Treatment for Brain Metastases With Stereotactic Radiation vs Hippocampal-Avoidance Whole Brain Radiation: A Randomized Clinical Trial.

Among patients with more than 4 brain metastases, the effects of stereotactic radiation targeting only individual tumors, compared with whole brain radiation with hippocampal avoidance, which radiates both tumors and normal brain, remain unknown.

在有超过4个脑转移的患者中，仅针对个别肿瘤的立体定向放射治疗与全脑放射治疗加海马回避的疗效相比，仍然未知。

Background

To determine whether stereotactic radiation improves symptom severity and interference with daily functioning, compared with whole brain radiation with hippocampal avoidance.

确定立体定向放射治疗是否比全脑放射治疗结合海马回避更能改善症状严重程度和日常生活功能的干扰。

DESIGN, SETTING, AND PARTICIPANTS: Phase 3, open-label, randomized clinical trial conducted at 4 United States-based centers.

设计、场所和参与者：在美国四个中心进行的第三阶段、开放标签、随机临床试验。

Eligible patients had 5 to 20 brain metastases and no prior brain-directed radiation.

符合条件的患者有5到20个脑转移瘤，且之前没有接受过针对脑部的放射治疗。

Enrollment occurred between April 11, 2017, and May 17, 2024 (final follow-up, March 18, 2025).

招募工作从2017年4月11日开始，至2024年5月17日结束（最终随访时间为2025年3月18日）。

intervention

Stereotactic radiation, compared with whole brain radiation with hippocampal avoidance.

立体定向放射治疗与全脑放射治疗配合海马回避的比较。

main_outcomes_and_measures

Mean weighted patient-reported symptom severity and interference score change over 6 months postbaseline relative to baseline using the MD Anderson Symptom Inventory-Brain Tumor instrument (scale, 0-10; score change range, -10 to 10; -10 = best).

使用MD安德森症状清单-脑肿瘤工具（量表，0-10；得分变化范围，-10至10；-10为最佳）评估患者自基线后6个月内的症状严重程度和干扰得分的平均加权变化相对于基线。

A clinically meaningful Δ was defined as 0.98.

临床意义上的Δ被定义为0.98。

Results

Of 196 randomized patients (mean age, 61 years; 129 [66%] female; 176 [90%] White; median number of brain metastases, 14 [IQR, 11-18]; 49 [25%] with prior neurosurgical resection), 83 (42%) completed the 6-month assessment.

在196名随机患者中（平均年龄61岁；129名[66%]为女性；176名[90%]为白人；脑转移的中位数为14个[IQR, 11-18]；49名[25%]有先前的神经外科切除史），有83名（42%）完成了6个月的评估。

For the primary outcome, between baseline and postbaseline assessments through the 6-month follow-up, stereotactic radiation changed the weighted composite MD Anderson Symptom Inventory-Brain Tumor score from 2.69 to 2.37 (mean change, -0.32) and hippocampal-avoidance whole brain radiation changed the score from 2.29 to 3.03 (mean change, 0.74) (mean difference, -1.06 [95% CI, -1.54 to -0.58]; P < .001).

主要结果方面，从基线到6个月随访期间的基线后评估，立体定向放射治疗将MD安德森症状清单-脑肿瘤加权综合评分从2.69改变至2.37（平均变化量，-0.32），而海马回避全脑放射治疗将评分从2.29改变至3.03（平均变化量，0.74）（平均差异，-1.06 [95% 置信区间，-1.54至-0.58]；P < .001）。

Related grade 3-5 adverse events occurred in 12 patients (12%) in the stereotactic radiation group and 13 patients (13%) in the hippocampal-avoidance whole brain radiation group; grade 1-3 fatigue was most frequent (27 [28%] vs 43 [44%], respectively).

在立体定向放射治疗组中，有12名患者（12%）发生了与之相关的3-5级不良事件，在海马回避全脑放射治疗组中，有13名患者（13%）发生了相关不良事件；1-3级疲劳是最常见的不良事件（分别为27名患者[28%]和43名患者[44%]）。

conclusions_and_relevance

In patients with 5 to 20 brain metastases, these findings support stereotactic radiation over hippocampal-avoidance whole brain radiation to improve symptoms and interference with daily functioning, key components of quality of life.

在5至20个脑转移的患者中，这些结果支持使用立体定向放射治疗而非海马回避全脑放射治疗，以改善症状和日常生活功能的干扰，这是生活质量的关键组成部分。

trial_registration

ClinicalTrials.gov Identifier: NCT03075072.

ClinicalTrials.gov 注册号：NCT03075072。