FOLFIRINOX versus gemcitabine (plus paclitaxel) for pancreatic cancer

an analysis based on data from the Clinical Cancer Registry of Lower Saxony

authored by

Jonathan Engelke, Mike Klora, Jan Zeidler, Tonia Brand

Abstract

Background: Clinical trials show that treatment with 5-fluorouracil + leucovorin + irinotecan + oxaliplatin (FOLFIRINOX) is superior to treatment with gemcitabine (Gem) alone or gemcitabine plus paclitaxel (Gem + Pac) for pancreatic cancer (PC). We examine whether positive effects on survival can be shown using real-world data from the Lower Saxony Clinical Cancer Registry (Germany). Methods: Our study population consisted of patients included in a retrospective, registry-based observational study. All patients were diagnosed with exocrine PC between 2019–2021 and treated in Lower Saxony. We compared treatment groups receiving FOLFIRINOX, Gem exclusively, Gem + Pac, other chemotherapy regimens, or no reported chemotherapy. We calculate the 1-, 2- and 3-year survival rates and the median survival by using Kaplan-Meier estimates and assess the hazard ratio (HR) of death by using multivariate Cox-regression, stratified by these treatment groups. The confidence interval for the median survival and HR is calculated at a 5% significance level. Results: Among 3,919 included patients, 458 received FOLFIRINOX, 362 Gem, 506 Gem + Pac, 826 other chemotherapy regimens, and 1,767 had no reported chemotherapy. Compared to FOL, the HR of death was 1.27 for Gem [95% confidence interval (CI): 1.06–1.52, P<0.001] and 1.20 for Gem + Pac (95% CI: 1.03–1.41, P<0.001), indicating superior survival associated with FOLFIRINOX compared to both regimens Gem and Gem + Pac. We find the trend that survival is lower with the administration of Gem (4.5 months, 95% CI: 3.7–6.1) with regard to survival in stage IV than with administration of Gem + Pac (7.2 months, 95% CI: 5.7–8.6). Conclusions: Our work therefore broadens the descriptive scope of existing clinical studies, including patients with other chemotherapy regimens or no reported chemotherapy. While the comparative analysis focuses on the three main regimens, FOLFIRINOX, Gem, and Gem + Pac, the inclusion of all patients treated for PC in Lower Saxony allows for a broader real-world perspective on treatment practices. This approach highlights the value of registry data for understanding care patterns in populations not typically covered by clinical trials.

Organisation(s)

Institute of Health Economics

External Organisation(s)

Clinical Cancer Registry of Lower Saxony

Type

Article

Journal

Annals of Pancreatic Cancer

Volume

8

Publication date

29.07.2025

Publication status

Published

Peer reviewed

Yes

ASJC Scopus subject areas

Internal Medicine, Endocrinology, Diabetes and Metabolism, Oncology, Endocrinology

Sustainable Development Goals

SDG 3 - Good Health and Well-being

Electronic version(s)

https://doi.org/10.21037/apc-24-36 (Access: Open)