The radiogenomic risk score stratifies outcomes in a XXXX phase 2 clinical trial.

@entity1 @entity1358
OBJECTIVES: To characterize a radiogenomic risk score (RRS), a previously defined biomarker, and to evaluate its potential for stratifying radiological progression-free survival (rPFS) in @entity1 with @entity1358 ( @entity1358 ) undergoing pre-surgical treatment with bevacizumab. METHODOLOGY: In this IRB-approved study, prospective imaging analysis of the RRS was performed on phase II clinical trial data of @entity1358 @entity1 (n   =   41) evaluating whether @entity1 stratification according to the RRS resulted in groups more or less likely to have a rPFS to pre-surgical bevacizumab prior to cytoreductive nephrectomy. Survival times of RRS subgroups were analyzed using Kaplan-Meier survival analysis. RESULTS: The RRS is enriched in diverse molecular processes including drug response, stress response, protein kinase regulation, and signal transduction pathways (P   <   0.05). The RRS successfully stratified rPFS to bevacizumab based on pre-treatment computed tomography imaging with a median progression-free survival of 6 versus >25  months (P   =   0.005) and overall survival of 25 versus >37  months in the high and low RRS groups (P   =   0.03), respectively. Conventional prognostic predictors including the Motzer and Heng criteria were not predictive in this cohort (P   >   0.05). CONCLUSIONS: The RRS stratifies rPFS to bevacizumab in @entity1 from a phase II clinical trial with @entity1358 undergoing cytoreductive nephrectomy and pre-surgical bevacizumab. KEY POINTS:     The RRS SOMA stratifies @entity1 outcomes in a phase II clinical trial.     RRS stratifies subjects into prognostic groups in a discrete or continuous fashion.     RRS is biologically enriched in diverse processes including drug response programs.
