Safety of Lanreotide Autogel (LAN) 120 mg plus Metformin (MET) in patients with advanced, well-differentiated (WD) gastro-intestinal (GI) or lung neuroendocrine tumors (NETs) - A pilot, open-label, prospective study: The MetNET-2 Trial (NCT02823691)

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Introduction: Preclinical and clinical evidence supports a potential role for MET as an antineoplastic agent in WD NETs.

Aim(s): MetNET-2 is phase Ib, prospective, single-arm study with the aim to assess the safety and activity of MET+LAN in patients (pts) with advanced WD NETs of GI and thoracic origin.

Materials and methods: Pts received LAN 120 mg every 28 days plus MET (starting dose of 850 mg/day, increased up to 1700 mg/day at day 14 and 2550 mg/day at day 28). The primary objective was safety, assessed as the incidence of treatment-related (TR) adverse events (AEs) and serious AEs (SAEs) according to CTCAE v. 4.03. 20 patients were required to test the null hypothesis (TR-SAE rate of 25%) against a one-sided alternative, with 10% type I error rate and 85% power. Secondary endpoints were ORR and PFS according to RECIST 1.1.

Conference:

Presenting Author: Pusceddu S

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

Keywords: neuroendocrine tumor, metformin, somatostatin analogues,