{"entity":{"id":"paper-dasari-fresco-2-fruquintinib-lancet-2023","kind":"paper","name":"Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2)","aka":[],"tldr":"A selective VEGF receptor pill, first approved in China, repeated its effect in a global trial of 691 heavily treated patients: 7.4 against 4.8 months.","summary":"Dasari, Lonardi, Garcia-Carbonero and colleagues conducted an international randomised double-blind placebo-controlled phase 3 study at 124 hospitals and cancer centres across 14 countries in patients aged 18 or older with metastatic colorectal adenocarcinoma who had received all current standard cytotoxic and targeted therapies and had progressed on or been intolerant to trifluridine-tipiracil or regorafenib, or both. Patients were randomised 2:1 to fruquintinib 5 mg or matched placebo orally once daily on days 1 to 21 of 28-day cycles plus best supportive care, stratified by previous trifluridine-tipiracil or regorafenib, RAS status and duration of metastatic disease. The primary endpoint was overall survival.\n\nBetween August 2020 and December 2021, 691 patients were randomised; they had received a median of four previous lines and 502 (73 percent) had received more than three.","asOf":"2026-09-24","links":[{"label":"Lancet 2023","url":"https://doi.org/10.1016/S0140-6736(23)00772-9"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37331369/"}],"tags":["colorectal-evidence"],"related":["paper-grothey-correct-regorafenib-lancet-2013","paper-prager-sunlight-trifluridine-tipiracil-bevacizumab-nejm-2023"],"cancers":["colorectal"],"sections":["targeted-therapy"],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf"],"drugs":["fruquintinib"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":["fresco-2"],"people":["eric-van-cutsem"],"bottlenecks":["b-global-access"],"keyPapers":[],"journals":["lancet"],"dependsOn":[],"notes":[],"journal":"The Lancet","year":2023,"doi":"10.1016/S0140-6736(23)00772-9","pmid":"37331369","authors":"Dasari A, Lonardi S, Garcia-Carbonero R, et al.","paperType":"rct","findings":["Median overall survival 7.4 months (95 percent CI 6.7 to 8.2) with fruquintinib against 4.8 months (4.0 to 5.8) with placebo: hazard ratio 0.66 (0.55 to 0.80, p<0.0001).","Grade 3 or worse adverse events in 286 of 456 (63 percent) on fruquintinib against 116 of 230 (50 percent) on placebo.","Commonest grade 3 or worse fruquintinib events: hypertension 62 (14 percent), asthenia 35 (8 percent), hand-foot syndrome 29 (6 percent).","One treatment-related death in each group."],"whatItMeans":"A third refractory-line option, and the clearest example in colorectal cancer of a drug developed and approved in China going on to a global registration trial.","caveats":["Placebo-controlled in patients who had exhausted everything, so the comparison is against no active treatment.","Anti-angiogenic class toxicity, chiefly hypertension.","No biomarker selects who benefits."],"changedPractice":true,"participants":691},"route":"/key-papers/paper-dasari-fresco-2-fruquintinib-lancet-2023/","neighbours":{"paper":[{"id":"paper-grothey-correct-regorafenib-lancet-2013","kind":"paper","name":"Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT)","route":"/key-papers/paper-grothey-correct-regorafenib-lancet-2013/"},{"id":"paper-prager-sunlight-trifluridine-tipiracil-bevacizumab-nejm-2023","kind":"paper","name":"Trifluridine-tipiracil and bevacizumab in refractory metastatic colorectal cancer (SUNLIGHT)","route":"/key-papers/paper-prager-sunlight-trifluridine-tipiracil-bevacizumab-nejm-2023/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"section":[{"id":"targeted-therapy","kind":"section","name":"Targeted Therapy","route":"/fronts/targeted-therapy/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"drug":[{"id":"fruquintinib","kind":"drug","name":"Fruquintinib","route":"/drugs/fruquintinib/"}],"company":[{"id":"hutchmed","kind":"company","name":"Hutchmed","route":"/companies/hutchmed/"}],"trial":[{"id":"fresco-2","kind":"trial","name":"FRESCO-2","route":"/trials/fresco-2/"}],"person":[{"id":"eric-van-cutsem","kind":"person","name":"Eric Van Cutsem","route":"/people/eric-van-cutsem/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"}],"journal":[{"id":"lancet","kind":"journal","name":"The Lancet","route":"/journals/lancet/"}],"roadmap":[{"id":"colorectal-roadmap","kind":"roadmap","name":"Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation","route":"/roadmaps/colorectal-roadmap/"}]}}