title: Response assessment criteria for brain metastases: proposal from the RANO group.
abstract: CNS metastases are the most common cause of malignant brain tumours in adults. Historically, patients with brain metastases have been excluded from most clinical trials, but their inclusion is now becoming more common. The medical literature is difficult to interpret because of substantial variation in the response and progression criteria used across clinical trials. The Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) working group is an international, multidisciplinary effort to develop standard response and progression criteria for use in clinical trials of treatment for brain metastases. Previous efforts have focused on aspects of trial design, such as patient population, variations in existing response and progression criteria, and challenges when incorporating neurological, neuro-cognitive, and quality-of-life endpoints into trials of patients with brain metastases. Here, we present our recommendations for standard response and progression criteria for the assessment of brain metastases in clinical trials. The proposed criteria will hopefully facilitate the development of novel approaches to this difficult problem by providing more uniformity in the assessment of CNS metastases across trials.
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: nlin@partners.org.
authors.forename: Nancy U
authors.initials: NU
authors.lastname: Lin
authors.affiliation: Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Eudocia Q
authors.initials: EQ
authors.lastname: Lee
authors.affiliation: Department of Radiology, Niigata University Graduate School of Medical and Dental Sciences, Chuo-ku, Niigata, Japan.
authors.forename: Hidefumi
authors.initials: H
authors.lastname: Aoyama
authors.affiliation: Department of Radiation Oncology, University of California, San Francisco, CA, USA.
authors.forename: Igor J
authors.initials: IJ
authors.lastname: Barani
authors.affiliation: Department of Radiology, Duke University Medical Center, Durham, NC, USA.
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Barboriak
authors.affiliation: Department of Radiation-Oncology, MediClin Robert Janker Clinic & University of Bonn Medical Centre, Cooperation Unit Neuro-oncology, Bonn, Germany.
authors.forename: Brigitta G
authors.initials: BG
authors.lastname: Baumert
authors.affiliation: Department of Neuroradiology, University of Heidelberg, Heidelberg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Bendszus
authors.affiliation: Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Brown
authors.affiliation: Division of Medical Oncology, School of Medicine, University of Colorado Denver, Denver, CO, USA.
authors.forename: D Ross
authors.initials: DR
authors.lastname: Camidge
authors.affiliation: Department of Neurosurgery, University of California, San Francisco, CA, USA.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Chang
authors.affiliation: NCIC Clinical Trials Group, Ontario Institute for Cancer Research, Queen's University, Kingston, ON, Canada.
authors.forename: Janet
authors.initials: J
authors.lastname: Dancey
authors.affiliation: Department of Medical Oncology, University Medical Center Groningen, University of Groningen, RB Groningen, Netherlands.
authors.forename: Elisabeth G E
authors.initials: EG
authors.lastname: de Vries
authors.affiliation: Department of Radiation Oncology, The Anschutz Medical Campus, University of Colorado Denver, Aurora, CO, USA.
authors.forename: Laurie E
authors.initials: LE
authors.lastname: Gaspar
authors.affiliation: MGH 3D Imaging Lab, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: Gordon J
authors.initials: GJ
authors.lastname: Harris
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: F Stephen
authors.initials: FS
authors.lastname: Hodi
authors.affiliation: Department of Neurosurgery, Henry Ford Health System, Detroit, MI, USA.
authors.forename: Steven N
authors.initials: SN
authors.lastname: Kalkanis
authors.affiliation: Department of Neurological Surgery, University of California, San Francisco, CA, USA; UC Irvine Medical Center, Orange, CA, USA.
authors.forename: Mark E
authors.initials: ME
authors.lastname: Linskey
authors.affiliation: Department of Oncology, London Regional Cancer Program, London Health Sciences Centre, University of Western Ontario, London, ON, Canada.
authors.forename: David R
authors.initials: DR
authors.lastname: Macdonald
authors.affiliation: Division of Oncology, Stanford University, Stanford, CA, USA.
authors.forename: Kim
authors.initials: K
authors.lastname: Margolin
authors.affiliation: Maryland Proton Treatment Center, University of Maryland School of Medicine, Baltimore, MA, USA.
authors.forename: Minesh P
authors.initials: MP
authors.lastname: Mehta
authors.affiliation: Division of Neuro-Oncology, University of Virginia, Charlottesville, VA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Schiff
authors.affiliation: Department of Neurology/Neuro-Oncology, University of Turin, Turin, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Soffietti
authors.affiliation: Department of Radiation Oncology/T28, Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Suh
authors.affiliation: Neuro-Oncology Unit, Daniel den Hoed Cancer Center, Erasmus University Medical Center, Rotterdam, Netherlands.
authors.forename: Martin J
authors.initials: MJ
authors.lastname: van den Bent
authors.affiliation: Department of Neurosurgery/ND40, Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Vogelbaum
authors.affiliation: Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Patrick Y
authors.initials: PY
authors.lastname: Wen
mesh_terms: D001932:Brain Neoplasms / Q000453:epidemiology* / Q000473:pathology / Q000556:secondary; D002490:Central Nervous System / Q000473:pathology*; D002986:Clinical Trials as Topic; D005910:Glioma / Q000453:epidemiology* / Q000473:pathology / Q000556:secondary; D006801:Humans; D008279:Magnetic Resonance Imaging