背景:对表现出高风险特征(Vp4和/或胆管侵犯,和/或肿瘤占有率≥50%)缺乏标准化方法,并产生不利的结果。这项研究试图评估安全性,功效,以及采用肝动脉灌注化疗(HAIC)的预后影响,lenvatinib,和人源化程序性死亡受体-1(PD-1)在高危HCC患者的治疗中。
方法:在本回顾性分析中,具有高风险特征的HCC患者接受lenvatinib联合PD-1(LEN-PD1)或HAIC组合治疗,lenvatinib,和PD-1(HAIC-LEN-PD1)。该研究通过计算总生存期(OS)来评估抗肿瘤疗效。无进展生存期(PFS),客观反应率(ORR),疾病控制率(DCR)。分析治疗相关不良事件(TRAEs)以评估安全性。
结果:在2019年6月至2022年9月之间,共有61例患者被纳入LEN-PD1组,103例患者纳入HAIC-LEN-PD1组.LEN-PD1组OS为9.8个月,而HAIC-LEN-PD1组的中位OS显著延长,为19.3个月(HR=0.43,p<0.001).此外,与LEN-PD1组相比,HAIC-LEN-PD1组的PFS显着延长(9.6个月vs.4.9个月,HR=0.48,p<0.001)。根据改良的RECIST,HAIC-LEN-PD1组患者的ORR和DCR较高(76.7%vs.23.0%,p<0.001;92.2%vs.72.1%,p=0.001)。HAIC-LEN-HAIC组比LEN-PD1组导致更多的不良事件,其中大多数是可以容忍和可控的。
结论:Lenvatinib,与单独使用lenvatinib相比,HAIC和PD-1对具有高风险特征的HCC显示出安全和有希望的抗肿瘤活性。
BACKGROUND: The treatment of hepatocellular carcinoma (HCC) patients exhibiting high-risk characteristics (Vp4, and/or bile duct invasion, and/or tumor occupancy ≥ 50%) lacks standardized approaches and yields unfavorable results. This
study endeavors to evaluate the safety, efficacy, and prognostic impacts of employing hepatic arterial infusion chemotherapy (HAIC), lenvatinib, and humanized programmed death receptor-1 (PD-1) in the treatment of high-risk HCC patients.
METHODS: In this retrospective analysis, HCC patients with high-risk features were treated with either lenvatinib combined with PD-1 (LEN-PD1) or a combination of HAIC, lenvatinib, and PD-1 (HAIC-LEN-PD1). The
study assessed the antitumor efficacy by calculating overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Treatment-related adverse events (TRAEs) were analyzed to assess the safety profiles.
RESULTS: Between June 2019 and September 2022, a total of 61 patients were included in the LEN-PD1 group, while 103 patients were enrolled in the HAIC-LEN-PD1 group. The OS was 9.8 months in the LEN-PD1 group, whereas the HAIC-LEN-PD1 group exhibited a significantly longer median OS of 19.3 months (HR = 0.43, p < 0.001). Furthermore, PFS was notably extended in the HAIC-LEN-PD1 group compared to the LEN-PD1 group (9.6 months vs. 4.9 months, HR = 0.48, p < 0.001). Patients in the HAIC-LEN-PD1 group had a higher ORR and DCR according to the modified RECIST (76.7% vs. 23.0%, p < 0.001; 92.2% vs. 72.1%, p = 0.001). HAIC-LEN-HAIC group led to more adverse events than LEN-PD1 group, most of which were tolerable and controllable.
CONCLUSIONS: Lenvatinib, HAIC and PD-1 showed safe and promising anti-tumor activity compared with lenvatinib alone for HCC with high-risk features.