Results from a 5-year phase III trial suggest that modified FOLRIRINOX as adjuvant treatment improves survival outcomes for patients with resected pancreatic ductal adenocarcinoma (PDAC). These findings were recently published in the journal JAMA Oncology.
The PRODIGE 24/Canadian Cancer Trials Group PA6 trial has investigated the efficacy and safety of adjuvant-modified FOLFIRINOX (oxaliplatin, irinotecan, leucovorin, and fluorouracil) versus gemcitabine for patients with resected PDAC.
The open-label, phase III randomized trial enrolled 493 PDAC (aged 18-79 years) patients who had undergone macroscopic resection. The participants were randomised (1:1) to either receive mFOLFIRINOX (n=247) or gemcitabine (n=246) as adjuvant therapy for 24 weeks. The study’s primary endpoint was disease-free survival (DFS), and the secondary endpoints included overall survival (OS), metastasis-free survival (MFS), and cancer-specific survival (CSS).
At a median of 69.7 months follow-up, the median DFS was significantly extended with mFOLFIRINOX treatment (21.4 months) versus gemcitabine (12.8 months, hazard ratio [HR], 0.66; 95% CI, 0.54-0.82; P <.001). The DFS rate, too, was higher in the mFOLFIRINOX arm (26.1%) than in the gemcitabine arm (19.0%). The mFOLFIRINOX treatment improved the OS to 53.5 months compared to 35.5 months with gemcitabine (HR, 0.68; 95% CI, 0.54-0.85; P =.001). Additionally, the MFS (29.4 and 17.7 months) and CSS (54.7 and 36.6 months) were also longer with mFOLFIRINOX than with gemcitabine.
The five-year outcomes demonstrate the clinical benefits of adjuvant mFOLFIRINOX treatment across all the survival endpoints. These findings support the treatment regimen as the recommended adjuvant treatment for PDAC patients following resection.
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