Insights From The NAPOLI-3 and PRODIGE4 Trials In Metastatic Pancreatic Adenocarcinoma
Panelists discuss how the NAPOLI-3 trial led to FDA approval of NALIRIFOX after demonstrating superior median overall survival (11.1 months) and progression-free survival (7.4 months) compared with gemcitabine/nab-paclitaxel, with key differences from the older PRODIGE 4 study including a lower oxaliplatin dose that may reduce adverse effects.
EP: 1.First-Line Treatment Options for Metastatic Pancreatic Adenocarcinoma
EP: 2.Insights From The NAPOLI-3 and PRODIGE4 Trials In Metastatic Pancreatic Adenocarcinoma
EP: 3.Managing AEs Associated With the FOLFIRINOX and NALIRIFOX Regimens in Pancreatic Cancer
EP: 4.NAPOLI-3 in Real World Practice: Expert Insights on Data From ASCO GI 2025
EP: 5.Evaluating the Impact of UGT1A128 Status on Tolerability Of NALIRIFOX in mPDAC
EP: 6.NALIRIFOX In Practice: Treatment Strategies for Patients With mPDAC
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Dr. Chandana provides a comprehensive review of the NAPOLI-3 and PRODIGE 4 clinical trials, which have shaped current treatment approaches for metastatic pancreatic adenocarcinoma. The NAPOLI-3 study led to the approval of NALIRIFOX, a 3-drug combination of 5-FU, oxaliplatin, and nanoliposomal irinotecan. This large international study involved approximately 770 patients across 18 countries who were randomly assigned to receive either NALIRIFOX or the standard gemcitabine plus nab-paclitaxel regimen.
The NAPOLI-3 trial demonstrated superior outcomes with NALIRIFOX, showing a median overall survival of 11.1 months compared with gemcitabine/nab-paclitaxel, along with improved progression-free survival of 7.4 months vs 5.6 months. These results led to FDA approval of NALIRIFOX as a treatment option for metastatic pancreatic adenocarcinoma. In contrast, the PRODIGE 4 (also known as ACCORD 11) study was an older, phase 2/3 trial conducted solely in France with 342 patients, comparing full-dose FOLFIRINOX with gemcitabine monotherapy.
Dr. Chandana highlights key differences between the 2 studies, noting that NAPOLI-3 was significantly larger and compared NALIRIFOX with the combination of gemcitabine/nab-paclitaxel, while PRODIGE 4 compared FOLFIRINOX with gemcitabine alone. Importantly, the oxaliplatin dose in NALIRIFOX (60 mg/m²) is lower than in FOLFIRINOX (85 mg/m²), which may contribute to differences in the adverse effect profiles between the regimens, potentially offering advantages for certain patients.
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