{"entity":{"id":"decision-sorafenib","kind":"trial","name":"DECISION","aka":[],"tldr":"The first drug approved for thyroid cancers that stopped responding to radioactive iodine.","summary":"DECISION, trial NCT00984282 sponsored by Bayer and reported in 2013, produced the first drug approved for differentiated thyroid cancers that stopped responding to radioactive iodine. It randomised 417 patients to sorafenib or placebo and met its primary progression-free survival endpoint, leading to FDA approval in November 2013, with hand-foot skin reaction and fatigue common. OnCo links it to thyroid cancer, kinase inhibitors, VEGF and BRAF as targets, the radioiodine-refractory term and Marcia S. Brose, and SELECT confirmed the class effect with a larger benefit for lenvatinib. Sorafenib has been largely displaced by lenvatinib but is still used, and whether it retains a niche in patients who cannot tolerate lenvatinib is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00984282","url":"https://clinicaltrials.gov/study/NCT00984282"},{"label":"Lancet 2014","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60421-9/fulltext"}],"tags":[],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["vegf","braf"],"drugs":[],"companies":["bayer"],"institutions":[],"pathways":[],"terms":["rai-refractory"],"trials":[],"people":["marcia-brose"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00984282","phase":"3","setting":"Radioiodine-refractory differentiated thyroid cancer: sorafenib vs placebo","sponsor":"Bayer","result":"PFS 10.8 vs 5.8 months; HR 0.59.","started":"2009-10-15","startedType":"actual","yearReported":2013,"enrolled":417,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Sorafenib","value":10.8},{"name":"Placebo","value":5.8}],"hr":0.59,"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60421-9/fulltext"}],"replication":"SELECT confirmed the class effect with a larger benefit."},"route":"/trials/decision-sorafenib/","neighbours":{"cancer":[{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"},{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}],"term":[{"id":"rai-refractory","kind":"term","name":"Radioiodine-refractory (RAI-R) thyroid cancer","route":"/terms/rai-refractory/"}],"person":[{"id":"marcia-brose","kind":"person","name":"Marcia S. Brose","route":"/people/marcia-brose/"}],"paper":[{"id":"paper-decision-sorafenib-lancet-2014","kind":"paper","name":"DECISION: sorafenib in radioactive iodine-refractory differentiated thyroid cancer","route":"/key-papers/paper-decision-sorafenib-lancet-2014/"}]}}