Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours.

Abstract

INTRODUCTION:

Patients with metastatic or locally advanced, non-resectable, grade 1 or 2 well-differentiated duodeno-pancreatic (WDDP) NETs are treated following European guidelines. Patients (Pts) with aggressive disease, i.e. progressive and/or symptomatic metastases and/or with significant hepatic invasion (>30-50%), and/or bone metastases, anti-tumour therapy should receive systemic combination of chemotherapy once disease control is obtained.

AIM(S):

The aim is to stop chemotherapy until progression. REMINET is an academic randomized, double-blind, placebo-controlled, phase II/III study designed to evaluate lanreotide (LAN) as maintenance treatment after L1 chemotherapy in G1-G2 WDDP NET.

MATERIALS AND METHODS:

Main eligibility criteria: adults pts with a metastatic (synchronous or metachronous) or locally advanced, non-resectable, grade 1 or 2 WDDP NETs and documented control disease after L1 therapy at least 4 weeks prior to randomization.

RESULTS:

222 patients will be randomly assigned in a 1:1 ratio to receive 120mg LAN or placebo, every 28 days, until disease progression or unacceptable toxicity. The aim of the phase II part is to demonstrate a 6-months PFS >45% in LAN arm. Secondary endpoints are PFS according to central review, overall survival, safety and quality of life. A bio-bank of frozen blood will be constituted.

CONCLUSION:

The study is currently open in France, Germany, Belgium, United Kingdom and Ireland. A total of 25 patients are randomized (NCT02288377).

• Authors: Côme Lepage, Laetitia Dahan, Nadia Bouarioua, Christos Toumpanakis, Jean-Louis Legoux, Karine Le Malicot, Rosine Guimbaud, Denis Smith, David Tougeron, Astrid Lievre, Guillaume Cadiot, Frédéric Di Fiore, Karine Bouhier-Leporrier, Olivia Hentic, Roger Faroux, Marianne Pavel, Ivan Borbath, Juan W Valle, Anja Rinke, Jean-Yves Scoazec, Michel Ducreux, Thomas Walter
• Journal: Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver (Dig Liver Dis) Vol. 49 Issue 5 Pg. 568-571 (May 2017) ISSN: 1878-3562 [Electronic] Netherlands
• PMID: 28292641 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Chemical References

• Antineoplastic Agents
• Peptides, Cyclic
• lanreotide
• Somatostatin

Topics

• Adolescent
• Adult
• Aged
• Antineoplastic Agents (administration & dosage, adverse effects)
• Clinical Protocols
• Disease-Free Survival
• Double-Blind Method
• Duodenal Neoplasms (drug therapy, pathology)
• Europe
• Female
• Humans
• Male
• Middle Aged
• Neuroendocrine Tumors (drug therapy, pathology)
• Pancreatic Neoplasms (drug therapy, pathology)
• Peptides, Cyclic (administration & dosage, adverse effects)
• Prospective Studies
• Quality of Life
• Somatostatin (administration & dosage, adverse effects, analogs & derivatives)
• Treatment Outcome
• Young Adult