Edward K Avila, Anne S Reiner, Terri S Armstrong, Ashley E Aaroe, Elizabeth M Cunningham, Julie G Brown, Francesco Bruno, Jose Diarte, Aya Haggiagi, Rebecca A Harrison, Adela Joanta-Gomez, Johan A F Koekkoek, Eudocia Q Lee, Emilie Le Rhun, Hope Miller, Katherine S Panageas, Edwin N Peguero, Roberta Ruda, Riccardo Soffietti, Jessica W Templer, Steven Tobochnik, Elizabeth Vera, Michael A Vogelbaum, Michael Weller, Martin van den Bent
{"title":"肿瘤相关癫痫评估工具（RANO- treat）用于评估胶质瘤治疗试验和临床实践的癫痫控制。","authors":"Edward K Avila, Anne S Reiner, Terri S Armstrong, Ashley E Aaroe, Elizabeth M Cunningham, Julie G Brown, Francesco Bruno, Jose Diarte, Aya Haggiagi, Rebecca A Harrison, Adela Joanta-Gomez, Johan A F Koekkoek, Eudocia Q Lee, Emilie Le Rhun, Hope Miller, Katherine S Panageas, Edwin N Peguero, Roberta Ruda, Riccardo Soffietti, Jessica W Templer, Steven Tobochnik, Elizabeth Vera, Michael A Vogelbaum, Michael Weller, Martin van den Bent","doi":"10.1093/neuonc/noaf165","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":19377,"journal":{"name":"Neuro-oncology","volume":" ","pages":""},"PeriodicalIF":16.4000,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"RANO seizure working group-Tumor Related Epilepsy Assessment Tool (RANO-TREAT) to assess seizure control for glioma treatment trials and clinical practice.\",\"authors\":\"Edward K Avila, Anne S Reiner, Terri S Armstrong, Ashley E Aaroe, Elizabeth M Cunningham, Julie G Brown, Francesco Bruno, Jose Diarte, Aya Haggiagi, Rebecca A Harrison, Adela Joanta-Gomez, Johan A F Koekkoek, Eudocia Q Lee, Emilie Le Rhun, Hope Miller, Katherine S Panageas, Edwin N Peguero, Roberta Ruda, Riccardo Soffietti, Jessica W Templer, Steven Tobochnik, Elizabeth Vera, Michael A Vogelbaum, Michael Weller, Martin van den Bent\",\"doi\":\"10.1093/neuonc/noaf165\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":19377,\"journal\":{\"name\":\"Neuro-oncology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":16.4000,\"publicationDate\":\"2025-07-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Neuro-oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/neuonc/noaf165\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neuro-oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/neuonc/noaf165","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
RANO seizure working group-Tumor Related Epilepsy Assessment Tool (RANO-TREAT) to assess seizure control for glioma treatment trials and clinical practice.
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.
期刊介绍：
Neuro-Oncology, the official journal of the Society for Neuro-Oncology, has been published monthly since January 2010. Affiliated with the Japan Society for Neuro-Oncology and the European Association of Neuro-Oncology, it is a global leader in the field.
The journal is committed to swiftly disseminating high-quality information across all areas of neuro-oncology. It features peer-reviewed articles, reviews, symposia on various topics, abstracts from annual meetings, and updates from neuro-oncology societies worldwide.
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