{"entity":{"id":"paper-espac-3-fluorouracil-vs-gemcitabine-adjuvant-neoptolemos-jama-2010","kind":"paper","name":"ESPAC-3: adjuvant fluorouracil plus folinic acid versus gemcitabine after pancreatic cancer resection","aka":[],"tldr":"After surgery for pancreatic cancer, six months of gemcitabine gave the same survival as fluorouracil with folinic acid, about 23 months, with half as many serious side effects.","summary":"Phase 3 trial at 159 centres in Europe, Australasia, Japan and Canada: 1,088 patients with resected pancreatic ductal adenocarcinoma were randomised to six months of fluorouracil plus folinic acid (551) or gemcitabine (537). The primary endpoint was overall survival.\n\nAfter a median follow-up of 34.2 months and 753 deaths, median survival was 23.0 months with fluorouracil and 23.6 months with gemcitabine (hazard ratio 0.94, p 0.39); progression-free survival and quality of life did not differ. Treatment-related serious adverse events occurred in 14 percent of fluorouracil patients and 7.5 percent of gemcitabine patients.","asOf":"2026-09-22","links":[{"label":"JAMA 2010","url":"https://doi.org/10.1001/jama.2010.1275"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/20823433/"}],"tags":[],"related":[],"cancers":["resectable-pdac","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["gemcitabine","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["espac-3"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["jama"],"dependsOn":[],"notes":[],"journal":"JAMA","year":2010,"doi":"10.1001/jama.2010.1275","pmid":"20823433","authors":"Neoptolemos JP, Stocken DD, Bassi C, et al.","paperType":"rct","findings":["Median overall survival 23.0 months (95% CI 21.1 to 25.0) with fluorouracil plus folinic acid versus 23.6 months (21.4 to 26.4) with gemcitabine; hazard ratio 0.94 (0.81 to 1.08).","Treatment-related serious adverse events in 14 percent versus 7.5 percent of patients (p < 0.001)."],"whatItMeans":"Either regimen was acceptable adjuvant therapy in 2010, with gemcitabine preferred for tolerability; combination regimens (ESPAC-4, PRODIGE 24) have since superseded both.","caveats":["Open-label; the observation arm was dropped after ESPAC-1, so the trial does not itself test chemotherapy against no chemotherapy."],"changedPractice":true,"participants":1088},"route":"/key-papers/paper-espac-3-fluorouracil-vs-gemcitabine-adjuvant-neoptolemos-jama-2010/","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":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"}],"trial":[{"id":"espac-3","kind":"trial","name":"ESPAC-3","route":"/trials/espac-3/"}],"journal":[{"id":"jama","kind":"journal","name":"JAMA","route":"/journals/jama/"}]}}