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Clinical Experience:Increased Efficacy, Reduced Systemic ExposureA Randomized Phase II Study of Transarterial Chemoembolization with Doxorubicin Eluting HepaSphere Microspheres in Patients with Hepatocellular Carcinoma
Validating preclinical studies of hqTACE, clinical experience with doxorubicin-loaded HepaSphere Microspheres demonstrates that hqTACE provides high efficacy, reduced systemic exposure and lower complication rates, while minimizing the impact on normal liver function.
• 30 HCC patients were randomized – 14 patients received lipiodol and doxorubicin (cTACE, control group) – 16 patients received doxorubicin delivery Hepasphere Microspheres (hqTACE)
• The doxorubicin levels were assessed to determine – Peak concentration of doxorubicin (Cmax) – Area under the curve of doxorubicin (AUC) up to 3 hours after infusion
• Liver function was analyzed – AST (at day 1, 2 and 3 and after 1 month) – ALT (at day 1, 2 and 3 and after 1 month)
• Side-effects were reported – Following the Common Toxicity Criteria
LIVER FUNCTION
AST Levels After TACE
Time points
AST
U/L
Day 1 Day 2 Day 3 1 Month0
130
260
390
520
650
Controls HepaSphere Microspheres
Baseline
Controls HepaSphere Microspheres
ALT Levels After TACE
Time points
ALT
U/L
Baseline Day 1 Day 2 Day 3 1 Month
120
240
360
480
600
DOXORUBICIN PHARMACOKINETICS
Area Under the Curve of Doxorubicin
AUC
(ng/
mL
min
)
Controls
100
200
300
HepaSphere Microspheres
p < 0.001
Peak Concentration Doxorubicin
Cmax
(ng/
mL)
Controls0
1000
2000
3000
HepaSphere Microspheres
p < 0.001
Results and ConclusionResults• Minimal impact on normal liver function – Significantly lower peak concentration of doxorubicin and smaller AUC (area under curve) in patients receiving HepaSphere Microspheres compared to cTACE (p<0.001) – Serum liver enzyme analyses showed better preserved liver function
• Reduced systemic exposure – hqTACE shown to have less systemic effect of doxorubicin than cTACE
• Fewer adverse events – Significantly fewer grade 3 and 4 adverse events in the HepaSphere Microspheres group (p=0.027)
ConclusionhqTACE with doxorubicin delivery HepaSphere Microspheres leads to low circulating plasma levels of the antimitotic drug and reduces toxicity.
Reference: van Malenstein H, Maleux G, et al. A randomized phase II study of drug-eluting beads versus transarterial chemoembolization for unresectable
hepatocellular carcinoma. Onkologie 2011; 34(7):368-76.
2000 1500 1000 500
0
Mea
n Cm
ax
cTACE
p < 0.0011826.9 ±
658.5 ng/ml
494.5 ±304.2 ng/ml
SIGNIFICANTLY LOWER PEAK CONCENTRATION OF DOXORUBICIN
WITH HEPASPHERE MICROSPHERES hqTACE
HepaSphereMicrospheres
hqTACE
100
75
50
25
0
Mea
n Cm
ax
cTACE cTACE
FEWER ADVERSE EVENTS WITH HEPASPHERE MICROSPHERES hqTACE
53%Grade 3
33%Grade 3
27%Grade 4
0%Grade 4
HepaSphereMicrospheres
hqTACE
HepaSphereMicrospheres
hqTACE
40,000
30,000
20,000
10,000
0
Mea
n AU
C
HepaSphere Microspheres
hqTACE
cTACE
p < 0.001
SMALLER AUC WITH HEPASPHEREMICROSPHERES hqTACE
28,673.9 ±6769.3
ng/ml min
12,351.3 ±4950.9
ng/ml min
©2013 Merit Medical Systems, Inc. All rights reserved. MR10-044 Rev. C 01/13 402269001/B ID 012213
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