PMID- 37304208 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230613 IS - 2253-5969 (Print) IS - 2253-5969 (Electronic) IS - 2253-5969 (Linking) VI - 10 DP - 2023 TI - Population Sensitive to Lenvatinib Plus Anti-PD-1 for Unresectable Hepatocellular Carcinoma Infected with Hepatitis B Virus. PG - 847-861 LID - 10.2147/JHC.S411748 [doi] AB - BACKGROUND: We explore the dose-efficacy relationship of lenvatinib plus anti-PD-1 in patients with unresectable hepatocellular carcinoma (u-HCC) infected with hepatitis B virus (HBV) in real-world practice. Furthermore, we identify the population sensitive to lenvatinib plus anti-PD-1 treatments. METHODS: This retrospective study included 70 patients treated with lenvatinib plus at least 3 cycles of anti-PD-1 and 140 with lenvatinib alone. Stabilized inverse probability of treatment weighting (SIPTW) was used to balance clinical features between the two groups. The overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) were analyzed. Subpopulation treatment effect pattern plot (STEPP) estimated treatment-effect differences between the two groups. RESULTS: The median age was 54 years, and 189 (90%) cases were male. A total of 180 (85%) patients were infected with HBV. A slowly increasing 12-month survival rate was with the cycles of anti-PD-1, and 5 cycles and more of anti-PD-1 appeared the most beneficial and stable survival rate. The lenvatinib plus at least 3 cycles anti-PD-1 group had better OS (21.4 vs 14 months, p = 0.041), PFS (8.0 vs 6.3 months, p = 0.015) than the lenvatinib alone group in unadjusted cohorts, and the SIPTW adjusted cohorts had confirmed it. For patients with portal vein trunk invasion (PVTI) or extrahepatic spread (EHS) combined with Child-Pugh class B (CPB), lenvatinib plus anti-PD-1 made the 12-month survival rate increase by 38%, while, in the other population, it did only 18%. The two groups had similar AEs (p >/= 0.05). CONCLUSION: The lenvatinib combined with at least 3 cycles of anti-PD-1 was efficacy and safe for u-HCC patients infected with HBV. Especially, patients with PVTI or EHS combined with CPB may benefit most from the combination therapy. CI - (c) 2023 Chang et al. FAU - Chang, Xiujuan AU - Chang X AUID- ORCID: 0000-0002-4961-8560 AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. FAU - Yu, Shumin AU - Yu S AUID- ORCID: 0009-0004-5137-8502 AD - 302 Clinical Medical School Peking University, Beijing, 100039, People's Republic of China. FAU - Pang, Jianzhi AU - Pang J AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. FAU - Zhang, Wei AU - Zhang W AUID- ORCID: 0009-0009-3307-7905 AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. FAU - Kong, Huifang AU - Kong H AUID- ORCID: 0009-0006-7619-7980 AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. FAU - Huang, Jiagan AU - Huang J AUID- ORCID: 0009-0004-7234-0407 AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. FAU - Zhang, Guojie AU - Zhang G AUID- ORCID: 0009-0005-2160-932X AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. FAU - Zhang, Huixin AU - Zhang H AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. FAU - Gu, Yueyue AU - Gu Y AUID- ORCID: 0009-0002-3320-6964 AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. AD - The Fifth School of Clinical Medicine, Anhui Medical University, Hefei, Anhui Province, 230032, People's Republic of China. FAU - Chen, Yan AU - Chen Y AUID- ORCID: 0000-0001-6706-6301 AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. FAU - Yang, Bin AU - Yang B AUID- ORCID: 0009-0006-8471-735X AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. FAU - Liu, Jingping AU - Liu J AUID- ORCID: 0009-0003-6853-0892 AD - Oncology Department, Electric Power Hospital of Beijing, Beijing, 100073, People's Republic of China. FAU - Zeng, Zhen AU - Zeng Z AUID- ORCID: 0000-0002-1574-7196 AD - Department of Liver Disease Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, People's Republic of China. AD - 302 Clinical Medical School Peking University, Beijing, 100039, People's Republic of China. AD - The Fifth School of Clinical Medicine, Anhui Medical University, Hefei, Anhui Province, 230032, People's Republic of China. LA - eng PT - Journal Article DEP - 20230606 PL - New Zealand TA - J Hepatocell Carcinoma JT - Journal of hepatocellular carcinoma JID - 101674775 PMC - PMC10257432 OTO - NOTNLM OT - anti-PD-1 OT - hepatocellular carcinoma OT - lenvatinib OT - real-world study COIS- The authors have no conflicts of interest to declare. EDAT- 2023/06/12 06:42 MHDA- 2023/06/12 06:43 PMCR- 2023/06/06 CRDT- 2023/06/12 04:05 PHST- 2023/03/09 00:00 [received] PHST- 2023/06/01 00:00 [accepted] PHST- 2023/06/12 06:43 [medline] PHST- 2023/06/12 06:42 [pubmed] PHST- 2023/06/12 04:05 [entrez] PHST- 2023/06/06 00:00 [pmc-release] AID - 411748 [pii] AID - 10.2147/JHC.S411748 [doi] PST - epublish SO - J Hepatocell Carcinoma. 2023 Jun 6;10:847-861. doi: 10.2147/JHC.S411748. eCollection 2023.