Authors
N C Biesma, G A Cirkel, N Haj Mohammad, M Los, R C Verdonk, I Q Molenaar, L A Daamen, H C van Santvoort
Published in
Journal of surgical oncology. Oct 12, 2026. Epub Oct 12, 2026.
Abstract
The PRODIGE 24/CCTG PA.6- trial has shown an overall survival (OS) up to 55 months in patients treated with (modified) 5-fluorouracil, leucovorin, irinotecan and oxaliplatin ((m)FOLFIRINOX) chemotherapy after resection of pancreatic ductal adenocarcinoma (PDAC). The applicability of these results to a real-world patient population is, however, unknown. This study aimed to assess the efficacy of (m)FOLFIRINOX compared to other adjuvant chemotherapy regimens in a real-world cohort.
We performed a post-hoc analysis in a prospectively maintained cohort of patients undergoing PDAC resection in the Regional Academic Cancer Centre Utrecht, the Netherlands, from 2016 to 2020. Median OS was evaluated using Kaplan-Meier curves, primarily stratified by adjuvant chemotherapy regimen and secondarily by eligibility for the PRODIGE 24/CCTG PA.6- trial. Multivariable Cox regression was used to assess the association between chemotherapy regimen and OS, presented as hazard ratio's (HR) with 95% confidence interval (95%CI).
A total of 161 patients with a median follow-up of 51 months (interquartile range (IQR) 43-61) were included. With (m)FOLFIRINOX (n = 30), OS was 29 months (IQR 22-42; [HR 0.26, 95%CI 0.14-0.47, p < 0.01]). Comparing (m)FOLFIRINOX with gemcitabine monotherapy yielded a HR of 0.62 (95%CI 0.33-1.17, p = 0.14), while (m)FOLFIRINOX versus gemcitabine combination therapy had a HR of 0.66 (95% CI 0.35-1.24 p = 0.20). Patients without adjuvant therapy (n = 71) had a median OS of 13 months (IQR 11-23, reference group). In patients receiving gemcitabine monotherapy (n = 31), median OS was 21 months (IQR 15-31; [HR 0.41 95%CI 0.25-0.69, p < 0.01]); for gemcitabine combination therapy (n = 29), OS was 28 months (IQR 23-43; [HR 0.39, 95%CI 0.23-0.66, p < 0.01]) In patients who received (m)FOLFIRINOX and who did or did not meet trial eligibility criteria, OS was 27 months (IQR 12-NR), compared to 30 months (IQR 21-NR) (p = 0.16), respectively.
The survival benefit of (m)FOLFIRINOX observed in the clinical trial setting was not observed in our real-world cohort, not even in the selected subset of patients who would have deemed eligible for inclusion in the PRODIGE 24/CCTG PA.6- trial. Survival was not different for patients treated with (m)FOLFIRINOX and gemcitabine combination therapy.
PMID:
42861545
Bibliographic data and abstract were imported from PubMed on 12 Oct 2026.
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