University Hospital of Heidelberg, Department of Radiation Oncology, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany.
Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, USA.
Radiother Oncol. 2018 Aug;128(2):274-282. doi: 10.1016/j.radonc.2018.04.030. Epub 2018 May 26.
To report the primary endpoint of a randomized trial comparing pain response following palliative stereotactic body radiation therapy (SBRT) versus conventionally-fractionated 3D-conformal radiotherapy (3DCRT) for previously untreated spinal metastases.
Fifty-five patients with histologically/radiologically confirmed painful spinal metastases were analyzed in this single-institutional, non-blinded, randomized explorative trial. Participants were randomly assigned (1:1) to receive single-fraction SBRT (24 Gy) or 3DCRT (30 Gy in 10 fractions). The primary endpoint was pain relief of >2 points on the visual analog scale (VAS) measured within the irradiated region at 3 months following radiotherapy completion. Other recorded parameters included pain response (per International Bone Consensus response definitions), use of concurrent medications and opioid usage (oral morphine equivalent dose, OMED). All parameters were assessed at baseline and at three and six months after RT. Intention-to-treat analysis was applied. This trial is registered with ClinicalTrials.gov, number NCT02358720.
Despite no significant differences for VAS at 3 months between groups (p = 0.13), pain values decreased faster within this time period in the SBRT arm (p = 0.01). At 6 months following RT, significantly lower VAS values were reported in the SBRT group (p = 0.002). There were no differences in OMED consumption at 3 (p = 0.761) and 6 months (p = 0.174). There was a trend toward improved pain response in the SBRT arm at 3 months (p = 0.057), but significantly so after 6 months (p = 0.003). No patient in the SBRT group experienced grade ≥3 toxicities according to the Common Terminology Criteria for Adverse Events v.4.03.
This randomized trial demonstrates the utility of palliative SBRT for spinal metastases, which was associated with a quicker and improved pain response. Larger ongoing randomized studies will assist in further addressing these endpoints.
报告一项随机试验的主要终点，该试验比较了未经治疗的脊柱转移瘤患者接受姑息性立体定向体放射治疗（SBRT）与常规分割三维适形放疗（3DCRT）后的疼痛反应。
在这项单机构、非盲、随机探索性试验中，对 55 例经组织学/影像学证实的有疼痛性脊柱转移瘤患者进行了分析。参与者被随机分配（1:1）接受单次 SBRT（24Gy）或 3DCRT（30Gy 分 10 次）。主要终点是放疗完成后 3 个月内照射区域内视觉模拟量表（VAS）上疼痛缓解>2 分。其他记录的参数包括疼痛反应（根据国际骨骼共识反应定义）、同时使用的药物和阿片类药物使用（口服吗啡等效剂量，OMED）。所有参数均在基线和放疗后 3 个月和 6 个月进行评估。采用意向治疗分析。该试验在 ClinicalTrials.gov 注册，编号为 NCT02358720。
尽管两组在 3 个月时 VAS 无显著差异（p=0.13），但 SBRT 组在此期间疼痛值下降更快（p=0.01）。在放疗后 6 个月时，SBRT 组的 VAS 值显著较低（p=0.002）。3 个月（p=0.761）和 6 个月（p=0.174）时 OMED 消耗无差异。SBRT 组在 3 个月时疼痛反应有改善趋势（p=0.057），但在 6 个月时差异显著（p=0.003）。根据不良事件通用术语标准 v.4.03，SBRT 组无患者出现≥3 级毒性。
这项随机试验证明了姑息性 SBRT 治疗脊柱转移瘤的有效性，它与更快和更好的疼痛反应相关。更大规模的正在进行的随机研究将有助于进一步解决这些终点。
