Validation of diffusion MRI phenotypes for predicting response to bevacizumab in recurrent glioblastoma: post-hoc analysis of the EORTC-26101 trial.


Journal

Neuro-oncology
ISSN: 1523-5866
Titre abrégé: Neuro Oncol
Pays: England
ID NLM: 100887420

Informations de publication

Date de publication:
26 11 2020
Historique:
pubmed: 13 5 2020
medline: 17 3 2021
entrez: 13 5 2020
Statut: ppublish

Résumé

This study validated a previously described diffusion MRI phenotype as a potential predictive imaging biomarker in patients with recurrent glioblastoma receiving bevacizumab (BEV). A total of 396/596 patients (66%) from the prospective randomized phase II/III EORTC-26101 trial (with n = 242 in the BEV and n = 154 in the non-BEV arm) met the inclusion criteria with availability of anatomical and diffusion MRI sequences at baseline prior treatment. Apparent diffusion coefficient (ADC) histograms from the contrast-enhancing tumor volume were fitted to a double Gaussian distribution and the mean of the lower curve (ADClow) was used for further analysis. The predictive ability of ADClow was assessed with biomarker threshold models and multivariable Cox regression for overall survival (OS) and progression-free survival (PFS). ADClow was associated with PFS (hazard ratio [HR] = 0.625, P = 0.007) and OS (HR = 0.656, P = 0.031). However, no (predictive) interaction between ADClow and the treatment arm was present (P = 0.865 for PFS, P = 0.722 for OS). Independent (prognostic) significance of ADClow was retained after adjusting for epidemiological, clinical, and molecular characteristics (P ≤ 0.02 for OS, P ≤ 0.01 PFS). The biomarker threshold model revealed an optimal ADClow cutoff of 1241*10-6 mm2/s for OS. Thereby, median OS for BEV-patients with ADClow ≥ 1241 was 10.39 months versus 8.09 months for those with ADClow < 1241 (P = 0.004). Similarly, median OS for non-BEV patients with ADClow ≥ 1241 was 9.80 months versus 7.79 months for those with ADClow < 1241 (P = 0.054). ADClow is an independent prognostic parameter for stratifying OS and PFS in patients with recurrent glioblastoma. Consequently, the previously suggested role of ADClow as predictive imaging biomarker could not be confirmed within this phase II/III trial.

Sections du résumé

BACKGROUND
This study validated a previously described diffusion MRI phenotype as a potential predictive imaging biomarker in patients with recurrent glioblastoma receiving bevacizumab (BEV).
METHODS
A total of 396/596 patients (66%) from the prospective randomized phase II/III EORTC-26101 trial (with n = 242 in the BEV and n = 154 in the non-BEV arm) met the inclusion criteria with availability of anatomical and diffusion MRI sequences at baseline prior treatment. Apparent diffusion coefficient (ADC) histograms from the contrast-enhancing tumor volume were fitted to a double Gaussian distribution and the mean of the lower curve (ADClow) was used for further analysis. The predictive ability of ADClow was assessed with biomarker threshold models and multivariable Cox regression for overall survival (OS) and progression-free survival (PFS).
RESULTS
ADClow was associated with PFS (hazard ratio [HR] = 0.625, P = 0.007) and OS (HR = 0.656, P = 0.031). However, no (predictive) interaction between ADClow and the treatment arm was present (P = 0.865 for PFS, P = 0.722 for OS). Independent (prognostic) significance of ADClow was retained after adjusting for epidemiological, clinical, and molecular characteristics (P ≤ 0.02 for OS, P ≤ 0.01 PFS). The biomarker threshold model revealed an optimal ADClow cutoff of 1241*10-6 mm2/s for OS. Thereby, median OS for BEV-patients with ADClow ≥ 1241 was 10.39 months versus 8.09 months for those with ADClow < 1241 (P = 0.004). Similarly, median OS for non-BEV patients with ADClow ≥ 1241 was 9.80 months versus 7.79 months for those with ADClow < 1241 (P = 0.054).
CONCLUSIONS
ADClow is an independent prognostic parameter for stratifying OS and PFS in patients with recurrent glioblastoma. Consequently, the previously suggested role of ADClow as predictive imaging biomarker could not be confirmed within this phase II/III trial.

Identifiants

pubmed: 32393964
pii: 5836012
doi: 10.1093/neuonc/noaa120
pmc: PMC7690360
doi:

Substances chimiques

Angiogenesis Inhibitors 0
Bevacizumab 2S9ZZM9Q9V

Types de publication

Clinical Trial, Phase II Clinical Trial, Phase III Journal Article Research Support, Non-U.S. Gov't Validation Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

1667-1676

Informations de copyright

© The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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Auteurs

Marianne Schell (M)

Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
Section for Computational Neuroimaging, Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.

Irada Pflüger (I)

Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
Section for Computational Neuroimaging, Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.

Gianluca Brugnara (G)

Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
Section for Computational Neuroimaging, Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.

Fabian Isensee (F)

Medical Image Computing, German Cancer Research Center, Heidelberg, Germany.

Ulf Neuberger (U)

Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
Medical Image Computing, German Cancer Research Center, Heidelberg, Germany.
Section for Computational Neuroimaging, Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.

Martha Foltyn (M)

Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
Section for Computational Neuroimaging, Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.

Tobias Kessler (T)

Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany.
Clinical Cooperation Unit Neurooncology, German Cancer Research Center, Heidelberg, Germany.

Felix Sahm (F)

Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Clinical Cooperation Unit Neuropathology, German Cancer Research Center, Heidelberg, Germany.

Antje Wick (A)

Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany.

Martha Nowosielski (M)

Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany.
Clinical Cooperation Unit Neuropathology, German Cancer Research Center, Heidelberg, Germany.
Department of Neurology, Medical University, Innsbruck, Austria.

Sabine Heiland (S)

Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.

Michael Weller (M)

Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.

Michael Platten (M)

Department of Neurology, Mannheim Medical Center, University of Heidelberg, Mannheim, Germany.

Klaus H Maier-Hein (KH)

Medical Image Computing, German Cancer Research Center, Heidelberg, Germany.
Department of Neurology, Mannheim Medical Center, University of Heidelberg, Mannheim, Germany.

Andreas Von Deimling (A)

Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Clinical Cooperation Unit Neuropathology, German Cancer Research Center, Heidelberg, Germany.

Martin J Van Den Bent (MJ)

Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, Netherlands.

Thierry Gorlia (T)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.

Wolfgang Wick (W)

Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany.
Clinical Cooperation Unit Neurooncology, German Cancer Research Center, Heidelberg, Germany.
Clinical Cooperation Unit Neuropathology, German Cancer Research Center, Heidelberg, Germany.

Martin Bendszus (M)

Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.

Philipp Kickingereder (P)

Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
Section for Computational Neuroimaging, Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.

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