Lenvatinib prolongs the progression‑free survival time of patients with intermediate‑stage hepatocellular carcinoma refractory to transarterial chemoembolization: A multicenter cohort study using data mining analysis

Abstract

Tyrosine kinase inhibitors are considered for use in patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE). The aim of the present retrospective study was to identify factors associated with progression-free survival (PFS) and to evaluate the indications for lenvatinib treatment in patients with intermediate-stage HCC refractory to TACE using a data-mining analysis. A total of 171 patients with intermediate-stage HCC refractory to TACE were included. All patients were classified into three groups according to their HCC treatment: Lenvatinib (n=45), sorafenib (n=53) and TACE (n=73) groups. PFS time was calculated using the Kaplan-Meier method and analyzed using a log-rank test. Factors associated with PFS time were evaluated using multivariate and decision-tree analyses. The median PFS time was 5.8, 3.2 and 2.4 months in the lenvatinib, sorafenib and TACE groups, respectively (P<0.001). In the Cox regression analysis, lenvatinib treatment and being within the up-to-seven criteria were identified as independent factors for PFS (lenvatinib, P<0.0001; within up-to-seven, P=0.001). The decision-tree analysis revealed that patients beyond the up-to-seven criteria, treated with lenvatinib and with albumin-bilirubin (ALBI) grade 1 had a longer PFS time (245.2±107.9 days) than patients beyond the up-to-seven criteria, treated with lenvatinib and with ALBI grade 2 (147.1±78.6 days). Additionally, lenvatinib was independently associated with longer PFS time in patients with intermediate-stage HCC refractory to TACE. Therefore, lenvatinib may be recommended for patients who have intermediate-stage HCC refractory to TACE, ALBI grade 1 and who are within the up-to-seven criteria.

A Real-World Comparative Analysis of Lenvatinib and Sorafenib as a Salvage Therapy for Transarterial Treatments in Unresectable HCC

“…In this study, the survival outcomes with sorafenib treatment were similar to those reported by other real-world studies in Korea and Japan [ 27 , 37 ]. However, there were large differences in survival outcomes with lenvatinib treatment between our real-world data and those reported in the REFLECT trial (PFS 7.4 months, ORR 24.1%, DCR 75.5%).…”

“…In that study, the median PFS and OS were 4.1 and 6.4 months, respectively [ 14 ], which are similar to the findings of this study. Shimose et al [ 37 ] also reported a retrospective study comparing treatment efficacy of lenvatinib and sorafenib in TACE-refractory patients. The survival outcomes in that study were comparable to those in our study; PFS 5.8 vs 3.2 months, in lenvatinib and sorafenib group, respectively [ 37 ].…”

Lenvatinib for Hepatocellular Carcinoma: A Literature Review

“…A prospective international observational trial (OPTIMIS trial) showed that, in TACE-refractory patients, the survival time was better in those who received sorafenib in comparison to those who continued TACE [70]. In addition, a recent study showed that the median PFS in TACE-refractory patients that were treated with lenvatinib, sorafenib, and TACE was 5.8, 3.2, and 2.4 months, respectively [71]. Our retrospective studies reported that lenvatinib treatment was associated with a high ORR and good PFS in patients with intermediate stage HCC [18].…”

Optimizing the management of intermediate-stage hepatocellular carcinoma: Current trends and prospects

“…2 ). Lenvatinib is the only first-line agent to demonstrate a survival benefit over TACE in TACE naïve patients out of up-to-7 criteria in a retrospective propensity score-matched study [ 50 ]. Lenvatinib treatment seems to show favorable results in TACE-resistant HCC.…”