肝动脉灌注化疗联合免疫检查点抑制剂及乐伐替尼治疗胆管癌。

Hepatic artery infusion chemotherapy plus an immune checkpoint inhibitor and lenvatinib for the treatment of biliary tract carcinoma.

作者信息

Wang Junying, Zhu Guangyu, Guo Jinhe, Teng Gaojun

机构信息

Center of Interventional Radiology & Vascular Surgery, Department of Radiology, Cultivation and Construction Site of the State Key Laboratory of Intelligent Imaging and Interventional Medicine (Southeast University), Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing, 210009, China.

出版信息

World J Surg Oncol. 2025 Jun 13;23(1):233. doi: 10.1186/s12957-025-03882-3.

DOI:10.1186/s12957-025-03882-3

PMID:40514706

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12166571/

Abstract

BACKGROUND

The prognosis is still dismal, although several tyrosine kinase inhibitors (TKIs) with/without immune checkpoint inhibitors (ICIs) have shown promising results in the treatment of biliary tract carcinoma (BTC). However, the combination of hepatic artery infusion chemotherapy (HAIC) with ICIs and TKIs may have potential in patients with BTC, according to the success of such a regimen for hepatocellular carcinoma. Hence, this study aimed to evaluate the preliminary efficacy and safety profile of combination therapy with HAIC plus ICI and lenvatinib in BTC patients.

METHODS

This retrospective study included all BTC patients histologically diagnosed with combination therapy, which included HAIC with Gemox (Gemox-HAIC), programmed cell death-1 (PD-1)/programmed cell death-ligand 1 (PD-L1) inhibitor, and lenvatinib from July 2021 to October 2023. The outcomes were the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile.

RESULTS

The median follow-up period was 7.0 months (range: 1.0-28.0 months). The ORR and DCR were 72.7% and 90.9%, respectively, with 0.0% CR, 72.7% PR, 18.2% SD, and 9.1% PD. The median PFS was 6.1 (4.3-8.0 (95% CI) months, and the 12-month accumulating PFS rate was 26.0%. The median OS was 10.3 (8.1-12.5 (95% CI) months, and the 12-month accumulating OS rate was 43.2%. The major adverse events included leukopenia (22.7%), thrombocytopenia (22.7%), vomiting (9.1%), etc. All AEs were grade 1-2 except for grade 3-4 leukopenia and 3-4 thrombocytopenia in one patient.

CONCLUSION

The combination therapy of Gemox-HAIC with ICIs and lenvatinib shows promising efficacy and tolerable safety profiles in BTC patients.

摘要

背景

尽管几种酪氨酸激酶抑制剂（TKIs）联合或不联合免疫检查点抑制剂（ICIs）在胆管癌（BTC）治疗中已显示出有前景的结果，但预后仍然不佳。然而，鉴于肝动脉灌注化疗（HAIC）联合ICIs和TKIs的方案在肝细胞癌治疗中取得成功，其在BTC患者中可能具有潜力。因此，本研究旨在评估HAIC联合ICI和乐伐替尼的联合治疗在BTC患者中的初步疗效和安全性。

方法

本回顾性研究纳入了2021年7月至2023年10月期间所有经组织学诊断接受联合治疗的BTC患者，联合治疗包括使用吉西他滨奥沙利铂方案的肝动脉灌注化疗（Gemox-HAIC）、程序性细胞死亡蛋白1（PD-1）/程序性细胞死亡配体1（PD-L1）抑制剂和乐伐替尼。观察指标为客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和安全性。

结果

中位随访期为7.0个月（范围：1.0 - 28.0个月）。ORR和DCR分别为72.7%和90.9%，完全缓解（CR）为0.0%，部分缓解（PR）为72.7%，疾病稳定（SD）为18.2%，疾病进展（PD）为9.1%。中位PFS为6.1（4.3 - 8.0（95%CI））个月，12个月累积PFS率为26.0%。中位OS为10.3（8.1 - 12.5（95%CI））个月，12个月累积OS率为43.2%。主要不良事件包括白细胞减少（22.7%）、血小板减少（22.7%）、呕吐（9.1%）等。除1例患者出现3 - 4级白细胞减少和3 - 4级血小板减少外，所有不良事件均为1 - 2级。