Department of Neurosurgery, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
Department of Radiation Oncology, University of Washington School of Medicine, Seattle, Washington, USA.
Neuro Oncol. 2018 Aug 2;20(9):1215-1224. doi: 10.1093/neuonc/noy047.
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.
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.
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.
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).
约 40%的转移性癌症患者将发展为脊柱转移。本报告代表神经肿瘤脊柱反应评估 (SPINO) 小组,就脊柱肿瘤患者人群描述和结局评估超出局部控制终点的指标标准化提出建议。
为了确定在描述脊柱转移患者时使用基于临床医生和患者报告的结局测量的偏好,SPINO 小组进行了调查。随后,在 ClinicalTrials.gov 注册处搜索了脊柱肿瘤学临床试验,并确定了每个试验中用于患者描述和结局报告的措施。这两项搜索用于识别当前使用的描述符和工具。进行了一项文献搜索,重点关注调查和临床试验搜索中确定的措施,以评估它们在转移性脊柱肿瘤患者人群中的有效性。本文的参考文献是通过 PubMed 和 Medline 搜索确定的。
利用已发表的文献、专家调查和正在进行的临床试验,综合了报告脊柱稳定性、硬膜外肿瘤扩展、神经和功能状态以及症状严重程度的工具的建议。
准确描述患者人群和治疗效果需要结合基于临床医生和患者报告的结局测量。本报告提供了国际共识建议,用于系统报告患者和临床医生报告的措施,这些措施是制定适用于脊柱转移手术和术后脊柱立体定向体放射治疗 (SBRT) 的试验所必需的。