Analyses of objective response rate, progression-free survival, and adverse events in hepatocellular carcinoma patients treated with lenvatinib: A multicenter retrospective study.

Aim: The aim of this study was to investigate the predictive factors of objective response rate (ORR) and progression-free survival (PFS), and the correlation of albumin-bilirubin (ALBI) grade with decreased appetite and fatigue in hepatocellular carcinoma patients treated with lenvatinib.
Methods: From March 2018 to December 2018, a total of 94 patients was included in this retrospective multicenter study.
Results: The median age of all patients was 73 years (interquartile range 66-79.3 years), and approximately 78% patients were men. The ALBI grade was 1, 2, and 3 in 27 (28.7%), 64 (68.1%), and three patients (3.2%), respectively. The Barcelona Clinic Liver Cancer stage was early, intermediate, and advanced in one (1.1%), 22 (23.4%), and 71 patients (75.5%), respectively. Best radiological response was determined to complete response, partial response, stable disease, and progressive disease in 0 (0.0%), 24 (30.4%), 38 (48.1%), and 17 patients (21.5%), respectively, giving the ORR of 30.4%. The 3-, 6-, and 12-month PFS was calculated to be 78.7% (95% CI 70.3-87.1%), 46.7% (95% CI 36.1-57.3%), and 17.4% (95% CI 6.6-28.2%). Multivariate analysis showed that the Barcelona Clinic Liver Cancer intermediate stage was shown to be the only significant factor affecting the ORR (odds ratio 3.78, 95% CI 1.14-12.5, P = 0.030) and PFS (hazard ratio 0.49, 95% CI 0.26-0.94, P = 0.030). The incidence of all grades of decreased appetite and fatigue was significantly less in patients with ALBI grade 1 compared with ALBI grade 2 + 3.
Conclusions: The Barcelona Clinic Liver Cancer intermediate stage was the predictive factor affecting the ORR and PFS, and ALBI grade was a good predictive factor affecting the incidence of fatigue and decreased appetite.
(© 2019 The Japan Society of Hepatology.)