Population description and clinical response assessment for spinal metastases: Part 2 of the SPIne response assessment in Neuro-Oncology (SPINO) group report
Laufer, Ilya; Lo, Simon S.; Chang, Eric L.; Sheehan, Jason; Guckenberger, Matthias; Sohn, Moon Jun; Ryu, Samuel; Foote, Matthew; Muacevic, Alexander; Soltys, Scott G.; Chao, Samuel; Myrehaug, Sten; Gerszten, Peter C.; Lis, Eric; Maralani, Pejman; Bilsky, Mark; Fisher, Charles; Rhines, Laurence; Verlaan, Jorrit Jan; Schiff, David; Fehlings, Michael G.; Ma, Lijun; Chang, Susan; Parulekar, Wendy R.; Vogelbaum, Michael A.; Sahgal, Arjun
(2018) Neuro-Oncology, volume 20, issue 9, pp. 1215 - 1224
(Article)
Abstract
Background. Approximately 40% of metastatic cancer patients will develop spinal metastases. The current report provides recommendations for standardization of metrics used for spinal oncology patient population description and outcome assessment beyond local control endpoints on behalf of the SPIne response assessment in Neuro-Oncology (SPINO) group. Methods. The SPINO group survey
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was conducted in order to determine the preferences for utilization of clinician-based and patient-reported outcome measures for description of patients with spinal metastases. Subsequently, ClinicalTrials.gov registry was searched for spinal oncology clinical trials, and measures for patient description and outcome reporting were identified for each trial. These two searches were used to identify currently used descriptors and instruments. A literature search was performed focusing on the measures identified in the survey and clinical trial search in order to assess their validity in the metastatic spinal tumor patient population. References for this manuscript were identified through PubMed and Medline searches. Results. Published literature, expert survey, and ongoing clinical trials were used to synthesize recommendations for instruments for reporting of spinal stability, epidural tumor extension, neurological and functional status, and symptom severity. Conclusions. Accurate description of patient population and therapy effects requires a combination of clinician-based and patient-reported outcome measures. The current report provides international consensus recommendations for the systematic reporting of patient- and clinician-reported measures required to develop trials applicable to surgery for spinal metastases and postoperative spine stereotactic body radiotherapy (SBRT).
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Keywords: Metastases, Response assessment, Spine radiosurgery, Spine surgery, SPINO, Oncology, Clinical Neurology, Cancer Research
ISSN: 1522-8517
Publisher: Oxford University Press
Note: Funding Information: Conflict of interest statement. Dr Laufer has received personal fees from Medtronic, DePuy Synthes, Globus, Brainlab, and Spinewave. Dr Lo has received support from Elekta AB and travel expenses from Accuray Inc. Dr E. Chang has received honoraria and travel reimbursements from Brainlab and has been on Toshiba’s advisory board. Dr Soltys has received personal fees from Inovio Pharmaceuticals and Nektar Therapeutics. Dr Chao has received personal fees from Varian Medical System. Dr Fisher has received personal fees from Medtronic and Nuvasive, an OREF grant paid to institution, AOSpine and Medtronic fellowship support paid to institution. Dr Rhines has received support from Stryker and Medtronic. Dr S. Chang has received grants from Agios, Tocagen, Quest, and Novartis, personal fees from Blaze, Neuro Onc, Edge, and Agios. Dr Vogelbaum has received honoraria from Tocagen and Medicenna and is the founder and Chief Medical Officer with Infuseon Therapeutics (patent and royalty interests). Dr Arjun Sahgal has received honoraria for past educational seminars from Elekta AB, Accuray Inc, and Varian Medical Systems and research grants from Elekta AB. Dr Sahgal also belongs to the Elekta MR Linac Research Consortium. Publisher Copyright: © The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved.
(Peer reviewed)