{"entity":{"id":"paper-prodige-24-adjuvant-mfolfirinox-pancreatic-nejm-2018","kind":"paper","name":"PRODIGE 24/CCTG PA6: adjuvant modified FOLFIRINOX versus gemcitabine after resection of pancreatic cancer","aka":[],"tldr":"Six months of the four-drug combination modified FOLFIRINOX after surgery for pancreatic cancer kept the disease away for almost twice as long as gemcitabine alone and added about a year and a half to median survival. It is the reason fit patients are now offered FOLFIRINOX after a pancreatic operation.","summary":"Randomised phase 3 trial in 493 patients in France and Canada who had undergone a complete (R0 or R1) resection of pancreatic ductal adenocarcinoma, had a CA19-9 below 180 U/mL and were fit enough for combination chemotherapy. Patients received six months of modified FOLFIRINOX (oxaliplatin, irinotecan, leucovorin and infusional fluorouracil without the bolus) or gemcitabine.\n\nAt a median follow-up of 33.6 months, median disease-free survival was 21.6 months with modified FOLFIRINOX against 12.8 months with gemcitabine (hazard ratio 0.58), and median overall survival 54.4 against 35.0 months (hazard ratio 0.64). Grade 3 or 4 adverse events were more frequent with modified FOLFIRINOX (about 76 against 53 percent). Five-year results published in 2022 confirmed the survival benefit.","asOf":"2026-09-21","links":[{"label":"N Engl J Med 2018","url":"https://doi.org/10.1056/NEJMoa1809775"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/30575490/"}],"tags":[],"related":[],"cancers":["resectable-pdac","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["folfirinox","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["prodige-24"],"people":["thierry-conroy"],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2018,"doi":"10.1056/NEJMoa1809775","pmid":"30575490","authors":"Conroy T, Hammel P, Hebbar M, et al.","paperType":"rct","findings":["Median disease-free survival 21.6 versus 12.8 months, hazard ratio 0.58.","Median overall survival 54.4 versus 35.0 months, hazard ratio 0.64.","Grade 3 or 4 adverse events in about 76 percent with modified FOLFIRINOX and 53 percent with gemcitabine."],"whatItMeans":"Modified FOLFIRINOX is the adjuvant standard for patients who recover well from a pancreatic resection and can tolerate combination chemotherapy; gemcitabine-based regimens remain for those who cannot.","caveats":["Patients were selected for fitness and a low postoperative CA19-9, so the result does not transfer directly to frailer patients.","Adjuvant chemotherapy must start within 12 weeks of surgery, and many patients never recover enough to receive it, which is one argument for neoadjuvant treatment."],"changedPractice":true,"participants":493},"route":"/key-papers/paper-prodige-24-adjuvant-mfolfirinox-pancreatic-nejm-2018/","neighbours":{"cancer":[{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"resectable-pdac","kind":"cancer","name":"Resectable pancreatic ductal adenocarcinoma","route":"/cancers/resectable-pdac/"}],"drug":[{"id":"folfirinox","kind":"drug","name":"FOLFIRINOX / mFOLFIRINOX","route":"/drugs/folfirinox/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"}],"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/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}