superior
survival to PEI
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Ablative Therapy of HCCOther Embolization Techniques
• Radioembolization Theraspheres, SIR-Spheres
• Yttrium-90 microspheres Uses hypervascularity of
HCC to deliver high dose local radiation via source
• Small series (27 pts) showed reduction in size in 90%, complete tumor destruction in 8 on histology
• Concern for radiation hazards
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Treatment of HCCSurgery vs. Percutaneous local ablation therapy
• Comparison of surgery vs. PLAT• Surgical resection (5 studies)
Recurrence free survival • 3 yr 38-64% 5 yr 23-58%
• PLAT (7 studies – 4 PEI, 3 RFA) Recurrence free survival
• 2 yr 41-64% 4 yr 18-39% RFA superior to PEI
Lau et al, Annals of Surgery 2003
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Treatment of HCC Surgical Resection vs. OLT vs. ablation
1 yr 5 yr• Resection
Survival 74-96% 25-72%
• Liver Transplantation Survival 84-90% 69-75%
• Ablation (PEI) Survival 87-98% 29-54%
Recent citations 1995-2001Bruix and Llovett Hepatology 2002
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Treatment of HCCSurgery vs. Percutaneous Ethanol Injection
• Compared resection vs. PEI for small single nodule HCC 197 eligible, 82 matched Matched for age, CTP, date of diagnosis
• 1 and 3 yr survival PEI 91% 65% Resection 82% 63% Concluded no significant difference
• Higher cost and morbidity with resection
• Randomized trial neededDaniele et al, CLIP, J Clinical Gastro 2003
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Ablative Therapy for HCCConclusions
• Thermal ablation, chemoembolization, radioembolization part of multimodality approach to HCC
• Paucity of randomized trials• Unstable and evolving technology• Combination of therapies likely to be of
most benefit• Multidisciplinary approach essential
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Chemoembolization + RFA
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Therapy of HCCCombined Modalities
• TACE and surgery• TACE and PEI, RFA• RFA and surgery• Portal vein embolization and
surgery• Laparoscopic techniques
Diagnosis Determine resectability Biopsy RFA Resection
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HCC < 5 cm3 HCC < 3 cm
Child B/CChild A
Single lesionLimited resection
No medical problems
“Bridge” therapy,
CE, RFA, PEIPercutaneous
Or laparoscopic
Resect? Combine withOther therapy
Ablation,Chemoembo,CombinationPercutaneousor surgical
Surgical Candidate?
No
Yes
TransplantCandidate?
No
Yes
AlgorithmSmall HCC
Consider Laparoscopy
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HCC > 5 cm> 3 HCC
RadioemboSupportive
Therapy
Chemoembo - Possibly combinewith RFA
Adequateliver function,performance
Inadequateliver function
Bili<2 Bili>2
AlgorithmLarge HCC
SurgicalTherapy?
Tumorshrinkage
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Treatment options for HCCBasic principles
• Assess tumor burden Up to date imaging
• Vascular invasion• Focality• AFP
• Assess liver function Cirrhosis Portal hypertension Child’s score
• Assess patient status Surgical
candidate? Transplant
candidate? Chemotherapy
candidate?
• Develop multidisciplinary approach