Effect of Open-Label Everolimus After Disease Progression in Patients with Advanced Neuroendocrine Tumors: A RADIANT-2 Analysis

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Introduction: In the RADIANT-2 study (NCT00412061), Everolimus + Octreotide LAR (E+O) resulted in a clinically meaningful increase in median progression-free survival (PFS; by adjudicated central review) of 5.1 months v. placebo + Octreotide LAR (P+O) in patients with advanced NET with a history of carcinoid syndrome. Investigator-assessed PFS was 12.0 months for E+O compared with 8.6 months for P+O, respectively. On radiologically confirmed disease progression, P+O patients could cross over to open-label E+O.

Aim(s): To present the outcomes of P+O patients who crossed over to open-label E.

Materials and methods: Four-hundred and twenty-nine patients were randomly assigned: 216 to E (10 mg/d) + O (30 mg IM q 28 d) and 213 to P+O. After progression, crossover occurred for 124 patients.

Conference: 9th Annual ENETSConcerence (2012)

Presenting Author:

Authors: Hörsch D, Luppi G, Jehl V, Peeters M, Hainsworth J,

Keywords: Everolimus, Octreotide LAR, somatostatin analog, mTOR,