Abstract

The aim of this study was to investigate the efficacy and safety of transarterial chemoembolization (TACE) combined with Lenvatinib plus sequential microwave ablation (MWA) for the treatment of patients with large hepatocellular carcinoma (HCC) beyond up-to-seven criteria.
Methods: This multicenter prospective study included 135 patients diagnosed with Barcelona Clinic Liver Cancer beyond Upto 7(BCLC B2) between January 2015 and January 2022. Participants were grouped into: i) Transarterial Chemoembolization with Lenvatinib plus sequential Microwave ablation group (TLM, n=47), and ii) Transarterial Chemoembolization and Microwave ablation group (TM, n=88). Each group was subdivided based on the largest tumor diameter: a) 7-8 cm, b) 8-10 cm, and c) >10 cm. In the TLM group, Lenvatinib was administered 7 days post-transarterial Chemoembolization (TACE), followed by Microwave Ablation (MWA) after 21 days. Lenvatinib was resumed after recovery from MWA. The TM group underwent MWA 7 day’s post-TACE. Progression- Free Survival (PFS), Overall Survival (OS), and complications were assessed.
Results: Technical success of combined transarterial chemoembolization and Microwave Ablation was achieved in all patients (100% either in single or multiple sessions). Follow- up MRI/CT was done to assess the treatment response after one month. The median follow up period was 48.5 months. The TLM group had longer PFS than the TM group (median, 17.32 vs. 6.3 months, p < 0.001; median.1,3,5 year cumulative overall survival of patients in TM group: 7-8 tumor subgroup: 96%, 72 %, 42%; in 8-10 cm subgroup:87%, 45%,18%; in more than 10 cm tumor sub group: 48%, 24%, 3% and in TLM group: 7-8 tumor sub group: 95%, 77%, 51%; in 8-10 tumor sub group: 92%, 59%, 32%; in more than 10 cm tumor sub group: 61%, 34%, 9%. There was no treatment related death. Minor complications like pain, fever, nausea occurred in 13% cases while major complications such as Hepatic failure, hemorrhage, pleural effusion occurred in 1% cases. The occurrence of major complications were seen mainly in Cirrhosis Child Pugh B patients irrespective of TLM or TM groups.
Conclusion: The combination of TACE, Lenvatinib, and sequential MWA improves PFS and OS in patients with large unresectable HCC beyond the up-to-seven criteria, with a high safety profile.

Keywords

Hepatocellular Carcinoma, Transarterial Chemoembolization, Lenvatinib, Microwave Ablation, Survival Analysis