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 to gemcitabine/nab-paclitaxel, with key differences from the older PRODIGE 4 study including a lower oxaliplatin dose that may reduce side effects.
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Dr. Chandana provides a comprehensive review of the NAPOLI-3 and PRODIGE 4 clinical trials that have shaped current treatment approaches for metastatic pancreatic adenocarcinoma. The NAPOLI-3 study led to the approval of NALIRIFOX, a three-drug combination of 5-FU, oxaliplatin, and nanoliposomal irinotecan. This large international study involved approximately 770 patients across 18 countries who were randomized 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 to gemcitabine/nab-paclitaxel, along with improved progression-free survival of 7.4 months versus 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 to gemcitabine monotherapy.
Dr. Chandana highlights key differences between the two studies, noting that NAPOLI-3 was significantly larger and compared NALIRIFOX to the combination of gemcitabine/nab-paclitaxel, while PRODIGE 4 compared FOLFIRINOX to 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 side effect profiles between the regimens, potentially offering advantages for certain patients.
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