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Zap-X放射外科手术系统:复发性伽玛刀病例系列的初步临床经验。

Zap-X Radiosurgery System: Initial Clinical Experience in a Recurrent Gamma Knife Case Series.

作者信息

Horiba Ayako, Hayashi Motohiro, Maruyama Takashi, Nomura Ryutaro, Kim Phyo, Kawamata Takakazu

机构信息

Department of Neurosurgery, Tokyo Women's Medical University, Tokyo, JPN.

Department of Neurosurgery, Utsunomiya Brain and Spine Center, Utsunomiya, JPN.

出版信息

Cureus. 2024 Nov 19;16(11):e74005. doi: 10.7759/cureus.74005. eCollection 2024 Nov.

Abstract

INTRODUCTION

The ZAP-X® Gyroscopic Radiosurgery System (ZAP Surgical Systems, Inc., San Carlos, CA, USA) is expected to be a highly accurate next-generation treatment system that enables gyro-stereotactic irradiation of intracranial lesions. In this study, we report the initial treatment course using ZAP-X for intracranial lesions that recurred after Gamma Knife (GK) treatment.

METHODS

Patients with intracranial tumors treated with ZAP-X from April to August 2023 who relapsed after GK therapy were eligible for participating in this study. The primary endpoint was the progression control rate at six months; the secondary endpoints were the rate of target lesion reduction, treatment effect by tumor doubling time (TDT) before ZAP-X intervention, and adverse events.

RESULTS

Six lesions were evaluated in six patients (two meningiomas, one solitary fibrous tumor, one auditory neuroma, one glomus tumor, and one metastatic tumor). The mean follow-up period was 10.6 months after treatment. The mean lesion volume was 5.3 cm; the mean TDT was 241 days. The six-month progression control rate was 100%, with two partial responses and four stable diseases at the last evaluation. Adverse events were limited to only imaging changes in one patient (16.6%), indicating a significant correlation between ZAP-X pre-intervention TDT and post-intervention reduction rate.

CONCLUSIONS

The initial results of ZAP-X treatment in patients with recurrent disease following GK are reported for the first time. ZAP-X demonstrated potent anti-tumor efficacy and adequate tolerability and should be considered a new treatment option for relapsed refractory patients. Future studies should increase the number of cases and follow-up periods to further evaluate treatment outcomes and adverse events.

摘要

引言

ZAP-X® 陀螺式放射外科治疗系统(美国加利福尼亚州圣卡洛斯市 ZAP 外科系统公司)有望成为一种高精度的下一代治疗系统,能够对颅内病变进行陀螺立体定向照射。在本研究中,我们报告了使用 ZAP-X 治疗伽玛刀(GK)治疗后复发的颅内病变的初始治疗过程。

方法

2023 年 4 月至 8 月接受 ZAP-X 治疗且在 GK 治疗后复发的颅内肿瘤患者符合参与本研究的条件。主要终点是六个月时的疾病进展控制率;次要终点是靶病变缩小率、ZAP-X 干预前肿瘤倍增时间(TDT)的治疗效果以及不良事件。

结果

对 6 例患者的 6 个病变进行了评估(2 例脑膜瘤、1 例孤立性纤维瘤、1 例听神经瘤、1 例球瘤和 1 例转移瘤)。治疗后平均随访期为 10.6 个月。平均病变体积为 5.3 cm;平均 TDT 为 241 天。六个月时的疾病进展控制率为 100%,在最后一次评估时有 2 例部分缓解和 4 例病情稳定。不良事件仅限于 1 例患者(16.6%)的影像学改变,表明 ZAP-X 干预前的 TDT 与干预后的缩小率之间存在显著相关性。

结论

首次报告了 ZAP-X 治疗 GK 治疗后复发性疾病患者的初步结果。ZAP-X 显示出强大的抗肿瘤疗效和足够的耐受性,应被视为复发难治性患者的一种新的治疗选择。未来的研究应增加病例数量和随访时间,以进一步评估治疗结果和不良事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e3f9/11660191/289636439c66/cureus-0016-00000074005-i01.jpg

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