Background: In the phase III RADIANT-2 trial, everolimus, an oral inhibitor of mTOR, plus octreotide (E+O) demonstrated a clinically meaningful increase in median progression-free survival (PFS) compared with placebo + octreotide LAR (P+O) in pts with advanced low- or intermediate-grade NET and a history of secretory symptoms associated with carcinoid syndrome (ESMO 2010 Abstract #LBA8). In order to determine the factors that significantly influence PFS, a multivariate analysis was performed. Methods: Pts with advanced NET were randomized to oral everolimus 10 mg/d + octreotide LAR 30 mg IM q 28 days (n=216) or P+O (n=213). The primary endpoint was PFS per adjudicated central review (RECIST v1.0). Multivariate analysis using a Cox-proportional hazards model was performed. Significant factors (p<0.05) were determined after a stepwise elimination of the nonsignificant factors from the model. Results: Multivariate analysis indicated that significant prognostic factors for PFS were treatment (everolimus vs placebo) (p=0.001), WHO performance status (p=0.007), lung as primary site (p=0.044), baseline CgA (p<0.001), and bone involvement (p=0.022) (Table). Conclusions: Multivariate analysis of the RADIANT-2 trial has allowed, for the first time, evaluation of the prognostic risk factors associated with PFS in a large phase III, placebo-controlled trial in pts with advanced NET. A better understanding of these risk factors can help clinicians in the treatment of their pts.