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Comparison of CalliSpheres® microspheres drug-eluting beads and conventional transarterial chemoembolization in hepatocellular carcinoma patients: a randomized controlled trial Cover

Comparison of CalliSpheres® microspheres drug-eluting beads and conventional transarterial chemoembolization in hepatocellular carcinoma patients: a randomized controlled trial

Open Access
|Feb 2023

Figures & Tables

Figure 1

Flow diagram of the study.
ALB = albumin; ALT = alanine aminotransferase; AST = aspartate aminotransferase; cTACE = conventional transarterial chemoembolization; DEB-TACE = drug-eluting beads transarterial chemoembolization; HCC = hepatocellular carcinoma; TBIL = total bilirubin
Flow diagram of the study. ALB = albumin; ALT = alanine aminotransferase; AST = aspartate aminotransferase; cTACE = conventional transarterial chemoembolization; DEB-TACE = drug-eluting beads transarterial chemoembolization; HCC = hepatocellular carcinoma; TBIL = total bilirubin

Figure 2

The comparison of median overall survival (OS) and progression-free survival (PFS) between the two groups. (A) the median OS of the drug-eluting beads transarterial chemoembolization (DEB-TACE) group was significantly longer than the conventional transarterial chemoembolization (cTACE) group (P = 0.027). (B) the median PFS of the DEB-TACE group was significantly longer than the cTACE group (P = 0.004).
The comparison of median overall survival (OS) and progression-free survival (PFS) between the two groups. (A) the median OS of the drug-eluting beads transarterial chemoembolization (DEB-TACE) group was significantly longer than the conventional transarterial chemoembolization (cTACE) group (P = 0.027). (B) the median PFS of the DEB-TACE group was significantly longer than the cTACE group (P = 0.004).

Figure 3

Comparison of the liver function between the two groups. The aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin (TBIL) levels were higher in the drug-eluting beads transarterial chemoembolization (DEB-TACE) group than in the conventional transarterial chemoembolization (cTACE) group at 1 week (P < 0.05) after the operation, and all the liver function indexes had no difference between the 2 groups at 1 month after the operation.
Comparison of the liver function between the two groups. The aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin (TBIL) levels were higher in the drug-eluting beads transarterial chemoembolization (DEB-TACE) group than in the conventional transarterial chemoembolization (cTACE) group at 1 week (P < 0.05) after the operation, and all the liver function indexes had no difference between the 2 groups at 1 month after the operation.

Comparison of post-embolization syndrome

Adverse eventsDEB-TACE (n = 45)cTACE (n = 45)P value
Fatigue (n/%)5 (11.1)7 (15.6)0.535
Fever (n/%)23 (51.1)13 (28.9)0.031
Abdominal (n/%) distension9 (20)7 (15.6)0.581
Abdominal pain (n/%) Numeric Rating Scale (NRS)42 (93.3) 4.4 ± 1.943 (95.6) 3.6 ± 1.60.645 0.037
Nausea/emesis (n/%)10 (22.2)12 (26.7)0.624

Comparison of treatment response evaluated at 1-month, 3-month, and 6-month after treatment between the two groups

Parameters 1-month 3-month 6-month

DEB-TACE group (n = 45)cTACE group (n = 45)P valueDEB-TACE group (n = 45)cTACE group (n = 45)P valueDEB-TACE group (n = 44)cTACE group (n = 45)P value
CR (%)8 (17.8)6 (13.3)0.56110 (22.2)3 (6.7)0.0367 (15.9)3 (6.7)0.168
PR (%)24 (53.3)16 (35.6)0.09023 (51.1)16 (35.6)0.13723 (52.3)13 (28.9)0.025
ORR (%)32 (71.1)22 (48.9)0.03133 (73.3)19 (42.2)0.00330 (68.2)16 (35.6)0.002
SD (%)10 (22.2)18 (40.0)0.0696 (13.3)11 (24.4)0.17810 (22.7)17 (37.8)0.123
DCR (%)42 (93.3)40 (88.9)0.45939 (86.7)30 (66.7)0.02540 (90.9)33 (73.3)0.031
PD (%)3 (6.7)5 (11.1)0.4596 (13.3)15 (33.3)0.0254 (9.1)12 (26.7)0.031

Baseline characteristics of patients

ParametersDEB-TACE(n = 45)(cTACE n = 45)P value
Gender (male/female)40/539/60.747
Age (years)58.9 ± 7.160.6 ± 6.50.229
History (n/%) of alcohol consumption11 (24.4)15 (33.3)0.352
History of viral hepatitis (n/%)31 (68.9)27 (60.0)0.378
Child-Pugh stage (n/%)
A33 (73.3)29 (64.4)0.326
B12 (26.7)16 (35.6)-
BCLC stage (n/%)
A17 (37.8)14 (31.1)0.506
B28 (62.2)31 (68.9)-
ECOG performance status (n/%)
017 (37.8)13 (28.9)0.371
128 (62.2)32 (71.1)-
Liver function
ALT (U/L)38.0 ± 20.535.7 ± 18.70.585
AST (U/L)40.3 ± 16.840.1 ± 14.20.946
ALB (g/L)39.9 ± 8.240.1 ± 6.20.886
TBIL (μmol/L)19.1 ± 6.120.7 ± 7.00.246
Tumour location (n/%)
Unilobar35 (77.8)32 (71.1)0.468
Bilobar10 (22.2)13 (28.9)-
Tumour distribution (n/%)
Unifocal36 (80.0)34 (75.6)
Multifocal9 (20.0)11 (24.4)0.612
Diameter of the largest tumour (cm)7.2 ± 2.46.8 ± 2.30.397

Compared with the baseline, the changes of liver function at 1-week and 1-month after procedure in the two groups

ParametersDEB-TACE (n = 45)cTACE (n = 45)

Baseline1-weekP value1-monthP valueBaseline1-weekP value1-monthP value
ALT (U/L)38.0 ± 20.565.0 ± 18.3< 0.00135.3 ± 19.80.43135.7 ± 18.755.2 ± 19.8<0.00137.4 ± 13.50.558
AST (U/L)40.3 ± 16.861.3 ± 19.7< 0.00139.1 ± 12.20.72240.1 ± 14.252.4 ± 20.00.00338.2 ± 11.70.534
ALB (g/L)39.9 ± 8.236.7 ± 5.50.00440.3 ± 7.210.75840.1 ± 6.237.2 ± 5.40.02739.1 ± 6.90.508
TIBL (umol/L)19.1 ± 6.130.0 ± 10.2< 0.00118.0 ± 5.20.39920.7 ± 7.024.8 ± 10.40.00319.0 ± 7.00.328
DOI: https://doi.org/10.2478/raon-2023-0001 | Journal eISSN: 1581-3207 | Journal ISSN: 1318-2099
Language: English
Page range: 70 - 79
Submitted on: Oct 3, 2022
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Accepted on: Nov 8, 2022
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Published on: Feb 17, 2023
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2023 Zhongxing Shi, Dongqing Wang, Tanrong Kang, Ru Yi, Liming Cui, Huijie Jiang, published by Association of Radiology and Oncology
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.