立体定向放射外科治疗 1-10 个脑转移瘤以避免全脑放射治疗 - CYBER-SPACE 随机 2 期试验的结果。
Stereotactic Radiosurgery for 1-10 Brain Metastases to avoid Whole-Brain Radiotherapy - Results of the CYBER-SPACE Randomized Phase 2 Trial.
发表日期：2024 Sep 28
作者：
Rami A El Shafie, Denise Bernhardt, Thomas Welzel, Annabella Schiele, Daniela Schmitt, Paul Thalmann, Sinem Erdem, Angela Paul, Simon Höne, Kristin Lang, Laila König, Fabian Weykamp, Sebastian Adeberg, Adriane Lentz-Hommertgen, Cornelia Jäkel, Farastuk Bozorgmehr, Ursula Nestle, Michael Thomas, Anja Sander, Meinhard Kieser, Jürgen Debus, Stefan Rieken
来源：
NEURO-ONCOLOGY
摘要：
立体定向放射外科 (SRS) 是全脑放射治疗 (WBRT) 的一种新兴替代方案，用于治疗多发性脑转移瘤 (BM)、降低毒性并改善肿瘤控制。 CYBER-SPACE 试验比较了基于 SPACE 或 MPRAGE MRI 序列的 SRS 以避免或延迟 1-10 BM 患者的 WBRT。具有 1-10 未治疗 BM 的患者被随机以 1:1 的比例接受基于任一 SPACE 的所有病变的 SRS或 MPRAGE MRI 序列。如果随后出现新的 BM，则重复 SRS。当出现 >10 个新的 BM、软脑膜疾病或 SRS 放射耐受耗尽时，需要进行 WBRT。主要结局是摆脱 WBRT 指征 (WBRTi)。次要结局包括总生存期 (OS)、安全性和生活质量。202 名患者被随机分组；空间 n=99，MPRAGE n=103。 12 个月无 WBRTi 生存率为 77.1%（95%-CI：69.5%-83.1%），SPACE 为 78.5%（95%-CI：66.7%-86.5%），76.0%（95%-CI：69.5%-CI：66.7%-86.5%）。 MPRAGE 为 65.2%-83.9%）（HR=0.84，95%-CI：0.43-1.63，p=0.590）。 BM 5-10 次的患者无 WBRTi 生存期较短（HR=3.13，95%-CI：1.53-6.40，p=0.002）。总体中位 OS 为 13.1 个月，SPACE 为 10.5 个月，MPRAGE 为 15.2 个月（HR=1.10，95%-CI：0.78-1.56，p=0.585）。神经系统死亡率为10.1%。较长 OS 的预测因子包括卡诺夫斯基表现状态 >80%（HR=0.51，95%-CI：0.33-0.77，p=0.002）和同步免疫治疗（HR=0.34，95%-CI：0.23-0.52，p<0.001） .更敏感的 SPACE 序列并没有比 MPRAGE 改善结果。 SRS 对新病灶进行彻底监测和立即再治疗可减少 WBRT 的需求，并实现较低的神经系统死亡率。对于 1-10 BM 的患者，SRS 应被视为 WBRT 的有利替代方案。© 作者 2024。由牛津大学出版社代表神经肿瘤学会出版。
Stereotactic Radiosurgery (SRS) is an emerging alternative to whole-brain radiotherapy (WBRT) for treating multiple brain metastases (BM), reducing toxicity and improving tumor control. The CYBER-SPACE trial compared SRS based on either SPACE or MPRAGE MRI sequence for avoiding or delaying WBRT in patients with 1-10 BM.Patients with 1-10 untreated BM were randomized 1:1 to receive SRS of all lesions based on either SPACE or MPRAGE MRI sequences. If subsequently new BM occurred, SRS was repeated. WBRT was indicated upon occurrence of >10 new BM, leptomeningeal disease or exhausted SRS-radiotolerance. The primary outcome was freedom from WBRT indication (WBRTi). Secondary outcomes included overall survival (OS), safety, and quality of life.202 patients were randomized; SPACE n=99, MPRAGE n=103. 12-month WBRTi-free survival was 77.1% (95%-CI: 69.5%-83.1%) overall, 78.5% (95%-CI: 66.7%-86.5%) for SPACE, and 76.0% (95%-CI: 65.2%-83.9%) for MPRAGE (HR=0.84, 95%-CI: 0.43-1.63, p=0.590). Patients with 5-10 BM had shorter WBRTi-free survival (HR=3.13, 95%-CI: 1.53-6.40, p=0.002). Median OS was 13.1 months overall, 10.5 months for SPACE, and 15.2 months for MPRAGE (HR=1.10, 95%-CI: 0.78-1.56, p=0.585). Neurologic death rate was 10.1%. Predictors for longer OS included Karnofsky Performance Status >80% (HR=0.51, 95%-CI: 0.33-0.77, p=0.002) and concurrent immunotherapy (HR=0.34, 95%-CI: 0.23-0.52, p<0.001).The more sensitive SPACE sequence did not improve outcomes over MPRAGE. SRS with thorough monitoring and immediate re-treatment for new lesions decreases the need for WBRT and achieves low neurologic death rates. SRS should be considered a favorable alternative to WBRT for patients with 1-10 BM.© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Neuro-Oncology.