RANO seizure working group-Tumor-Related Epilepsy Assessment Tool (RANO-TREAT) to assess seizure control for glioma treatment trials and clinical practice Journal Article


Authors: Avila, E. K.; Reiner, A. S.; Armstrong, T. S.; Aaroe, A. E.; Cunningham, E. M.; Brown, J. G.; Bruno, F.; Diarte, J.; Haggiagi, A.; Harrison, R. A.; Joanta-Gomez, A.; Koekkoek, J. A. F.; Lee, E. Q.; Le Rhun, E.; Miller, H.; Panageas, K. S.; Peguero, E. N.; Ruda, R.; Soffietti, R.; Templer, J. W.; Tobochnik, S.; Vera, E.; Vogelbaum, M. A.; Weller, M.; van den Bent, M.
Article Title: RANO seizure working group-Tumor-Related Epilepsy Assessment Tool (RANO-TREAT) to assess seizure control for glioma treatment trials and clinical practice
Abstract: Background No standardized method exists for seizure assessment in glioma clinical trials. We describe the development and evaluation of RANO-TREAT (Tumor Related Epilepsy Assessment Tool) for seizure assessment and its association with changes on brain MRI.Methods Patients with glioma/glioneuronal tumors and >= 1 prior seizure along with clinicians completed RANO-TREAT in conjunction with brain MRIs, yielding multiple RANO-TREAT scores at clinic visits over time. Unweighted (primary) and weighted (post-hoc) scores were correlated with disease progression via MRI in all patients and patients with IDHmt tumors, separately. Cohorts were randomly split by patient into cohort-specific training and validation sets. Weights for RANO-TREAT items were defined by multivariable generalized estimating equation models in cohort-specific training sets and validated in cohort-specific validation sets. A nomogram was developed using overall cohort training and validation sets.Results Four hundred and ninety patients (310 IDHmt tumors) had >= 1 visits and 285 patients (168 IDHmt tumors) had >= 2 visits. Unweighted RANO-TREAT scores (OR:1.01; 95%CI:0.998-1.02; P = .13) and score changes (OR:1.00; 95%CI:0.99-1.02; P = .63) were not associated with progressive disease on MRI. Post-hoc analysis using training and validation sets demonstrated weighted RANO-TREAT scores were correlated with progressive disease in both overall cohort validation set (OR:2.51; 95%CI:1.80-3.52; P < .0001) and IDHmt cohort validation set (OR:4.53; 95%CI:2.11-9.75; P = .0001). Weighted analyses for patients with >= 2 visits showed similar associations in validation sets.Conclusions This prospective study suggests an association of seizure control evaluated by a new standardized tool with disease progression in glioma. This tool requires further systematic evaluation in glioma clinical trials alongside more traditional endpoints.
Keywords: glioma; radiotherapy; clinical trials; response assessment; quality-of-life; efficacy; assessment; antiepileptic drugs; seizures; tumor-related epilepsy; low-grade glioma
Journal Title: Neuro-Oncology
ISSN: 1522-8517
Publisher: Oxford University Press  
Publication status: Online ahead of print
Date Published: 2025-01-01
Online Publication Date: 2025-01-01
Language: English
ACCESSION: WOS:001538478300001
DOI: 10.1093/neuonc/noaf165
PROVIDER: wos
Notes: Article; Early Access -- Source: Wos
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