Nanoliposomal irinotecan in combination with fluorouracil and folinic acid improves survival in patients with metastatic pancreatic ductal adenocarcinoma who previously received gemcitabine-based chemotherapy and has a manageable safety profile, a new study published online ahead of print in the journal The Lancet has shown.1

For the international, open-label, phase 3 study, researchers enrolled 417 patients and randomly assigned them to receive nanoliposomal irinotecan plus fluorouracil and folinic acid, nanoliposomal irinotecan monotherapy, or fluorouracil and folinic acid.

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Results showed that median overall survival was 6.1 months with the irinotecan combination compared with 4.2 months with fluorouracil plus folinic acid (HR, 0.67; 95% CI: 0.49-0.92; P=.012). There was no significant difference in overall survival between patients in the liposomal irinotecan monotherapy arm and those in the fluorouracil and folinic acid arm (P=0.94).

In regard to safety, the most common adverse events in the liposomal irinotecan plus fluorouracil and folinic acid group were neutropenia, diarrhea, vomiting, and fatigue.

“This agent represents a new treatment option for this population,” the authors conclude.

The US Food and Drug Administration (FDA) has already approved liposomal irinotecan (Onivyde) in combination with fluorouracil and leucovorin for the treatment of patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based therapy. Approval was based on the result of this trial.


1. Wang-Gillam A, Li C-P, Bodoky G, et al. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial [published online ahead of print November 22, 2015]. Lancet. doi:10.1016/S0140-6736(15)00986-1.