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Recent advances in systemic therapy for advanced biliary tract cancer: A systematic review and meta-analysis using
Zhihao Li1, Daniel Aliseda2, Owen Jones1
1HBP & Multi-Organ Transplant Program, University Health Network, Toronto, ON, Canada.
JHEP Reports : Innovation in Hepatology
|February 21, 2025
Summary
First-line treatment for advanced biliary tract cancers (BTCs) now includes immune checkpoint inhibitors (ICIs) combined with gemcitabine/cisplatin (GemCis). This combination therapy shows modest survival benefits, but further improvements require biomarker identification for optimal patient selection.
Area of Science:
- Oncology
- Clinical Trials
- Cancer Research
Background:
- Gemcitabine/cisplatin (GemCis) was the standard first-line therapy for advanced biliary tract cancers (BTCs).
- Recent trials (TOPAZ-01, KEYNOTE-966) established immune checkpoint inhibitors (ICIs) combined with chemotherapy as the new standard of care.
Purpose of the Study:
- To compare the efficacy of first-line therapies for advanced BTCs.
- To evaluate the survival benefits of GemCis combined with ICIs versus GemCis alone.
Main Methods:
- Systematic review of randomized clinical trials (RCTs) published between January 2010 and June 2024.
- Inclusion of 17 RCTs with 4,584 treatment-naive adult patients with advanced BTCs.
- One-stage meta-analysis using reconstructed survival data, Cox models, and restricted mean survival time (RMST).
Main Results:
- GemCis plus pembrolizumab, durvalumab, S-1, or nab-paclitaxel demonstrated superior overall survival (OS) compared to GemCis alone.
- Combinations showed increased median OS and restricted mean survival time (RMST).
- GemCis with ICIs, S-1, or nab-paclitaxel also showed superior progression-free survival (PFS) with increased RMST.
Conclusions:
- GemCis plus ICIs offer a modest survival benefit for advanced BTCs, supporting current guideline adoption.
- Despite advancements, a breakthrough in treatment efficacy is yet to be achieved.
- Biomarker identification is crucial for optimizing combinational therapies and improving patient selection.
