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

Zhongxing Shi

Zhongxing Shi

Department of Interventional Radiology, The Second Affiliated Hospital of Harbin Medical UniversityHarbin, China
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Shi, Zhongxing
, 
Dongqing Wang

Dongqing Wang

Department of Interventional Radiology, The Second Affiliated Hospital of Harbin Medical UniversityHarbin, China
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Wang, Dongqing
, 
Tanrong Kang

Tanrong Kang

Department of Interventional Radiology, The Second Affiliated Hospital of Harbin Medical UniversityHarbin, China
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Kang, Tanrong
, 
Ru Yi

Ru Yi

Department of Radiology, The Second Affiliated Hospital of Harbin Medical UniversityHarbin, China
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Yi, Ru
, 
Liming Cui

Liming Cui

Department of Radiology, The Second Affiliated Hospital of Harbin Medical UniversityHarbin, China
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Cui, Liming
 and 
Huijie Jiang

Huijie Jiang

Department of Radiology, The Second Affiliated Hospital of Harbin Medical UniversityHarbin, China
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Jiang, Huijie
  
Feb 17, 2023
Comparison of CalliSpheres® microspheres drug-eluting beads and conventional transarterial chemoembolization in hepatocellular carcinoma patients: a randomized controlled trial's Cover Image
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Article Category: Research Article
Published Online: Feb 17, 2023
Page range: 70 - 79
Received: Oct 03, 2022
Accepted: Nov 08, 2022
DOI: https://doi.org/10.2478/raon-2023-0001
Keywords
© 2023 Zhongxing Shi, Dongqing Wang, Tanrong Kang, Ru Yi, Liming Cui, Huijie Jiang, published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

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 events DEB-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/%) distension 9 (20) 7 (15.6) 0.581
Abdominal pain (n/%) Numeric Rating Scale (NRS) 42 (93.3) 4.4 ± 1.9 43 (95.6) 3.6 ± 1.6 0.645 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 value DEB-TACE group (n = 45) cTACE group (n = 45) P value DEB-TACE group (n = 44) cTACE group (n = 45) P value
CR (%) 8 (17.8) 6 (13.3) 0.561 10 (22.2) 3 (6.7) 0.036 7 (15.9) 3 (6.7) 0.168
PR (%) 24 (53.3) 16 (35.6) 0.090 23 (51.1) 16 (35.6) 0.137 23 (52.3) 13 (28.9) 0.025
ORR (%) 32 (71.1) 22 (48.9) 0.031 33 (73.3) 19 (42.2) 0.003 30 (68.2) 16 (35.6) 0.002
SD (%) 10 (22.2) 18 (40.0) 0.069 6 (13.3) 11 (24.4) 0.178 10 (22.7) 17 (37.8) 0.123
DCR (%) 42 (93.3) 40 (88.9) 0.459 39 (86.7) 30 (66.7) 0.025 40 (90.9) 33 (73.3) 0.031
PD (%) 3 (6.7) 5 (11.1) 0.459 6 (13.3) 15 (33.3) 0.025 4 (9.1) 12 (26.7) 0.031

Baseline characteristics of patients

Parameters DEB-TACE(n = 45) (cTACE n = 45) P value
Gender (male/female) 40/5 39/6 0.747
Age (years) 58.9 ± 7.1 60.6 ± 6.5 0.229
History (n/%) of alcohol consumption 11 (24.4) 15 (33.3) 0.352
History of viral hepatitis (n/%) 31 (68.9) 27 (60.0) 0.378
Child-Pugh stage (n/%)
A 33 (73.3) 29 (64.4) 0.326
B 12 (26.7) 16 (35.6) -
BCLC stage (n/%)
A 17 (37.8) 14 (31.1) 0.506
B 28 (62.2) 31 (68.9) -
ECOG performance status (n/%)
0 17 (37.8) 13 (28.9) 0.371
1 28 (62.2) 32 (71.1) -
Liver function
ALT (U/L) 38.0 ± 20.5 35.7 ± 18.7 0.585
AST (U/L) 40.3 ± 16.8 40.1 ± 14.2 0.946
ALB (g/L) 39.9 ± 8.2 40.1 ± 6.2 0.886
TBIL (μmol/L) 19.1 ± 6.1 20.7 ± 7.0 0.246
Tumour location (n/%)
Unilobar 35 (77.8) 32 (71.1) 0.468
Bilobar 10 (22.2) 13 (28.9) -
Tumour distribution (n/%)
Unifocal 36 (80.0) 34 (75.6)
Multifocal 9 (20.0) 11 (24.4) 0.612
Diameter of the largest tumour (cm) 7.2 ± 2.4 6.8 ± 2.3 0.397

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

Parameters DEB-TACE (n = 45) cTACE (n = 45)
Baseline 1-week P value 1-month P value Baseline 1-week P value 1-month P value
ALT (U/L) 38.0 ± 20.5 65.0 ± 18.3 < 0.001 35.3 ± 19.8 0.431 35.7 ± 18.7 55.2 ± 19.8 <0.001 37.4 ± 13.5 0.558
AST (U/L) 40.3 ± 16.8 61.3 ± 19.7 < 0.001 39.1 ± 12.2 0.722 40.1 ± 14.2 52.4 ± 20.0 0.003 38.2 ± 11.7 0.534
ALB (g/L) 39.9 ± 8.2 36.7 ± 5.5 0.004 40.3 ± 7.21 0.758 40.1 ± 6.2 37.2 ± 5.4 0.027 39.1 ± 6.9 0.508
TIBL (umol/L) 19.1 ± 6.1 30.0 ± 10.2 < 0.001 18.0 ± 5.2 0.399 20.7 ± 7.0 24.8 ± 10.4 0.003 19.0 ± 7.0 0.328
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