Chen Song, Wang Ning, Xiao Yi, Jiang Xiongying, Shi Feng, Cai Hongjie, Tang Shuangyan, Guo Wenbo, Zhuang Wenquan
Department of Interventional Radiology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Department of Radiology, the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
Immunotargets Ther. 2025 Sep 2;14:953-965. doi: 10.2147/ITT.S542811. eCollection 2025.
This study aimed to evaluate the clinical efficiency and safety of hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and programmed cell death protein-1 (PD-1) inhibitor for patients with hepatocellular carcinoma (HCC) and lung metastasis.
In this multicenter retrospective study, treatment-naive patients with advanced (BCLC stage C) HCC and lung metastases who received lenvatinib and PD-1 inhibitor - with or without HAIC - between January 2019 and January 2024 were reviewed. Propensity score matching (PSM) was applied to balance baseline characteristics between the two groups. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) according to RECIST 1.1 criteria, as well as adverse events (AEs).
A total of 422 eligible patients were included, with 169 receiving HAIC (HLP group) and 253 receiving lenvatinib plus PD-1 inhibitor (LP group). After 1:1 PSM, 151 patients were matched in each group. The HLP group demonstrated significantly longer median OS compared to the LP group (26.0 8.4 months; hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.27-0.49; < 0.001). Median PFS was also improved in the HLP group (7.6 5.5 months; HR: 0.77; 95% CI: 0.59-1.00; = 0.048). ORR and DCR were significantly higher in the HLP group (ORR: 47.7% 20.5%, < 0.001; DCR: 86.1% 72.2%, = 0.003). Although the HLP group experienced a higher incidence of both all-grade and grade 3/4 AEs, all were manageable, and no grade 5 events occurred.
HAIC combined with lenvatinib and PD-1 inhibitor shows promise as a treatment for advanced HCC with lung metastases, offering improved prognosis and a manageable safety profile.
本研究旨在评估肝动脉灌注化疗(HAIC)联合乐伐替尼和程序性细胞死亡蛋白1(PD-1)抑制剂治疗肝细胞癌(HCC)伴肺转移患者的临床疗效和安全性。
在这项多中心回顾性研究中,对2019年1月至2024年1月期间接受乐伐替尼和PD-1抑制剂治疗(无论是否联合HAIC)的初治晚期(巴塞罗那临床肝癌分期C期)HCC伴肺转移患者进行了回顾。采用倾向评分匹配(PSM)来平衡两组之间的基线特征。主要终点为总生存期(OS)。次要终点包括根据实体瘤疗效评价标准(RECIST)1.1标准评估的无进展生存期(PFS)、客观缓解率(ORR)、疾病控制率(DCR)以及不良事件(AE)。
共纳入422例符合条件的患者,其中169例接受HAIC(HLP组),253例接受乐伐替尼联合PD-1抑制剂(LP组)。经过1:1 PSM后,每组各有151例患者匹配成功。HLP组的中位OS明显长于LP组(26.0±8.4个月;风险比[HR]:0.36;95%置信区间[CI]:0.27 - 0.49;P<0.001)。HLP组的中位PFS也有所改善(7.6±5.5个月;HR:0.77;95% CI:0.59 - 1.00;P = 0.048)。HLP组的ORR和DCR显著更高(ORR:47.7%对20.5%,P<0.001;DCR:86.1%对72.2%,P = 0.003)。尽管HLP组所有级别和3/4级AE的发生率较高,但均可控,且未发生5级事件。
HAIC联合乐伐替尼和PD-1抑制剂显示出有望成为治疗晚期HCC伴肺转移的一种方法,可改善预后且安全性可控。