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Article 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: 490 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=0.13) and score changes (OR:1.00; 95%CI:0.99-1.02; P=0.63) 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<0.0001) and IDHmt cohort validation set (OR:4.53; 95%CI:2.11-9.75; P=0.0001). 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.
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| http://dx.doi.org/10.1093/neuonc/noaf165 | DOI Listing |
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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.