Activity and safety of metformin (MET), Everolimus (EVE) and Octreotide (OCT) in patients (pts) with advanced, well-differentiated (WD) pancreatic neuroendocrine tumors (pNETs). The prospective phase II MetNET-1 trial (NCT02294006). Interim analysis

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Introduction: Preclinical and clinical evidences support a role for metformin as an antineoplastic agent in WD pNETs.

Aim(s): MetNET-1 is phase II, prospective study with the aim to assess the activity and safety of the MET+EVE+OCT combination in pts with advanced WD pNETs.

Materials and methods: Pts received EVE 10 mg/day + OCT 30 mg every 28 days + MET (starting dose 500 mg/day, increased to 1000 mg/day at day 7, 1500 mg/day at day 14 and 2000 mg/day at day 21). The primary objective was PFS rate at 12 months (mos). Under the assumption of a 47% PFS rate at 12 mos based on the results of the everolimus arm of the RADIANT-3 study (null hypothesis), 43 pts were needed to demonstrate a 20% PFS increase, (α = 0.10 one-tailed and β = 0.10 - 90% power). Secondary endpoints were OS, ORR and safety profile in terms of treatment-related (TR) adverse events (AEs) according to CTCAE v. 4.03.

Conference:

Presenting Author: Pusceddu S

Authors: Pusceddu S, Prinzi N, Corti F, Beninato T, Milione M,

Keywords: pancreatic NET, metformin, somatostatin analogues, everolimus,