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Guidelines for SIRT in HCC
An Evolution
2nd Asia Pacific Symposium on LiverDirected Y-90 Microspheres Therapy
1st November 2014, Singapore
SGH – Surgery
Pierce Chow FRCSE PhD
The challenge of HCC
Surgery is potentially
curative in early HCC
But 80% are inoperable
at time of diagnosis
Median survival of untreated inoperable HCC 3 – 8 months
High recurrence rates after surgical resection
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LOCALLY ADVANCED HEPATOCELLULAR CARCINOMA
Clinical Presentation
Treatment Options
Consider Clinical Trial
Present for evaluation
by multi-disciplinary
team
Surgical resection for carefully selected cases after
multidisciplinary board evaluation
LOCOREGIONAL THERAPY
Good liver function
Locally Advanced HCC
No Vascular Invasion*
Transarterial chemoembolisation (TACE) + DC-Beads [32,33]
(level – 1b)
Selective Internal Radiation Therapy (SIRT)
[34-36] (level – 2b)
External beam RT (alone or as part of combined modality)
Sorafenib [32-35] (level – 1b)
Poor liver function
 - Palliative treatment
 - Consider Clinical Trial
 - Transplant within UCSF
With Vascular Invasion
 Sorafenib [37-40] (level –1b)
 Selective Internal Radiation Therapy (SIRT)
[34-36] (level – 2b)
 External beam RT (alone or as part of combined modality)
[41,42] (level – 2a)
Transplantation is a consideration for HCC within the
USCF expanded criteria (single tumours < 6.5cm or
2-3 tumours < 4.5cm at the most, with a total tumour
diameter < 8cm) after assessment by a multidisciplinary tumour board [43,44] (level – 2b)
*Sorafenib may also be considered when local regional therapy is not feasible or fails [40] (level - 2b)
National Cancer Center Singapore Consensus Guidelines on Liver Cancer
http://www.nccs.com.sg/PatientCare/ComprehensiveLiverCancerClinic/Documents/CLCC guideline Final Ver to upload PDF
26092014.pdf
Main Loco-regional Therapies
• Trans-arterial chemo-embolisation (TACE):
• widely used - disease control approx 40%
• used mainly in HCC, NETs (includes DC Beads)
• Selective Internal Radiation Therapy (SIRT):
• higher disease control (approx 80%)
• SIR-Sphere®, Thera-Sphere®
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Hepatology 2008; 47(1): 71-81
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Guidelines for SIRT
1) ESMO Guidelines
2) NCCN Guidelines
3) APPLE Guidelines
4) National Cancer Center Guidelines
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European Society of
Medical Oncology
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ESMO Guidelines (2010)
BCLC Staging for HCC
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Summary of Treatment
Options and
Recommendations
according to BCLC
S. Jelic, 2010
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• “… Yttrium-90 microsphere
radioembolization is a recently FDAapproved, non-surgical procedure used to
treat inoperable HCC……”
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C.Verslype, 2012
10
Hepatocellular carcinoma: ESMO–ESDO Clinical Practice
Guidelines for diagnosis, treatment and follow-up
Annals of Oncology 23 (Supplement 7): vii41–vii48, 2012
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National Comprehensive
Cancer Network
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Pierce Chow FRCS, PhD
NCCN Guidelines (2009)
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“………randomized, controlled studies on the use of
radioembolization therapy in the treatment of patients
with HCC are needed………..”
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“… may be amenable to embolization
(chemoembolization, bland
embolization, radioembolization)
provided that the arterial blood supply
to the tumor may be isolated….”
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*Arterially directed therapies include transarterial embolization (TAE), chemoembolization
(transarterial chemoembolization[TACE] and TACE with drug-eluting beads [DEB-TACE] )and
radioembolization with yttrium-90 microspheres.
