基于 TOPAZ-1 研究的积极结果，由吉西他滨、顺铂和程序性死亡配体一抑制剂 durvalumab (GCD) 组成的联合免疫化疗是胆道癌 (BTC) 患者的新护理标准。我们在此评估GCD 在德国多中心真实世界患者队列中对 BTC 的疗效和安全性。纳入了来自 9 个德国中心接受 GCD 治疗的 BTC 患者。回顾性分析临床病理学基线参数、总生存期（OS）、缓解率和不良事件（AE）。通过Kaplan-Meier分析和Cox回归模型确定预后影响。该研究共纳入了2021年至2024年期间接受GCD治疗的165名患者。中位 OS 和中位无进展生存期分别为 14 个月 (95% CI 10.3-17.7) 和 8 个月 (95% CI 6.8-9.2)。最佳总缓解率为28.5%，疾病控制率为65.5%。虽然肝外和肝内 BTC 显示相似的结果，但胆囊癌 (GB-CA) 患者的 9 个月 mOS 显着缩短（95% CI 5.5-12.4；p = 0.02）。在单变量分析中，年龄 ≥70 岁、东部肿瘤合作组 (ECOG) 体能状态 (PS) ≥1、胆囊切除术后状态、GB-CA 和高基线 CRP 值与 OS 显着相关。在多变量 cox 回归分析中，ECOG PS ≥ 1 和 GB-CA 仍然是 OS 的独立预后因素。 130 名患者 (78.8%) 报告了 AE，其中包括 149 名 3-4 级 AE (25.5%)。一名患者死于严重传染性肺炎。 17例患者（10.3%）发生免疫相关（ir）AE，其中9例3-4级irAE（2.2%），导致4例患者治疗中断。BTC患者的免疫化疗可行、有效且安全在现实生活场景中。我们的结果与 3 期临床试验结果 (TOPAZ-1) 相当。注意到 GB-CA 患者的疗效降低和/或体力状态降低，需要进一步调查。© 2024 作者。 《联合欧洲胃肠病学杂志》由 Wiley periodicals LLC 代表联合欧洲胃肠病学出版。

Combined Immuno-chemotherapy consisting of gemcitabine, cisplatin and the programmed death-ligand one inhibitor durvalumab (GCD) is the new standard of care for patients with biliary tract cancers (BTC) based on positive results of the TOPAZ-1 study.We here evaluated the efficacy and safety of GCD for BTC in a German multicenter real-world patient cohort.Patients with BTC treated with GCD from 9 German centers were included. Clinicopathological baseline parameters, overall survival (OS), response rate and adverse events (AEs) were retrospectively analyzed. The prognostic impact was determined by Kaplan-Meier analyses and Cox regression models.A total of 165 patients treated with GCD between 2021 and 2024 were included in the study. Median OS and median progression-free survival were 14 months (95% CI 10.3-17.7) and 8 months (95% CI 6.8-9.2), respectively. The best overall response rate was 28.5% and disease control rate was 65.5%. While extrahepatic and intrahepatic BTC showed similar outcomes, mOS was significantly shorter in patients with gall bladder cancer (GB-CA) with 9 months (95% CI 5.5-12.4; p = 0.02). In univariate analyses age ≥70 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥1, status post cholecystectomy, GB-CA and high baseline CRP values were significantly associated with OS. ECOG PS ≥ 1 and GB-CA remained independent prognostic factors for OS in multivariable cox regression analysis. AEs have been reported in 130 patients (78.8%), including 149 grade 3-4 AEs (25.5%). One patient died of severe infectious pneumonia. Immune-related (ir)AEs occurred in 17 patients (10.3%), including 9 grade 3-4 irAEs (2.2%), which led to treatment interruption in 4 patients.Immuno-chemotherapy in patients with BTC was feasible, effective and safe in a real-life scenario. Our results were comparable to the phase 3 clinical trial results (TOPAZ-1). Reduced efficacy was noted in patients with GB-CA and/or a reduced performance status that warrants further investigation.© 2024 The Author(s). United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.