Lepage Côme, Dahan Laetitia, Bouarioua Nadia, Toumpanakis Christos, Legoux Jean-Louis, Le Malicot Karine, Guimbaud Rosine, Smith Denis, Tougeron David, Lievre Astrid, Cadiot Guillaume, Di Fiore Frédéric, Bouhier-Leporrier Karine, Hentic Olivia, Faroux Roger, Pavel Marianne, Borbath Ivan, Valle Juan W, Rinke Anja, Scoazec Jean-Yves, Ducreux Michel, Walter Thomas
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.
Department of Digestive Oncology, Aix-Marseille University - Assistance Publique Hôpitaux de Marseille, Marseille, France.
Dig Liver Dis. 2017 May;49(5):568-571. doi: 10.1016/j.dld.2017.02.004. Epub 2017 Mar 11.
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.
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.
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.
The study is currently open in France, Germany, Belgium, United Kingdom and Ireland. A total of 25 patients are randomized (NCT02288377).
转移性或局部晚期、不可切除的1级或2级高分化十二指肠-胰腺（WDDP）神经内分泌肿瘤（NET）患者按照欧洲指南进行治疗。对于疾病侵袭性强的患者，即出现进展性和/或有症状的转移和/或有显著肝转移（>30-50%）和/或骨转移，一旦获得疾病控制，抗肿瘤治疗应采用全身化疗联合方案。
目的是在疾病进展前停止化疗。REMINET是一项学术性随机、双盲、安慰剂对照的II/III期研究，旨在评估兰瑞肽（LAN）作为G1-G2 WDDP NET患者L1化疗后的维持治疗。
主要入选标准：患有转移性（同时性或异时性）或局部晚期、不可切除的1级或2级WDDP NET的成年患者，且在随机分组前至少4周经记录显示L1治疗后疾病得到控制。
222例患者将按1:1比例随机分配，每28天接受120mg LAN或安慰剂治疗，直至疾病进展或出现不可接受的毒性反应。II期部分的目的是证明LAN组6个月无进展生存期（PFS）>45%。次要终点包括根据中心评估的PFS、总生存期、安全性和生活质量。将建立一个冷冻血液生物样本库。
该研究目前在法国、德国、比利时、英国和爱尔兰开展。共有25例患者被随机分组（NCT02288377）。
