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First-Line NALIRIFOX Improves Survival Outcomes for Patients With Metastatic Pancreatic Ductal Adenocarcinoma
According to an analysis of the NAPOLI 3 trial, liposomal irinotecan plus 5-fluorouracil/leucovorin and oxaliplatin (NALIRIFOX) demonstrated clinically meaningful and statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared with gemcitabine plus nab-paclitaxel among patients with metastatic pancreatic ductal adenocarcinoma.
These data were presented by Zev Wainberg, MD, David Geffen School of Medicine at University of California–Los Angeles, California, at the 2023 World Congress on Gastrointestinal Cancers on June 28, 2023, in Barcelona, Spain.
In the open label, phase 3 NAPOLI 3 trial, 770 patients with metastatic pancreatic ductal adenocarcinoma were randomized on a 1-to1- basis to receive either NALIRIFOX on days 1 and 15 of a 28-day cycle (n = 383) or gemcitabine plus nab-paclitaxel on days 1, 8, and 15 of a 28-day cycle (n = 387) in the first-line setting. The primary end point of this study was overall survival with secondary end points including progression-free survival and overall response rate.
At a median follow-up of 16.1 months, the median OS was 11.1 months among the NALIRIFOX arm compared with 9.2 months in the gemcitabine plus nab-paclitaxel arm (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.70 to 0.99; P = .04). The 18-month survival rate was 26.2% and 19.3% respectively. The median PFS in the NALIRIFOX arm was 7.4 months vs 5.6 months in the gemcitabine plus nab-paclitaxel arm (HR, 0.96; 95% CI, 0.58 to 0.83; P < .0001). The 18-month progression-free rate was 11.4% and 3.6% respectively.
Among the safety population, the most common grade 3/4 treatment-emergent adverse events, occurring in at least 10% of patients receiving NALIRIFOX vs gemcitabine plus nab-paclitaxel, were diarrhea (20.3% vs 4.5%), nausea (11.9% vs 2.6%), hypokalemia (15.1% vs 4.0%), anemia (10.5% vs 17.4%), and neutropenia (14.1% vs 24.5)
Dr Wainberg and coauthors concluded “these results support the NALIRIFOX regimen as a new reference regimen for the first-line treatment of patients with [metastatic pancreatic ductal adenocarcinoma.
Source:
Wainberg Z, Melisi D, Macarulla T, et al. Liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma: Sensitivity analysis of survival from the NAPOLI 3 trial. Presented at the World Congress on Gastrointestinal Cancers; June 28-July 1, 2023; Barcelona, Spain. Abstract O-1.
