Published online Aug 14, 2020. doi: 10.3748/wjg.v26.i30.4465
Peer-review started: March 14, 2020
First decision: April 12, 2020
Revised: April 25, 2020
Accepted: July 4, 2020
Article in press: July 4, 2020
Published online: August 14, 2020
Lenvatinib has become an indispensable part of regimens for patients with advanced hepatocellular carcinoma (aHCC). Recently, several real-world studies appear to have confirmed this.
Ethnicity appears to, at least partially, cause etiological differences, which necessitates further real-world studies of lenvatinib across diverse populations, such as in China.
To develop a more comprehensive understanding of the real-world effectiveness of lenvatinib by analyzing its efficacy and safety from a variety of aspects.
This is a retrospective and multiregional study involving patients from across China who were diagnosed with aHCC and received lenvatinib monotherapy. Data were collected from patients during lenvatinib interventions from December 2018 to December 2019. After strict eligibility criteria were applied, efficacy was assessed using the RECIST 1.1 criteria. Baseline characteristics and adverse events (AEs) were recorded throughout the entire study.
In total, 54 HCC patients treated with lenvatinib monotherapy were included for final analysis. The majority of patients in this Chinese sample were suffering from concomitant HBV-related HCC. The objective response rate was 22% with a progression-free survival (PFS) of 168 d; however, AEs occurred in 92.8% of patients. The multivariate analysis showed that the Barcelona Clinic Liver Cancer stage, portal vein tumor thrombus and Child-Pugh classifications were significant factors affecting PFS. The sensitivity and specificity were calculated for decreasing serum biomarkers including alpha-fetoprotein in order to predict tumor size reduction. Gene sequencing also provided insights into potential gene mutation signatures related to the lenvatinib effect.
Our findings confirm previous evidence from the phase III REFLECT study. Further analysis suggests that baseline characteristics, changes in serum biomarkers and gene sequencing may hold the key for predicting lenvatinib responses.
Randomized controlled studies and real-world studies consistently report the beneficial effect of lenvatinib, but its application in HCC patients has only recently begun. Future research should focus on screening patients to ensure that we can identify those who will benefit most from lenvatinib and how the side effects can be effectively managed.