PMID- 36790032 OWN - NLM STAT- MEDLINE DCOM- 20230510 LR - 20230511 IS - 2045-7634 (Electronic) IS - 2045-7634 (Linking) VI - 12 IP - 8 DP - 2023 Apr TI - Effectiveness and safety of lenvatinib plus anti-programmed death-1 antibodies in patients with hepatocellular carcinoma: A real-world cohort study. PG - 9202-9212 LID - 10.1002/cam4.5661 [doi] AB - OBJECTIVE: Lenvatinib plus anti-programmed death-1 (anti-PD-1) antibody combinations have shown potent anti-tumor effect in phase I/II trials in advanced or unresectable hepatocellular carcinoma (HCC), but real-world data are limited. METHODS: To investigate the effectiveness and safety of lenvatinib plus anti-PD-1 antibodies in a real-world cohort, we retrospectively evaluated 210 patients with unresectable or advanced HCC treated with these regimens between October 2018 and February 2022. RESULTS: The objective response rate and disease control rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 were 28.1% and 75.2%. Median overall survival (OS) and progression-free survival (PFS) in the overall cohort were 17.2 and 8.4 months, respectively. Median OS and PFS of patients receiving first-line treatment reached 18.9 and 9.6 months. Median OS was significantly longer in patients with Child-Pugh class A versus B (18.8 vs. 5.9 months, respectively), as was median PFS (9.1 vs. 4.4 months). Patients with albumin-bilirubin (ALBI) grade 1 versus grade 2/3 also had significantly greater median OS (23.5 vs. 13.4 months). Treatment-related adverse events (AEs) occurred in 79.5% of patients. Patients with ALBI grade 2/3 had a higher rate of grade 3/4 AEs than patients with ALBI grade 1 (57.5% vs. 38.5%). CONCLUSION: Lenvatinib combined with anti-PD-1 antibody therapy was effective in patients with sufficient liver function reserve. Further study is needed to improve therapeutic efficacy and AE management in patients with Child-Pugh class B or ALBI grade 2/3. CI - (c) 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. FAU - Xu, Ming-Hao AU - Xu MH AUID- ORCID: 0000-0001-5656-8090 AD - Department of Liver Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Huang, Cheng AU - Huang C AD - Department of Liver Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Li, Mei-Ling AU - Li ML AD - Department of Liver Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Zhu, Xiao-Dong AU - Zhu XD AD - Department of Liver Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Tan, Chang-Jun AU - Tan CJ AD - Department of Liver Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Zhou, Jian AU - Zhou J AUID- ORCID: 0000-0002-2118-1117 AD - Department of Liver Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Fan, Jia AU - Fan J AUID- ORCID: 0000-0001-5158-629X AD - Department of Liver Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Sun, Hui-Chuan AU - Sun HC AUID- ORCID: 0000-0003-3761-7058 AD - Department of Liver Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Shen, Ying-Hao AU - Shen YH AUID- ORCID: 0000-0001-6476-0648 AD - Department of Liver Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230215 PL - United States TA - Cancer Med JT - Cancer medicine JID - 101595310 RN - EE083865G2 (lenvatinib) RN - 0 (Albumins) RN - RFM9X3LJ49 (Bilirubin) SB - IM MH - Humans MH - *Carcinoma, Hepatocellular/drug therapy MH - Cohort Studies MH - Retrospective Studies MH - *Liver Neoplasms/drug therapy MH - Albumins MH - Bilirubin PMC - PMC10166966 OTO - NOTNLM OT - ALBI grade OT - Child-Pugh class OT - anti-PD-1 antibody OT - hepatocellular carcinoma OT - lenvatinib COIS- No conflicts of interest were declared. EDAT- 2023/02/16 06:00 MHDA- 2023/05/10 06:42 PMCR- 2023/02/15 CRDT- 2023/02/15 07:22 PHST- 2022/11/24 00:00 [revised] PHST- 2022/08/02 00:00 [received] PHST- 2023/01/17 00:00 [accepted] PHST- 2023/05/10 06:42 [medline] PHST- 2023/02/16 06:00 [pubmed] PHST- 2023/02/15 07:22 [entrez] PHST- 2023/02/15 00:00 [pmc-release] AID - CAM45661 [pii] AID - 10.1002/cam4.5661 [doi] PST - ppublish SO - Cancer Med. 2023 Apr;12(8):9202-9212. doi: 10.1002/cam4.5661. Epub 2023 Feb 15.