Lai Shih-Fan, Chen Yi-Lun, Xiao Fu-Ren, Chen Ya-Fang, Lu Szu-Huai, Hsu Feng-Ming
Department of Radiation Oncology, National Taiwan University Cancer Center, Taipei, Taiwan; Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.
Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan; Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital Hsin-Chu Branch, Biomedical Park Hospital, Zhubei, Taiwan.
Spine J. 2025 Jul;25(7):1360-1370. doi: 10.1016/j.spinee.2025.01.019. Epub 2025 Jan 31.
Stereotactic spine radiosurgery (SSRS) shows potentials of better tumor and pain control for limited spinal metastases. However, the optimal schedule of SSRS is not well established and has never been investigated in a prospective randomized trial.
To compare 2 SSRS schedules to determine which results in the lowest rate of Grade 3 or higher protocol-specified adverse events at 4 months.
A prospective randomized Phase II trial.
Patients with biopsy-proven nonhematogenous malignancy and limited unirradiated spine metastases not requiring upfront spine surgery were eligible. Between November 2015 and April 2019, 69 patients were randomly assigned, yielding a total cohort of 63 analyzable patients with 79 treated spinal segments.
Primary outcomes were the 4-month Grade 3 or higher adverse events determined by the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE) definitely, probably, or possibly related to single fraction or multiple fractions spine SSRS.
All patients at a single tertiary medical center who had radiographic evidence of limited spine metastases not requiring upfront spinal surgery were randomized to receive 16 Gy in SF or 24 Gy in 3 fractions. A posthoc analysis was performed to assess the cumulative incidences and prognostic factors of local progression (LP) and vertebral compression fracture (VCF) by the Fine and Gray competing risk model.
Sixty-three patients (29 with 38 spinal segments in the SF arm and 34 with 41 spinal segments in the MF arm) were analyzed. Median follow-up was 16.6 months. At 4 months, none of the patients in the SF arm and 1 patient in the MF arm experienced protocol-specified grade 3 or higher toxicity. The 1-year cumulative incidence of LP was 2.6% for the SF arm and 4.9% for the MF arm, respectively. The 1-year cumulative incidence of VCF was 7.9% and 10.1% for the SF arm and the MF arm, respectively.
Both single-fraction and multifraction SSRS are safe. There was no difference in cumulative incidence of LP or VCF between 2 dose-fractionation schedules. Single-fraction SSRS is more efficient and provides the most acceptable outcome profile for all assessed endpoints.
立体定向脊柱放射外科手术（SSRS）在治疗局限性脊柱转移瘤方面显示出更好地控制肿瘤和疼痛的潜力。然而，SSRS的最佳方案尚未完全确立，且从未在前瞻性随机试验中进行过研究。
比较两种SSRS方案，以确定哪种方案在4个月时导致3级或更高等级的方案指定不良事件发生率最低。
一项前瞻性随机II期试验。
经活检证实为非血源性恶性肿瘤且有局限性未照射脊柱转移瘤、无需先行脊柱手术的患者符合入选标准。2015年11月至2019年4月期间，69例患者被随机分组，最终共有63例可分析患者，共79个脊柱节段接受治疗。
主要观察指标是根据不良事件通用毒性标准第4.0版（CTCAE）明确、很可能或可能与单次分割或多次分割脊柱SSRS相关的4个月时3级或更高等级的不良事件。
在单一三级医疗中心，所有有影像学证据显示有局限性脊柱转移瘤且无需先行脊柱手术的患者被随机分组，分别接受单次分割16 Gy或3次分割24 Gy的治疗。采用Fine和Gray竞争风险模型进行事后分析，以评估局部进展（LP）和椎体压缩骨折（VCF）的累积发生率及预后因素。
分析了63例患者（单次分割组29例，38个脊柱节段；多次分割组34例，41个脊柱节段）。中位随访时间为16.6个月。4个月时，单次分割组无患者，多次分割组有1例患者发生方案指定的3级或更高等级毒性反应。单次分割组和多次分割组1年LP累积发生率分别为2.6%和4.9%。单次分割组和多次分割组1年VCF累积发生率分别为7.9%和10.1%。
单次分割和多次分割SSRS均安全。两种剂量分割方案在LP或VCF累积发生率方面无差异。单次分割SSRS效率更高，在所有评估终点方面提供了最可接受的结果。
