Proposed response assessment and endpoints for meningioma clinical trials: report from the Response Assessment in Neuro-Oncology Working Group

Raymond Y Huang; Wenya Linda Bi; Michael Weller; Thomas Kaley; Jaishri Blakeley; Ian Dunn; Evanthia Galanis; Matthias Preusser; Michael McDermott; Leland Rogers; Jeffrey Raizer; David Schiff; Riccardo Soffietti; Jörg-Christian Tonn; Michael Vogelbaum; Damien Weber; David A Reardon; Patrick Y Wen

doi:10.1093/neuonc/noy137

Proposed response assessment and endpoints for meningioma clinical trials: report from the Response Assessment in Neuro-Oncology Working Group

Neuro Oncol. 2019 Jan 1;21(1):26-36. doi: 10.1093/neuonc/noy137.

Authors

Raymond Y Huang¹, Wenya Linda Bi², Michael Weller³, Thomas Kaley⁴, Jaishri Blakeley⁵, Ian Dunn², Evanthia Galanis⁶, Matthias Preusser⁷, Michael McDermott⁸, Leland Rogers⁹, Jeffrey Raizer¹⁰, David Schiff¹¹, Riccardo Soffietti¹², Jörg-Christian Tonn¹³, Michael Vogelbaum¹⁴, Damien Weber¹⁵, David A Reardon¹⁶, Patrick Y Wen¹⁶

Affiliations

¹ Department of Radiology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
² Center for Skull Base and Pituitary Surgery, Department of Neurosurgery, Brigham and Women's Hospital, Boston, Massachusetts, USA.
³ Department of Neurology, University Hospital Zurich, Zürich, Switzerland.
⁴ Neuro-Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
⁵ The Johns Hopkins Hospital, Baltimore, Maryland, USA.
⁶ Division of Medical Oncology, Department of Oncology, Mayo Clinic, Rochester, Minnesota, USA.
⁷ Clinical Division of Oncology, Department of Medicine I, Comprehensive Cancer Centre, Medical University Vienna-General Hospital, Vienna, Austria.
⁸ Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.
⁹ Radiation Oncology, Barrow Neurological Institute, Phoenix, Arizona, USA.
¹⁰ Medical Neuro-Oncology, Northwestern Medicine, Chicago, Illinois, USA.
¹¹ Departments of Neurology, Neurological Surgery, and Medicine, University of Virginia, Charlottesville, Virginia, USA.
¹² Department of Neuro-Oncology, University of Turin and City of Health and Science University Hospital, Torino, Italy.
¹³ Department of Neurosurgery, Ludwig-Maximilians-Universität, Munich, Germany.
¹⁴ Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center, Cleveland Clinic, Cleveland, Ohio, USA.
¹⁵ Paul Scherrer Institut, Villigen, Switzerland.
¹⁶ Center of Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, USA.

Abstract

No standard criteria exist for assessing response and progression in clinical trials involving patients with meningioma, and there is no consensus on the optimal endpoints for trials currently under way. As a result, there is substantial variation in the design and response criteria of meningioma trials, making comparison between trials difficult. In addition, future trials should be designed with accepted standardized endpoints. The Response Assessment in Neuro-Oncology Meningioma Working Group is an international effort to develop standardized radiologic criteria for treatment response for meningioma clinical trials. In this proposal, we present the recommendations for response criteria and endpoints for clinical trials involving patients with meningiomas.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Review

MeSH terms

Clinical Trials as Topic*
Combined Modality Therapy
Disease Progression
Humans
Meningeal Neoplasms / diagnostic imaging
Meningeal Neoplasms / pathology*
Meningeal Neoplasms / therapy
Meningioma / diagnostic imaging
Meningioma / pathology*
Meningioma / therapy
Neuroimaging / methods*
Outcome and Process Assessment, Health Care*
Practice Guidelines as Topic / standards*