TY - JOUR
T1 - Evaluation of the Implementation of the Response Assessment in Neuro-Oncology Criteria in the HERBY Trial of Pediatric Patients with Newly Diagnosed High-Grade Gliomas
AU - Rodriguez, D.
AU - Chambers, T.
AU - Warmuth-Metz, M.
AU - Aliaga, E. Sanchez
AU - Warren, D.
AU - Calmon, R.
AU - Hargrave, D.
AU - Garcia, J.
AU - Vassal, G.
AU - Grill, J.
AU - Zahlmann, G.
AU - Morgan, P. S.
AU - Jaspan, T.
N1 - © 2019 by American Journal of Neuroradiology.
PY - 2019
Y1 - 2019
N2 - BACKGROUND AND PURPOSE: HERBY was a Phase II multicenter trial setup to establish the efficacy and safety of adding bevacizumab to radiation therapy and temozolomide in pediatric patients with newly diagnosed non-brain stem high-grade gliomas. This study evaluates the implementation of the radiologic aspects of HERBY. MATERIALS AND METHODS: We analyzed multimodal imaging compliance rates and scan quality for participating sites, adjudication rates and reading times for the central review process, the influence of different Response Assessment in Neuro-Oncology criteria in the final response, the incidence of pseudoprogression, and the benefit of incorporating multimodal imaging into the decision process. RESULTS: Multimodal imaging compliance rates were the following: diffusion, 82%; perfusion, 60%; and spectroscopy, 48%. Neuroradiologists' responses differed for 50% of scans, requiring adjudication, with a total average reading time per patient of approximately 3 hours. Pseudoprogression occurred in 10/116 (9%) cases, 8 in the radiation therapy/temozolomide arm and 2 in the bevacizumab arm (P < .01). Increased target enhancing lesion diameter was a reason for progression in 8/86 cases (9.3%) but never the only radiologic or clinical reason. Event-free survival was predicted earlier in 5/86 (5.8%) patients by multimodal imaging (diffusion, n = 4; perfusion, n = 1). CONCLUSIONS: The addition of multimodal imaging to the response criteria modified the assessment in a small number of cases, determining progression earlier than structural imaging alone. Increased target lesion diameter, accounting for a large proportion of reading time, was never the only reason to designate disease progression.
AB - BACKGROUND AND PURPOSE: HERBY was a Phase II multicenter trial setup to establish the efficacy and safety of adding bevacizumab to radiation therapy and temozolomide in pediatric patients with newly diagnosed non-brain stem high-grade gliomas. This study evaluates the implementation of the radiologic aspects of HERBY. MATERIALS AND METHODS: We analyzed multimodal imaging compliance rates and scan quality for participating sites, adjudication rates and reading times for the central review process, the influence of different Response Assessment in Neuro-Oncology criteria in the final response, the incidence of pseudoprogression, and the benefit of incorporating multimodal imaging into the decision process. RESULTS: Multimodal imaging compliance rates were the following: diffusion, 82%; perfusion, 60%; and spectroscopy, 48%. Neuroradiologists' responses differed for 50% of scans, requiring adjudication, with a total average reading time per patient of approximately 3 hours. Pseudoprogression occurred in 10/116 (9%) cases, 8 in the radiation therapy/temozolomide arm and 2 in the bevacizumab arm (P < .01). Increased target enhancing lesion diameter was a reason for progression in 8/86 cases (9.3%) but never the only radiologic or clinical reason. Event-free survival was predicted earlier in 5/86 (5.8%) patients by multimodal imaging (diffusion, n = 4; perfusion, n = 1). CONCLUSIONS: The addition of multimodal imaging to the response criteria modified the assessment in a small number of cases, determining progression earlier than structural imaging alone. Increased target lesion diameter, accounting for a large proportion of reading time, was never the only reason to designate disease progression.
KW - Bevacizumab/therapeutic use
KW - Brain Stem Neoplasms/diagnostic imaging
KW - Chemoradiotherapy/methods
KW - Child
KW - Clinical Trials, Phase II as Topic/methods
KW - Disease Progression
KW - Disease-Free Survival
KW - Female
KW - Glioma/diagnostic imaging
KW - Humans
KW - Male
KW - Multicenter Studies as Topic/methods
KW - Multimodal Imaging/methods
KW - Neuroimaging
KW - Randomized Controlled Trials as Topic/methods
KW - Temozolomide/therapeutic use
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85062952359&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30819765
U2 - https://doi.org/10.3174/ajnr.A5982
DO - https://doi.org/10.3174/ajnr.A5982
M3 - Article
C2 - 30819765
SN - 0195-6108
VL - 40
SP - 568
EP - 575
JO - American journal of neuroradiology
JF - American journal of neuroradiology
IS - 3
ER -