Abstract
Background: This study investigated the impact of baseline liver function according to the Child–Pugh score and ALBI (albumin-bilirubin) grade on the outcomes of patients with unresectable hepatocellular carcinoma treated with lenvatinib. Methods: A total of 82 lenvatinib treated patients were included. The correlations of baseline liver function according to the Child–Pugh score and ALBI grade with treatment outcomes, including objective response rate per mRECIST (modified Response Evaluation Criteria in the Solid Tumor), time to treatment failure, treatment duration, and likelihood of treatment discontinuation due to adverse events, were assessed in patients with hepatocellular carcinoma treated with lenvatinib. Patients were divided into four groups: (1) Child–Pugh score 5 and ALBI grade 1 (group 1), (2) Child–Pugh score 5 and ALBI grade 2 (group 2), (3) Child–Pugh score 6 (group 3), and (4) Child–Pugh score ≥7 (group 4). Univariate and multivariate analyses were performed to identify the factors contributing to the objective response rate and likelihood of discontinuation due to adverse events. Results: Among the 82 patients analyzed, group 1 had the highest objective response rate (57.1%) and the lowest likelihood of treatment discontinuation because of adverse events (11.1%) among the four groups (p < 0.05 and p < 0.05). Multivariate analysis identified ALBI grade 1 and baseline AFP level <200 ng/mL as the significant predictors of a high objective response rate (p < 0.05 and p < 0.01), and confirmed that patients with ALBI grade 1 had the lowest probability of treatment discontinuation due to adverse events (p < 0.01). Conclusions: Patients with Child–Pugh score of 5 and ALBI grade 1 predicted a higher response rate and lower treatment discontinuation due to adverse events by lenvatinib treatment.
Highlights
IntroductionSorafenib and lenvatinib are the only targeted therapies approved for the first-line treatment of advanced unresectable Hepatocellular carcinoma (HCC) [5,6,7]
Hepatocellular carcinoma (HCC) is one of the major causes of cancer-related death worldwide [1,2,3,4].Currently, sorafenib and lenvatinib are the only targeted therapies approved for the first-line treatment of advanced unresectable HCC [5,6,7]
We investigated the impact of ALBI grade and Child–Pugh score on the outcomes of patients with HCC treated with lenvatinib
Summary
Sorafenib and lenvatinib are the only targeted therapies approved for the first-line treatment of advanced unresectable HCC [5,6,7]. A phase I study of lenvatinib in HCC showed that the maximum tolerable dose in patients with Child–Pugh class A and class B liver function was 12 mg and 8 mg QD, respectively [14]. Based on the results of the REFLECT study, lenvatinib was recently approved as a promising first-line agent for patients with unresectable HCC in Japan, the EU, the USA, and Asia, including China, Korea, and Taiwan. Child–Pugh score and ALBI (albumin-bilirubin) grade on the outcomes of patients with unresectable hepatocellular carcinoma treated with lenvatinib. The correlations of baseline liver function according to the Child–Pugh score and ALBI grade with treatment outcomes, including objective response rate per mRECIST
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