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.
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 UGT1A1*28 Status On Tolerability Of NALIRIFOX In mPDAC
EP: 6.NALIRIFOX In Practice: Treatment Strategies for Patients With mPDAC
Video content above is prompted by the following:
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.
Prolaris in Practice: Guiding ADT Benefits, Clinical Application, and Expert Insights From ACRO 2025
April 15th 2025Steven E. Finkelstein, MD, DABR, FACRO discuses how Prolaris distinguishes itself from other genomic biomarker platforms by providing uniquely actionable clinical information that quantifies the absolute benefit of androgen deprivation therapy when added to radiation therapy, offering clinicians a more precise tool for personalizing prostate cancer treatment strategies.
CCR Scores and Beyond: Precision Strategies for Treatment Intensification in Prostate Cancer
April 15th 2025Alvaro Martinez, MD discusses how emerging genomic risk stratification tools such as the clinical cell-cycle risk (CCR) score are transforming personalized prostate cancer treatment by enabling more nuanced assessments of metastasis risk and treatment intensification strategies beyond traditional NCCN risk groupings.
