Everolimus (EVE) for Advanced, Progressive Pancreatic Neuroendocrine Tumors (pNET): Final Overall Survival (OS) from a Randomized, Double-blind, Placebo (PBO)-Controlled, Multicenter Phase 3 RADIANT-3 Study

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Introduction: EVE showed a significant improvement of 6.4 mo in median progression-free survival (PFS) vs PBO (HR 0.35, 95% CI 0.27-0.45; P<0.001) in patients (pts) with pNET in RADIANT-3.

Aim(s): To report final OS and safety updates from RADIANT-3.

Materials and methods: 410 pts with advanced, progressive, low-/intermediate-grade pNET were randomized to EVE 10 mg/d (n=207) or PBO (n=203) both with best supportive care. Crossover from PBO to open-label EVE upon disease progression was allowed in double-blind phase. At the end of core phase, ongoing patients from both arms were switched to open-label EVE at investigator’s discretion after unblinding. After 256 events, OS was analyzed by stratified log-rank test. OS by baseline CgA levels (low [≤2xULN] vs high [>2xULN]) was compared.

Conference: 12th Annual ENETSConcerence (2015)

Presenting Author:

Authors: Yao J, Pavel M, Lombard-Bohas C, Van Cutsem E, Lam D,

Keywords: everolimus, pNET, OS,