XXXX in @entity5 : a phase II, open-label trial of the Spanish Task Force Group for @entity5 (GETNE)   .

@entity1 @entity7802 @entity50901 @entity6219 @entity41932 @entity5 @entity3470
BACKGROUND: The management of advanced @entity5 ( @entity5 ) has recently changed. We assessed the activity of @entity6219 after failure of other systemic treatments in advanced @entity5 . METHODS: This was a multicenter, open-label, phase II study evaluating @entity6219 as a single agent in advanced @entity5 (PAZONET study). The clinical benefit rate (CBR) at 6 months was the primary end point. Translational correlation of radiological response and progression-free survival (PFS) with circulating and tissue biomarkers was also evaluated. RESULTS: A total of 44 @entity1 were enrolled. Twenty-five @entity1 (59.5%) were progression-free at 6 months (4 partial responses, 21 stable diseases) with a median PFS of 9.5 months [95% confidence interval (CI) 4.8-14.1]. The CBR varied according to prior therapy received, with 73%, 60% and 25% in @entity1 treated with prior multitarget inhibitors, prior @entity3470 inhibitors and both agents, respectively. A nonsignificant increase in PFS was observed in @entity1 presenting lower baseline circulating @entity5 cell (CTC) counts (9.1 versus 5.8 months; P = 0.22) and in those with decreased levels of soluble-vascular endothelial growth factor receptor-2 (sVEGFR-2) (12.6 versus 9.1 months; P = 0.067). A trend toward reduced survival was documented in @entity1 with @entity7802 @entity50901 and @entity41932 missense polymorphisms [hazard ratio (HR): 12.3; 95% CI 1.09-139.2; P = 0.042 and HR: 6.9; 95% CI 0.96-49.9; P = 0.055, respectively]. CONCLUSIONS: @entity6219 showed clinical activity in @entity1 with advanced @entity5 regardless of previous treatments. Additionally, CTCs, soluble-s VEFGR-2 and @entity7802 gene polymorphisms constitute potential biomarkers for selecting @entity1 for @entity6219 (NCT01280201). CLINICAL TRIAL NUMBER: NCT01280201.
