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复发性脑膜瘤挽救性全身治疗疗效的基准研究:RANO组的系统评价和荟萃分析以指导临床试验设计

Benchmarking the efficacy of salvage systemic therapies for recurrent meningioma: A RANO group systematic review and meta-analysis to guide clinical trial design.

作者信息

Kotecha Rupesh, Akdemir Eyub Y, Kutuk Tugce, Ilgın Can, Ahluwalia Manmeet S, Bi Wenya L, Blakeley Jaishri, Dixit Karan S, Dunn Ian F, Galanis Evanthia, Galldiks Norbert, Huang Raymond Y, Johnson Derek R, Kaley Thomas J, Kamson David O, Kurz Sylvia C, McDermott Michael W, Odia Yazmin, Preusser Matthias, Raizer Jeffrey, Reardon David A, Rogers C Leland, Ruda Roberta, Schiff David, Vogelbaum Michael A, Weller Michael, Wen Patrick Y, Mehta Minesh P

机构信息

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA.

Department of Radiation Oncology, Koç University School of Medicine, Istanbul, Turkey.

出版信息

Neuro Oncol. 2025 Sep 8;27(7):1670-1685. doi: 10.1093/neuonc/noaf009.

DOI:10.1093/neuonc/noaf009
PMID:39807850
Abstract

BACKGROUND

Despite advances in our understanding of the molecular underpinnings of meningioma progression and innovations in systemic and local treatments, recurrent meningiomas remain a substantial therapeutic challenge. The objective of this systematic review and meta-analysis is to provide a historical baseline, contemporary analysis, and propose a "rate of probable interest" to inform future clinical trial design and development on behalf of the Response Assessment in Neuro-Oncology meningioma group.

METHODS

PubMed, ClinicalTrials.gov, and ASCOpubs databases were screened for clinical trials evaluating the activity of systemic therapies for adults with recurrent meningiomas. The pooled progression-free survival at 6-months and 1-year (PFS-6 and PFS-1 year) values were calculated using the random effects technique with I2 indices.

RESULTS

The pooled PFS-6 and PFS-1 year rates for recurrent WHO grade 1 meningiomas were 43.6% (95% CI: 22.7-67.0%, I2 = 80%) and 21.7% (95% CI: 6.2-53.9%, I2 = 76%), and for grades 2-3 meningiomas, the PFS-6 was 38.0% (95% CI: 28.3-48.8%, I2 = 68%). In the targeted therapy group, PFS-6 and PFS-1 year rates stood at 62.0% (I2 = 58%) and 49.0% (I2 = 63%) for grade 1, while for grades 2-3 tumors, the PFS-6 rates with targeted therapy and immunotherapy were 42.1% (I² = 60%) and 46.0% (I² = 0%), respectively. The benchmarks were set at 67% and 54% for PFS-6 and PFS-1 year for grade 1 tumors, and PFS-6 of 49% for grades 2-3 tumors.

CONCLUSIONS

Several studies have reported outcomes in patients with recurrent meningiomas testing a variety of agents with modest, but variable and progressively increasing activity. In this context, we recommend new benchmarks for future trials to define efficacy of future investigational therapies.

摘要

背景

尽管我们对脑膜瘤进展的分子基础的理解有所进展,并且全身和局部治疗也有创新,但复发性脑膜瘤仍然是一个重大的治疗挑战。本系统评价和荟萃分析的目的是提供一个历史基线、当代分析,并提出一个“可能感兴趣的率”,以指导未来神经肿瘤学脑膜瘤反应评估组的临床试验设计和开展。

方法

对PubMed、ClinicalTrials.gov和ASCOpubs数据库进行筛选,以查找评估复发性脑膜瘤成年患者全身治疗活性的临床试验。使用带有I2指数的随机效应技术计算6个月和1年的无进展生存期合并值(PFS-6和PFS-1年)。

结果

WHO 1级复发性脑膜瘤的PFS-6和PFS-1年合并率分别为43.6%(95%CI:22.7-67.0%,I2 = 80%)和21.7%(95%CI:6.2-53.9%,I2 = 76%),2-3级脑膜瘤的PFS-6为38.0%(95%CI:28.3-48.8%,I2 = 68%)。在靶向治疗组中,1级的PFS-6和PFS-1年率分别为62.0%(I2 = 58%)和49.0%(I2 = 63%),而对于2-3级肿瘤,靶向治疗和免疫治疗的PFS-6率分别为42.1%(I² = 60%)和46.0%(I² = 0%)。1级肿瘤的PFS-6和PFS-1年基准分别设定为67%和54%,2-3级肿瘤的PFS-6基准为49%。

结论

多项研究报告了复发性脑膜瘤患者使用多种活性适度但变化且逐渐增加的药物的试验结果。在此背景下,我们建议为未来试验设定新的基准,以界定未来研究性治疗的疗效。

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