ArticleTargeted oncology2024
Durvalumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Biliary Tract Cancer: a Real-World Retrospective, Multicenter Study.
Article in Targeted oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Safety evaluation of TOPAZ-1 and KEYNOTE-966 regimens in metastatic biliary tract cancer: a systematic review and meta-analysis.Clinical & experimental metastasis · 2026Pooled it
- PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment for advanced biliary tract cancer: a systematic review and meta-analysis.Frontiers in medicine · 2026Pooled 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
- Real-world outcomes of chemoimmunotherapy in advanced biliary tract cancer: a multicenter study with a propensity-matched historical cohort.ESMO real world data and digital oncology · 2026Article
- S100A10 promotes glycolysis and malignant progression of CCA by activating the HK2/ERK signaling pathway.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Impact of TOPAZ-1 eligibility on the survival benefit of durvalumab plus gemcitabine-cisplatin in advanced biliary tract cancer: a multicenter real-world study.Journal of gastroenterology · 2026Article
- New progress and clinical research translation of immune checkpoint inhibitors in systemic therapy of gallbladder cancer.Frontiers in immunology · 2026Review
- Durvalumab plus gemcitabine-cisplatin versus S-1 plus gemcitabine-cisplatin in advanced biliary tract cancer: a comparative study.ESMO gastrointestinal oncology · 2025Article
- ASO Author Reflections: Real-World Outcomes of Neoadjuvant Gemcitabine, Cisplatin, and Durvalumab for Surgical Conversion of Borderline Resectable Cholangiocarcinoma.Annals of surgical oncology · 2025Article
- Ivosidenib for IDH1-Mutant Intrahepatic Cholangiocarcinoma: Insights From a Multicenter Real-World Study.Liver international : official journal of the International Association for the Study of the Liver · 2025Observational
- Article
- Article
- Population pharmacokinetics and exposure-response analysis of durvalumab in combination with gemcitabine and cisplatin in patients with advanced biliary tract cancer.Cancer chemotherapy and pharmacology · 2025Article
- New systemic treatment options for advanced cholangiocarcinoma.Journal of liver cancer · 2024Article
- Superior survival benefits of triple combination immunotherapy compared to standard chemotherapy as second-line treatment for advanced biliary tract cancer: a retrospective analysis.Frontiers in oncology · 2024Article
- Comparison of lenvatinib plus pembrolizumab versus first-line systemic chemotherapy for advanced intrahepatic cholangiocarcinoma: a real-world retrospective study.Frontiers in immunology · 2024Article
- Focusing on the Immune Cells: Recent Advances in Immunotherapy for Biliary Tract Cancer.Cancer management and research · 2024Review
Corrections and comments
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Authors and funding
49 authors at 20 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe TOPAZ-1 phase III trial reported a survival benefit with the anti-programmed cell death ligand 1 (anti-PD-L1) durvalumab in combination with gemcitabine and cisplatin in patients with advanced biliary tract cancer (BTC).
objectiveThe present study investigated for the first time the impact on survival of adding durvalumab to cisplatin/gemcitabine compared with cisplatin/gemcitabine in a real-world setting. PATIENTS AND
methodsThe analyzed population included patients with unresectable, locally advanced, or metastatic BTC treated with durvalumab in combination with cisplatin/gemcitabine or with cisplatin/gemcitabine alone. The impact of adding durvalumab to chemotherapy in terms of overall survival (OS) and progression free survival (PFS) was investigated with univariate and multivariate analysis.
resultsOverall, 563 patients were included in the analysis: 213 received cisplatin/gemcitabine alone, 350 received cisplatin/gemcitabine plus durvalumab. At the univariate analysis, the addition of durvalumab was found to have an impact on survival, with a median OS of 14.8 months versus 11.2 months [hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.50-0.80, p = 0.0002] in patients who received cisplatin/gemcitabine plus durvalumab compared to those who received cisplatin/gemcitabine alone. At the univariate analysis for PFS, the addition of durvalumab to cisplatin/gemcitabine demonstrated a survival impact, with a median PFS of 8.3 months and 6.0 months (HR 0.57, 95% CI 0.47-0.70, p < 0.0001) in patients who received cisplatin/gemcitabine plus durvalumab and cisplatin/gemcitabine alone, respectively. The multivariate analysis confirmed that adding durvalumab to cisplatin/gemcitabine is an independent prognostic factor for OS and PFS, with patients > 70 years old and those affected by locally advanced disease experiencing the highest survival benefit. Finally, an exploratory analysis of prognostic factors was performed in the cohort of patients who received durvalumab: neutrophil-lymphocyte ratio (NLR) and disease stage were to be independent prognostic factors in terms of OS. The interaction test highlighted NLR ≤ 3, Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0, and locally advanced disease as positive predictive factors for OS on cisplatin/gemcitabine plus durvalumab.
conclusionIn line with the results of the TOPAZ-1 trial, adding durvalumab to cisplatin/gemcitabine has been confirmed to confer a survival benefit in terms of OS and PFS in a real-world setting of patients with advanced BTC.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.