Yeboa Debra Nana, Li Jing, Lin Ruitao, Prabhu Sujit S, Beckham Thomas H, Woodhouse Kristina, Swanson Todd Allen, Weinberg Jeffrey S, Wang Xuemei, Chi Xiaohan, Ejezie Chinenye Lynette, Suki Dima, Wang Chenyang, Ene Chibawanye, McCutcheon Ian E, McGovern Susan, McAleer Mary Frances, Tom Martin, Ghia Amol, Perni Subha, Jiang Wen, De Brian, Chung Caroline, Kim Betty Y S, O'Brien Barbara J, Huse Jason T, Wefel Jeffrey S, Court Laurence, Tawbi Hussein, Janku Filip, Guha-Thakurta Nandita, Debnam J Matthew, Johnson Jason, Taslicay Ceylan Altintas, Alvarez-Breckenridge Christopher, Raza Shaan M, Heimberger Amy B, DeMonte Franco, North Robert, Briere Tina M, de Groot John F, Sawaya Raymond, Grosshans David, Lang Frederick F, Rao Ganesh, Ferguson Sherise D
University of Texas MD Anderson Cancer Center, Houston.
Merck & Co, Upper Gywnedd, Pennsylvania.
JAMA Oncol. 2025 Jun 18. doi: 10.1001/jamaoncol.2025.1770.
Preoperative stereotactic radiation therapy (SRT) vs postoperative SRT logistics and toxic effects provides clinically significant data on management outcomes.
To determine preoperative SRT logistics and safety profile compared with postoperative in patients with brain metastases.
DESIGN, SETTING, AND PARTICIPANTS: This single-institution phase 3 randomized clinical trial included patients 18 years and older and undergoing a planned surgical resection. 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. 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. Data were collected from December 2018 to August 2023, and data were analyzed from September 2023 to December 2024.
Patients were randomized 1:1. Patients randomized to the preoperative SRT cohort underwent SRT (in 1 to 5 fractions) followed by surgical resection within 1 month of radiation therapy. Patients randomized to the postoperative SRT cohort underwent resection followed by postoperative SRT within 1 month of surgery.
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.
Of 103 patients, 56 (54.4%) were male, and the median (range) age was 59 (26-83) years. Of 103 patients, 83 (80.6%) completed both radiation and surgery for brain metastases while in the study. 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. In the preoperative stereotactic radiosurgery (SRS)/SRT cohort, 45 (88%) completed both treatments compared with 38 (73%) in the postoperative SRS/SRT arm. There were no statistically significant differences between treatment groups in 30-day postoperative morbidity or postprocedural events. 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). 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).
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.
ClinicalTrials.gov Identifier: NCT03741673.
术前立体定向放射治疗（SRT）与术后SRT的后勤保障及毒性作用为管理结果提供了具有临床意义的数据。
确定脑转移瘤患者术前SRT与术后SRT相比的后勤保障及安全性。
设计、地点和参与者：这项单机构3期随机临床试验纳入了18岁及以上且计划进行手术切除的患者。患者东部肿瘤协作组体能状态评分为2分或更高，且在手术切除后30天内适合接受SRT。排除具有放射敏感性组织学类型（如小细胞肺癌和淋巴瘤）、原发灶不明的脑转移瘤以及/或软脑膜疾病影像学证据的患者。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。
患者按1:1随机分组。随机分配至术前SRT组的患者先接受SRT（分1至5次），然后在放疗后1个月内进行手术切除。随机分配至术后SRT组的患者先进行切除，然后在术后1个月内接受术后SRT。
报告的结局聚焦于该试验的非主要终点分析，包括术前与术后SRT术后事件的比较毒性效应结局、术前SRT的可行性以及放射治疗管理。
103例患者中，56例（54.4%）为男性，中位（范围）年龄为59（26 - 83）岁。103例患者中，83例（80.6%）在研究期间完成了脑转移瘤的放疗和手术。其中，70例患者（84%）入组时患有1至4个脑转移瘤，11例（13%）有5至10个病灶，2例（2%）有超过10个病灶。在术前立体定向放射外科（SRS）/SRT组中，45例（88%）完成了两种治疗，而术后SRS/SRT组为38例（73%）。治疗组之间在术后30天发病率或术后事件方面无统计学显著差异。术前组手术与SRT之间的中位（范围）时间（6 [0 - 24]天）显著短于术后组（22 [12 - 42]天；P < .001）。术前组从随机分组到接受两种脑靶向治疗的中位（范围）时间为10（4 - 31）天，而术后组为32.5（19 - 55）天（P < .001）。
在这项随机临床试验中，术前SRT与术后SRT安全性相当，且治疗完成时间更短，可能有助于加快治疗进程。
ClinicalTrials.gov标识符：NCT03741673。
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