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The 2016 trial that gave patients whose pancreatic cancer had grown through gemcitabine a proven second treatment: liposomal irinotecan with fluorouracil lengthened survival from about four to six months.
NAPOLI-1 randomised 417 patients with metastatic pancreatic ductal adenocarcinoma previously treated with gemcitabine-based therapy at 76 sites in 14 countries between January 2012 and September 2013 to nanoliposomal irinotecan plus fluorouracil and folinic acid (117, an arm added by amendment), nanoliposomal irinotecan alone (151) or fluorouracil and folinic acid (149). After 313 events, median overall survival was 6.1 months with the combination against 4.2 months with fluorouracil and folinic acid (hazard ratio 0.67, 95 percent confidence interval 0.49 to 0.92, p = 0.012); monotherapy did not differ from control (4.9 versus 4.2 months, hazard ratio 0.99). The commonest grade 3 or 4 events with the combination were neutropenia (27 percent), fatigue (14 percent), diarrhoea (13 percent) and vomiting (11 percent). Funded by Merrimack Pharmaceuticals; the drug is now marketed by Ipsen.
The first approved second-line regimen and the basis of NALIRIFOX, which NAPOLI 3 later moved to first line; it fixed the sequence (gemcitabine-based first, then liposomal irinotecan with fluorouracil) written into the 2018 ASCO guideline.
Shares Conroy 2011: FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer (PRODIGE 4/ACCORD 11), Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Pancreatic ductal adenocarcinoma and the tag pancreatic-evidence.
Shares Fluorouracil (5-FU), Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag pancreatic-evidence.
Shares Hazard ratio (HR), Overall survival (OS), Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Cytotoxic chemotherapy and the tag pancreatic-evidence.
Shares NAPOLI 3, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Pancreatic ductal adenocarcinoma and the tag pancreatic-evidence.
Shares Hazard ratio (HR), Overall survival (OS), Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Pancreatic ductal adenocarcinoma and the tag pancreatic-evidence.
Shares Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag pancreatic-evidence.
Shares Overall survival (OS), Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Pancreatic ductal adenocarcinoma and the tag pancreatic-evidence.
Shares 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 and the tag pancreatic-evidence.