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Abstract：
OBJECTIVE: Limited treatment options exist for unresectable intrahepatic cholangiocarcinoma (ICC), with systemic chemotherapy (SC) serving as the primary approach. This study aimed to assess the effectiveness of first-line hepatic arterial infusion chemotherapy (HAIC) in combination with lenvatinib and PD-(L)1 inhibitors (HLP) compared to SC combined with PD-(L)1 inhibitors (SCP) or SC alone in treating unresectable ICC.
METHODS: Patient with unresectable ICC who underwent first-line treatment with HLP, SCP or SC from January 2016 to December 2022 were retrospectively analyzed. The study evaluated and compared efficacy and safety outcomes across the three treatment groups.
RESULTS: The study comprised 42, 49, and 50 patients in the HLP, SCP, and SC groups, respectively. Median progression-free survival (PFS) times were 30.0, 10.2, and 6.5 months for HLP, SCP, and SC groups. While the SC group had a median overall survival (OS) time of 21.8 months, the HLP and SCP groups hadn\'t reached median OS. The HLP group demonstrated significantly superior PFS (p < 0.001) and OS (p = 0.014) compared to the others. Moreover, the HLP group exhibited the highest objective response rate (ORR) at 50.0% and the highest disease control rate (DCR) at 88.1%, surpassing the SC group (ORR, 6.0%; DCR, 52.0%) and SCP group (ORR, 18.4%; DCR, 73.5%) (p < 0.05). Generally, the HLP group reported fewer grades 3-4 adverse events (AEs) compared with others.
CONCLUSIONS: In contrast to systemic chemotherapy with or without PD-(L)1 inhibitors, the triple combination therapy incorporating HAIC, lenvatinib, and PD-(L)1 inhibitors showcased favorable survival benefits and manageable adverse events for unresectable ICC.
METHODS: Patient with unresectable ICC who underwent first-line treatment with HLP, SCP or SC from January 2016 to December 2022 were retrospectively analyzed. The study evaluated and compared efficacy and safety outcomes across the three treatment groups.
RESULTS: The study comprised 42, 49, and 50 patients in the HLP, SCP, and SC groups, respectively. Median progression-free survival (PFS) times were 30.0, 10.2, and 6.5 months for HLP, SCP, and SC groups. While the SC group had a median overall survival (OS) time of 21.8 months, the HLP and SCP groups hadn\'t reached median OS. The HLP group demonstrated significantly superior PFS (p < 0.001) and OS (p = 0.014) compared to the others. Moreover, the HLP group exhibited the highest objective response rate (ORR) at 50.0% and the highest disease control rate (DCR) at 88.1%, surpassing the SC group (ORR, 6.0%; DCR, 52.0%) and SCP group (ORR, 18.4%; DCR, 73.5%) (p < 0.05). Generally, the HLP group reported fewer grades 3-4 adverse events (AEs) compared with others.
CONCLUSIONS: In contrast to systemic chemotherapy with or without PD-(L)1 inhibitors, the triple combination therapy incorporating HAIC, lenvatinib, and PD-(L)1 inhibitors showcased favorable survival benefits and manageable adverse events for unresectable ICC.
摘要：
目的：不可切除肝内胆管癌（ICC）的治疗方案有限，以全身化疗（SC）为主要方法。本研究旨在评估一线肝动脉灌注化疗（HAIC）联合lenvatinib和PD-（L）1抑制剂（HLP）与SC联合PD-（L）1抑制剂（SCP）或SC单独治疗不可切除的ICC的有效性。
方法：接受HLP一线治疗的不可切除ICC患者，对2016年1月至2022年12月的SCP或SC进行回顾性分析。该研究评估并比较了三个治疗组的疗效和安全性结果。
结果：该研究包括42、49和50名HLP患者，SCP,和SC组，分别。HLP的中位无进展生存期（PFS）时间分别为30.0、10.2和6.5个月，SCP,SC组。虽然SC组的中位总生存期（OS）为21.8个月，HLP和SCP组尚未达到中位OS。与其他组相比，HLP组显示出明显优于PFS（p<0.001）和OS（p=0.014）。此外，HLP组客观缓解率（ORR）最高，为50.0%，疾病控制率最高，为88.1%，超越SC组(ORR，6.0%；DCR，52.0%)和SCP组(ORR，18.4%；DCR，73.5%)(p<0.05)。一般来说,与其他组相比,HLP组报告的3-4级不良事件(AE)较少.
结论：与使用或不使用PD-（L）1抑制剂的全身化疗相比，结合HAIC的三联疗法，lenvatinib,和PD-（L）1抑制剂对不可切除的ICC显示出良好的生存获益和可控制的不良事件。
方法：接受HLP一线治疗的不可切除ICC患者，对2016年1月至2022年12月的SCP或SC进行回顾性分析。该研究评估并比较了三个治疗组的疗效和安全性结果。
结果：该研究包括42、49和50名HLP患者，SCP,和SC组，分别。HLP的中位无进展生存期（PFS）时间分别为30.0、10.2和6.5个月，SCP,SC组。虽然SC组的中位总生存期（OS）为21.8个月，HLP和SCP组尚未达到中位OS。与其他组相比，HLP组显示出明显优于PFS（p<0.001）和OS（p=0.014）。此外，HLP组客观缓解率（ORR）最高，为50.0%，疾病控制率最高，为88.1%，超越SC组(ORR，6.0%；DCR，52.0%)和SCP组(ORR，18.4%；DCR，73.5%)(p<0.05)。一般来说,与其他组相比,HLP组报告的3-4级不良事件(AE)较少.
结论：与使用或不使用PD-（L）1抑制剂的全身化疗相比，结合HAIC的三联疗法，lenvatinib,和PD-（L）1抑制剂对不可切除的ICC显示出良好的生存获益和可控制的不良事件。
