Ilya Laufer1, Simon S Lo2, Eric L Chang3, Jason Sheehan4, Matthias Guckenberger5, Moon-Jun Sohn6, Samuel Ryu7, Matthew Foote8, Alexander Muacevic9, Scott G Soltys10, Samuel Chao11, Sten Myrehaug12, Peter C Gerszten13, Eric Lis14, Pejman Maralani15, Mark Bilsky1, Charles Fisher16, Laurence Rhines17, Jorrit-Jan Verlaan18, David Schiff19, Michael G Fehlings20, Lijun Ma21, Susan Chang22, Wendy R Parulekar12, Michael A Vogelbaum23, Arjun Sahgal24. 1. Department of Neurosurgery, Memorial Sloan-Kettering Cancer Center, New York, New York, USA. 2. Department of Radiation Oncology, University of Washington School of Medicine, Seattle, Washington, USA. 3. Department of Radiation Oncology, University of Southern California, Los Angeles, California, USA. 4. Department of Neurosurgery, University of Virginia Health System, Charlottesville, Virginia, USA. 5. Department of Radiation Oncology, University Hospital Zurich, Zurich, Switzerland. 6. Department of Neurosurgery, Neuroscience & Radiosurgery Hybrid Research Center, Inje University Ilsan Paik Hospital, Goyang, Korea. 7. Department of Radiation Oncology, Stony Brook University, Stony Brook, New York, USA. 8. Department of Radiation Oncology, University of Queensland, Princess Alexandra Hospital, Brisbane, Australia. 9. Department of Neurosurgery, University of Munich Hospital, Munich, Germany. 10. Department of Radiation Oncology, Stanford University Medical Center, Stanford, California, USA. 11. Department of Radiation Oncology, Rose Ella Burkhardt Brain Tumor and Neuro-oncology Center, Cleveland Clinic, Cleveland, Ohio, USA. 12. NCIC Canadian Cancer Trials Group, Kingston, Ontario, Canada. 13. Department of Neurosurgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. 14. Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, New York, USA. 15. Department of Medical Imaging, University of Toronto, Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada. 16. Department of Orthopedics, University of British Columbia, Vancouver, British Columbia, Canada. 17. Department of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. 18. Department of Orthopedic Surgery, University Medical Center Utrecht, Utrecht, Netherlands. 19. Division of Neuro-Oncology, University of Virginia Health System, Charlottesville, Virginia, USA. 20. Department of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada. 21. Department of Radiation Oncology, University of California San Francisco, San Francisco, California, USA. 22. Department of Neurosurgery, University of California San Francisco, San Francisco, California, USA. 23. Brain Tumor and Neuro Oncology Center and Department of Neurosurgery, Cleveland Clinic, Cleveland, Ohio, USA. 24. Department of Radiation Oncology, University of Toronto, Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada.
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 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).
Background: Approximately 40% of metastatic cancerpatients 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 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 tumorpatient 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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