提高放疗剂量治疗转移性脊髓压迫症的前瞻性多中心研究（RAMSES-01）
Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01): a prospective multicenter study.
机构信息
Department of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.
Department of Oncology, Odense University Hospital, Odense, Denmark.
出版信息
BMC Cancer. 2019 Nov 29;19(1):1163. doi: 10.1186/s12885-019-6390-x.
BACKGROUND
Patients with metastatic spinal cord compression (MSCC) and favorable survival prognoses can benefit from radiation doses greater than 30Gy in 10 fractions in terms of improved local progression-free survival (LPFS) and overall survival (OS).
METHODS/DESIGN: This prospective study mainly investigates LPFS after precision radiotherapy (volumetric modulated arc therapy or stereotactic body radiotherapy) with 18 × 2.33Gy in 3.5 weeks. LPFS is defined as freedom from progression of motor deficits during radiotherapy and an in-field recurrence of MSCC following radiotherapy. The maximum relative dose allowed to the spinal cord is 101.5% of the prescribed dose, resulting in an equivalent dose in 2Gy-fractions (EQD2) for radiation myelopathy is 45.5Gy, which is below the tolerance dose of 50Gy according to the Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC). The EQD2 of this regimen for tumor cell kill is 43.1Gy, which is 33% higher than for 30Gy in 10 fractions (EQD2 = 32.5Gy). Primary endpoint is LPFS at 12 months after radiotherapy. Secondary endpoints include the effect of 18 × 2.33Gy on motor function, ambulatory status, sensory function, sphincter dysfunction, LPFS at other follow-up times, overall survival, pain relief, relief of distress and toxicity. Follow-up visits for all endpoints will be performed directly and at 1, 3, 6, 9 and 12 months after radiotherapy. A total of 65 patients are required for the prospective part of the study. These patients will be compared to a historical control group of at least 235 patients receiving conventional radiotherapy with 10x3Gy in 2 weeks.
DISCUSSION
If precision radiotherapy with 18 × 2.33Gy results in significantly better LPFS than 10x3Gy of conventional radiotherapy, this regimen should be strongly considered for patients with MSCC and favorable survival prognoses.
TRIAL REGISTRATION
Clinicaltrials.gov NCT04043156. Registered 30-07-2019.
背景
对于生存预后良好的转移性脊髓压迫症（MSCC）患者，30Gy/10f 以上剂量的放射治疗可改善局部无进展生存期（LPFS）和总生存期（OS），从而使患者获益。
方法/设计：本前瞻性研究主要探讨 3.5 周内接受 18 次 2.33Gy 精准放疗（容积调强弧形治疗或立体定向体部放疗）后的 LPFS。LPFS 定义为放疗期间运动功能障碍无进展，且放疗后 MSCC 未出现野内复发。脊髓最大允许相对剂量为处方剂量的 101.5%，由此得出脊髓放射病的 2Gy 等效剂量（EQD2）为 45.5Gy，低于 50Gy 的耐受剂量，这是根据临床正常组织效应定量分析（QUANTEC）得出的。该方案的肿瘤细胞杀灭 EQD2 为 43.1Gy，比 30Gy/10f （EQD2=32.5Gy）高 33%。主要终点为放疗后 12 个月的 LPFS。次要终点包括 18 次 2.33Gy 对运动功能、步行状态、感觉功能、括约肌功能障碍、其他随访时间的 LPFS、总生存期、疼痛缓解、痛苦缓解和毒性的影响。所有终点的随访均直接进行，并在放疗后 1、3、6、9 和 12 个月进行。本研究的前瞻性部分需要 65 例患者。这些患者将与至少 235 例接受常规放疗（2 周内 10x3Gy）的历史对照组进行比较。
讨论
如果 18 次 2.33Gy 的精准放疗比 10x3Gy 的常规放疗显著改善 LPFS，则对于生存预后良好的 MSCC 患者，应强烈考虑这种方案。
试验注册
Clinicaltrials.gov NCT04043156。注册日期：2019 年 7 月 30 日。
Zotero 插件