Department of Interventional Radiology, Fujian Medical University Union Hospital, Fuzhou, China.
Front Immunol. 2024 Jan 15;14:1286771. doi: 10.3389/fimmu.2023.1286771. eCollection 2023.
To evaluate the efficacy and safety of biliary stenting implantation with iodine-125 seed strand (SI) followed by hepatic artery infusion chemotherapy (HAIC) plus lenvatinib (Len) with programmed death-1 (PD-1) inhibitor for patients diagnosed with extrahepatic cholangiocarcinoma (ECC) and malignant obstructive jaundice (MOJ).
In this single-center retrospective study, the data of ECC patients with MOJ from March 2015 to January 2023 was assessed. Using probability score matching (PSM), the selection bias of patients was reduced. Primary study outcomes included overall survival (OS) and progression-free survival (PFS). The OS and PFS were performed using the Kaplan-Meier method and evaluated with the log-rank test.
A total of 104 patients were enrolled finally, including 52 patients treated with interventional therapy (SI+HAIC) plus Len with PD-1 inhibitor (SI+HAIC+Len+P group) and 52 patients treated with interventional therapy (SI+HAIC) plus lenvatinib (SI+HAIC+Len group). 26 pairs of patients were matched after PSM analysis. After PSM analysis, the median OS and PFS in the SI+HAIC+Len+P group were significantly longer compared to those in the SI+HAIC+Len group (OS:16.6 12.3 months, = 0.001; PFS:12.6 8.5 months, = 0.004). The DCR was significantly different between groups ( = 0.039), while ORR not ( = 0.548). The addition of PD-1 inhibitor was generally well tolerated without treatment-associated mortality.
Interventional therapy (SI+HAIC) plus Len with PD-1 inhibitor was effective for ECC patients accompanied by MOJ with a manageable safety profile.
评估碘-125 种子 strand（SI）胆道支架植入联合肝动脉灌注化疗（HAIC）加仑伐替尼（Len）联合程序性死亡受体-1（PD-1）抑制剂治疗经病理证实的肝外胆管癌（ECC）合并恶性梗阻性黄疸（MOJ）患者的疗效和安全性。
本单中心回顾性研究纳入了 2015 年 3 月至 2023 年 1 月期间 MOJ 的 ECC 患者，采用概率评分匹配（PSM）减少患者选择偏倚。主要研究终点为总生存期（OS）和无进展生存期（PFS）。采用 Kaplan-Meier 法计算 OS 和 PFS，并采用对数秩检验进行比较。
共纳入 104 例患者，其中 52 例患者接受介入治疗（SI+HAIC）加仑伐替尼（Len）联合 PD-1 抑制剂（SI+HAIC+Len+P 组），52 例患者接受介入治疗（SI+HAIC）加仑伐替尼（SI+HAIC+Len 组）。PSM 分析后匹配 26 对患者。PSM 分析后，SI+HAIC+Len+P 组的中位 OS 和 PFS 明显长于 SI+HAIC+Len 组（OS：16.6 vs. 12.3 个月， = 0.001；PFS：12.6 vs. 8.5 个月， = 0.004）。两组间疾病控制率（DCR）差异有统计学意义（ = 0.039），客观缓解率（ORR）差异无统计学意义（ = 0.548）。加用 PD-1 抑制剂总体耐受性良好，无治疗相关死亡。
对于伴有 MOJ 的 ECC 患者，介入治疗（SI+HAIC）加仑伐替尼（Len）联合 PD-1 抑制剂是一种有效的治疗方法，具有可管理的安全性。
