Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours - Université de Bourgogne Accéder directement au contenu
Article Dans Une Revue Digestive and Liver Disease Année : 2017

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

Nadia Bouarioua
  • Fonction : Auteur
Denis Smith
  • Fonction : Auteur
Karine Bouhier-Leporrier
  • Fonction : Auteur
Olivia Hentic
  • Fonction : Auteur
Marianne Pavel
  • Fonction : Auteur
Ivan Borbath
  • Fonction : Auteur
Juan W. Valle
  • Fonction : Auteur
Anja Rinke
  • Fonction : Auteur

Résumé

IntroductionPatients 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 methodsMain 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.Results222 patients will be randomly assigned in a 1:1 ratio to receive 120 mg 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.ConclusionThe study is currently open in France, Germany, Belgium, United Kingdom and Ireland. A total of 25 patients are randomized (NCT02288377).

Domaines

Cancer
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Dates et versions

hal-01599909 , version 1 (02-10-2017)

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Citer

Come Lepage, Laetitia Dahan, Nadia Bouarioua, Christos Toumpanakis, Jean-Louis Legoux, et al.. Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours. Digestive and Liver Disease, 2017, 49 (5), pp.568 - 571. ⟨10.1016/j.dld.2017.02.004⟩. ⟨hal-01599909⟩
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