The real-world clinical effectiveness of durvalumab in advanced biliary tract cancer: a mimic comparative analysis through survival data reconstruction Article Swipe
Hong-xiang Ji
,
Ma-Hui Si
,
Zhe Sun
,
Ning Yang
,
Zhan Chen
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.3389/fimmu.2025.1643844
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.3389/fimmu.2025.1643844
Background The TOPAZ-1 study results represented significant advancement in the treatment of advanced biliary tract cancer (BTC) by combining durvalumab with gemcitabine–cisplatin (DGC). However, the highly selected patient population may not reflect the real-world scenarios. To gain deeper insights into this combination regimen, we conducted an evidence collection and a mimic survival comparative analysis. Methods Records were identified through a formal search of PubMed and Web of Science. Six retrospective cohort studies with real-world evidence were definitively included. The individual patient data for OS and PFS were reconstructed and analyzed. The outcomes different from TOPAZ-1 were summarized and compared. Results Whether Asia or non-Asia group, the mOS was similar to the TOPAZ-1 (Asian group: 12.57 months vs. TOPAZ-1, HR = 0.91, 95% CI: 0.69-1.21, log rank P = 0.53; non-Asian group: 13.61 months vs. TOPAZ-1, HR = 1.10, 95% CI: 0.91-1.31, log rank P = 0.323). The mPFS for the Asian group did not show significant differences compared with TOPAZ-1 (5.63 months vs. TOPAZ-1, HR = 1.09, 95% CI: 0.88-1.35, log rank P = 0.422), whereas for the non-Asian group differences exist (6.58 months vs. TOPAZ-1, HR = 0.80, 95% CI: 0.70-0.92, log rank P = 0.002), but potentially influenced by patient ethnicity. The disease control rate in the real world was not so favorable as that in TOPAZ-1. The most common adverse events (AEs) in real-world scenarios were fatigue (26.01%), leukopenia (24.64%), anemia (24.30%), and thrombocytopenia (21.14%). The incidence of immune-related AEs of grades 3–4 was slightly higher in the real world compared with TOPAZ-1 (4.0% vs. 2.4%). Factors such as ECOG-PS, age, alternative doses of durvalumab, neutrophil-to-lymphocyte ratio (NLR), baseline CEA levels, baseline CA19–9 levels, and metastatic disease could be prognostic factors under DGC regimen, with NLR showing a potential as a predictive marker for survival benefit. Conclusions The efficacy and safety of the DGC regimen for patients with advanced BTC are confirmed through a comparative analysis and aggregation of real-world evidence in this study. Further real-world investigations are still warranted to determine if the DGC regimen has a broader therapeutic indication and to identify predictive markers for survival benefit. Efforts are required to improve the cost-effectiveness of the DGC regimen to facilitate its wider and standardized use.
Related Topics
Concepts
Durvalumab
Medicine
Log-rank test
Internal medicine
Incidence (geometry)
Retrospective cohort study
Cohort
Population
Oncology
Survival analysis
Anemia
Cancer
Survival rate
Adverse effect
Proportional hazards model
Overall survival
Surgery
Real world data
Disease
Biliary tract
Leukopenia
Biliary tract cancer
Hazard ratio
Rank (graph theory)
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.3389/fimmu.2025.1643844
- https://public-pages-files-2025.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1643844/pdf
- OA Status
- gold
- References
- 38
- OpenAlex ID
- https://openalex.org/W7105924186
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W7105924186Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.3389/fimmu.2025.1643844Digital Object Identifier
- Title
-
The real-world clinical effectiveness of durvalumab in advanced biliary tract cancer: a mimic comparative analysis through survival data reconstructionWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2025Year of publication
- Publication date
-
2025-11-18Full publication date if available
- Authors
-
Hong-xiang Ji, Ma-Hui Si, Zhe Sun, Ning Yang, Zhan ChenList of authors in order
- Landing page
-
https://doi.org/10.3389/fimmu.2025.1643844Publisher landing page
- PDF URL
-
https://public-pages-files-2025.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1643844/pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
- OA URL
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https://public-pages-files-2025.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1643844/pdfDirect OA link when available
- Concepts
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Durvalumab, Medicine, Log-rank test, Internal medicine, Incidence (geometry), Retrospective cohort study, Cohort, Population, Oncology, Survival analysis, Anemia, Cancer, Survival rate, Adverse effect, Proportional hazards model, Overall survival, Surgery, Real world data, Disease, Biliary tract, Leukopenia, Biliary tract cancer, Hazard ratio, Rank (graph theory)Top concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- References (count)
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38Number of works referenced by this work
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