| Added by | JPPOUGET |
|---|---|
| Group name | EquipeJPP |
| Item Type | Journal Article |
| Title | A prospective, randomized, phase II study to assess the schemas of retreatment with Lutathera® in patients with new progression of an intestinal, well-differentiated neuroendocrine tumor (ReLUTH) |
| Creator | Deshayes et al. |
| Author | Emmanuel Deshayes |
| Author | Eric Assenat |
| Author | Laetitia Meignant |
| Author | Manuel Bardiès |
| Author | Lore Santoro |
| Author | Sophie Gourgou |
| Abstract | Abstract Background Although neuroendocrine tumors (NET) are classed as rare, they have a high prevalence and their incidence is increasing. Effective treatment with lutetium 17 -[177Lu]Lu-oxodotreotide (Lutathera®) is possible in patients with well-differentiated NET, improving progression-free survival (PFS), overall survival (OS), and quality of life (QoL). However, progression does occur. Retreatment with additional Lutathera® cycles is an option to extend PFS and OS. Two retreatment cycles are usually proposed. We aim to compare four versus two Lutathera® retreatment cycles in patients with new progression of a well-differentiated intestinal NET. Methods This will be a multicenter, randomized, controlled, open-label, phase II study in France (ReLUTH). The aim is to evaluate the efficacy of retreatment with Lutathera® in patients with progressive intestinal NET (determined by somatostatin-receptor positive imaging) after previous treatment with two cycles of Lutathera®. Before randomization, all patients will have already received two Lutathera® retreatment cycles (7.4 GBq infusion each, 8 weeks apart). A total of 146 patients will be randomized (1:1) to two additional cycles of Lutathera® (7.4 GBq infusion each, separated by 8 weeks) or to no treatment (active surveillance). Primary objective: efficacy of two additional Lutathera® retreatment cycles compared to active surveillance over 6 months. Primary endpoint: disease control rate at 6 months from randomization (defined as Complete Response, Partial Response, and Stable Disease in the Response Evaluation Criteria In Solid Tumours) with an evaluation every 2 months. A secondary objective will be the safety, as well as the PFS, OS, and QoL. It is expected that the efficacy of retreatment will increase after two additional Lutathera® cycles, with no increased safety concerns. Discussion Our prospective, randomized controlled study may lead to new recommendations for the use of Lutathera® in patients with intestinal progressive NET, and should confirm that four cycles will be more effective than two, with limited adverse impact on safety. Four Lutathera® treatment cycles have the potential to prolong life and improve quality of life in patients. Trial registration ClinicalTrials.gov: NCT04954820. |
| Publication | BMC Cancer |
| Volume | 22 |
| Issue | 1 |
| Pages | 1346 |
| Date | 2022-12-22 |
| Journal Abbr | BMC Cancer |
| Language | en |
| DOI | 10.1186/s12885-022-10443-4 |
| ISSN | 1471-2407 |
| URL | https://bmccancer.biomedcentral.com/articles/10.1186/s12885-022-10443-4 |
| Accessed | 2023/11/23 - 12:12:02 |
| Library Catalog | DOI.org (Crossref) |
| Extra | Number: 1 |
| Tags | 177Lu-DOTA-TATE, clinic, first-last-coresponding, first-last-corresponding, Humans, Intestinal Neoplasms, Neuroendocrine tumor, Neuroendocrine Tumors, Octreotide, Organometallic Compounds, Pancreatic Neoplasms, Prospective Studies, PRRT, Quality of Life, Retreatment, Stomach Neoplasms |
| Date Added | 2023/11/23 - 12:44:39 |
| Date Modified | 2024/12/15 - 11:20:30 |
| Notes and Attachments | Full Text (Attachment) Full Text (Attachment) PubMed entry (Attachment) PubMed entry (Attachment) Texte intégral (Attachment) |
Institut de Recherche en Cancérologie de
