Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany; Department of Radiation Oncology, University Hospital Tübingen, Tübingen, Germany.
Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany.
Radiother Oncol. 2023 Sep;186:109744. doi: 10.1016/j.radonc.2023.109744. Epub 2023 Jun 15.
There is no randomized evidence comparing whole-brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS) in the treatment of multiple brain metastases. This prospective nonrandomized controlled single arm trial attempts to reduce the gap until prospective randomized controlled trial results are available.
We included patients with 4-10 brain metastases and ECOG performance status ≤ 2 from all histologies except small-cell lung cancer, germ cell tumors, and lymphoma. The retrospective WBRT-cohort was selected 2:1 from consecutive patients treated within 2012-2017. Propensity-score matching was performed to adjust for confounding factors such as sex, age, primary tumor histology, dsGPA score, and systemic therapy. SRS was performed using a LINAC-based single-isocenter technique employing prescription doses from 15-20Gyx1 at the 80% isodose line. The historical control consisted of equivalent WBRT dose regimens of either 3Gyx10 or 2.5Gyx14.
Patients were recruited from 2017-2020, end of follow-up was July 1st, 2021. 40 patients were recruited to the SRS-cohort and 70 patients were eligible as controls in the WBRT-cohort. Median OS, and iPFS were 10.4 months (95%-CI 9.3-NA) and 7.1 months (95%-CI 3.9-14.2) for the SRS-cohort, and 6.5 months (95%-CI 4.9-10.4), and 5.9 months (95%-CI 4.1-8.8) for the WBRT-cohort, respectively. Differences were non-significant for OS (HR: 0.65; 95%-CI 0.40-1.05; P =.074) and iPFS (P =.28). No grade III toxicities were observed in the SRS-cohort.
This trial did not meet its primary endpoint as the OS-improvement of SRS compared to WBRT was non-significant and thus superiority could not be proven. Prospective randomized trials in the era of immunotherapy and targeted therapies are warranted.
在治疗多发性脑转移瘤方面，尚无比较全脑放疗（WBRT）和立体定向放疗（SRS）的随机证据。本前瞻性非随机对照单臂试验旨在缩小差距，直到获得前瞻性随机对照试验结果。
我们纳入了来自除小细胞肺癌、生殖细胞瘤和淋巴瘤以外的所有组织学类型的 4-10 个脑转移瘤和 ECOG 表现状态≤2 的患者。回顾性 WBRT 队列是从 2012 年至 2017 年连续治疗的患者中按 2:1 比例选择的。采用倾向评分匹配来调整性别、年龄、原发肿瘤组织学、dsGPA 评分和全身治疗等混杂因素。SRS 采用基于 LINAC 的单中心技术，采用 15-20Gy x1 的处方剂量，在 80%等剂量线上。历史对照由等效的 WBRT 剂量方案组成，分别为 3Gy x10 或 2.5Gy x14。
患者于 2017 年至 2020 年入组，随访截止日期为 2021 年 7 月 1 日。SRS 队列纳入 40 例患者，WBRT 队列纳入 70 例符合条件的患者作为对照。SRS 队列的中位 OS 和 iPFS 分别为 10.4 个月（95%CI 9.3-NA）和 7.1 个月（95%CI 3.9-14.2），WBRT 队列的中位 OS 和 iPFS 分别为 6.5 个月（95%CI 4.9-10.4）和 5.9 个月（95%CI 4.1-8.8）。OS（HR：0.65；95%CI 0.40-1.05；P=0.074）和 iPFS（P=0.28）差异无统计学意义。SRS 队列未观察到 3 级毒性。
本试验未达到主要终点，因为与 WBRT 相比，SRS 的 OS 改善无统计学意义，因此不能证明其优越性。在免疫治疗和靶向治疗时代，需要进行前瞻性随机试验。
