Pembrolizumab治疗复发性脑膜瘤和单发纤维瘤的II期开放标签单臂试验。

IF 3.7 Q1 CLINICAL NEUROLOGY
Neuro-oncology advances Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI:10.1093/noajnl/vdae154
Dror Limon, Alexandra Amiel, Shaked Even Haim, Noa Gordon, Roi Tschernichovsky, Salomon Stemmer, Omer Gal, Yosef Laviv, Andrew Kanner, Tali Siegal, Shlomit Yust-Katz
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引用次数: 0

摘要

背景:非典型和无弹性脑膜瘤占所有脑膜瘤病例的 20%。孤立性纤维瘤(SFT)是一种软组织肉瘤,其特性与脑膜瘤相似。对于既往接受过手术或放疗的难治性或复发性患者,目前尚无有效的治疗方法。抗程序性细胞死亡 1(PD-1)抗体 Pembrolizumab 是治疗各种实体瘤的有效药物。PD-1配体在侵袭性脑膜瘤中高度表达。我们旨在评估pembrolizumab治疗脑膜瘤及手术和放疗后SFT复发的有效性:这项前瞻性单臂II期试验包括15例复发脑膜瘤患者和3例无弹性SFT患者,于2018年至2022年期间在一家机构接受治疗。该研究因缺乏疗效和进展缓慢而终止。主要终点为6个月无进展生存期(PFS-6):中位无进展生存期(PFS)为2.6个月,中位总生存期(OS)为40个月。6个月和12个月的PFS均为11.1%。6个月和12个月的OS分别为94.4%和61.1%。根据神经肿瘤学反应评估(RANO)标准,总反应率为11%,其中2名患者病情稳定,2名患者部分反应。3名患者(16.7%)出现了3级毒性:我们的研究结果表明,pembrolizumab未能改善侵袭性脑膜瘤或无弹性SFT患者的PFS-6。不过,有两名患者(一名是非典型性脑膜瘤患者,另一名是无弹性SFT患者)获得了部分应答。还需要进行更多的临床研究,以确定哪些患者可能从这种治疗方法中获益。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A phase II, open-label, single-arm trial of pembrolizumab for recurrent meningioma and solitary fibrous tumor.

Background: Atypical and anaplastic meningiomas account for 20% of all meningioma cases. Solitary fibrous tumor (SFT) is a type of soft tissue sarcoma with similar attributes to meningioma. For patients with refractory or recurrent disease after previous surgery or radiotherapy, there is no effective treatment. Pembrolizumab, an anti-programmed cell death 1 (PD-1) antibody, is an effective treatment for various solid tumors. PD-1 ligand is highly expressed in aggressive meningiomas. We aimed to assess the effectiveness of pembrolizumab in treating meningioma and SFT recurrence after surgery and radiation therapy.

Methods: This prospective single-arm phase II trial comprised 15 patients with recurrent meningioma and 3 with anaplastic SFT, treated at a single institution during 2018 to 2022. The study was terminated due to a lack of efficacy and slow accrual. The primary endpoint was 6-month progression-free survival (PFS-6).

Results: Median progression-free survival (PFS) was 2.6 months, and median overall survival (OS) was 40 months. The 6- and 12-month PFS were both 11.1%. The 6- and 12-month OS were 94.4% and 61.1%, respectively. According to the Response Assessment in Neuro-Oncology (RANO) criteria, the overall response rate was 11%, with 2 patients achieving stable disease and 2 with partial response. Three patients (16.7%) developed grade 3 toxicity.

Conclusions: Our results showed that pembrolizumab failed to improve PFS-6 in patients with aggressive meningioma or anaplastic SFT. However, two patients, one with atypical meningioma and one with anaplastic SFT, achieved a partial response. More clinical studies are needed to identify which subset of patients may benefit from this treatment.

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CiteScore
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