{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Stewart GD"],"funding":["Cancer Research UK","Medical Research Council","Engineering and Physical Sciences Research Council"],"pagination":["1051-1060"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9470559"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["127(6)"],"pubmed_abstract":["<h4>Background</h4>Surgery for renal cell carcinoma (RCC) with venous tumour thrombus (VTT) extension into the renal vein (RV) and/or inferior vena cava (IVC) has high peri-surgical morbidity/mortality. NAXIVA assessed the response of VTT to axitinib, a potent tyrosine kinase inhibitor.<h4>Methods</h4>NAXIVA was a single-arm, multi-centre, Phase 2 study. In total, 20 patients with resectable clear cell RCC and VTT received upto 8 weeks of pre-surgical axitinib. The primary endpoint was percentage of evaluable patients with VTT improvement by Mayo level on MRI. Secondary endpoints were percentage change in surgical approach and VTT length, response rate (RECISTv1.1) and surgical morbidity.<h4>Results</h4>In all, 35% (7/20) patients with VTT had a reduction in Mayo level with axitinib: 37.5%"],"journal":["British journal of cancer"],"pubmed_title":["A Phase II study of neoadjuvant axitinib for reducing the extent of venous tumour thrombus in clear cell renal cell cancer with venous invasion (NAXIVA)."],"pmcid":["PMC9470559"],"funding_grant_id":["27176","23471","MC_UP_1101/2","EP/T017961/1","28667","16628","27150","MC_UU_12022/5","A23471"],"pubmed_authors":["Couper N","Jones RJ","Matakidou A","Hill R","Bex A","Hamid A","Griffin A","Smith CG","Carruthers J","Mumtaz F","Riddick ACP","Rossi S","Dodd M","Jones JO","Leslie S","Watson J","Martin E","Baxter J","Laird A","Riddle K","Deng W","Cowan C","Haddow T","Ursprung S","Howden P","Shields J","Anand S","Mitchell TJ","Hopcroft LEM","Willsher L","Larkin J","Welsh SJ","Gallagher FA","Ho L","Priest AN","Welsh M","Warren AY","Wenlock S","Oades G","Grant L","Caasi C","George A","Pejnovic A","Cross R","Brush J","Burge SW","Orr R","Nicol D","Fielding A","Nuttall M","Tincey S","Symeonides S","Armitage JN","Stewart GD","Aho TF","Mendichovszky IA","Klatte T","Sala E","NAXIVA Trial Group","Fife K","Massie C","McLaren D","Malik J","Wallis L","Boleti E","Eisen T","Powles T","O'Donnell M","Barnett C","Venugopal B","Leung S"],"additional_accession":[]},"is_claimable":false,"name":"A Phase II study of neoadjuvant axitinib for reducing the extent of venous tumour thrombus in clear cell renal cell cancer with venous invasion (NAXIVA).","description":"<h4>Background</h4>Surgery for renal cell carcinoma (RCC) with venous tumour thrombus (VTT) extension into the renal vein (RV) and/or inferior vena cava (IVC) has high peri-surgical morbidity/mortality. NAXIVA assessed the response of VTT to axitinib, a potent tyrosine kinase inhibitor.<h4>Methods</h4>NAXIVA was a single-arm, multi-centre, Phase 2 study. In total, 20 patients with resectable clear cell RCC and VTT received upto 8 weeks of pre-surgical axitinib. The primary endpoint was percentage of evaluable patients with VTT improvement by Mayo level on MRI. Secondary endpoints were percentage change in surgical approach and VTT length, response rate (RECISTv1.1) and surgical morbidity.<h4>Results</h4>In all, 35% (7/20) patients with VTT had a reduction in Mayo level with axitinib: 37.5%","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Oct","modification":"2026-05-28T06:59:51.705Z","creation":"2024-11-06T18:42:56.549Z"},"accession":"S-EPMC9470559","cross_references":{"pubmed":["35739300"],"doi":["10.1038/s41416-022-01883-7"]}}