PMID- 32874058 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20220531 IS - 2219-2840 (Electronic) IS - 1007-9327 (Print) IS - 1007-9327 (Linking) VI - 26 IP - 30 DP - 2020 Aug 14 TI - Efficacy and safety of lenvatinib for patients with advanced hepatocellular carcinoma: A retrospective, real-world study conducted in China. PG - 4465-4478 LID - 10.3748/wjg.v26.i30.4465 [doi] AB - 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 progression-free 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: 0.22-0.97; P = 0.042) were significant factors affecting PFS. The sensitivity (56.7%) and specificity (83.3%) of decreasing serum biomarkers including alpha-fetoprotein 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. CI - (c)The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved. FAU - Wang, Dong-Xu AU - Wang DX AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China. FAU - Yang, Xu AU - Yang X AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China. FAU - Lin, Jian-Zhen AU - Lin JZ AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China. FAU - Bai, Yi AU - Bai Y AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China. FAU - Long, Jun-Yu AU - Long JY AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China. FAU - Yang, Xiao-Bo AU - Yang XB AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China. FAU - Seery, Samuel AU - Seery S AD - Department of Humanities, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China. FAU - Zhao, Hai-Tao AU - Zhao HT AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China. zhaoht@pumch.cn. LA - eng PT - Journal Article PL - United States TA - World J Gastroenterol JT - World journal of gastroenterology JID - 100883448 RN - 0 (Phenylurea Compounds) RN - 0 (Quinolines) RN - EE083865G2 (lenvatinib) SB - IM MH - *Carcinoma, Hepatocellular/drug therapy MH - China/epidemiology MH - Humans MH - *Liver Neoplasms/drug therapy MH - Phenylurea Compounds/adverse effects MH - Quinolines MH - Retrospective Studies PMC - PMC7438196 OTO - NOTNLM OT - Efficacy OT - Hepatocellular carcinoma OT - Lenvatinib OT - Real-world study OT - Safety OT - Treatment COIS- Conflict-of-interest statement: The authors declare that they have no competing interests. EDAT- 2020/09/03 06:00 MHDA- 2021/05/15 06:00 PMCR- 2020/08/14 CRDT- 2020/09/03 06:00 PHST- 2020/03/14 00:00 [received] PHST- 2020/04/25 00:00 [revised] PHST- 2020/07/04 00:00 [accepted] PHST- 2020/09/03 06:00 [entrez] PHST- 2020/09/03 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/08/14 00:00 [pmc-release] AID - 10.3748/wjg.v26.i30.4465 [doi] PST - ppublish SO - World J Gastroenterol. 2020 Aug 14;26(30):4465-4478. doi: 10.3748/wjg.v26.i30.4465.