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Asia-Pacific Primary Liver
Cancer Expert (APPLE)
conference 2014
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APPLE 2014 Consensus Workshop
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Apple 2014 Consensus
Workshop Report
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APPLE recommendations for SIRT 2014
• first- line therapy in Advanced HCC with vascular invasion
and/or which are liver dominant with bilirubin <2 mg/dL and
which are Child-Pugh A or <B7 1-3. (Level B1). In this
context sorafenib may be added in patients with extra-hepatic
disease4. (Level B2)
• first-line therapy in multi-focal or bilobar HCC with high
disease burden5,6. (Level B1)
• second-line therapy in patients with multi-focal HCC who has
progressed on TACE1-3. (Level B1)
• bridging therapy in patients on the waiting list for cadaveric
transplantation7,8. (Level B1)
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90Y
microspheres in Patients with HCC and PVT

90Y
microspheres in Patients with HCC and PVT
Data from SGH/NCC
• Number of SIRT administrations - single : 82.5%
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Khor et al 2014
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Chow et al 2014
Comparative Median Survival
European
US
Patients Patients
Asian Patients
AHCC05
2014
(Phase II
multicenter
study)
Khor 2013
(Retrospec
tive study)
Y-90 + Sorafenib
Y-90
Sorafenib
Placebo
Y-90
Y-90
BCLC B
20.3mo
23.8mo
14.3 mo
8 mo
16.9 mo
17.2 mo
BCLC C
8.6mo
11.8mo
5.6 mo
4.1 mo
10.0 mo
7.3 mo
Study
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Cheng 2009
(Prospective
Study)
Sangro 2011 Salem 2010
(Retrospective (Prospective
study)
study)
SIRSA – 1 patient down-staged to transplantation, 2 to RFA
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Patient Outcomes According to
Suitability for TACE in the ENRY Series
Median Survival (months)
No difference
not
reached
n = 52
n = 32
n = 39
n = 55
n = 48
n = 31
(unresectable)
Candidates
for TACE
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Poor Candidates
for TACE
Failed
TACE
Sangro et al., Hepatology 2011;54:868-878
Overall Survival by BCLC Stage
Data from SGH/NCC
• Number of SIRT administrations - single : 82.5%
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Downstaging for HCC:
Chemoembolization VS Y90 SIRT
Downstaged patients stratified according
to size/distribution
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Table for follow-up/survivals
Lewandowski, 2009
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T3 to T2
Tumor size changes after 3 months
30
PD
20
10
0
SD
-10
-20
-30
-40
PR
-50
+32
mo
+8 mo
-60
-70
Retrospective analysis of 86 UNOS T3 patients (2000-2008; indication by MDT)
TACE (43)
RE (43)
TACE (43)
RE (43)
Portal HT
77%
74%
Ds T3 → T2
31%
58%
Single
53%
47%
Med. time to prog
12.8
33.3
Child A
53%
56%
Transplanted
26%
21%
BCLC B
85%
79%
RFA
23%
42%
Selective Treat
56%
46%
Med Surv (cens)
18.7
35.7
G3/4 Bil Toxicity
26%
7%
Med Surv (uncens)
19.2
41.6
MELD Pre/Post
9/9
8/9.5
Recurrence
18%
22%
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Lewandowski, RJ, et al. Am J Transpl. 2009;9:1920-8.
SIR-Spheres microspheres in down-sizing primary liver
cancers to resection, ablation or radiation lobectomy
Investigator
n
Whitney
Lau
Iñarrairaegui
Chow
Barakat
Ettorre
44‡
71
72‡
21‡
29
1‡
1‡
Miglioresi
4‡
Gramenzi
Saxena
Coldwell
Högberg
Gaba
63‡
25
23‡
2
1‡
of which
Tx
line
# Outcomes
SIR-Spheres†
2nd–4th
SIR-Spheres†
1st–2nd
SIR-Spheres†
>1st
SIR-Spheres†
>1st 3
SIR-Spheres† + sorafenib >1st
SIR-Spheres†
1st
SIR-Spheres†
1st
SIR-Spheres†
1st
SIR-Spheres†
nr
SIR-Spheres†
>1st
SIR-Spheres†
>3rd
SIR-Spheres†
1st
SIR-Spheres†
2nd
Tumour Type(s)
4 R0
2 CCC; CRC; OeC
4 R0
HCC
3 R0, 2 LT HCC
R0, 2 LT, 1 RF
UNOS stage T3
2 RF, 1 LT HCC
1 R0
HCC
1 LT
HCC
4 LT
HCC
2 LT
HCC
1 R0
CCC
1 RF
CCC
2 R0
CCC
1 RL
CCC
retrospective data; † SIR-Spheres microspheres;
R0: complete surgical resection; LT: transplant; RF: radiofrequency ablation; RL: radiation lobectomy
‡
SGH – Surgery
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APPLE 2014 Consensus Workshop
SGH – Surgery
Apple 2014 Consensus
Workshop Report
34
National Cancer Center
Singapore
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LOCALLY ADVANCED HEPATOCELLULAR CARCINOMA
Clinical Presentation
Treatment Options
Consider Clinical Trial
Present for evaluation
by multi-disciplinary
team
Surgical resection for carefully selected cases after
multidisciplinary board evaluation
LOCOREGIONAL THERAPY
Good liver function
Locally Advanced HCC
No Vascular Invasion*
Transarterial chemoembolisation (TACE) + DC-Beads [32,33]
(level – 1b)
Selective Internal Radiation Therapy (SIRT)
[34-36] (level – 2b)
External beam RT (alone or as part of combined modality)
Sorafenib [32-35] (level – 1b)
Poor liver function
 - Palliative treatment
 - Consider Clinical Trial
 - Transplant within UCSF
With Vascular Invasion
 Sorafenib [37-40] (level –1b)
 Selective Internal Radiation Therapy (SIRT)
[34-36] (level – 2b)
 External beam RT (alone or as part of combined modality)
[41,42] (level – 2a)
Transplantation is a consideration for HCC within the
USCF expanded criteria (single tumours < 6.5cm or
2-3 tumours < 4.5cm at the most, with a total tumour
diameter < 8cm) after assessment by a multidisciplinary tumour board [43,44] (level – 2b)
*Sorafenib may also be considered when local regional therapy is not feasible or fails [40] (level - 2b)
National Cancer Center Singapore Consensus Guidelines on Liver Cancer
http://www.nccs.com.sg/PatientCare/ComprehensiveLiverCancerClinic/Documents/CLCC guideline Final Ver to upload PDF
26092014.pdf
Thank
You!
SGH – Surgery
37

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