Lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumors - An international double-blind, placebo-controlled randomized phase 2. Prodige 31 REMINET. A FFCD study
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Introduction: Following European guidelines, patients (pts) with aggressive metastatic or locally advanced, non-resectable, duodeno-pancreatic (DP) neuroendocrine tumors (NETs), should receive systemic combination of chemotherapy until progression. Aggressive disease is defined as progressive and/or symptomatic metastases and/or with significant hepatic invasion (>30-50%), and/or bone metastases.
Aim(s): The aim of this academic randomized, double-blind, placebo-controlled phase 2 study was to evaluate lanreotide autogel 120 mg (LAN) as maintenance treatment after at least 2 months of first line treatment (L1) in aggressive G1-G2 DP-NET
Materials and methods: Pts were randomly assigned in a 1:1 ratio to receive LAN or placebo (PBO), every 28 days, until progression or toxicity. The primary endpoint was the rate of pts alive without progression at 6 months (progression-free survival, PFS at 6 months).
Conference: 18th Annual ENETS Concerence (2021)
Presenting Author: Lepage C
Authors: Lepage C, Phelip J, Lievre A, Le Malicot K, Dahan L,
Keywords: clinical trial, non-resectable, duodeno-pancreatic, neuroendocrine tumor, maintenance,
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