{"entity":{"id":"paper-alliance-a021501-mfolfirinox-radiotherapy-borderline-resectable-jama-oncol-2022","kind":"paper","name":"Alliance A021501: preoperative modified FOLFIRINOX with or without hypofractionated radiotherapy for borderline resectable pancreatic cancer","aka":[],"tldr":"In the first randomised US trial of neoadjuvant treatment for borderline resectable pancreatic cancer, eight cycles of modified FOLFIRINOX alone gave two-thirds of patients an 18-month survival, while replacing the last cycle with short-course radiotherapy did worse and that arm was stopped early.","summary":"Multicentre randomised phase 2 trial in 126 patients with borderline resectable pancreatic ductal adenocarcinoma, assigned to eight cycles of modified FOLFIRINOX or to seven cycles followed by stereotactic body radiotherapy or hypofractionated image-guided radiotherapy, then surgery and adjuvant FOLFOX. The radiotherapy arm was closed at a planned interim analysis for futility.\n\nEighteen-month overall survival was 66.7 percent with chemotherapy alone and 47.3 percent with chemotherapy and radiotherapy; median overall survival was 29.8 against 17.1 months. The chemotherapy-alone arm met its prespecified benchmark against historical controls.","asOf":"2026-09-21","links":[{"label":"JAMA Oncol 2022","url":"https://doi.org/10.1001/jamaoncol.2022.2319"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/35834226/"}],"tags":[],"related":[],"cancers":["borderline-resectable-pdac","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["jama-oncology"],"dependsOn":[],"notes":[],"journal":"JAMA Oncology","year":2022,"doi":"10.1001/jamaoncol.2022.2319","pmid":"35834226","authors":"Katz MHG, Shi Q, Meyers J, et al.","paperType":"rct","findings":["Eighteen-month overall survival 66.7 percent with modified FOLFIRINOX alone versus 47.3 percent with added radiotherapy.","Median overall survival 29.8 versus 17.1 months; the radiotherapy arm was closed early for futility."],"whatItMeans":"Neoadjuvant modified FOLFIRINOX without routine radiotherapy became the reference approach for borderline resectable disease in North America; radiotherapy is reserved for selected patients or trials.","caveats":["The two arms were not formally compared with each other; each was judged against a historical benchmark.","Only about half of patients in each arm went on to resection, and the radiotherapy arm was small after early closure."],"changedPractice":true,"participants":126},"route":"/key-papers/paper-alliance-a021501-mfolfirinox-radiotherapy-borderline-resectable-jama-oncol-2022/","neighbours":{"cancer":[{"id":"borderline-resectable-pdac","kind":"cancer","name":"Borderline resectable pancreatic ductal adenocarcinoma","route":"/cancers/borderline-resectable-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"drug":[{"id":"folfirinox","kind":"drug","name":"FOLFIRINOX / mFOLFIRINOX","route":"/drugs/folfirinox/"}],"journal":[{"id":"jama-oncology","kind":"journal","name":"JAMA Oncology","route":"/journals/jama-oncology/"}]}}