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A four-drug chemotherapy combination gave fit patients with metastatic pancreatic cancer clearly longer survival than the standard gemcitabine, the first real improvement in the disease in over a decade, at the cost of more side effects.
This French phase 2-3 trial randomised 342 patients with metastatic pancreatic adenocarcinoma and good performance status to FOLFIRINOX (oxaliplatin, irinotecan, leucovorin and fluorouracil) or gemcitabine. FOLFIRINOX improved overall survival, progression-free survival and response rate, and delayed the decline in quality of life despite more grade 3 and 4 toxicity, particularly neutropenia, febrile neutropenia, diarrhoea and sensory neuropathy. It made FOLFIRINOX a first-line standard for fit patients and the backbone later moved into the adjuvant setting.
FOLFIRINOX and, soon after, gemcitabine plus nab-paclitaxel ended the era of single-agent gemcitabine for metastatic pancreatic cancer. The regimen's modified form later improved survival after surgery in PRODIGE 24, and its toxicity is why fitness, not just stage, decides which treatment a patient is offered.
With FOLFIRINOX this trial defined the two chemotherapy standards for metastatic pancreatic cancer that still apply, and the gemcitabine and nab-paclitaxel backbone is the comparator in most current first-line pancreatic trials.
A fixed point for readers who want to see how much, and how little, has changed since 2010.
This trial introduced a patient-centred composite endpoint and a drug that remained the backbone of pancreatic cancer treatment for a generation. Its small survival gain also shows how low the bar was, which is the context for the FOLFIRINOX and MPACT trials that followed.
Shares PRODIGE 24 / CCTG PA6, Progression-free survival (PFS), Overall survival (OS), Gemcitabine.
Shares Thierry Conroy, Irinotecan (and liposomal irinotecan), Oxaliplatin, Fluorouracil (5-FU).
Shares MPACT (Von Hoff 2013): nab-paclitaxel plus gemcitabine for metastatic pancreatic cancer, 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.
Shares Thierry Conroy, PRODIGE 24 / CCTG PA6, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Gemcitabine.
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 Thierry Conroy, PRODIGE 24 / CCTG PA6, 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 Thierry Conroy, PRODIGE 24 / CCTG PA6, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Pancreatic ductal adenocarcinoma.
Shares Irinotecan (and liposomal irinotecan), Progression-free survival (PFS), Overall survival (OS), Fluorouracil (5-FU).