Comparison of treatment efficacy and safety between drug-eluting bead transarterial chemoembolization with CalliSpheres® microspheres and conventional transarterial chemoembolization as first-line treatment in hepatocellular carcinoma patients

Abstract

We aimed to compare the treatment response, survivals and safety of drug-eluting bead (DEB) transarterial chemoembolization (TACE) with CalliSpheres^® microspheres (CSM) and conventional TACE (cTACE) as first-line treatment in Chinese HCC patients. 192 HCC patients from multiple centers received DEB-TACE with CSM or cTACE treatment as first-line treatment were included and assigned to DEB-TACE group (N=94) or cTACE group (N=98) accordingly. Treatment response was assessed at 1 month (M1), M3 and M6 after treatment. Progression-free survival (PFS) and overall survival (OS) was evaluated. Liver function indexes and adverse events were recorded. Complete response (CR) and objective response rate (ORR) were higher, while disease control rate (DCR) rate was similar in DEB-TACE group compared with cTACE group, and further multivariate logistic regression analysis validated that DEB-TACE vs cTACE independently predicted higher ORR. For survivals, no difference in PFS or OS was observed between DEB-TACE and cTACE groups, and multivariate Cox's proportional hazards regression revealed that DEB-TACE vs cTACE was not correlated with PFS or OS either. Additionally, no difference in liver function indexes at M1 or changes of liver function indexes from M0 to M1 between DEB-TACE and cTACE groups after treatment was observed, whereas DEB-TACE resulted in higher incidence of pain and fever during treatment or hospitalization. DEB-TACE with CSM discloses better treatment response, similar survival profiles and equal liver function injury but increased incidence of short-term adverse events than cTACE as the first-line therapy in treating HCC patients.

Keywords: DEB-TACE; HCC; safety; survival profiles; tumor response.

Figure 1

Study flow. HCC, hepatocellular carcinoma; DEB-TACE, drug-eluting bead transarterial chemo-embolization; cTACE, conventional transarterial chemo-embolization; M, month.

Figure 2

Comparing PFS and OS between DEB-TACE and cTACE groups. No difference in PFS (A) or OS (B) was observed between DEB-TACE and cTACE groups. Kaplan-Meier method was used to evaluate PFS and OS of patients and Log-rank test was applied to determine the difference of PFS and OS between the two groups. P value <0.05 was considered significant. PFS, progression free survival; OS, overall survival; DEB-TACE, drug-eluting bead transarterial chemo-embolization; cTACE, conventional transarterial chemo-embolization.

Figure 3

Subgroup analysis for difference in PFS. In all subgroups (A-P), no difference in PFS between patients received DEB-TACE and patients underwent cTACE was observed. In each subgroup, Kaplan-Meier method was used to evaluate PFS of patients and Log-rank test were applied to determine the difference of PFS. P<0.05 was considered significant. PFS, progression free survival; DEB-TACE, drug-eluting bead transarterial chemo-embolization; cTACE, conventional transarterial chemo-embolization.

Figure 4

Subgroup analysis for difference in OS. There was no difference of OS between patients underwent DEB-TACE and patients received cTACE in all subgroups (A-P). In each subgroup, Kaplan-Meier method was used to evaluate OS of patients and Log-rank test were applied to determine the difference of OS. P<0.05 was considered significant. OS, overall survival; DEB-TACE, drug-eluting bead transarterial chemo-embolization; cTACE, conventional transarterial chemo-embolization.