Exploring the impact of first-line durvalumab plus chemotherapy on advanced biliary tract cancer: a systematic review and meta-analysis

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Conflicts of Interest

Identified Weaknesses

Rating Explanation

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Paper Summary

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Durvalumab Plus Chemo Improves Survival in Advanced Biliary Tract Cancer (Meta-Analysis)

This meta-analysis of four two-arm trials, including the TOPAZ-1 trial and three real-world studies, found that durvalumab plus gemcitabine/cisplatin improved overall survival (OS) and progression-free survival (PFS) in patients with advanced biliary tract cancer (BTC) compared to chemotherapy alone. Five additional single-arm studies supported these findings but had limitations due to their design and heterogeneity.

Possible Conflicts of Interest

None identified

Identified Weaknesses

Limited number of trials

The meta-analysis only included four two-arm trials, limiting the robustness of the findings. More trials are needed to confirm the results.

Heterogeneity in study designs

The single-arm trials included in the review had various limitations such as small sample sizes, short follow-up periods, and variations in chemotherapy backbones, affecting the comparability and generalizability of results.

Historic controls

Two of the included trials used historical control groups, potentially introducing bias as treatment standards and patient characteristics may have changed over time.

Small control group size

Several trials had relatively small numbers of patients in their control group, which may affect the precision and reliability of the comparison between treatments.

Rating Explanation

This is a well-conducted meta-analysis and systematic review addressing an important clinical question. The combination of RCT data and real-world evidence strengthens the findings. However, the limited number of trials and heterogeneity in some study designs warrant a slightly lower rating than 5. The lack of declared COI and rigorous methodology contribute to a positive assessment.

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