{"entity":{"id":"paper-conko-001-adjuvant-gemcitabine-observation-jama-2007","kind":"paper","name":"Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial","aka":[],"tldr":"The 2007 German and Austrian trial in which six months of gemcitabine after surgery roughly doubled the time before the cancer came back, making gemcitabine the standard after resection until 2017.","summary":"CONKO-001 randomised 368 patients with gross complete (R0 or R1) resection and no prior radiation or chemotherapy at 88 centres in Germany and Austria between 1998 and 2004 to six cycles of gemcitabine on days 1, 8 and 15 every four weeks (179) or observation (175). More than 80 percent had R0 resection. Grade 3 or 4 toxicities were rare and quality of life did not differ. At 53 months median follow-up, 74 percent of the gemcitabine group and 92 percent of controls had recurred; median disease-free survival was 13.4 months against 6.9 months. The 2013 long-term report (recorded separately) showed the overall survival gain.","asOf":"2026-09-24","links":[{"label":"JAMA 2007","url":"https://doi.org/10.1001/jama.297.3.267"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/17227978/"}],"tags":["pancreatic-evidence"],"related":["paper-conko-001-adjuvant-gemcitabine-long-term-oettle-jama-2013","paper-espac-1-chemoradiotherapy-chemotherapy-resected-pancreatic-nejm-2004"],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":["charite"],"pathways":[],"terms":[],"trials":["conko-001"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["jama"],"dependsOn":[],"notes":[],"journal":"JAMA","year":2007,"doi":"10.1001/jama.297.3.267","pmid":"17227978","authors":"Oettle H, Post S, Neuhaus P, et al.","paperType":"rct","findings":["368 patients; six cycles of adjuvant gemcitabine versus observation.","Median disease-free survival 13.4 versus 6.9 months.","Recurrence in 74 percent versus 92 percent at 53 months; grade 3 or 4 toxicity rare."],"whatItMeans":"The trial that made adjuvant gemcitabine standard in Europe and the control arm PRODIGE 24 and ESPAC-4 later beat.","caveats":["Disease-free survival was the primary endpoint; overall survival benefit came in the 2013 update.","Registered with ISRCTN (ISRCTN34802808), not ClinicalTrials.gov."],"changedPractice":true,"participants":368},"route":"/key-papers/paper-conko-001-adjuvant-gemcitabine-observation-jama-2007/","neighbours":{"paper":[{"id":"paper-espac-1-chemoradiotherapy-chemotherapy-resected-pancreatic-nejm-2004","kind":"paper","name":"A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer","route":"/key-papers/paper-espac-1-chemoradiotherapy-chemotherapy-resected-pancreatic-nejm-2004/"},{"id":"paper-conko-001-adjuvant-gemcitabine-long-term-oettle-jama-2013","kind":"paper","name":"CONKO-001: adjuvant gemcitabine and long-term outcomes after resected pancreatic cancer","route":"/key-papers/paper-conko-001-adjuvant-gemcitabine-long-term-oettle-jama-2013/"}],"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/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"}],"institution":[{"id":"charite","kind":"institution","name":"Charité Universitätsmedizin Berlin","route":"/institutions/charite/"}],"trial":[{"id":"conko-001","kind":"trial","name":"CONKO-001","route":"/trials/conko-001/"}],"journal":[{"id":"jama","kind":"journal","name":"JAMA","route":"/journals/jama/"}],"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/"}]}}