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DSM – TACE in comparison with c- and DEB-TACE
EmboCept® S, DSM 35 – 50*
*) DSM = degradable starch microspheres (Amilomer)
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DSM (EMBOCEPT® S) IN COMPARISON
EmboCept® Svs. DC Beads Pharmacokinetics Clinics Therapeutic/technical recommendation
vs. lipiodol
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CHEMOEMBOLIZATION – DSM-TACE
EmboCept® S - parameters
• cross-linked, partially hydrolyzed starch
• polymere matrix
• median diameter: 50 /um (lodge in precapillary vessel area)
• half-time: app. 35-40 min.
• degadation by -amylase
• fragments: 100 - 106 Dalton (water-soluble)
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Angiographic documentation of vessels
permanent embolization N collateral tumor
vessels
6 h 4 4
4 h 5 3
2 h 5 0
CHEMOEMBOLIZATION – advantages of a degradable material
Persson BG et al. World J Surg 1987;11(5):672–7
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DSM (EMBOCEPT® S) VS. DC BEADS
pharmacokinetics
clinics
therapeutic/technical recommendation
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AUC: 10 mg 5-FU i.a. versus 10 mg 5-FU + 6 mg Amilomer i.a.
10000
20000
40000
50000
AU
C (
15
-12
0 m
in)
µg
/g*m
in655
62655
1704
27822
5-FU i.a. 5-FU+Amilomer i.a.0
95 x
60000
10 mg 5-FU i.a.
0 15 30 45 60 90 Min0
10
20
30
40
50
60
70
µg
/g 5
-FU
Tumor
Liver
25,09 µg/g
58,65 µg/g
10 mg 5-FU i.a. + 6 mg Amilomer0 15 30 45 60 90 2 h4 h 8 h12 h24 h0
100
200
300
400
500
600
700
µg
/g 5
-FU
Tumor
Liver
433.39 µg/g
664.39 µg/g
5-FU-CONCENTTRATION IN TUMOR AND LIVER(locoregional with and without amilomer)
Chirurgische Klinik I Universitätsklinikum Benjamin Franklin FU Berlin
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PHARMACOKINETIC WITH DE BEADS:TUMOR DOXORUBICIN CONCENTRATION
Hong K, et al. Clin Cancer Res 2006;12:2563–7, Courtesy: R. Lencioni, Pisa
Dox
oru
bic
in in t
um
or
(nm
ole
s/g)
450
400
350
300
250
200
150
100
50
0
Time from doxorubicin administration (hours)
0 100 200 300 400
HAI
DE Beads
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0 15 30 45 60 90 2 h 4 h 8 h 12 h 24 h0
100
200
300
400
500
600
700
µg/g
5-F
U
+ 30 x
Time from doxorubicin administration (hours)
Dox
oru
bic
in in
tu
mor
(nm
ole
s/g
)
450
400
350
300
250
200
150
100
50
0
0 100 200 300 400
TACE
DE Beads
0 15 30 45 60 90 2 h 4 h 8 h 12 h 24 h0
100
200
300
400
500
600
700
5-FU + DSM
µg/g
5-F
U
+ 30 x
5-FU-concentration in tumor and liver (locoregional with and without Amilomer)
AUC ?+ 3 x
EMBOCEPT S VS. BEADSPK DATA
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TUMOR GROWTH AND NECROSIS
Dt. Krebskongress Berlin2014
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DSM (EMBOCEPT® S) VS. DC BEADS
pharmacokinetics
clinics
therapeutic/technical recommendation
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DSM – CLINICAL DATA
Taguchi et al. Reg Cancer Treatment 3-4:117 1992
clinics (TACE)
Taguchi, T. (1992): random. phase III - study
indications: 1) HCC (n=60)2) liver metastases (n=60)
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DSM – CLINICAL DATA
Taguchi et al. Reg Cancer Treatment 3-4:117 1992
clinics (TACE)
Taguchi, T. results (HCC)
*) p<0,05
DSM CR PR CR+PR* (%)
MR NC PD Mediansurvival*
(days)
With 2 6 36,4 4 10 0 661
without
0 2 9,5 1 11 7 259
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DC BEADS – CLINICAL DATA
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PRECISION V
Event DC beads(N=93)
Lipiodol TACE(N=108)
Lipiodol TACE
(N=263)
DSM-TACE(N=98)
PES (pain)
25 26 23 2
Nausea 16 14 15 3
Vomiting 11 13 10 4
Pyrexia 17 24 17 3
Bonn data
DC BEADS VS. DSM-TACE – TOLERABILITY
Vogl et al. AJR 197 2011, Schlee et al. 1999
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C-TACE VS. DSM-TACE – TOLERABILITY
Schlee et al. 1999
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Thomas Albrecht, Julian Wirsching, Gerd Berger
Institut für Radiologie und Interventionelle TherapieVivantes-Klinikum Neukölln, Berlin
Charité, Campus BF, Berlin
Sequence of repeated non-selective non-occlusive TACE of far advanced HCC with degradable starch microspheres (DSM) –
long term results of a retrospective analysis
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DSM (EMBOCEPT® S) VS. DC BEADS
pharmacokinetics
clinics
therapeutic/technical recommendation
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HANDLING OF DC BEADS
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HANDLING OF DSMapplication modus 1
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HANDLING OF DSMapplication modus 2
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HANDLING OF DSMapplication modus 3
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DC beads® EmboCept® S
Vials 2x2 1
Preparation time app. 24 h app. 5 min.
