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使用Leksell伽玛刀Icon面罩系统对转移性脑肿瘤进行立体定向放射治疗的倾向评分匹配分析:一项关于符合和不符合JLGK0901标准病例的单中心回顾性对照研究。

A propensity score-matched analysis of stereotactic radiotherapy for metastatic brain tumors using the Leksell Gamma Knife Icon Mask system: a single-center retrospective comparative study of cases meeting and not meeting the JLGK0901 Criteria.

作者信息

Oi Yuta, Kawabe Takuya, Ogawa Takahiro, Taniyama Ichita, Yamanaka Takumi, Takahashi Yoshinobu, Sato Manabu, Hashimoto Naoya

机构信息

1Department of Neurosurgery, National Hospital Organization Maizuru Medical Center, Maizuru.

3Department of Neurosurgery, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.

出版信息

J Neurosurg. 2025 May 9;143(3):829-838. doi: 10.3171/2025.1.JNS242424. Print 2025 Sep 1.

Abstract

OBJECTIVE

Stereotactic radiosurgery (SRS) for metastatic brain tumors (METs) has previously been considered to be indicated only for cases with a few lesions with small sizes. Expansion of the indication of SRS for METs is mainly due to the JLGK0901 study. Furthermore, since introduction of Leksell Gamma Knife Icon system, both single-irradiation SRS and fractionated irradiation (stereotactic radiotherapy) have become possible using a mask fixation system. The purpose of this study was to evaluate the authors' own institutional experience in order to re-examine the limitations on the number and volume of lesions established in the JLGK0901 study.

METHODS

The study period was 6.5 years from the start of operations using the Leksell Gamma Knife Icon system at Rakusai Shimizu Hospital (September 2017 to February 2024). A retrospective study was conducted on 1043 patients who had undergone initial treatment with Gamma Knife Icon and had at least one posttreatment follow-up report. A comparison was made between cases that did (group A) and did not (group B, extended indication) meet the JLGK0901 criteria. Propensity score matching (PSM) was used to establish matched cases. Neurological death was the primary endpoint. Functional outcomes, imaging changes, and overall survival were secondary endpoints.

RESULTS

Of 1043 cases with newly diagnosed brain metastases treated with Gamma Knife Icon radiotherapy (GKRT) at Rakusai Shimizu Hospital, 673 (64.5%) were in group A and 370 (35.5%) in group B. PSM selected 321 cases in each group. The median survival time after GKRT was shorter in group B (19.7 vs 10.6 months, p < 0.01), but the incidence of neurological death did not differ significantly between the two groups (p = 0.635). There were also no significant differences in the rates of poor local control (p = 0.381), new distant intracranial lesions (imaging changes) (p = 0.925), neurological deterioration (p = 0.738), and severe radiation-induced adverse events (functional outcomes) (p = 0.994). Subgroup analysis of patients in group B with more than the allowed number of metastases or a greater tumor volume than that allowed in the JLGK0901 study showed no significant differences in neurological death and functional outcomes compared to group A for both subgroups.

CONCLUSIONS

The results support expansion of the indication for Leksell Gamma Knife Icon for METs from that in JLGK0901 based on the absence of the influence of the number of metastases and tumor volume on outcomes.

摘要

目的

立体定向放射外科治疗(SRS)转移性脑肿瘤(METs)以前被认为仅适用于少数小病灶病例。SRS治疗METs适应证的扩大主要归因于JLGK0901研究。此外,自从引进Leksell伽玛刀Icon系统以来,使用面罩固定系统既可以进行单次照射SRS,也可以进行分次照射(立体定向放射治疗)。本研究的目的是评估作者所在机构的经验,以便重新审视JLGK0901研究中确定的病灶数量和体积的限制。

方法

研究时间段为清水洛西医院开始使用Leksell伽玛刀Icon系统进行手术起的6.5年(2017年9月至2024年2月)。对1043例接受伽玛刀Icon初始治疗且至少有一份治疗后随访报告的患者进行回顾性研究。比较符合(A组)和不符合(B组,扩大适应证)JLGK0901标准的病例。采用倾向评分匹配(PSM)来建立匹配病例。神经源性死亡是主要终点。功能结局、影像学变化和总生存期是次要终点。

结果

在清水洛西医院接受伽玛刀Icon放射治疗(GKRT)的1043例新诊断脑转移瘤病例中,673例(64.5%)属于A组,370例(35.5%)属于B组。PSM在每组中选择了321例病例。GKRT后的中位生存时间在B组较短(19.7个月对10.6个月,p<0.01),但两组间神经源性死亡的发生率无显著差异(p=0.635)。局部控制不佳率(p=0.381)、新的远处颅内病灶(影像学变化)(p=0.925)、神经功能恶化(p=0.738)和严重放射性不良事件(功能结局)(p=0.994)也无显著差异。对B组中转移灶数量超过允许数量或肿瘤体积大于JLGK0901研究中允许体积的患者进行亚组分析,结果显示两个亚组与A组相比在神经源性死亡和功能结局方面均无显著差异。

结论

基于转移灶数量和肿瘤体积对结局无影响的结果,支持将Leksell伽玛刀Icon治疗METs的适应证从JLGK0901研究中的适应证进行扩大。

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