Lin Lihui, Lin Yansong, Chen Wei, Yang Xia, Guo Xianwen, Wu Yanqin, Yin Xiaoyu, Ding Zhen, Yun Jingping
Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.
State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.
BMC Cancer. 2025 Jul 1;25(1):1087. doi: 10.1186/s12885-025-14459-4.
The recurrence rate of cholangiocarcinoma (CCA) is high, and there are currently no evidence-based treatments for recurrent CCA. This study aimed to evaluate the effectiveness and safety of programmed cell death protein-1 (PD-1) and programmed cell death ligand-1 (PD-L1) inhibitors in patients with recurrent CCA.
Patients diagnosed with recurrent CCA and treated with PD-1/PD-L1 inhibitors between January 2019 and June 2024 were retrospectively enrolled and analyzed. Overall survival (OS), progression-free survival (PFS), and tumor responses were evaluated, and immunotherapy-related adverse events were recorded. Cox regression analyses were conducted to assess prognostic factors associated with the efficacy of PD-1/PD-L1 inhibitors in recurrent CCA.
A total of 140 recurrent CCA patients were enrolled for analysis. The median follow-up time of the cohort was 16.7 months, the median OS and median PFS were 32.5 months and 9.5 months, respectively. The 6-month, 1-year and 2-year OS rates were 93.7%, 76.3% and 57.5%, respectively. The 6-month and 1-year PFS rates were 71.5% and 42.1%, respectively. The objective response rate and disease control rate were 30.0% and 66.4%, respectively. Recurrence interval, immunotherapy cycles, and immunotherapy responder were associated with OS and PFS. In addition, carcinoembryonic antigen and Eastern Cooperative Oncology Group performance status score independently served as prognostic factors for OS. The most common adverse events were anemia, leukopenia, fatigue, elevated AST, neutropenia, hypoalbuminemia. There were no treatment-related deaths reported in this study.
PD-1/PD-L1 inhibitors therapy offers a promising option for recurrent CCA.
The online version contains supplementary material available at 10.1186/s12885-025-14459-4.
胆管癌（CCA）的复发率很高，目前对于复发性CCA尚无循证治疗方法。本研究旨在评估程序性细胞死亡蛋白1（PD-1）和程序性细胞死亡配体1（PD-L1）抑制剂在复发性CCA患者中的有效性和安全性。
回顾性纳入并分析了2019年1月至2024年6月期间诊断为复发性CCA并接受PD-1/PD-L1抑制剂治疗的患者。评估总生存期（OS）、无进展生存期（PFS）和肿瘤反应，并记录免疫治疗相关不良事件。进行Cox回归分析以评估与PD-1/PD-L1抑制剂治疗复发性CCA疗效相关的预后因素。
共纳入140例复发性CCA患者进行分析。队列的中位随访时间为16.7个月，中位OS和中位PFS分别为32.5个月和9.5个月。6个月、1年和2年的OS率分别为93.7%、76.3%和57.5%。6个月和1年的PFS率分别为71.5%和42.1%。客观缓解率和疾病控制率分别为30.0%和66.4%。复发间隔、免疫治疗周期和免疫治疗反应者与OS和PFS相关。此外，癌胚抗原和东部肿瘤协作组体能状态评分独立作为OS的预后因素。最常见的不良事件为贫血、白细胞减少、疲劳、谷草转氨酶升高、中性粒细胞减少、低白蛋白血症。本研究未报告与治疗相关的死亡。
PD-1/PD-L1抑制剂治疗为复发性CCA提供了一个有前景的选择。
在线版本包含可在10.1186/s12885-025-14459-4获取的补充材料。
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