{"entity":{"id":"velour","kind":"trial","name":"VELOUR","aka":[],"tldr":"A decoy receptor that mops up the signals feeding tumour blood vessels added about six weeks of life in second-line treatment. England decided that was not worth the price.","summary":"VELOUR randomised 1,226 patients whose metastatic colorectal cancer had progressed after an oxaliplatin-based regimen, including patients who had already had bevacizumab, to FOLFIRI with ziv-aflibercept 4 mg/kg or placebo every two weeks. Median overall survival was 13.50 against 12.06 months (hazard ratio 0.817, 95.34% CI 0.713 to 0.937, p=0.0032) and progression-free survival also improved (hazard ratio 0.758, 0.661 to 0.869). The FDA approved ziv-aflibercept in August 2012 and the EU marketing authorisation for Zaltrap followed on 1 February 2013, but NICE TA307 in March 2014 did not recommend it, so it is not routinely funded in England. It remains an option in guidelines where the modest absolute gain is judged worthwhile.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00561470","url":"https://clinicaltrials.gov/study/NCT00561470"},{"label":"VELOUR: aflibercept added to FOLFIRI after an oxaliplatin-based regimen (Journal of Clinical Oncology 2012)","url":"https://doi.org/10.1200/JCO.2012.42.8201"},{"label":"NICE TA307: aflibercept in combination with irinotecan and fluorouracil-based therapy (not recommended)","url":"https://www.nice.org.uk/guidance/ta307"},{"label":"EMA Zaltrap","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy"],"targets":["vegf"],"drugs":["ziv-aflibercept","folfiri","irinotecan","fluorouracil"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["cancer-drugs-fund"],"trials":["raise"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00561470","phase":"3","setting":"Metastatic colorectal cancer after an oxaliplatin-based regimen: FOLFIRI with ziv-aflibercept or placebo","sponsor":"Sanofi","result":"Median overall survival 13.50 against 12.06 months (hazard ratio 0.817).","yearReported":2012,"enrolled":1226,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"FOLFIRI plus ziv-aflibercept","n":612,"value":13.5},{"name":"FOLFIRI plus placebo","n":614,"value":12.06}],"hr":0.817,"ci":[0.713,0.937],"p":"0.0032","source":"https://doi.org/10.1200/JCO.2012.42.8201"}],"replication":"RAISE showed a similar size of benefit for ramucirumab in the same setting (13.3 against 11.7 months)."},"route":"/trials/velour/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"target":[{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"folfiri","kind":"drug","name":"FOLFIRI (5-FU, leucovorin, irinotecan)","route":"/drugs/folfiri/"},{"id":"irinotecan","kind":"drug","name":"Irinotecan (and liposomal irinotecan)","route":"/drugs/irinotecan/"},{"id":"ziv-aflibercept","kind":"drug","name":"Ziv-aflibercept","route":"/drugs/ziv-aflibercept/"}],"company":[{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"term":[{"id":"cancer-drugs-fund","kind":"term","name":"Cancer Drugs Fund (England)","route":"/terms/cancer-drugs-fund/"},{"id":"colorectal-failed-programmes","kind":"term","name":"Colorectal cancer: the failed and stopped programmes, and why","route":"/terms/colorectal-failed-programmes/"}],"trial":[{"id":"raise","kind":"trial","name":"RAISE","route":"/trials/raise/"}]}}