Treatment Response, Survival, and Safety of Transarterial Chemoembolization With CalliSpheres® Microspheres Versus Conventional Transarterial Chemoembolization in Hepatocellular Carcinoma: A Meta-Analysis

Abstract

BackgroundDrug-eluting embolic transarterial chemoembolization (DEE-TACE) is an advance in TACE technique. However, at present there is insufficient evidence to support that DEE-TACE is superior to conventional TACE (cTACE) for hepatocellular carcinoma (HCC). The aim of this meta-analysis is to evaluate the efficacy and safety of TACE with CalliSpheres® microspheres (CSM-TACE) compared with cTACE in patients with HCC.Data SourcesPubMed, Embase, Web of Science, CNKI and Wanfang Databases were searched to identify relevant articles published before March 26, 2020. The data regarding treatment response, survival profile, adverse events and liver function indexes were retrieved.ResultsA total of 16 studies with 1454 HCC patients (722 treated with CSM-TACE and 732 with cTACE) were included. Patients receiving CSM-TACE had higher 1-month complete response (CR), objective response rate (ORR), disease control rate (DCR) (odds ratio (OR): 2.00, 95% confidence interval (95% CI): 1.29–3.09; OR: 2.87, 95% CI: 2.15–3.83; OR: 2.01, 95% CI: 1.37–2.95, respectively), 3-month CR, ORR, DCR (OR: 4.04, 95%CI: 2.46–6.64; OR: 3.39, 95%CI: 2.45–4.70; OR: 1.71, 95%CI: 1.14–2.55 respectively), and 6-month CR, ORR, DCR (OR: 4.02, 95%CI: 2.26–7.16; OR: 3.00, 95%CI: 2.05–4.38; OR: 2.66, 95%CI: 1.70–4.16 respectively) than those treated with cTACE. Furthermore, CSM-TACE exhibited a trend toward improved progression free survival (hazard ratio (HR): 0.86, 95%CI: 0.67–1.11) and overall survival (HR: 0.79, 95%CI: 0.59–1.07) over cTACE although these differences did not reach statistical significance. In terms of safety, the two TACE treatments showed similar post-treatment pain (OR: 0.84, 95%CI: 0.55–1.28), fever (OR: 0.99, 95%CI: 0.60–1.63), nausea/vomiting (OR: 0.84, 95% CI: 0.60–1.17), as well as 1-month follow-up alanine aminotransferase (Mean difference (MD): −3.66, 95%CI: −10.38–3.07), aspartate aminotransferase (MD: −2.30, 95%CI: −8.91–4.31) and total bilirubin (MD: −0.15, 95%CI: −2.26–1.96).ConclusionCSM-TACE displays superior treatment response, non-inferior survival profile and safety over cTACE in HCC patients.

Conventional Transarterial Chemoembolization Versus Drug-Eluting Beads in Patients with Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis

“…However, a recent meta-analysis of six RCTs did not find significant differences between these two treatments in overall survival or major complications and concluded that the safety and efficacy profile of DEB-TACE was comparable to that of the C-TACE profile [ 30 ]. In another recent meta-analysis, although the study also found comparable overall survival and adverse events between C-TACE and TACE with CalliSpheres ® microspheres (CSM), a polyvinyl alcohol hydrogel microsphere, the pooled analysis revealed that CSM-TACE showed significantly superior efficacy outcomes compared to that in C-TAC-treated patients [ 31 ]. These differences are likely due to heterogeneity between study populations included in the pooled analyses and differences in methodological designs.…”

“…The current study has considerable strengths over more recently published meta-analyses [ 30 , 31 ]. In our review, we have pooled all available evidence published to date including RCTs and observational studies, whereas Wang et al (2020) included only evidence from randomized trials.…”

“…While a number of studies have evaluated the safety and efficacy of DEB-TACE for treating unresectable HCC [ 14 , 15 , 16 , 17 , 18 ], relatively fewer prospective and retrospective studies have compared C-TACE to DEB-TACE [ 19 , 20 , 21 ]. More recent clinical studies [ 22 , 23 ], as well as several meta-analyses [ 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 ] comparing these two treatment modalities, provide inconsistent results, with some reporting no significant differences in tumor response rate between the two in managing patients with unresectable HCC [ 22 , 23 , 25 , 27 ], while others found a greater overall survival rate, as well as tumor response in DEB-TACE-treated patients with HCC compared to those with C-TACE treatment [ 24 , 26 ].…”

“…Therefore, the overarching aim of this meta-analysis was to re-evaluate the safety, efficacy, and survival benefit of DEB-TACE compared to C-TACE treatment for managing patients with unresectable HCC. Given that recent meta-analyses have focused only on randomized trials [ 30 ], have posed no restriction on stage of disease [ 31 ], or have reported only some of the outcomes [ 31 ], we aimed to include both observational and controlled trials as well as all reported outcomes with a focus on unresectable or recurrent HCC.…”

In the Era of Systemic Therapy for Hepatocellular Carcinoma Is Transarterial Chemoembolization Still a Card to Play?

“…In a Chinese population treated with CalliSpheres, a meta-analysis of 16 studies with 1454 HCC patients by Liang et al showed a higher 1-month and 3-month OR (odds ratio: 2.87, 95% CI: 2.15-3.83 and odds ratio: 3.39, 95%CI: 2.45-4.70) and disease control rate in favor of microsphere treatment (odds ratio: 2.01, 95% CI: 1.37-2.95 and odds ratio: 1.71, 95%CI: 1.14-2.55) [81]. No difference in the PFS, OS, adverse events, or liver function was observed between the two therapies.…”