Dataset related to article "Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform"

This record contains raw data related to article "Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform" Abstract Background: Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A). Methods: Adults patients with 1-4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2-3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS). Results: A total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9-7.4%) in Arm-B, and 9.3% (95% CI 6.2-13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25-1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15-54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9-54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2-32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions: Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2-3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. Trial registration: ClinicalTrials.gov Identifier NCT02355613.

本数据集收录了与题为《实体瘤原发灶有限脑转移瘤的立体定向放射外科治疗：比较专用平台与C型臂直线加速器为基础的治疗方案的III期随机临床试验（NCT02355613）结果》的文章相关的原始数据。摘要背景：目前尚无针对实体瘤脑转移瘤（Brain Metastases, BMs）的不同立体定向放射外科（Stereotactic Radiosurgery, SRS）治疗方案的前瞻性对比数据。本研究依托单一研究中心开展III期随机临床试验，旨在对比以直线加速器（Linear Accelerator, Linac）实施的SRS（B组）与专用多源伽马射线立体定向治疗平台（A组）的疗效优劣。方法：将1~4枚最大直径不超过30mm的实体瘤脑转移瘤成年患者随机分配至A、B两组。本研究的主要终点为有症状（2~3级）放射性坏死（Radionecrosis, RN）的累积发生率（CIRN）；次要终点包括局部进展累积发生率（CILP）、脑远处失败、无病生存期（Disease-Free Survival, DFS）及总生存期（Overall Survival, OS）。结果：共计251例患者被随机分配至A组（121例）与B组（130例）。全队列的1年放射性坏死累积发生率为6.7%，其中B组为3.8%（95%置信区间[CI] 1.9%~7.4%），A组为9.3%（95%CI 6.2%~13.8%，p=0.43）。仅在A组中，靶区照射体积对CIRN存在显著影响（p << 0.001；风险比[HR] 1.36，95%CI 1.25~1.48）。共计56例患者出现症状性放射性坏死，中位出现时间为10.3个月（范围1.15~54.8个月）；其中B组27例，中位出现时间15.9个月（范围4.9~54.8个月），A组29例，中位出现时间6.9个月（范围1.2~32.3个月），两组间差异无统计学意义。两组在局部进展累积发生率、脑远处失败、无病生存期及总生存期方面均无统计学差异。A组实施SRS的平均束流照射时间为49.0±36.2分钟，B组为3.1±1.6分钟。结论：鉴于本单中心研究中两种治疗平台的技术差异，在小体积有限脑转移瘤患者群体中，以直线加速器为基础的SRS（B组）并未较多源伽马射线治疗系统（A组）显著降低2~3级放射性坏死的发生率。两组的局部控制效果无显著差异。B组的治疗实施时间显著短于A组。试验注册：本试验已在ClinicalTrials.gov注册，注册号为NCT02355613。