Abstract
BackgroundLenvatinib is approved for patients with advanced hepatocellular carcinoma (HCC) due to its non-inferiority to sorafenib of overall survival (OR) in clinical trials. This study was to compare the effectiveness and safety of lenvatinib and sorafenib in the real world.MethodsWe retrospectively evaluated 338 patients with unresectable HCC who had undergone lenvatinib or sorafenib treatment between January 2018 and August 2020. Propensity-score matching analysis was performed with a 1:2 ratio to reduce the real-life baseline difference between the two groups.ResultsA total of 210 patients (Male/Female: 150/60, mean age: 65.8 years) were recruited including 70 patients in the Lenvatinib group and 140 patients in the Sorafenib group. Compared with sorafenib, lenvatinib had significantly longer progression-free survival (PFS) (5.2 vs 3.3 months, p=0.019) but similar OR (13.3 vs 11.8 months, p=0.714). Additionally, lenvatinib had better disease control rates (62.3 vs 48.6%, p=0.029) and equivalent incidences of treatment-related adverse events over sorafenib. In multivariate analysis, lenvatinib was associated with better PFS over sorafenib (hazard ratio: 0.49, 95% confidence interval: 0.3–0.79, p=0.004) after adjustments of albumin-bilirubin grade and alpha-fetoprotein level; however, different agents using lenvatinib or sorafenib did not contribute to OS, whether in univariate or multivariate analysis. Patients who failed lenvatinib had a lower proportion of having sequential systemic therapies compared with the Sorafenib group (36.2 vs 47.8%, p=0.02). The most frequently used sequential therapy following lenvatinib and sorafenib was chemotherapy (n=9, 42.8%) and regorafenib (n=33, 50.8%), respectively.ConclusionsIn clinical real-life practice, lenvatinib illustrated promising survival benefits and acceptable safety for patients with unresectable HCC, while reducing the risk of progression disease compared with sorafenib. Additionally, lack of approved post-lenvatinib systemic therapies is a serious issue in the real world.
Highlights
Hepatocellular carcinoma (HCC) is the most common liver cancer and one of the leading causes of cancer-related deaths worldwide, accounting for approximately 700,000 mortalities per year [1]
A total of 322 patients including 81 (25.2%) with lenvatinib and 241 (74.8%) with sorafenib were further assigned to the Lenvatinib group and the Sorafenib group (n=140) by using propensity score (PS)-matching analysis with a 1:2 ratio (Supplementary Figure 1)
We indicate that using lenvatinib had a better DCR than using sorafenib (62.3 vs 48.6%, p=0.029); there was no significant difference in objective response rate (ORR) between Lenvatinib and Sorafenib groups (9.4 vs 8.1%, p=0.776)
Summary
Hepatocellular carcinoma (HCC) is the most common liver cancer and one of the leading causes of cancer-related deaths worldwide, accounting for approximately 700,000 mortalities per year [1]. Approval of sorafenib is based on two randomized, open-label, phase III clinical trials, SHARP study and AP study, where sorafenib significantly improved overall survival (OS) in patients with advanced HCC compared with a placebo [8, 9]. Lenvatinib especially prolonged progression-free survival (PFS), time to progression (TTP), and objective response rate (ORR) compared with sorafenib [10] According to these positive results from the REFLECT study, lenvatinib became the second approved agent in first-line systemic treatment for advanced HCC over the decade. Lenvatinib is approved for patients with advanced hepatocellular carcinoma (HCC) due to its non-inferiority to sorafenib of overall survival (OR) in clinical trials. This study was to compare the effectiveness and safety of lenvatinib and sorafenib in the real world
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