Hepatic Arterial Infusion Chemotherapy Combined Lenvatinib and PD-1 Inhibitor Showed Improved Survival for Infiltrative Hepatocellular Carcinoma: A Multicenter Cohort Study

IF 4.2 3区医学 Q2 ONCOLOGY

Journal of Hepatocellular Carcinoma Pub Date : 2024-09-09 DOI:10.2147/jhc.s477872

Ruixia Li, Xiaohui Wang, Hui Li, Murong Wang, Juncheng Wang, Wei Wang, Qunfang Zhou

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Abstract

Purpose: Lenvatinib and programmed cell death protein-1 (PD-1) inhibitor on infiltrative hepatocellular carcinoma (HCC) have obtained demonstrated efficacy and still need improvement. Hepatic arterial infusion chemotherapy (HAIC) has shown promising results for advanced HCC. This study aimed to compare the efficacy of HAIC combined Lenvatinib and PD-1 inhibitor versus Lenvatinib combined PD-1 inhibitor for infiltrative HCC.
Patients and Methods: A total of 232 patients were enrolled. There were 114 patients received Lenvatinib combined PD-1 inhibitor (Len+PD-1 group) and 118 patients received HAIC combined Lenvatinib and PD-1 inhibitor (HAIC+Len+PD-1 group). Overall survival (OS), progression-free survival (PFS) and safety of patients were compared between the two groups by propensity score–matching (PSM).
Results: The 6-, 12-, and 24-month OS rates were 93.8%, 65.1% and 13.4% in Len+PD-1 group, and 100%, 77.3% and 32.1% in HAIC+Len+PD-1 group, respectively. The 3-, 6-, and 12-month PFS rates were 86.4%, 45.7% and 14.1% in Len+PD-1 group, and 95.1%, 59.3% and 25.9% in HAIC+Len+PD-1 group, respectively. The HAIC+Len+PD-1 group had obviously better survival than the Len+PD-1 group both in OS (P=0.002) and PFS (P=0.004). Subgroup analysis revealed that OS in patients with metastasis was improved with HAIC+Len+PD-1 treatment. Patients with alpha-fetoprotein (AFP) response after treatment showed better survival than the non-response. In addition, HAIC+Len+PD-1 group showed manageable adverse events (AEs).
Conclusion: Patient with infiltrative HCC, HAIC+Len+PD-1 treatment had longer OS and PFS than Len+PD-1 treatment. Early AFP response was an effective indicator of better survival and tumor response to therapy.

Plain Language Summary: Infiltrative hepatocellular carcinoma (HCC) is an odd group that is not well adjudicated in the current staging systems, and treatment options for patients with infiltrative HCC are challenging with scant and insufficient clinical evidence. In this multi-center study, we innovatively analyzed the outcome of hepatic arterial infusion chemotherapy (HAIC) combined lenvatinib and PD-1 inhibitor (HAIC+Len+PD-1) was associated longer progression-free survival and overall survival than Lenvatinib plus PD-1 inhibitor combination (Len+PD-1) for patient with infiltrative HCC. In addition, further intragroup analysis revealed that OS of patients with and without metastasis in Len+PD-1 group was significant difference. However, no difference was observed in OS for patients with and without metastasis in HAIC+Len+PD-1 group. Patients with alpha-fetoprotein (AFP) response after treatment showed better survival than the non-response. Our research provides evidence that HAIC combined Lenvatinib and PD-1 inhibitor results in clinically significant improvements in infiltrative HCC. It could be recommended as a first choice for infiltrative HCC therapy.

Keywords: infiltrative hepatocellular carcinoma, hepatic arterial infusion chemotherapy, lenvatinib, PD-1 inhibitor, alpha-fetoprotein response

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肝动脉灌注化疗联合乐伐替尼和PD-1抑制剂可提高浸润性肝细胞癌的生存率：一项多中心队列研究

目的：伦伐替尼和程序性细胞死亡蛋白-1（PD-1）抑制剂对浸润性肝细胞癌（HCC）有明显疗效，但仍需改进。肝动脉灌注化疗（HAIC）对晚期 HCC 有着良好的疗效。本研究旨在比较 HAIC 联合伦伐替尼和 PD-1 抑制剂与伦伐替尼联合 PD-1 抑制剂治疗浸润性 HCC 的疗效：共纳入232例患者。114例患者接受了伦伐替尼联合PD-1抑制剂治疗（Len+PD-1组），118例患者接受了HAIC联合伦伐替尼和PD-1抑制剂治疗（HAIC+Len+PD-1组）。通过倾向评分匹配（PSM）比较了两组患者的总生存期（OS）、无进展生存期（PFS）和安全性：结果：Len+PD-1组的6个月、12个月和24个月OS率分别为93.8%、65.1%和13.4%，HAIC+Len+PD-1组分别为100%、77.3%和32.1%。Len+PD-1组的3个月、6个月和12个月的PFS率分别为86.4%、45.7%和14.1%，HAIC+Len+PD-1组分别为95.1%、59.3%和25.9%。在OS（P=0.002）和PFS（P=0.004）方面，HAIC+Len+PD-1组的生存率明显优于Len+PD-1组。亚组分析显示，HAIC+Len+PD-1治疗可改善转移患者的OS。治疗后甲胎蛋白（AFP）有反应的患者比无反应的患者生存率更高。此外，HAIC+Len+PD-1组的不良反应（AEs）也在可控范围内：结论：浸润性 HCC 患者接受 HAIC+Len+PD-1 治疗的 OS 和 PFS 均长于 Len+PD-1 治疗。白话摘要：浸润性肝细胞癌（HCC）是一个奇特的群体，在目前的分期系统中没有得到很好的判定，浸润性肝细胞癌患者的治疗方案具有挑战性，临床证据稀少且不足。在这项多中心研究中，我们创新性地分析了肝动脉灌注化疗（HAIC）联合来伐替尼和PD-1抑制剂（HAIC+Len+PD-1）与来伐替尼和PD-1抑制剂联合治疗（Len+PD-1）相比，对浸润性HCC患者的无进展生存期和总生存期更长。此外，进一步的组内分析显示，在伦+PD-1组中，有转移和无转移患者的OS存在显著差异。然而，在HAIC+Len+PD-1组中，有转移和无转移患者的OS无差异。治疗后甲胎蛋白（AFP）有反应的患者生存率高于无反应的患者。我们的研究证明，HAIC联合伦伐替尼和PD-1抑制剂可显著改善浸润性HCC的临床疗效。关键词：浸润性肝细胞癌；肝动脉灌注化疗；来伐替尼；PD-1抑制剂；甲胎蛋白反应

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