Therapy, Safety, and Logistics of Preoperative vs Postoperative Stereotactic Radiation Therapy: A Preliminary Analysis of a Randomized Clinical Trial.

Background

To determine preoperative SRT logistics and safety profile compared with postoperative in patients with brain metastases.

确定与术后相比，脑转移患者术前SRT的后勤和安全性特征。

DESIGN, SETTING, AND PARTICIPANTS: This single-institution phase 3 randomized clinical trial included patients 18 years and older and undergoing a planned surgical resection.

设计、场所和参与者：这是一项单机构的III期随机临床试验，包括18岁及以上的计划接受手术切除的患者。

Patients were required to have an Eastern Cooperative Oncology Group Performance Status score of 2 or greater and be candidates for SRT within 30 days of surgical resection.

患者必须具有东方肿瘤协作组表现状态评分2分或以上，并且在手术切除后30天内有立体定向放射治疗（SRT）的候选人资格。

Patients with radiosensitive histologies (eg, small cell lung cancer and lymphoma), brain metastasis of unknown primary, and/or radiographic evidence of leptomeningeal disease were excluded.

排除了具有放射敏感组织学特征的患者（例如，小细胞肺癌和淋巴瘤）、未知原发部位的脑转移和/或放射影像学证据显示的软脑膜疾病。

Data were collected from December 2018 to August 2023, and data were analyzed from September 2023 to December 2024.

数据收集时间为2018年12月至2023年8月，数据分析时间为2023年9月至2024年12月。

Methods

Patients were randomized 1:1.

患者按1:1的比例随机分组。

Patients randomized to the preoperative SRT cohort underwent SRT (in 1 to 5 fractions) followed by surgical resection within 1 month of radiation therapy.

被随机分配到术前立体定向放射治疗(SRT)队列的患者接受了SRT治疗（1至5次分割），并在放射治疗后1个月内进行了手术切除。

Patients randomized to the postoperative SRT cohort underwent resection followed by postoperative SRT within 1 month of surgery.

被随机分配到术后SRT队列的患者在手术后1个月内接受了手术切除并进行了术后SRT。

main_outcomes_and_measures

Outcomes reported focus on nonprimary end point analysis of the trial, including comparative toxic effect outcomes of preoperative vs postoperative SRT postprocedural events, feasibility of preoperative SRT, and radiation therapy management.

报告的结果侧重于试验的非主要终点分析，包括术前与术后SRT的比较毒性效应结果、术后事件、术前SRT的可行性以及放射治疗管理。

Results

Of 103 patients, 56 (54.4%) were male, and the median (range) age was 59 (26-83) years.

在103名患者中，56名（54.4%）为男性，中位年龄为59岁（范围26-83岁）。

Of 103 patients, 83 (80.6%) completed both radiation and surgery for brain metastases while in the study.

在103名患者中，有83名（80.6%）在研究期间完成了对脑转移瘤的放射治疗和手术。

Of these, 70 patients (84%) had 1 to 4 brain metastases at enrollment, 11 (13%) had 5 to 10 lesions, and 2 (2%) had more than 10 lesions.

在这些患者中，70名（84%）在入组时有1到4个脑转移瘤，11名（13%）有5到10个病灶，另外2名（2%）有超过10个病灶。

In the preoperative stereotactic radiosurgery (SRS)/SRT cohort, 45 (88%) completed both treatments compared with 38 (73%) in the postoperative SRS/SRT arm.

在术前立体定向放射外科（SRS）/立体定向放射治疗（SRT）队列中，45名（88%）患者完成了两种治疗，而在术后SRS/SRT组中，有38名（73%）患者完成了治疗。

There were no statistically significant differences between treatment groups in 30-day postoperative morbidity or postprocedural events.

在治疗组之间，30天术后发病率或术后事件没有统计学上的显著差异。

The median (range) time between surgery and SRT was significantly shorter in the preoperative arm (6 [0-24] days) compared with the postoperative arm (22 [12-42] days; P < .001).

手术与立体定向放疗(SRT)之间的时间中位数（范围）在术前组显著短于术后组（6 [0-24] 天对比 22 [12-42] 天；P < .001）。

The median (range) time from randomization to receiving both brain-directed therapies was 10 (4-31) days in the preoperative arm compared with 32.5 (19-55) days for the postoperative arm (P < .001).

在这项随机临床试验中，术前立体定向放射治疗（SRT）的安全性与术后SRT相当，并且治疗完成时间更短，可能有助于加快护理流程。

conclusions_and_relevance

In this randomized clinical trial, preoperative SRT had comparable safety to postoperative SRT and resulted in shorter time to treatment completion, potentially facilitating expedited care.

在这项随机临床试验中，术前SRT（立体定向放射治疗）与术后SRT的安全性相当，并且治疗完成时间更短，可能有助于加速治疗流程。

trial_registration

ClinicalTrials.gov Identifier: NCT03741673.

临床试验注册号：NCT03741673。