免疫检查点抑制剂联合抗血管生成药物在体弱的晚期胆道恶性肿瘤患者中的疗效和安全性分析

Efficacy and safety of immune checkpoint inhibitors combined with anti⁃angiogenic therapy for frail patients with advanced biliary tract malignancies

目的:探讨免疫检查点抑制剂联合抗血管生成药物治疗体弱的晚期胆道恶性肿瘤患者中的疗效和安全性。方法:前瞻性筛选2020年1月至2022年12月在武汉大学人民医院肿瘤中心确诊的晚期胆道恶性肿瘤患者,并纳入体弱患者使用免疫检查点抑制剂联合抗血管生成药物治疗,总结该疗法的效果和安全性。结果:纳入的33例患者中,胆囊癌13例、肝内胆管癌17例、肝外胆管癌3例;接受一线治疗18例、二线治疗15例。经联合治疗后客观缓解率和疾病控制率分别为66.7%和90.9%。中位无进展生存期和中位总生存期分别为8.1个月和13.7个月。7例(21.2%)观察到3级治疗相关不良事件(TRAEs),未观察到4级或5级TRAEs。结论:免疫检查点抑制剂联合抗血管生成药物治疗晚期胆道恶性肿瘤的临床效果显著,安全性良好,为体弱的晚期胆道恶性肿瘤患者提供了新的选择。

Objective To investigate the efficacy and safety of immune checkpoint inhibitors combined with anti⁃angiogenic drugs in the treatment of frail patients with advanced biliary tract malignancies.Methods From January 2020 to December 2022,frail patients with advanced biliary malignancies diagnosed at the Oncology Center in Renmin Hospital of Wuhan University were prospectively screened and included during the treatment with immune checkpoint inhibitors in combination with antiangiogenic drugs,and the efficacy and safety were summarized.Results Among the 33 patients,13 cases of gallbladder carcinoma,17 cases of intrahepatic cholangiocarcinoma,and 3 cases of extrahepatic cholangiocarcinoma.A total of 18 cases received first⁃line treatment and 15 cases received second⁃line treatment.The objective response rate(ORR)and disease control rate(DCR)were 66.7%and 90.9%,respectively.Median progression⁃free time(PFS)and median overall survival(OS)were 8.1 and 13.7 months,respectively.Grade 3 treatment⁃related adverse events(TRAEs)were observed in 7 patients(21.2%),while no grade 4 or 5 TRAEs were found.Conclusion Immune checkpoint inhibitors combined with anti⁃angiogenic drugs have significant clinical effects and good safety in the treatment of advanced biliary malignancies,providing a new option for advanced biliary malignancies.