Title :

Trabectedin for recurrent who grade 2 or 3 meningioma: a randomized phase 2 study of the eortc brain tumor group (eortc-1320-btg)

Author(s) :

Preusser, Matthias [Auteur]
Silvani, Antonio [Auteur]
Le Rhun, Emilie [Auteur]
Soffietti, Riccardo [Auteur]
Lombardi, Giuseppe [Auteur]
Sepulveda, Juan Manuel [Auteur]
Brandal, Petter [Auteur]
Brazil, Lucy [Auteur]
Bonneville-Levard, Alice [Auteur]
Lorgis, Veronique [Auteur]
Vauleon, Elodie [Auteur]
Bromberg, Jacoline E. C. [Auteur]
Erridge, Sara [Auteur]
Cameron, Alison [Auteur]
Lefranc, Florence [Auteur]
Clement, Paul M. [Auteur]
Dumont, Sarah [Auteur]
Sanson, Marc [Auteur]
Bronnimann, Charlotte [Auteur]
Balana, Carmen [Auteur]
Thon, Niklas [Auteur]
Lewis, Joanne [Auteur]
Mair, Maximilian J. [Auteur]
Sievers, Philipp [Auteur]
Furtner, Julia [Auteur]
Pichler, Josef [Auteur]
Bruna, Jordi [Auteur]
Ducray, Francois [Auteur]
Reijneveld, Jaap C. [Auteur]
Mawrin, Christian [Auteur]
Bendszus, Martin [Auteur]
Marosi, Christine [Auteur]
Golfinopoulos, Vassilis [Auteur]
Coens, Corneel [Auteur]
Gorlia, Thierry [Auteur]
Weller, Michael [Auteur]
Sahm, Felix [Auteur]
Wick, Wolfgang [Auteur]

Journal title :

Neuro-Oncology

Abbreviated title :

Neuro Oncol

Publication date :

2021-10-21

ISSN :

1523-5866

Keyword(s) :

clinical trial
DNA methylation class
trabectedin
quality of life
meningioma

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

BACKGROUND: No systemic treatment has been established for meningioma progressing after local therapies. METHODS: This randomized, multicenter, open-label, phase II study included adult patients with recurrent WHO grade 2 ...
Show more >BACKGROUND: No systemic treatment has been established for meningioma progressing after local therapies. METHODS: This randomized, multicenter, open-label, phase II study included adult patients with recurrent WHO grade 2 or 3 meningioma. Patients were 2:1 randomly assigned to intravenous trabectedin (1.5 mg/m2 every 3 weeks) or local standard of care (LOC). The primary endpoint was progression-free survival (PFS). Secondary endpoints comprised overall survival (OS), objective radiological response, safety, quality of life (QoL) assessment using the QLQ-C30 and QLQ-BN20 questionnaires, and we performed tissue-based exploratory molecular analyses. RESULTS: Ninety patients were randomized (n = 29 in LOC, n = 61 in trabectedin arm). With 71 events, median PFS was 4.17 months in the LOC and 2.43 months in the trabectedin arm (hazard ratio [HR] = 1.42; 80% CI, 1.00-2.03; P = .294) with a PFS-6 rate of 29.1% (95% CI, 11.9%-48.8%) and 21.1% (95% CI, 11.3%-32.9%), respectively. Median OS was 10.61 months in the LOC and 11.37 months in the trabectedin arm (HR = 0.98; 95% CI, 0.54-1.76; P = .94). Grade >/=3 adverse events occurred in 44.4% of patients in the LOC and 59% of patients in the trabectedin arm. Enrolled patients had impeded global QoL and overall functionality and high fatigue before initiation of systemic therapy. DNA methylation class, performance status, presence of a relevant co-morbidity, steroid use, and right hemisphere involvement at baseline were independently associated with OS. CONCLUSIONS: Trabectedin did not improve PFS and OS and was associated with higher toxicity than LOC treatment in patients with non-benign meningioma. Tumor DNA methylation class is an independent prognostic factor for OS.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

INSERM
Université de Lille

Collections :

• Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U1192

Submission date :

2022-06-15T14:00:50Z