Everolimus + Octreotide LAR v. Placebo + Octreotide LAR in Patients With Advanced NET: Results of a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial (RADIANT-2)

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Introduction: Everolimus, an oral inhibitor of mTOR, demonstrated promising antitumor activity in patients with NET as a single agent and in combination with octreotide LAR in two phase 2 studies.

Aim(s): To evaluate Everolimus in combination with octreotide LAR in the treatment of advanced NET in a randomized, placebo-controlled, phase 3 study.

Materials and methods: Patients with well- or moderately differentiated advanced NET and a history of carcinoid symptoms received Everolimus 10 mg/d + octreotide LAR 30 mg IM q28 days (E+O, n=216) or placebo + octreotide LAR (P+O, n=213). Primary endpoint was PFS by adjudicated central review (RECIST). Crossover from P+O to open-label E+O was allowed at disease progression.

Conference: 8th Annual ENETSConcerence (2011)

Presenting Author:

Authors: Pavel M, Peeters M, Höersch D, Van Cutsem E, Öberg K,

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