Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Zurich, Switzerland; Department of Radiation Oncology, University Hospital Wuerzburg, Wuerzburg, Germany.
Department of Radiation Oncology, University Hospital Wuerzburg, Wuerzburg, Germany.
Int J Radiat Oncol Biol Phys. 2021 Jun 1;110(2):348-357. doi: 10.1016/j.ijrobp.2020.12.045. Epub 2021 Jan 4.
To report long-term outcome of fractionated stereotactic body radiation therapy (SBRT) for painful spinal metastases.
This prospective, single-arm, multicenter phase 2 clinical trial enrolled 57 patients with 63 painful, unirradiated spinal metastases between March 2012 and July 2015. Patients were treated with 48.5 Gy in 10 SBRT fractions (long life expectancy [Mizumoto score ≤4]) or 35 Gy in 5 SBRT fractions (intermediate life expectancy [Mizumoto score 5-9]). Pain response was defined as pain improvement of a minimum of 2 points on a visual analog scale, and net pain relief was defined as the sum of time with pain response (complete and partial) divided by the overall follow-up time.
All 57 patients received treatment per protocol; 32 and 25 patients were treated with 10- and 5-fraction SBRT, respectively. The median follow-up of living patients was 60 months (range, 33-74 months). Of evaluable patients, 82% had complete or partial pain response (responders) at 3 months' follow-up (primary endpoint), and pain response remained stable over 5 years. Net pain relief was 74% (95% CI, 65%-80%). Overall survival rates of 1, 3, and 5 years were 59.6% (95% CI, 47%-72%), 33.3% (95% CI, 21%-46%), and 21% (95% CI, 10%-32%), respectively. Freedom from local spinal-metastasis progression was 82% at the last imaging follow-up. Late grade-3 toxicity was limited to pain in 2 patients (nonresponders). There were no cases of myelopathy. SBRT resulted in long-term improvements of all dimensions of the 5-level EuroQol 5-Dimension Questionnaire except anxiety/depression.
Fractionated SBRT achieved durable pain response and improved quality of life at minimum late toxicity.
报告分次立体定向体部放射治疗（SBRT）治疗疼痛性脊柱转移瘤的长期结果。
这是一项前瞻性、单臂、多中心的 2 期临床试验，纳入了 2012 年 3 月至 2015 年 7 月期间的 57 例 63 处疼痛性、未经放疗的脊柱转移瘤患者。患者接受 48.5Gy 的 10 次 SBRT 分割治疗（长预期寿命[Mizumoto 评分≤4]）或 35Gy 的 5 次 SBRT 分割治疗（中预期寿命[Mizumoto 评分 5-9]）。疼痛缓解定义为视觉模拟量表上至少 2 分的疼痛改善，净疼痛缓解定义为疼痛缓解时间（完全和部分）总和除以总随访时间。
所有 57 例患者均按方案接受治疗；32 例和 25 例患者分别接受 10 次和 5 次 SBRT 治疗。存活患者的中位随访时间为 60 个月（范围，33-74 个月）。可评估患者中，82%在 3 个月随访时（主要终点）有完全或部分疼痛缓解（缓解者），且疼痛缓解在 5 年内保持稳定。净疼痛缓解率为 74%（95%CI，65%-80%）。1、3、5 年的总生存率分别为 59.6%（95%CI，47%-72%）、33.3%（95%CI，21%-46%）和 21%（95%CI，10%-32%）。最后一次影像学随访时，局部脊柱转移瘤进展无进展率为 82%。晚期 3 级毒性仅限于 2 例患者（无缓解者）的疼痛。无脊髓病病例。SBRT 可长期改善欧洲五维健康量表 5 维度问卷的所有维度，除焦虑/抑郁外。
分次 SBRT 可达到持久的疼痛缓解和提高生活质量，且毒性最小。
