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In locally advanced pancreatic cancer, FOLFIRINOX provides no significant overall or progression-free survival benefit compared to gemcitabine-based regimens, but significantly increases the risk of severe and febrile neutropenia. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

May 30, 2026

Efficacy and safety of FOLFIRINOX versus gemcitabine-based regimens in locally advanced pancreatic carcinoma: A systematic review and meta-analysis.

Key Points

This review aims to compare the efficacy and safety of FOLFIRINOX versus gemcitabine-based regimens for treating locally advanced pancreatic carcinoma.
Conducted a systematic review and meta-analysis of randomized controlled trials and comparative cohort studies.
Included studies evaluated adults with locally advanced pancreatic carcinoma receiving FOLFIRINOX or gemcitabine-based regimens.
Analysis utilized random-effects meta-analysis to pool hazard ratios for overall survival and progression-free survival, and risk ratios for various outcomes.
FOLFIRINOX showed a borderline improvement in overall survival (HR 0.81; 95% CI 0.66–1.01; p = 0.06).
No significant difference in progression-free survival (HR 1.11; 95% CI 0.79–1.54; p = 0.55).
Increased risk of grade ≥3 neutropenia (RR 2.21; 95% CI 1.21–4.04; p = 0.01) and febrile neutropenia (RR 4.26; 95% CI 1.78–10.17; p = 0.001) with FOLFIRINOX.

Abstract

e16391 Background: Locally advanced pancreatic cancer (LAPC) is often unresectable due to vascular involvement, and systemic therapy is the treatment backbone with the goal of improving survival and, in selected patients, enabling resection. FOLFIRINOX is commonly used in fit patients, but its comparative benefit over gemcitabine-based regimens in LAPC remains uncertain. We conducted a systematic review and meta-analysis to compare efficacy and safety of these approaches in LAPC. Methods: We searched PubMed, Embase, Scopus, CENTRAL, and ClinicalTrials.gov for randomized controlled trials and comparative cohort studies in adults with LAPC evaluating FOLFIRINOX versus gemcitabine-based regimens (including nab-paclitaxel). Random-effects meta-analysis pooled hazard ratios (HR) for overall survival (OS) and progression-free survival (PFS), and risk ratios (RR) for response, progression, resection, and grade ≥3 hematologic toxicity. Subgroup analyses were performed by comparator regimen. Results: Six comparative studies (n = 1,766) were included. Overall survival (OS) favored FOLFIRINOX but did not reach statistical significance (HR 0.81; 95% CI 0.66–1.01; p = 0.06; I² = 45). Progression free survival (PFS) showed no significant difference (HR 1.11; 95% CI 0.79–1.54; p = 0.55; I² = 60%). There were no significant differences in objective response (RR 1.07; 95% CI 0.79–1.47; p = 0.65; I² = 38%), disease control (RR 1.13; 95% CI 0.99–1.30; p = 0.08; I² = 0%), progressive disease (RR 0.82; 95%CI 0.43–1.56; p = 0.54; I² = 55%), or resection rate (RR 1.03; 95% CI 0.57–1.86; p = 0.91; I² = 0%). Grade ≥3 neutropenia was higher with FOLFIRINOX (RR 2.21; 95% CI 1.21–4.04; p = 0.01; I² = 49%), as was febrile neutropenia (RR 4.26; 95% CI 1.78–10.17; p = 0.001; I² = 0%) with consistent findings in subgroup analyses. Conclusions: In LAPC, FOLFIRINOX showed borderline, non-significant improvement in overall survival and no improvement in progression-free survival. Response, disease control, progression, and resection outcomes were similar between regimens. FOLFIRINOX increased the risk of grade ≥3 neutropenia and febrile neutropenia. Treatment selection should be individualized based on patient fitness and toxicity risk, and perspective comparative studies are needed.

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