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Efficacy and safety of lenvatinib for patients with advanced hepatocellular carcinoma: A retrospective, real-world study conducted in China

查看全文 作　　者：Dong-Xu [1]Wang;Xu [1]Yang;Jian-Zhen [1]Lin;Yi [1]Bai;Jun-Yu [1]Long;Xiao-Bo [1]Yang;Samuel [2]Seery;Hai-Tao [1]Zhao 高影响力作者 机构地区：[1]Department of Liver Surgery,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China;[2]Department of Humanities,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China高影响力机构 出　　处：《World Journal of Gastroenterology》索引2020年第26卷第30期,共14页高影响力期刊 基　　金：Supported by the International Science and Technology Cooperation Projects,No.2016YFE0107100;the Capital Special Research Project for Health Development,No.2014-2-4012;the Beijing Natural Science Foundation,No.L172055 and No.7192158;the National Tenthousand Talent Program,the Fundamental Research Funds for the Central Universities,No.3332018032;and the CAMS Innovation Fund for Medical Science(CIFMS),No.2017-I2M-4-003 and No.2018-I2M-3-001. 摘　　要：BACKGROUND Lenvatinib has become an indispensable part of treatment regimens for patients with advanced hepatocellular carcinoma(aHCC).Several recent real-world studies appear to have confirmed this;however,there are etiological differences.This necessitates further real-world studies of lenvatinib across diverse populations,such as in China.AIM To investigate the efficacy and safety of lenvatinib in a Chinese HCC patient population under real-world conditions.METHODS This is a retrospective and multiregional study involving patients with aHCC receiving lenvatinib monotherapy.Efficacy was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1.Baseline characteristics and adverse events(AEs)were recorded throughout the entire study.RESULTS In total,54 HCC patients treated with lenvatinib monotherapy were included for final analysis.The objective response rate was 22%(n=12)with a progressionfree survival(PFS)of 168 d;however,AEs occurred in 92.8%of patients.Multivariate analysis showed that the Barcelona Clinic Liver Cancer stage[hazard ratio(HR)0.465;95%CI:0.23-0.93;P=0.031],portal vein tumor thrombus(HR 0.38;95%CI:0.15-0.94;P=0.037)and Child-Pugh classifications(HR 0.468;95%CI:and specificity(83.3%)of decreasing serum biomarkers including alphafetoprotein were calculated in order to predict tumor size reduction.Gene sequencing also provided insights into potential gene mutation signatures related to the effect of lenvatinib.CONCLUSION Our findings confirm previous evidence from the phase III REFLECT study.The majority of patients in this Chinese sample were suffering from concomitant hepatitis B virus-related HCC.However,further analysis suggested that baseline characteristics,changes in serum biomarkers and gene sequencing may hold the key for predicting lenvatinib responses.Further large-scale prospective studies that incorporate more basic medical science measures should be conducted. 关 键 词：Lenvatinib Real-world study Hepatocellular carcinoma EFFICACY Safety TREATMENT
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