Loading
NAPOLI-3 randomised 770 patients with untreated metastatic pancreatic cancer to NALIRIFOX, a four-drug regimen built on liposomal irinotecan, or to gemcitabine plus nab-paclitaxel, the doublet most patients receive. NALIRIFOX lengthened life and delayed progression, the first positive first-line trial in a decade, though conventional FOLFIRINOX remains the usual choice where affordable.
Open-label phase 3 trial of 770 patients with untreated metastatic pancreatic adenocarcinoma randomised to NALIRIFOX (liposomal irinotecan, oxaliplatin, fluorouracil, leucovorin) or gemcitabine plus nab-paclitaxel. Primary endpoint was overall survival.
Median OS was 11.1 vs 9.2 months (HR 0.83) and median PFS 7.4 vs 5.6 months (HR 0.69). It was the first randomised evidence that a FOLFIRINOX-type regimen beats gemcitabine plus nab-paclitaxel, and led to FDA approval of NALIRIFOX in 2024, though conventional FOLFIRINOX remains the usual choice where it is affordable.
For fit patients with newly diagnosed metastatic pancreatic cancer, a FOLFIRINOX-type regimen is now proven to be better than gemcitabine plus nab-paclitaxel, settling a long-standing debate. The absolute gain is about two months of median survival, and the regimen is more toxic for the gut. Whether liposomal irinotecan adds anything over conventional irinotecan (standard FOLFIRINOX) has never been tested head-to-head.
Shares Zev A. Wainberg, 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, Cold tumours and the immunosuppressive microenvironment, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question.
Shares 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, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Metastatic pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma.
Shares 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, Progression-free survival (PFS), Overall survival (OS), Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question.
Shares Standard of care, Progression-free survival (PFS), Overall survival (OS), The Lancet.
Shares Standard of care, Progression-free survival (PFS), Overall survival (OS), The Lancet.
Shares Progression-free survival (PFS), Overall survival (OS), Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Metastatic pancreatic ductal adenocarcinoma.
Shares 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, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Topoisomerase-I inhibitors (and ADC payloads), Metastatic pancreatic ductal adenocarcinoma.
Shares Progression-free survival (PFS), Overall survival (OS), Metastatic pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma.