Radiopharmaceutical Therapy with [ 177 Lu]Lu-DOTATATE in Refractory Meningiomas: Results from the French Multicenter MELUTE Cohort

Evidence supporting the efficacy and safety of [177Lu]Lu-DOTATATE in refractory meningiomas derives mainly from small, single-center studies. The French national multicenter MELUTE study aimed to consolidate these data using a standardized regimen within a compassionate-use program approved by a national multidisciplinary tumor board. Methods: In this retrospective multicenter cohort study, patients with refractory meningiomas treated with [177Lu]Lu-DOTATATE in 18 French centers between July 2022 and December 2024 were included. Treatment consisted of 7.4 GBq every 8 wk for up to 4 cycles. Clinical data (demographics, histologic World Health Organization grade [WHO], prior treatments, number of cycles, toxicity, progression, survival status as of October 1, 2025) were collected. Baseline [68Ga]Ga-DOTATOC PET and brain MRI scans obtained before and after treatment were centrally reviewed. The primary endpoint was 6-mo progression-free survival (PFS) assessed using volumetric Response Assessment in Neuro-Oncology Group criteria. Secondary endpoints were PFS, overall survival (OS), and safety. Results: Sixty-nine patients were included (mean age, 65.1 ± 13.2 y; 52% female): 13 WHO grade 1, 42 WHO grade 2, 8 WHO grade 3, and 6 without histology. Most had prior surgery (86%) or radiotherapy (93%); 32% received prior systemic therapy. Twelve patients (17%) did not complete 4 cycles; only one discontinuation was toxicity-related. Six-month PFS was 70% (95% CI, 58.7–80.4%). Median PFS was 14.6 mo (95% CI, 13.3–18.5 mo), and median OS was 27.6 mo (95% CI, 24.2 mo to not reached). Grade 3 adverse events, mainly lymphopenia, occurred in 16%. Meningioma WHO grade independently predicted PFS, whereas higher Karnofsky performance status and corticosteroid use were protective; worse OS was associated with higher baseline tumor growth rate and prior systemic therapy. Conclusion: MELUTE demonstrates promising efficacy and favorable safety of [177Lu]Lu-DOTATATE in refractory meningiomas with limited therapeutic options.

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Journal
Journal of Nuclear Medicine
Published
2026-10-15
DOI
https://doi.org/10.2967/jnumed.126.272735
Primary Topic
Meningioma and schwannoma management
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article

Radiopharmaceutical Therapy with [ 177 Lu]Lu-DOTATATE in Refractory Meningiomas: Results from the French Multicenter MELUTE Cohort

Marie Onno, Jacques Darcourt, Inna Dygai‐Cochet, Anthime Flaus et al.
Journal of Nuclear Medicine
Meningioma and schwannoma management
article

Radiopharmaceutical Therapy with [ 177 Lu]Lu-DOTATATE in Refractory Meningiomas: Results from the French Multicenter MELUTE Cohort

Marie Onno, Jacques Darcourt, Inna Dygai‐Cochet, Anthime Flaus, Ghoufrane Tlili, Sarah Boughdad, Gauthier Delaby, Jeanne Riverain, Caroline Bund, Pierre Meneret, Agathe Edet‐Sanson, Luc Taillandier, Élodie Vauléon, Thomas Graillon, Thibault Fidani, Timothée Zaragori, Laëtitia Imbert, Enora Vauléon, A. Huchet, Caroline Boursier, Matthieu Peyre, Tatiana Horowitz, Vincent Bourbonne, François Ducray, Elske Quak, Éric Guedj, Betty Salgues, Marc Sanson, Anthony Joncour, Julien Boetto, Emmanuel Deshayes, Catherine Ansquer, Antoine Verger, Georges Noël, Édouard Samarut, Jean‐Sébastien Guillamo, Lavinia Vija, François Ghiringhelli, Emeline Tabouret, Solène Querellou, Nicolas Garabedian, Justine Attal, Gabriela Hossu, Catherine Cheze-Le-Rest, Adrien Carle-Ortiz
article en

Abstract

Evidence supporting the efficacy and safety of [177Lu]Lu-DOTATATE in refractory meningiomas derives mainly from small, single-center studies. The French national multicenter MELUTE study aimed to consolidate these data using a standardized regimen within a compassionate-use program approved by a national multidisciplinary tumor board. Methods: In this retrospective multicenter cohort study, patients with refractory meningiomas treated with [177Lu]Lu-DOTATATE in 18 French centers between July 2022 and December 2024 were included. Treatment consisted of 7.4 GBq every 8 wk for up to 4 cycles. Clinical data (demographics, histologic World Health Organization grade [WHO], prior treatments, number of cycles, toxicity, progression, survival status as of October 1, 2025) were collected. Baseline [68Ga]Ga-DOTATOC PET and brain MRI scans obtained before and after treatment were centrally reviewed. The primary endpoint was 6-mo progression-free survival (PFS) assessed using volumetric Response Assessment in Neuro-Oncology Group criteria. Secondary endpoints were PFS, overall survival (OS), and safety. Results: Sixty-nine patients were included (mean age, 65.1 ± 13.2 y; 52% female): 13 WHO grade 1, 42 WHO grade 2, 8 WHO grade 3, and 6 without histology. Most had prior surgery (86%) or radiotherapy (93%); 32% received prior systemic therapy. Twelve patients (17%) did not complete 4 cycles; only one discontinuation was toxicity-related. Six-month PFS was 70% (95% CI, 58.7–80.4%). Median PFS was 14.6 mo (95% CI, 13.3–18.5 mo), and median OS was 27.6 mo (95% CI, 24.2 mo to not reached). Grade 3 adverse events, mainly lymphopenia, occurred in 16%. Meningioma WHO grade independently predicted PFS, whereas higher Karnofsky performance status and corticosteroid use were protective; worse OS was associated with higher baseline tumor growth rate and prior systemic therapy. Conclusion: MELUTE demonstrates promising efficacy and favorable safety of [177Lu]Lu-DOTATATE in refractory meningiomas with limited therapeutic options.

Journal of Nuclear Medicine
Université Claude Bernard Lyon 1 (FR), Centre National de la Recherche Scientifique (FR), Inserm (FR), Université de Bretagne Occidentale (FR), Université de Montpellier (FR), Aix-Marseille Université (FR), Commissariat à l'Énergie Atomique et aux Énergies Alternatives (FR), Centre Hospitalier Universitaire de Bordeaux (FR), Centre Hospitalier Universitaire de Lille (FR), Université de Poitiers (FR), Sorbonne Université (FR), Physiologie et Médecine Expérimentale du Coeur et des Muscles (FR), Hôpital Charles-Nicolle (FR), Centre de Recherche en Cancérologie et Immunologie Intégrée Nantes Angers (FR), Centre Georges François Leclerc (FR), Centre de Recherche en Neurosciences de Lyon (FR), Assistance Publique – Hôpitaux de Paris (FR), Institut de Neurophysiopathologie (FR), Centre Hospitalier Régional et Universitaire de Nancy (FR), Hospices Civils de Lyon (FR), Hôpital Roger Salengro (FR), Centre d’Investigation Clinique Innovation Technologique de Nancy (FR), Levi Strauss (United States) (US), Centre Eugène Marquis (FR), Centre Hospitalier Universitaire de Poitiers (FR), Hôpital Gui de Chauliac (FR), Institut de Myologie (FR), Imagerie Adaptative Diagnostique et Interventionnelle (FR), Laboratoire d’Imagerie Biomédicale (FR), Pitié-Salpêtrière Hospital (FR), Centre François Baclesse (FR), Centre de Recherche en Cancérologie de Lyon (FR), Institut NeuroMyoGène (FR), Institut Claudius Regaud (FR), Laboratoire National Henri Becquerel (FR), Institut de Recherche en Cancérologie de Montpellier (FR), Centrale Méditerranée (FR), Hôpital Pasteur (FR), Centre Antoine Lacassagne (FR), Institut du Cerveau (FR), Hôpital Claude Huriez (FR), Université de Rouen Normandie (FR), Université de Nîmes (FR), Université de Lorraine (FR), Nantes Université (FR)
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Meningioma and schwannoma management
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