title: Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  The study is currently open in France, Germany, Belgium, United Kingdom and Ireland. A total of 25 patients are randomized (NCT02288377).
authors.affiliation: Department of Digestive Oncology, Burgundy Franche-Conté University, University hospital Dijon, Dijon, France; Burgundy Franche-Conté University, EPICAD, INSERM LNC UMR1231, Dijon, France; French Federation of Digestive Oncology (FFCD), INSERM LNC UMR1231 EPICAD, Dijon, France. Electronic address: come.lepage@u-bourgogne.fr.
authors.forename: Côme
authors.initials: C
authors.lastname: Lepage
authors.affiliation: Department of Digestive Oncology, Aix-Marseille University - Assistance Publique Hôpitaux de Marseille, Marseille, France.
authors.forename: Laetitia
authors.initials: L
authors.lastname: Dahan
authors.affiliation: Department of Gastroenterology and Digestive Oncology, Saint Etienne, France.
authors.forename: Nadia
authors.initials: N
authors.lastname: Bouarioua
authors.affiliation: Royal Free Hospital, Neuroendocrine Tumour Unit, Londres, Grande-Bretagne, UK.
authors.forename: Christos
authors.initials: C
authors.lastname: Toumpanakis
authors.affiliation: Regional Hospital of Orleans, Orleans, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Legoux
authors.affiliation: French Federation of Digestive Oncology (FFCD), INSERM LNC UMR1231 EPICAD, Dijon, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Le Malicot
authors.affiliation: Hôpital Rangueil, Toulouse, France.
authors.forename: Rosine
authors.initials: R
authors.lastname: Guimbaud
authors.affiliation: Hôpital Haut Lévêque, Service d'hépato-gastroentérologie, Pessac, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Smith
authors.affiliation: Hôpital de la Milétrie, Poitiers, France.
authors.forename: David
authors.initials: D
authors.lastname: Tougeron
authors.affiliation: CHU de Rennes-Hôpital Pontchaillou, Rennes, France.
authors.forename: Astrid
authors.initials: A
authors.lastname: Lievre
authors.affiliation: Hôpital Robert Debré, Reims, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cadiot
authors.affiliation: CHU Charles Nicolle, Rouen, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Di Fiore
authors.affiliation: CHU Côte de Nacre, Caen, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Bouhier-Leporrier
authors.affiliation: Hôpital Beaujon, Clichy, France.
authors.forename: Olivia
authors.initials: O
authors.lastname: Hentic
authors.affiliation: CH Les Oudairies, La Roche sur Yon, France.
authors.forename: Roger
authors.initials: R
authors.lastname: Faroux
authors.affiliation: Charite Campus Virchow Kinikum, Berlin, Germany.
authors.forename: Marianne
authors.initials: M
authors.lastname: Pavel
authors.affiliation: Cliniques universitaires Saint-Luc, Bruxelles, Belgium.
authors.forename: Ivan
authors.initials: I
authors.lastname: Borbath
authors.affiliation: University of Manchester, Division of Cancer Sciences/The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Juan W
authors.initials: JW
authors.lastname: Valle
authors.affiliation: University Hospital Marburg, Marburg, Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Rinke
authors.affiliation: Pathology Department, Gustave Roussy, Villejuif, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Scoazec
authors.affiliation: Gastrointestinal Oncology Department, Gustave Roussy Institute, Villejuif, France; Faculté de Médecine, Paris Sud University Le Kremlin Bicêtre, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Ducreux
authors.affiliation: Edouard Herriot Hospital, Department of Gastroenterology, Hospices Civils de Lyon, Lyon, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Walter
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004379:Duodenal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018358:Neuroendocrine Tumors / Q000188:drug therapy* / Q000473:pathology; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010456:Peptides, Cyclic / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life; D013004:Somatostatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D010456:Peptides, Cyclic; C060347:lanreotide; D013004:Somatostatin
keywords: Clinical trial; Duodenopancreatic neuroendocrine tumours; First line; Maintenance