Efficacy and safety of PD-1 inhibitors for advanced intrahepatic cholangiocarcinoma with or without MAFLD

iLIVER Pub Date : 2025-06-01 DOI:10.1016/j.iliver.2025.100169

Teng Long , Zhenyun Yang , Weijie Wu , Minshan Chen , Dandan Hu

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引用次数: 0

Abstract

Background

This study sought to evaluate the efficacy and safety of programmed cell death protein-1 (PD-1) inhibitor immunotherapy specifically in metabolic dysfunction-associated fatty liver disease (MAFLD)-associated intrahepatic cholangiocarcinoma (ICC) patients, in comparison to those without MAFLD.

Methods

We retrospectively included 161 ICC patients, both with and without MAFLD, who underwent PD-1 inhibitors between March 2019 and August 2024. Subsequent locoregional interventions (e.g., hepatic arterial infusion chemotherapy) and second-line systemic agents (e.g., lenvatinib) were allowed. The primary endpoints included overall survival (OS) and progression-free survival (PFS), while the secondary endpoints comprised objective response rate (ORR), disease control rate (DCR), and adverse events (AEs).

Results

The MAFLD group included 20 patients, while the Non-MAFLD group comprised 141 patients. The OS was 18.0 months for the MAFLD group and 20.1 months for the Non-MAFLD group, while the median PFS was 8.0 and 11.5 months, respectively. According to the modified RECIST (mRECIST) criteria, the Non-MAFLD group exhibited a greater clinical benefit, reflected in higher ORR and DCR (45.4% vs. 20.0%, p = 0.031; 92.9% vs. 75.0%, p = 0.024). Multivariate Cox proportional hazard analysis identified carcinoembryonic antigen (CEA), tumor number, and C-reactive protein (CRP) as independent prognostic factors for OS, whereas CEA and tumor number were significant predictors of PFS. Additionally, the overall incidence of AEs was notably lower in the Non-MAFLD group compared to the MAFLD group.

Conclusion

This study demonstrated that PD-1 inhibitors resulted in similarly prolonged OS and PFS between ICC patients with and without MAFLD, but a superior tumor response was observed in patients without MAFLD. Additionally, the Non-MAFLD group experienced a significantly lower incidence of AEs than the MAFLD group undergoing PD-1 inhibitors.

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PD-1抑制剂治疗伴或不伴MAFLD的晚期肝内胆管癌的疗效和安全性

本研究旨在评估程序性细胞死亡蛋白-1 （PD-1）抑制剂免疫治疗在代谢功能障碍相关脂肪性肝病（MAFLD）相关肝内胆管癌（ICC）患者中的疗效和安全性，并与没有MAFLD的患者进行比较。方法回顾性纳入了161例在2019年3月至2024年8月期间接受PD-1抑制剂治疗的有或无MAFLD的ICC患者。随后的局部干预（如肝动脉输注化疗）和二线全身药物（如lenvatinib）是允许的。主要终点包括总生存期（OS）和无进展生存期（PFS），次要终点包括客观缓解率（ORR）、疾病控制率（DCR）和不良事件（ae）。结果MAFLD组20例，Non-MAFLD组141例。MAFLD组的OS为18.0个月，Non-MAFLD组的OS为20.1个月，而中位PFS分别为8.0和11.5个月。根据修改后的RECIST （mRECIST）标准，非mafld组表现出更大的临床获益，反映在更高的ORR和DCR (45.4% vs. 20.0%, p = 0.031；92.9% vs. 75.0%, p = 0.024)。多因素Cox比例风险分析发现癌胚抗原（CEA）、肿瘤数量和c反应蛋白（CRP）是OS的独立预后因素，而CEA和肿瘤数量是PFS的重要预测因素。此外，与MAFLD组相比，非MAFLD组的ae总发生率显着降低。本研究表明，PD-1抑制剂在伴有和不伴有MAFLD的ICC患者中导致的OS和PFS延长相似，但在没有MAFLD的患者中观察到更好的肿瘤反应。此外，非MAFLD组的ae发生率明显低于接受PD-1抑制剂治疗的MAFLD组。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

iLIVER

CiteScore

0.60

自引率

0.00%

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