ArticleUnited European gastroenterology journal2024
Efficacy, safety and differential outcomes of immune-chemotherapy with gemcitabine, cisplatin and durvalumab in patients with biliary tract cancers: A multicenter real world cohort.
Article in United European gastroenterology journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
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Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Exploring the impact of first-line durvalumab plus chemotherapy on advanced biliary tract cancer: a systematic review and meta-analysis.The oncologist · 2025Pooled it
- The real-world clinical effectiveness of durvalumab in advanced biliary tract cancer: a mimic comparative analysis through survival data reconstruction.Frontiers in immunology · 2025Pooled it
- Observational
- Article
- Durvalumab plus gemcitabine-cisplatin versus S-1 plus gemcitabine-cisplatin in advanced biliary tract cancer: a comparative study.ESMO gastrointestinal oncology · 2025Article
- Pathologically confirmed complete remission after neoadjuvant chemotherapy in patients with advanced intrapancreatic cholangiocarcinoma following robot-assisted excision of choledochal cyst: A case report.Annals of hepato-biliary-pancreatic surgery · 2025Article
- Beyond chemotherapy in biliary tract cancer: a closer look at the updated long-term follow-up data of the TOPAZ-1 trial.Hepatobiliary surgery and nutrition · 2025Article
- New systemic treatment paradigms in advanced biliary tract cancer and variations in patient access across Europe.The Lancet regional health. Europe · 2025Review
- Ablatio-bilica: safety of biliary intraductal radiofrequency ablation in patients with unresectable extrahepatic biliary tract cancer undergoing systemic anti-tumor therapy: a phase II, multi-center, randomized, and controlled study.Frontiers in oncology · 2025Article
- Efficacy, safety and differential outcomes of immune-chemotherapy with gemcitabine, cisplatin and durvalumab in patients with biliary tract cancers: A multicenter real world cohort.United European gastroenterology journal · 2024Article
- Comparison of lenvatinib plus pembrolizumab versus first-line systemic chemotherapy for advanced intrahepatic cholangiocarcinoma: a real-world retrospective study.Frontiers in immunology · 2024Article
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Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCombined 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.
objectiveWe here evaluated the efficacy and safety of GCD for BTC in a German multicenter real-world patient cohort.
methodsPatients 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.
resultsA 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.
conclusionsImmuno-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.
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