Download 2.7%–12.1%‡,20 1.5%–1.9%1,19 0.4%1,19

High absorbed dose coverage is achieved while
minimising exposure to normal tissue
From 2001 to 2014, a retrospective
analysis was conducted across
25
2,165 patients*
with HCC or
peer-reviewed
publications involving
metastatic
liver cancer.15,19
TheraSphere™ offers the flexibility to deliver high absorbed doses in a variety
of patient settings, personalised for specific treatment goals in HCC and mCRC
The majority of adverse effects are
mild to moderate in severity and
are manageable or resolve over
time.1,4,9,11 Adverse event reporting
in clinical practice is similar to that
seen in the published literature.1,3,19
Metastatic
Liver Cancer
HCC
1.5%–1.9%
1,19
Common AEs†
(fatigue, abdominal
pain, nausea)
Radiation
Segmentectomy
in HCC5,12
Lobar Infusion
Without PVT in
HCC4,6,8,9
Lobar Infusion
With PVT in
HCC4,6,8,9
Gastric Ulceration
2.7%–12.1%
Incidence of REILD is low with TheraSphere™
Metastatic
Liver Cancer
0.4%
References 1.TheraSphere™ Yttrium-90 Glass Microspheres – Instructions for Use – English, #990252. SPE Rev. 8. Biocompatibles UK Ltd, a BTG International group
company. Available at www.therasphere.com. 2. Atassi B et al. Radiographics 2008;28(1):81–99. 3. Walrand S et al. J Nucl Med 2014;55(8):1317–22. 4. Mazzaferro
V et al. Hepatology 2013;57(5):1826–37. 5. Vouche M et al. Hepatology 2014;60(1):192–201. 6. Garin E et al. Liver Int 2016;[Epub ahead of print]. 7. Mauxion T
et al. J Vasc Interv Radiol 2016;27:S61. 8. Salem R et al. Gastroenterology 2010;138(1):52–64. 9. Hilgard P et al. Hepatology 2010;52(5):1741–9. 10. SIR-Spheres®
Microspheres Package Insert. Date of issue: December, 2013 (CR1645). Sirtext Medical Inc. Available at: www.sirtex.com/ap/clinicians/package-insert. 11. Salem R et
al. Gastroenterology 2011;140(2):497–507. 12. Riaz A et al. Int J Radiat Oncol Biol Phys 2011;79(1):163–71. 13. Gaba RC et al. Ann Surg Oncol 2009;16:1587–96.
14. Edeline J et al. Ann Surg Oncol 2013;20:2518–25. 15. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
for Hepatobiliary Cancers V.2.2015. © National Comprehensive Cancer Network, Inc 2015. All rights reserved. Accessed February 12, 2015. To view the most recent
and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other
NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. 16. Lewandowski RJ et al. Am J Transplant 2009;9(8):1920–8. 17. Garin E
et al. J Nucl Med 2012;53(2):255–63. 18. Hickey R et al. J Nucl Med 2016;57(5):665–71. 19. US Package Insert – TheraSphere® Yttrium-90 Glass Microspheres – Rev. 14.
Biocompatibles UK Ltd, a BTG International group company. Available at: www.btg-im.com/therasphere/US. 20. Benson AB et al. Eur J Cancer 2013;49(15):3122–30.
Appropriate patient selection
is important for achieving high
Reported
Incidence of REILD
0.1%
18,20
TheraSphere™ offers the flexibility to deliver high
absorbed doses of radiation to the tumour without
compromising patient safety.1–3
Absorbed Dose Coverage is influenced by
AE = adverse event; BSA = body surface area; CPN = complete pathological necrosis; CR = complete response; CTCAE = Common Terminology Criteria for
Adverse Events; HCC = hepatocellular carcinoma; mCRC = metastatic colorectal cancer; MS = microspheres; OS = overall survival; PD = progressive disease;
PM = partition model; PN = partial necrosis; PR = partial response; PVT = portal vein thrombosis; SD = stable disease; SIRT = selective internal radiation therapy
Radioembolisation-Induced Liver Disease (REILD)
1,19
Bilobar Treatment
in mCRC18
0.1%18,20
* Proportion of patients with HCC: 75.5%, and mCRC: 24.5%.
†
CTCAE grade ≥3.
‡
All grade common AEs for mCRC: 19%–55%.
HCC
Because radiation is the primary
mode of action, treatment with
other modalities is not precluded.1
TheraSphere™ offers flexibility
to optimise absorbed dose to
tumour to meet individual patient
treatment goals in both the
curative and palliative setting.15–17
‡,20
Radiation
Lobectomy in
HCC13,14
0.4%1,19
All SIRT is
not the same
absorbed tumour dose without
TheraSphere™ is used in the treatment of hepatic neoplasia.1
compromising patient safety.3,19
Common adverse effects include fatigue, pain, and nausea. The majority of adverse effects are mild to moderate in severity and are manageable
or resolve over time. For more important safety information, please refer to the TheraSphere™ Instructions for Use at www.therasphere.com.1,4,9
Imagine where we can go.
TheraSphere™ is manufactured for Biocompatibles UK Ltd, a BTG International group company. TheraSphere and the TheraSphere logo are trademarks of
Theragenics Corporation, used under license by Biocompatibles UK Ltd. TheraSphere is a registered trademark in the US, EU and certain other territories.
