仑伐替尼联合抗程序性死亡蛋白1（PD-1）抗体加局部区域治疗用于初始不可切除的伴有门静脉癌栓的肝细胞癌：一项多中心真实世界研究
Lenvatinib combined with anti-PD-1 antibodies plus locoregional treatment for initial unresectable hepatocellular carcinoma with portal vein tumor thrombosis: a multicenter real-world study.
作者信息
Chi Qi-Yu, Liu Quan-Yuan, Wang Shuang-Jia, Liu Ye-Dong, Gao Xiao-Di, Lin Kong-Ying, Yang Lan-Fang, Liu Zi-Jian, Chi Min-Hui, Weng Shan-Geng, Zeng Yong-Yi, Zhang Zhi-Bo
机构信息
Department of Hepatopancreatobiliary Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
Department of Hepatopancreatobiliary Surgery, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, China.
出版信息
BMC Cancer. 2025 Jul 10;25(1):1162. doi: 10.1186/s12885-025-14543-9.
BACKGROUND
Unresectable hepatocellular carcinoma (uHCC) with portal vein tumor thrombosis (PVTT) has poor prognoses. This study evaluated the efficacy and safety of lenvatinib (LEN) combined with anti-PD-1 antibodies (PD-1) and locoregional therapy (LRT) in uHCC patients with PVTT.
METHODS
Consecutive uHCC patients with PVTT who received LEN, PD-1, and LRT (LPLRT), such as transcatheter arterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), or TACE-HAIC, were analyzed. Objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and treatment-related adverse events (TRAEs) were assessed. Subgroup analysis and multivariate Cox regression analysis was performed to identify independent risk factors for OS and PFS.
RESULTS
Between January 2019 and December 2021, 74 uHCC patients with PVTT at four tertiary hospitals were enrolled. Of these, 38 were treated with LEN, PD-1, and TACE (LPT), 12 with LEN, PD-1, and HAIC (LPH), and 24 with LEN, PD-1, and TACE-HAIC (LPTH). According to the modified Response Evaluation Criteria in Solid Tumors, the ORR and DCR were 62.1% and 85.1%, respectively. The median OS was 23.3 months (95% CI, 18.9-27.7 months), and the median PFS was 13.2 months (95% CI, 8.8-17.6 months). Subgroup analyses revealed no significant differences in ORR, DCR, OS or PFS among the LPT, LPH, and LPTH groups. No grade 5 TRAEs occurred. Twenty-nine patients underwent salvage surgery. Significant differences in OS and PFS rates were observed between the resection and non-resection groups (p < 0.001 for both). Multivariate analysis showed that surgical resection was an independent prognostic factor for OS and PFS.
CONCLUSION
LPLRT therapy offers a promising treatment for uHCC patients with PVTT, demonstrating high tumor response and conversion rates, prolonged survival, and manageable safety. Notably, for patients who remain eligible for surgery following LPLRT, salvage surgery is a safe, effective, and potentially prognostic treatment option.
背景
伴有门静脉癌栓（PVTT）的不可切除肝细胞癌（uHCC）预后较差。本研究评估了乐伐替尼（LEN）联合抗程序性死亡蛋白1（PD-1）抗体及局部区域治疗（LRT）在伴有PVTT的uHCC患者中的疗效和安全性。
方法
对连续接受LEN、PD-1及LRT（LPLRT）治疗的伴有PVTT的uHCC患者进行分析，LRT包括经动脉化疗栓塞术（TACE）、肝动脉灌注化疗（HAIC）或TACE-HAIC。评估客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）、无进展生存期（PFS）及治疗相关不良事件（TRAEs）。进行亚组分析和多因素Cox回归分析以确定OS和PFS的独立危险因素。
结果
2019年1月至2021年12月，四家三级医院的74例伴有PVTT的uHCC患者入组。其中，38例接受LEN、PD-1及TACE治疗（LPT），12例接受LEN、PD-1及HAIC治疗（LPH），24例接受LEN、PD-1及TACE-HAIC治疗（LPTH）。根据实体瘤改良疗效评价标准，ORR和DCR分别为62.1%和85.1%。中位OS为23.3个月（95%CI，18.9 - 27.7个月），中位PFS为13.2个月（95%CI，8.8 - 17.6个月）。亚组分析显示，LPT、LPH和LPTH组在ORR、DCR、OS或PFS方面无显著差异。未发生5级TRAEs。29例患者接受了挽救性手术。手术切除组与未切除组的OS和PFS率存在显著差异（两者p均<0.001）。多因素分析显示，手术切除是OS和PFS的独立预后因素。
结论
LPLRT治疗为伴有PVTT的uHCC患者提供了一种有前景的治疗方法，显示出高肿瘤缓解率和转化率、延长生存期及可控的安全性。值得注意的是，对于LPLRT后仍符合手术条件的患者，挽救性手术是一种安全、有效且可能改善预后的治疗选择。
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