Real-world outcomes of FOLFIRINOX versus gemcitabine plus nab-paclitaxel and prognostic factors in advanced pancreatic cancer: a retrospective cohort study

Autores de IIS La Fe

• Carlos Escriva Aranda

  Autor

• Patricia Capdevila Gaudens

  Autor

• Alba Ortiz Gracia

  Autor

• Jorge Aparicio Urtasun

  Autor

• Roberto Pedro Díaz Beveridge

  Autor

Participantes ajenos a IIS La Fe

• Giner-Moreno, E
• Hernández, ES
• Gallego, JE
• Roch, EG
• Picazo, CC
• Jiménez, DV

Grupos

• Investigación Clínica y Traslacional en Cáncer

Abstract

Background: FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GnP) are the main first-line regimens for advanced pancreatic adenocarcinoma. No randomized clinical trials have directly compared their efficacy, and real-world data remain limited.Objectives: The primary endpoint of this study was to compare overall survival (OS) and progression-free survival (PFS) between the two regimens. Secondary endpoints included the objective response rate (ORR) and the identification of prognostic factors.Design: Retrospective, single-center cohort study.Methods: Patients with locally advanced or metastatic pancreatic adenocarcinoma treated with first-line FFX or GnP at a tertiary referral center in Spain between 2011 and 2024 were included. OS and PFS were estimated using the Kaplan-Meier method and compared with the log-rank test. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox proportional hazard models. Propensity score matching was performed as a sensitivity analysis.Results: A total of 200 patients were analyzed (FFX, n = 42; GnP, n = 158). Median OS was 10.6 months (95% CI 8.0-14.3) for FFX and 9.6 months (95% CI 8.4-11.6) for GnP (HR 1.05, 95% CI 0.74-1.50; p = 0.78). Median PFS was 5.19 months (95% CI 3.12-8.64) and 4.63 months (95% CI 3.61-5.72), respectively (HR 1.09, 95% CI 0.77-1.54; p = 0.64). ORR was 44.2% for FFX and 29.1% for GnP (p = 0.063). Independent prognostic factors for OS included Eastern Cooperative Oncology Group performance status >= 2, elevated neutrophil-to-lymphocyte ratio, lactate dehydrogenase, and CA 19-9 levels. Propensity score-matched analysis confirmed comparable OS and PFS between groups.Conclusion: In this real-world cohort, FFX and GnP were associated with similar OS and PFS outcomes. The retrospective design and baseline imbalances between groups limit causal inference due to potential residual confounding and selection bias.