‘Power Within’ is a trademark of Biocompatibles UK Ltd. ‘Imagine where we can go’, BTG and the BTG roundel logo are trademarks of BTG International Ltd.
BTG and the BTG roundel logo are registered trademarks in the US, EU and certain other territories. All rights reserved.
© 2017 BTG International Canada Inc.
EM-THS-2017-0110
CE 0086
EMEA
02/2017
Microsphere Coverage
and
Administered Activity
The goal of radioembolisation is achieved with high
absorbed dose coverage, leading to greater absorbed
dose to tumor, yielding radiobiologic necrosis4–6
Published data show that for patients with HCC, high absorbed dose coverage contributes to improved patient outcomes
220
180
140
100
220
140
100
120 Gy
27 mm
260
5 mm
220
1 MS
Resin (BSA)
*Thursday 1 week
Absorbed
Dose (Gy)
2 MS
?
180
Mauxion, T et al. J Vasc Interv Radiol 2016, Volume 27, Issue 3, S61
Mean = 110 Gy
AA=1.8 GBq
260140
BSA = 1.79m2
220
100
*Thursday 1st week
*Thursday 1st week
Imagine where we can go.
r Within
Survival with
with PVT
PVT
Survival
51.5% (17/33)
transplanted
patients had CPN
(100% necrosis)
1.0
1.0
= 0.0052
0.0052
PP =
= 0.0004
0.0004
PP =
0.8
0.8
0.8
0.8
0.6
0.6
TD ≥205
≥205 Gy
Gy
TD
0.4
0.4
0.6
0.6
0.4
0.4
TD ≥205
≥205 Gy
Gy
TD
275
0.2
0.2
0
SD
PR
CR
Non-responders:
OS 10 months
0.2
0.2
TD <205
<205 Gy
Gy
TD
00
00
00
>90% pathologic necrosis in patients resected for
transplantation with high absorbed dose*,3
Median OS
OS
Median
TD <205
<205 Gy
Gy
TD
10
10
6.5 m
m
6.5
20
20
30
40
30
40
Time (months)
(months)
21 m
m Time
21
50
50
60
60
10
10
00
4.35 m
m
4.35
15.7 m
m
15.7
20
30
40
20
30
40
Time (months)
(months)
Time
50
50
60
60
* Total dose to the liver does not exceed 150 Gy.
56.5 months (includes transplanted patients)
34.5 months (excludes transplanted patients)
Mauxion, T et al. J Vasc Interv Radiol 2016, Volume 27, Issue 3, S61
Right lobe*: Perfused volume = 1302 mL; T:N = 2
Glass: Standard dosimetry
Imagine where we can
Resin: Body Surface Area (BSA) and Partition Model (PM); Average† BSA for adults = 1.79 m2
Specific activity at calibration time: Glass = 2500 Bq/MS; Resin = 50 Bq/MS
Consistent dose delivery achieves the intended prescribed dose of 90Y in patients with mCRC
go.
Mauxion,
T et al. J Vasc Interv Radiol 2016, Volume 27,
Issue 3, S61
Glass
Resin
Microsphere
Method
100
500
Median OS:
ver the Power Within
8-cm diameter
tumour (268 mL)
48.5 (16/33)
of patients had
PN (>90%)
PN classified as
50 -99%
necrosis
Responders:
OS 17 months
5 mm
Methods: Model Geometry and Input
Normal tissue (1034 mL)
180
1000
140
100
BSA = 1.79m2
27 mm
36 million MS
Overall Survival
Survival
Overall
1.0
1.0
140
Mauxion, T et al. J Vasc Interv Radiol 2016, Volume 27, Issue 3, S61
Improved survival was achieved through higher tumour dose above
a threshold of 205 Gy in HCC patients, with or without PVT*,6
260
1500
220
PD
180
Imagine where we can go.
More complete pathologic necrosis is observed
when the delivered dose is >190 Gy in ≤2 segments5
Survival (%)
180
4 million MS
st
A significantly predicted response is observed with a
threshold dose of 500 Gy* to the tumour with TheraSphere™ 4
120 Gy
260
Survival (%)
Mean = 199 Gy
AA=3.2 GBq
IS
ALL
SIRT
THE
Within
SAME
?
260
Mean lesion-absorbed dose (Gy)
?
High activity TheraSphere™ glass microspheres deliver greater tumour
absorbed dose coverage while resin has greater microsphere coverage7
1st week
Wed
Thurs
2nd week
Fri
Mon
Tue
Calibration day
BSA
PM
AD Perfused Volume (Gy)
120
67
96
AD Tumor (Gy)
199
110
160
100
55
80
Imagine where we can go.
AD Normal Tissue (Gy)
Total # MS in
Perfused Volume (x106)
2.8
3.6
4.7
10.3
13.3
35.9
52.1
Specific activity (Bq/MS)
1148
885
683
314
242
50
50
* Vouche et al. - 2013 - Journal of Hepatology
†
Sacco et al. - 2010 - PloS One
For heavily pretreated
chemorefractory patients with
mCRC in the salvage setting:18,20
≥90% of the dose was
Standardised and uniformly
delivered prescribed doses
demonstrated in all centres20
Median OS for 531 patients*
Overall: 10.6 months
Extrahepatic disease absent: 14.4 months
Extrahepatic disease present: 6.6 months
Median OS for 61 patients
Overall: 8.8 months
Liver-only disease: 10.5 months
delivered in all treatments18
* From date of first 90Y treatment.