Relationship between Metabolic Toxicity and Efficacy of Everolimus in Patients with Neuroendocrine Tumors (NETs): A Pooled Analysis from the Randomized, Phase 3 RADIANT-3 and RADIANT-4 Trials

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Introduction: Hyperglycemia and hypercholesterolemia are class effects of mTOR inhibitors such as everolimus (EVE).

Aim(s): The present post-hoc pooled analysis was conducted to explore the potential impact of these events on efficacy of EVE.

Materials and methods: Patients (Pts) with advanced, low-, or intermediate-grade pancreatic (p), gastrointestinal (GI), or lung NETs received either EVE 10 mg/day oral or placebo in RADIANT-3 (p; N=207, N=203) and RADIANT-4 (GI or lung; N=205, N=97) trials. Key study outcomes were progression-free survival (PFS), duration of exposure, and safety. A landmark analysis of PFS (central review) was performed on pts treated for at least 16 weeks (wks; N=308 [n=200/412]) and according to occurrence of any-grade adverse events (AEs) within this treatment period.

Conference: 15th Annual ENETSConcerence (2018)

Presenting Author:

Authors: Fazio N, Carnaghi C, Buzzoni R, Valle J, Herbst F,

Keywords: adverse events, everolimus, RADIANT-3, RADIANT-4, landmark analysis, mTOR inhibitors, targeted therapy, neuroendocrine tumors,