Catheter positioning (super-) selective
non-selective (incl. IA ports)
Micro-catheter X -
Additional embol. material(e.g. Bead block) X -
DSM (EMBOCEPT® S) VS. DC BEADSapplication modus
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Indication(liver mets)
Active substances in combination
Cycles
Pancreatic Ca Gemcitabin, Mitomycin C
every 3-4 weeks
CRC Irinotecan, Oxaliplatin, Mitomycin C
every 3-4 weeks
Neuroendocrine Tm Doxorubicin, Mitomycin C
every 3-4 weeks
Breast Ca Gemcitabin,Mitomycin C,Taxanes
every 3-4 weeks
Melanoma Fotemustine,cisDDP
every 3-4 weeks
DSM-TACE –indications and schedules
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DSM (EMBOCEPT® S) IN COMPARISON
EmboCept® Svs. DC BeadsPharmacokineticsClinicsTherapeutic/technical recommendationvs. lipiodol
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CHEMOEMBOLIZATION – LIPIODOL ® + / - DSM
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60-80 mg cisplatin +
Lipiodol(4.8+/-2 mL) DSM 120-3000 mg Lipiodol 4.1+/-2 mL + (+CM) DSM 427+/-405 mg +
CM (until stasis)
CHEMOEMBOLIZATION – LIPIODOL® + / - DSM
Yamasaki T et al. J Gastroenterol (2011) 46: 359-66
Randomization
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1y 2y 3y
Lipiodol-group: 13 % 13 %
DSM-group: 27 %
Lipiodol+DSM-group:53 % 13 % 7 %p=0.02/0.035
CHEMOEMBOLIZATION – LIPIODOL® + / - DSM
Yamasaki T et al. J Gastroenterol (2011) 46: 359-66
Results 2(progression-free survival):
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TRANSARTERIAL CHEMOEMBOLIZATION (TACE)
Institut of Diagnostic and Interventional RadiologyJohann Wolfgang Goethe-University, Frankfurt am Main
of hepatocellular carcinoma (HCC):
Comparison of tumor response rates between c(lipiodol)-TACE and DSM-TACE plus lipiodol
Gruber-Rouh T, Nagy N, Eichler K, Lehnert T, Harth M, Zangos S, Beeres M,
Nour-Eldin NE, Vogl TJ
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PURPOSE
Evaluation and comparison of local tumor response
under transarterial chemoembolization (TACE) of HCC
with lipiodol or lipiodol plus DSM-microspheres
(EmboCept® S)
Institut of Diagnostic and Interventional RadiologyJohann Wolfgang Goethe-University, Frankfurt am Main
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MATERIAL AND METHODS
Patients: n = 50
Recruitment time: 2010-2012
Median Age: 60,3 years (39-80)
TACE: n = 367 medium: 7,3 treatments/patient (3-15) therapeutic interval:: 4 weeks
Institut of Diagnostic and Interventional RadiologyJohann Wolfgang Goethe-University, Frankfurt am Main
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MATERIAL AND METHODS
Institut of Diagnostic and Interventional RadiologyJohann Wolfgang Goethe-University, Frankfurt am Main
chemotherapy
Embolization
Mitomycin (n=50)
Lipiodol (n=25)
lipiodol + DSM (n=25)
TACE-protocol:
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MATERIAL AND METHODS
Evaluation:
Radilogical tumor response: MRT, CT (RECIST-criterias)
Statistical significance:(Wilcoxon-Mann-Whitney-Test)
Institut of Diagnostic and Interventional RadiologyJohann Wolfgang Goethe-University, Frankfurt am Main
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RESULTS
Amount of liver metastasis: multiple (≥ 5): 50% (n=25) 1: 18% (n=9) 2: 16% (n=8) 3-4: 16% (n=8)
Location of the metastasis: both sides: 70% (n=35) Right lobe: 30% (n=15) left lobe: 0% (n=0)
Institut of Diagnostic and Interventional RadiologyJohann Wolfgang Goethe-University, Frankfurt am Main
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RESULTS
Local tumor control (RECIST- criterias):
Institut of Diagnostic and Interventional RadiologyJohann Wolfgang Goethe-University, Frankfurt am Main
PR26%
SD60%
PD14%
►partial response (PR): 26 % (n=13)
►stable disease (SD): 60 % (n=30)
►progressive disease (PD): 14 % (n=7)
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RESULTS
Institut of Diagnostic and Interventional RadiologyJohann Wolfgang Goethe-University, Frankfurt am Main
Lipiodol-group DSM-lipiodol-
group
Tumor response(PR + SD)
80% (n=20)
92% (n=23)p =
0,32
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SUMMARY 1/4
DSM – TACE: highest accumulation of co-applicated drugs within the tumor tissue
EmboCept® S (DSM 35/50) – short-time embolization:
• no initiation signals for collateral tumor vessel• comparable high tumor necrosis
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SUMMARY 2/4
DSM-TACE comparable to DEB-TACE in tumor response, but better in tolerability
DSM-TACE better than c-TACE
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SUMMARY 3/4
DSM-TACE: options for new scientific concepts
combination with:• LITT/RF,• Radiation / SIRT• immune-/ genembolization
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SUMMARY 4/4
EmboCept® S: unique chemoembolization material
• combination
• indication
• application