A real-world comparison of treatment strategies for metastatic pancreatic cancer: 4-month FOLFIRINOX followed by maintenance therapy versus 6-month FOLFIRINOX followed by observation
Authors
Term
5. Term (Master thesis)
Education
Publication year
2025
Submitted on
2025-12-22
Pages
17
Abstract
Introduction Pancreatic adenocarcinoma is associated with one of the poorest prognoses in oncology. Although presenting high toxicity, the FOLFIRINOX chemotherapy regimen has resulted in considerable improvements in overall survival. The 2021 PANOPTIMOX-PRODIGE 35 Trial demonstrated the effectiveness in maintaining patient quality of life while preserving overall survival of a novel approach of 4 months of chemotherapy followed by 5-FU maintenance therapy as opposed to 6 months of chemotherapy followed by treatment pause. This study aims to compare the two strategies regarding overall survival and progression free survival in a real-world setting and to describe the treatment courses of the included patients. Methods This retrospective cohort identified 118 patients who received FOLFIRINOX between October 2020 and October 2025, of which 90 were included for statistical analysis. The primary endpoint was overall survival. Statistical analysis described differences in characteristics and outcomes between groups. The group receiving 5-FU maintenance was labeled maintenance group (MG) (n=24), the group receiving treatment pause was labeled pause group (PG) (n=15) and the group of patients that deviated from protocol was labeled deviation group (DG) (n=51). Results In the 90 included patients, the mean age was 66. 56% were male, and 44% were female. Treatment courses of patients were illustrated with a Sankey plot. Rates of hospitalization during 1st line treatment were 29% for MG, 47% for PG, and 71% for DG (p=0.003). mOS was 12.0 months, while PFS was 8 months. Group mOS was 22.6 in MG and 14.2 in PG (p=0.222). mOS was 22.5 months in resected patients and 11.5 months in non-resected patients (p=0.033). Median PFS was 11 months in MG and 9.1 months in PG (p=0.999). Cox regression on survival showed PG had a HR of 0.697 and MG had a HR of 0.259 when compared to DG, the latter difference being significant (p=0.260, p<0.001). Discussion This study’s findings support the conclusion of the 2021 PANOPTIMOX-PRODIGE 35 Trial that 5-FU maintenance in PDAC may yield similar OS when compared to treatment pause. However, intention-to-treat analysis was not possible, which limits comparability. Confounding may skew results as patients may be selected for certain treatment strategies depending on prognostic factors. In this real-world setting, lacking adherence to protocol caused low sample sizes in MG and PG while DG made up over half the cohort, underlining the difficult treatment course for PDAC patients.
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