低风险脑膜瘤：NRG 肿瘤学/RTOG 0539 的初步结果。
Low-risk meningioma: Initial outcomes from NRG Oncology/RTOG 0539.
机构信息
GammaWest Cancer Services, Salt Lake City, Utah, USA.
NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania, USA.
出版信息
Neuro Oncol. 2023 Jan 5;25(1):137-145. doi: 10.1093/neuonc/noac137.
BACKGROUND
Three- and five-year progression-free survival (PFS) for low-risk meningioma managed with surgery and observation reportedly exceeds 90%. Herewith we summarize outcomes for low-risk meningioma patients enrolled on NRG/RTOG 0539.
METHODS
This phase II trial allocated patients to one of three groups per World Health Organization grade, recurrence status, and resection extent. Low-risk patients had either gross total (GTR) or subtotal resection (STR) for a newly diagnosed grade 1 meningioma and were observed after surgery. The primary endpoint was 3-year PFS. Adverse events (AEs) were scored using Common Terminology Criteria for Adverse Events (CTCAE) version 3.
RESULTS
Among 60 evaluable patients, the median follow-up was 9.1 years. The 3-, 5-, and 10-year rates were 91.4% (95% CI, 84.2 to 98.6), 89.4% (95% CI, 81.3 to 97.5), 85.0% (95% CI, 75.3 to 94.7) for PFS and 98.3% (95% CI, 94.9 to 100), 98.3%, (95% CI, 94.9 to 100), 93.8% (95% CI, 87.0 to 100) for overall survival (OS), respectively. With centrally confirmed GTR, 3/5/10y PFS and OS rates were 94.3/94.3/87.6% and 97.1/97.1/90.4%. With STR, 3/5/10y PFS rates were 83.1/72.7/72.7% and 10y OS 100%. Five patients reported one grade 3, four grade 2, and five grade 1 AEs. There were no grade 4 or 5 AEs.
CONCLUSIONS
These results prospectively validate high PFS and OS for low-risk meningioma managed surgically but raise questions regarding optimal management following STR, a subcohort that could potentially benefit from adjuvant therapy.
背景
据报道，手术和观察治疗的低危脑膜瘤患者的 3 年和 5 年无进展生存率（PFS）超过 90%。在此，我们总结了 NRG/RTOG 0539 研究中入组的低危脑膜瘤患者的结果。
方法
这项 2 期临床试验根据世界卫生组织（WHO）分级、复发情况和切除程度，将患者分配至三组。低危患者诊断为新发 1 级脑膜瘤，行全切除（GTR）或次全切除（STR），术后观察。主要终点是 3 年 PFS。采用不良事件通用术语标准（CTCAE）第 3 版对不良事件（AE）进行评分。
结果
在 60 例可评估患者中，中位随访时间为 9.1 年。3 年、5 年和 10 年的 PFS 率分别为 91.4%（95%CI，84.2 至 98.6）、89.4%（95%CI，81.3 至 97.5）和 85.0%（95%CI，75.3 至 94.7），OS 率分别为 98.3%（95%CI，94.9 至 100）、98.3%（95%CI，94.9 至 100）和 93.8%（95%CI，87.0 至 100）。经中心确认的 GTR 患者的 3/5/10 年 PFS 和 OS 率分别为 94.3%/94.3%/87.6%和 97.1%/97.1%/90.4%。STR 患者的 3/5/10 年 PFS 率分别为 83.1%/72.7%/72.7%，10 年 OS 率为 100%。5 例患者报告 1 例 3 级 AE，4 例 2 级 AE，5 例 1 级 AE。无 4 级或 5 级 AE。
结论
这些结果前瞻性地验证了手术治疗低危脑膜瘤的高 PFS 和 OS，但提出了关于 STR 后最佳治疗方法的问题，STR 亚组患者可能受益于辅助治疗。
Zotero 插件