{"entity":{"id":"paper-demetri-sunitinib-gist-lancet-2006","kind":"paper","name":"Sunitinib in advanced gastrointestinal stromal tumour after failure of imatinib","aka":[],"tldr":"Sunitinib more than quadrupled the time to progression compared with placebo in gastrointestinal stromal tumours that had become resistant to or intolerant of imatinib, establishing the standard second-line treatment.","summary":"Phase 3 placebo-controlled trial of 312 patients with advanced gastrointestinal stromal tumour after imatinib failure randomised 2:1 to sunitinib 50 mg daily (four weeks on, two off) or placebo, unblinded early after an interim analysis.\n\nMedian time to progression was 27.3 versus 6.4 weeks (hazard ratio 0.33) with a survival benefit at interim analysis (hazard ratio 0.49); fatigue, diarrhoea, skin discolouration and hand-foot syndrome were common.","asOf":"2026-09-17","links":[{"label":"Lancet 2006","url":"https://doi.org/10.1016/S0140-6736(06)69446-4"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/17046465/"}],"tags":[],"related":[],"cancers":["gist-imatinib-resistant"],"sections":[],"technologies":[],"targets":[],"drugs":["imatinib","sunitinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["lancet"],"dependsOn":[],"notes":[],"journal":"The Lancet","year":2006,"doi":"10.1016/S0140-6736(06)69446-4","pmid":"17046465","authors":"Demetri GD, van Oosterom AT, Garrett CR, et al.","paperType":"rct","findings":["Median time to progression 27.3 vs 6.4 weeks; hazard ratio 0.33.","Interim overall survival hazard ratio 0.49."],"whatItMeans":"Sunitinib is the standard second-line kinase inhibitor for GIST, with particular activity against KIT exon 9 and exon 13/14 secondary mutations.","caveats":["Trial unblinded early; final survival analysis confounded by crossover.","Less active against exon 17/18 secondary mutations."],"changedPractice":true,"participants":312},"route":"/key-papers/paper-demetri-sunitinib-gist-lancet-2006/","neighbours":{"cancer":[{"id":"gist-imatinib-resistant","kind":"cancer","name":"Imatinib-resistant GIST","route":"/cancers/gist-imatinib-resistant/"}],"drug":[{"id":"imatinib","kind":"drug","name":"Imatinib","route":"/drugs/imatinib/"},{"id":"sunitinib","kind":"drug","name":"Sunitinib","route":"/drugs/sunitinib/"}],"journal":[{"id":"lancet","kind":"journal","name":"The Lancet","route":"/journals/lancet/"}]}}