Comparison of Treatment Response, Survival Profiles, as Well as Safety Profiles Between CalliSpheres® Microsphere Transarterial Chemoembolization and Conventional Transarterial Chemoembolization in Huge Hepatocellular Carcinoma.

Xuhua Duan,Fengyao Li,Jianzhuang Ren,Hao Li,Xinwei Han,Shuguang Ju,Juanfang Liu

doi:10.3389/fonc.2021.793581

Abstract

PurposeCalliSpheres® microspheres (CSM) are the first drug-eluting beads (DEB) developed in China. This study aimed to compare treatment response, survival, and safety profiles between DEB transarterial chemoembolization (DEB-TACE) with CSM and conventional TACE (cTACE) in huge hepatocellular carcinoma (HCC) patients.MethodsA total of 71 patients with huge HCC who underwent DEB-TACE or cTACE were consecutively enrolled in this retrospective cohort study. Treatment response was assessed at first month (M1), third month (M3), and sixth month (M6) after TACE therapy; progression-free survival (PFS) and overall survival (OS) were evaluated; liver function indexes were recorded before TACE operation (M0), at first week (W1), M1 and M6 after TACE therapy; adverse events which occurred after TACE operation were recorded.ResultsDEB-TACE presented with higher objective response rate (60.0% vs. 29.7%, p < 0.05) and disease control rate (86.7% vs. 59.4%, p < 0.05) compared with cTACE at M3. Regarding survival profiles, PFS [median: 3.3 months (95% CI: 2.8–3.7) vs. 2.1 months (95% CI: 1.7–2.5)] as well as OS [median: 7.8 months (95% CI: 4.6–11.0) vs. 5.7 months (95% CI: 5.0–6.3)] were longer in DEB-TACE group compared with cTACE group (both p < 0.01). Multivariate Cox’s regression further illustrated that DEB-TACE vs. cTACE was an independent protective factor for PFS and OS (both p < 0.01). As for safety profiles, patients’ liver function injury was reduced in the DEB-TACE group compared with the cTACE group. The incidence of fever was lower, and CINV was less severe in the DEB-TACE group compared with the cTACE group (both p < 0.05), while no difference in occurrence of liver abscess, increase of ascites, or moderate pain between two groups was observed.ConclusionDEB-TACE with CSM presents with better treatment response, survival profiles, as well as safety profiles compared with cTACE in treatment for huge HCC patients.

Highlights

Hepatocellular carcinoma (HCC) is the most common carcinoma as well as the second cause of cancer-related deaths in China, and huge HCC, accounting for around 20% of HCC cases, is defined as HCC whose nodule size is greater than 10 cm in diameter [1,2,3]
progression-free survival (PFS) [median: 3.3 months vs. 2.1 months] as well as overall survival (OS) [median: 7.8 months vs. 5.7 months] were longer in drug-eluting beads (DEB)-transarterial chemoembolization (TACE) group compared with Conventional TACE (cTACE) group
DEB-TACE with CalliSpheres® microspheres (CSM) presents with better treatment response, survival profiles, as well as safety profiles compared with cTACE in treatment for huge HCC patients

Summary

Introduction

Hepatocellular carcinoma (HCC) is the most common carcinoma as well as the second cause of cancer-related deaths in China, and huge HCC, accounting for around 20% of HCC cases, is defined as HCC whose nodule size is greater than 10 cm in diameter [1,2,3]. Surgical resection is not applicable in most of HCC patients due to hidden onset of diseases, loss of liver function, and severe complications especially in huge HCC patients who need to resect over 80% of liver [7]. Other therapeutic approaches such as associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) and radiofrequency ablation are less commonly applied for treatment of huge HCC and are complicated with severe liver injury and risk of future liver remnant hypertrophy [8, 9]. CSM is the first DEB developed in China, which possesses good loading and releasing profile as well as acceptable biocompatibility; it exhibits good efficacy and tolerance in treating HCC patients [15,16,17,18]

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