2684 - International Multidisciplinary Delphi Consensus to Align Definitions, Reporting Items and Study Endpoints for Future Clinical Trials and Audits on Malignant Spinal Cord Compression
Presenter(s)
H. C. Y. Wong1, I. J. Choi2,3, G. N. Marta4, C. Hircock5, S. F. Lee6,7, W. Chan8, S. Raman8, E. S. A. Oldenburger9, C. B. Simone II2, D. Dearnaley10, E. Maranzano11, E. Chow5, D. Rades12, and P. Hoskin13,14; 1Department of Oncology, Princess Margaret Hospital, Kwai Chung, Hong Kong, 2New York Proton Center, New York, NY, 3Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, 4Department of Radiation Oncology, Hospital Sírio-Libanês, Sao Paulo, Brazil, 5Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada, 6Department of Radiation Oncology, National University Cancer Institute, National University Hospital, Singapore, Singapore, 7Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Sinagpore, Singapore, 8British Columbia Cancer Agency, Vancouver, BC, Canada, 9University Hospitals Leuven, Leuven, Belgium, 10The Institute of Cancer Research and Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom, 11University of Perugia, Perugia, Italy, 12Department of Radiation Oncology, University Medical Center Schleswig-Holstein, Lubeck, Germany, 13Mount Vernon Cancer Centre, Middlesex, United Kingdom, 14Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom
Purpose/Objective(s):
Malignant spinal cord compression (MSCC) is a complication of spinal metastases that significantly affects patients' quality of life and survival. Previous prospective trials have employed varying MSCC definitions and study endpoints, hindering the ability to compare interventions effectively.Materials/Methods:
Following a systematic review of prospective clinical trials on MSCC published between 2003 and 2024, a Delphi consensus process was conducted via an electronic survey from June 2024 to January 2025. Authors of important MSCC trials and international experts in the management of spinal metastases and MSCC were invited, with snowball sampling for additional participants. Participants evaluated statements on inclusion/exclusion criteria, MSCC definitions, reporting standards, treatment outcome response criteria, and endpoint selection for various clinical scenarios. Unresolved statements were revised and re-voted in subsequent rounds.Results:
Seventy-four experts from 20 countries and 7 disciplines participated in Round 1, with 71 (95.9%) completing Round 2 to form the expert panel. In Round 1, 23/32 (71.8%) statements achieved consensus. Thirty revised statements generated based on participant feedback were voted in Round 2, with 29 (96.7%) reaching consensus. One unresolved statement was removed, finalizing a list of 49 recommendations. The panel agreed on definitions for clinical spinal cord compression (cSCC), radiological SCC (rSCC), and impending SCC (iSCC) using the Bilsky scale. They recommended documenting pain, motor function, sensory function, ambulatory status, urinary function, and anal sphincter function at baseline and follow-ups. Consensus was also reached on study endpoint definitions, functional assessment scales, response criteria and timing of clinical and radiological assessments. A set of mandatory and secondary endpoints was recommended for studies on cSCC, rSCC, and iSCC, alongside minimal reporting standards for surgery- and radiotherapy-related toxicities.Conclusion:
This international Delphi study offers a comprehensive set of recommendations to standardize the methodology for future clinical trials and audits on MSCC. By establishing a unified framework, it seeks to harmonize data presentation and enhance comparability across future studies, ultimately advancing the understanding and management of MSCC. The study was exempted from ethics review by the Western Institutional Board (ID NYPC ERC #2024-057).