{"entity":{"id":"paper-conroy-folfirinox-pancreatic-nejm-2011","kind":"paper","name":"Conroy 2011: FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer (PRODIGE 4/ACCORD 11)","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Full text (DOI)","url":"https://doi.org/10.1056/NEJMoa1011923"},{"label":"ClinicalTrials.gov NCT00112658","url":"https://clinicaltrials.gov/study/NCT00112658"}],"tags":[],"related":["paper-napoli-1-nanoliposomal-irinotecan-lancet-2016"],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["oxaliplatin","irinotecan","fluorouracil","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":["os","pfs","febrile-neutropenia"],"trials":["prodige-24"],"people":["thierry-conroy"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2011,"doi":"10.1056/NEJMoa1011923","pmid":"21561347","authors":"Conroy T, Desseigne F, Ychou M, et al.","paperType":"rct","findings":["342 patients with metastatic pancreatic cancer and ECOG performance status 0 or 1; FOLFIRINOX vs gemcitabine.","Median overall survival 11.1 vs 6.8 months, hazard ratio 0.57.","Median progression-free survival 6.4 vs 3.3 months, hazard ratio 0.47; response rate 31.6% vs 9.4%.","Grade 3 or 4 neutropenia 45.7% vs 21.0%, febrile neutropenia 5.4% vs 1.2%, sensory neuropathy 9.0% vs 0%."],"whatItMeans":"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.","caveats":["Restricted to fit patients under 76 with good performance status; most patients with pancreatic cancer are not eligible.","Toxicity is substantial and needs experienced supportive care.","Open-label design."],"changedPractice":true,"participants":342},"route":"/key-papers/paper-conroy-folfirinox-pancreatic-nejm-2011/","neighbours":{"paper":[{"id":"paper-burris-gemcitabine-pancreatic-jco-1997","kind":"paper","name":"Burris 1997: gemcitabine becomes the first standard treatment for advanced pancreatic cancer","route":"/key-papers/paper-burris-gemcitabine-pancreatic-jco-1997/"},{"id":"paper-mpact-nab-paclitaxel-gemcitabine-nejm-2013","kind":"paper","name":"MPACT (Von Hoff 2013): nab-paclitaxel plus gemcitabine for metastatic pancreatic cancer","route":"/key-papers/paper-mpact-nab-paclitaxel-gemcitabine-nejm-2013/"},{"id":"paper-napoli-1-nanoliposomal-irinotecan-lancet-2016","kind":"paper","name":"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","route":"/key-papers/paper-napoli-1-nanoliposomal-irinotecan-lancet-2016/"},{"id":"paper-hidalgo-pancreatic-cancer-review-nejm-2010","kind":"paper","name":"Pancreatic cancer","route":"/key-papers/paper-hidalgo-pancreatic-cancer-review-nejm-2010/"}],"cancer":[{"id":"borderline-resectable-pdac","kind":"cancer","name":"Borderline resectable pancreatic ductal adenocarcinoma","route":"/cancers/borderline-resectable-pdac/"},{"id":"locally-advanced-pdac","kind":"cancer","name":"Locally advanced unresectable pancreatic ductal adenocarcinoma","route":"/cancers/locally-advanced-pdac/"},{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"irinotecan","kind":"drug","name":"Irinotecan (and liposomal irinotecan)","route":"/drugs/irinotecan/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"}],"term":[{"id":"febrile-neutropenia","kind":"term","name":"Febrile neutropenia","route":"/terms/febrile-neutropenia/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"},{"id":"pfs","kind":"term","name":"Progression-free survival (PFS)","route":"/terms/pfs/"}],"trial":[{"id":"prodige-24","kind":"trial","name":"PRODIGE 24 / CCTG PA6","route":"/trials/prodige-24/"}],"person":[{"id":"thierry-conroy","kind":"person","name":"Thierry Conroy","route":"/people/thierry-conroy/"}],"roadmap":[{"id":"pancreatic-roadmap","kind":"roadmap","name":"Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question","route":"/roadmaps/pancreatic-roadmap/"}]}}