Lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours: An international double-blind, placebo-controlled randomised phase II trial - Prodige 31 REMINET: An FFCD study.

Frédéric Di-Fiore, Thomas Walter, Denis Smith, Jean-Yves Scoazec, Pierre Michel, Rosine Guimbaud, Thierry Lecomte, Romain Coriat, Ivan Borbath, Catherine Lombard-Bohas, Christos Toumpanakis, David Tougeron, Laetitia Dahan, Karine Le-Malicot, Astrid Lievre, Jean-Marc Phelip, Côme Lepage, Caroline Pétorin, Jean-Louis Legoux

Journal: European journal of cancer (Oxford, England : 1990) 2022;175():31-40

PMID: 36087395

Free Full Text on Elsevier Science View on PubMed

Abstract

BACKGROUND

Following European guidelines, patients with aggressive metastatic or locally advanced, non-resectable, duodeno-pancreatic (DP) neuroendocrine tumours (NETs) should receive systemic combination chemotherapy until progression. Aggressive disease is defined as progressive and/or symptomatic metastases with or without significant hepatic invasion (>30-50%), and/or bone metastases.

METHODS

This academic randomised, double-blind, placebo-controlled phase II study aims 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. Patients were randomly assigned in a 1:1 ratio to receive LAN or placebo (PBO), every 28 days, until progression or toxicity. The primary end-point was progression-free survival (PFS) at 6 months.

RESULTS

Among the 118 planned patients, 53 were included. Of these, 81.1% had a G2 tumour, and 90.6% had metastatic disease. L1 therapy consisted of chemotherapy (96.8%). Median duration of L1 was 4.6 months (range: 2.0-7.7). At the time of randomisation, 81.1% of patients had stable disease. Median follow-up was 27.0 months (95% CI: 19.5; 31.2). PFS at 6 months was 73.1% (90% CI: 55.3; 86.6) in LAN versus 54.2% (90% CI: 35.8; 71.8) in PBO. Median PFS was 19.4 months (95% CI: 7.6; 32.6) and 7.6 months (95% CI: 3.0; 9.0), respectively. Median overall survival was 41.9 months in PBO and was not reached in LAN. The toxicity profile was mainly grade 1-2 expected toxicities.

CONCLUSIONS

The encouraging results of lanreotide autogel 120 mg as a maintenance treatment after L1 in aggressive G1/2 DP-NET should be confirmed.

TRIAL REGISTRATION

NCT02288377 (clinicaltrials.gov).

Address: EPICAD INSERM UMR LNC 1231, University of Burgundy Franche Comté, Dijon, France; Department of HGE & Digestive Oncology, University Hospital Dijon, University of Burgundy, Dijon, France. Electronic address: [email protected].; Department of HGE & Digestive Oncology, University Hospital St Etienne, France.; Department of Gastroenterology, Rennes University Hospital, Rennes 1 University, INSERM U1242 "Chemistry Oncogenesis Stress Signalling", Rennes, FFCD, France.; EPICAD INSERM UMR LNC 1231, University of Burgundy Franche Comté, Dijon, France.; C.H.U. la Timone and Université de la Méditerranée, Marseille, France.; Department of Hepato-gastroenterology, Poitiers University Hospital and Poitiers University, Poitiers, France.; Centre for Gastroenterology, Neuroendocrine Tumour Unit, ENETS Centre of Excellence, Royal Free Hospital, London, UK.; Normandie University, UNIROUEN, Inserm 1245, IRON Group, Hôpital Universitaire de Rouen, Centre Henri-Becquerel, Département d'oncolgie Médicale, Service d'hépato-gastroentérologie, 76000 Rouen, France.; Cancer Institute, ENETS Centre of Excellence, Hospices Civils de Lyon, France.; Department of Gastroenterology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.; AP-HP, Université Paris Descartes, Faculté de Médecine, Hôpital Cochin, Gastroenterology and Endoscopy Unit, Sorbonne Paris Cité, 75014 Paris, France.; Department of HGE & Digestive Oncology, University Hospital Tours, François-Rabelais University, Tours, France.; Centre Hospitalier Universitaire de Toulouse, Toulouse, France.; Digestive Surgery and Oncological Department, Hospital Estaing, Clermont-Ferrand, France.; Department of Hepato-Gastroenterology, La Source Hospital, Orléans, France.; Department of Pathology, University Paris-Saclay, Gustave Roussy Cancer Center, Villejuif, France.; Hôpital Haut Lévêque, Service d'hépato-gastroentérologie, Pessac, France.

DOI: 10.1016/j.ejca.2022.07.033