Efficacy and Safety of Everolimus in Japanese Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET): Japanese Subgroup Analysis of RADIANT-3

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Introduction: Everolimus, an oral inhibitor of mTOR, significantly improved progression-free survival (PFS) v. placebo in a phase III trial (RADIANT-3) in patients with advanced pNET.

Aim(s): The purpose of this analysis was to investigate the efficacy and safety in the Japanese subgroup of RADIANT-3 (n=23, Everolimus; n=17, placebo).

Materials and methods: This subgroup analysis compared the efficacy and safety of Everolimus 10 mg/d orally plus best supportive care (BSC) with the efficacy and safety of matching placebo plus BSC. The primary efficacy end point was PFS. Tumor response was assessed using RECIST criteria (version 1.0). Safety was evaluated based on the incidence of adverse events (AEs).

Conference: 8th Annual ENETSConcerence (2011)

Presenting Author:

Authors: Okusaka T, Ito T, Ikeda M, Tajima T, Kasuga A,

Keywords: mTOR, everolimus, octreotide LAR, neuroendocrine tumor,