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Randomized Controlled Trial
. 2023 Feb 17;57(1):70-79.
doi: 10.2478/raon-2023-0001. eCollection 2023 Mar 1.

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

Zhongxing Shi  1 , Dongqing Wang  1 , Tanrong Kang  1 , Ru Yi  2 , Liming Cui  2 , Huijie Jiang  2
Affiliations
Randomized Controlled Trial

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

Zhongxing Shi et al. Radiol Oncol. .

Abstract

Background: This trial aimed to compare the outcomes of drug-eluting beads transarterial chemoembolization (DEB-TACE) with CalliSpheres® microspheres (CSM) and conventional transarterial chemoembolization cTACE in the treatment of patients with unresectable hepatocellular carcinoma (HCC).

Patients and methods: A total of 90 patients were divided into DEB-TACE group (n = 45) and cTACE group (n = 45). The treatment response, overall survival (OS), progression-free survival (PFS), and the safety were compared between the two groups.

Results: The objective response rate (ORR) in the DEB-TACE group was significantly higher than that in cTACE group at 1, 3, and 6 months of follow-up (P = 0.031, P = 0.003, P = 0.002). The complete response (CR) in DEB-TACE group was significantly higher than that in cTACE group at 3 months (P = 0.036). Survival analysis revealed that, DEB-TACE group had better survival benefits than cTACE group (median OS: 534 days vs. 367 days, P = 0.027; median PFS: 352 days vs. 278 days P = 0.004). The degree of liver function injury was more serious in DEB-TACE group at 1 week, but was similar between the two groups at 1 month. DEB-TACE with CSM caused a high incidence of fever and a severe abdominal pain (P = 0.031, P = 0.037).

Conclusions: DEB-TACE with CSM showed better treatment response and survival benefits than cTACE group. Although a transient more severe liver damage, high incidence of fever and a severe abdominal pain occurred in the DEB-TACE group, it could be resolved through symptomatic treatment.

Keywords: CalliSpheres® microspheres; DEB-TACE; cTACE; hepatocellular carcinoma; tumor response.

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Figures

Figure 1
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
Figure 2
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).
Figure 3
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.
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