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 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. Conclusion The study is currently open in France, Germany, Belgium, United Kingdom and Ireland. A total of 25 patients are randomized (NCT02288377).
Type de document :
Article dans une revue
Digestive and Liver Disease, WB Saunders, 2017, 49 (5), pp.568 - 571. 〈10.1016/j.dld.2017.02.004〉
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https://hal-univ-bourgogne.archives-ouvertes.fr/hal-01599909
Contributeur : Lnc - Université de Bourgogne <>
Soumis le : lundi 2 octobre 2017 - 15:48:00
Dernière modification le : jeudi 12 avril 2018 - 02:00:15

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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, WB Saunders, 2017, 49 (5), pp.568 - 571. 〈10.1016/j.dld.2017.02.004〉. 〈hal-01599909〉

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