SynthesisEuropean journal of clinical pharmacology2026
Systematic review and first meta-analysis of the efficacy and safety of gemcitabine-cisplatin combined with paclitaxel in patients with advanced biliary tract cancer.
Synthesis in European journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAdvanced biliary tract cancer (BTC) has a poor prognosis with limited options. Gemcitabine–cisplatin (Gem/Cis) is standard first-line therapy, but outcomes remain suboptimal. This meta-analysis evaluated the efficacy and safety of adding paclitaxel complex to Gem/Cis (Gem/Cis/P) in advanced BTC.
methodsThe PROSPERO-registered protocol (CRD420251177440) guided searches of PubMed, EMBASE, Cochrane Library, and Web of Science for clinical studies on Gem/Cis/P in BTC. Three reviewers independently selected studies, extracted data, and assessed quality. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using a fixed-effects model when heterogeneity was low (I² ≤ 50% and p ≥ 0.1), otherwise a random-effects model was applied. All analyses were conducted with RevMan 5.3.
resultsTen studies (1,401 patients) were included; four controlled studies (739 patients) were meta-analyzed. Compared with Gem/Cis, Gem/Cis/P significantly improved response rates: objective response rate (OR = 1.51; 95% CI: 1.08 ~ 2.11; p = 0.02), disease control rate (OR = 1.47; 95% CI: 1.04 ~ 2.08; p = 0.03), and partial response (OR = 1.77; 95% CI: 1.1 ~ 2.62; p = 0.005). However, no significant differences were observed in overall survival (HR = 0.86; 95% CI: 0.71 ~ 1.03; p = 0.11) or progression-free survival (HR = 0.86; 95% CI: 0.73 ~ 1.02; p = 0.08). Grade ≥ 3 adverse events were significantly higher with triplet therapy (OR = 1.79; 95% CI: 1.27 ~ 2.51; p = 0.0008), particularly neutropenia (OR = 1.65; 95% CI: 1.19 ~ 2.28; p = 0.003).
conclusionAdding paclitaxel to gemcitabine–cisplatin improves response rates but not survival in advanced BTC, with increased toxicity. These findings highlight the need for careful patient selection and validation in large-scale trials.
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