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3D volume growth rate evaluation in the EORTC-BTG-1320 clinical trial for recurrent WHO grade 2 and 3 meningiomas
Neuro-Oncology ( IF 15.9 ) Pub Date : 2024-03-06 , DOI: 10.1093/neuonc/noae037
E Tabouret 1 , J Furtner 2 , T Graillon 3 , A Silvani 4 , E Le Rhun 5, 6 , R Soffietti 7 , G Lombardi 8 , J M Sepúlveda-Sánchez 9 , P Brandal 10 , M Bendszus 11 , V Golfinopoulos 12 , T Gorlia 12 , M Weller 6 , F Sahm 13 , W Wick 14 , M Preusser 15
Affiliation  

Background We previously reported that tumor 3D volume growth rate (3DVGR) classification could help in the assessment of drug activity in patients with meningioma using three main classes and a total of five subclasses: class 1: decrease; 2: stabilization or severe slowdown; 3: progression. The EORTC-BTG-1320 clinical trial was a randomized phase II trial evaluating the efficacy of trabectedin for recurrent WHO 2 or 3 meningioma. Our objective was to evaluate the discriminative value of 3DVGR classification in the EORTC-BTG-1320. Methods All patients with at least one available MRI before trial inclusion were included. 3D volume was evaluated on consecutive MRI until progression. 2D imaging response was centrally assessed by MRI modified Macdonald criteria. Clinical benefit was defined as neurological or functional status improvement or steroid decrease or discontinuation. Results Sixteen patients with a median age of 58.5 years were included. Best 3DVGR classes were: 1, 2A, 3A and 3B in 2 (16.7%), 4 (33.3%), 2 (16.7%) and 4 (33.3%) patients, respectively. All patients with progression-free survival longer than 6 months had best 3DVGR class 1 or 2. 3DVGR classes 1 and 2 (combined) had a median overall survival of 34.7 months versus 7.2 months for class 3 (p=0.061). All class 1 patients (2/2), 75% of class 2 patients (3/4) and only 10% of class 3 patients (1/10) had clinical benefit. Conclusions Tumor 3DVGR classification may be helpful to identify early signals of treatment activity in meningioma clinical trials.

中文翻译:

EORTC-BTG-1320 临床试验中针对复发性 WHO 2 级和 3 级脑膜瘤的 3D 体积增长率评估

背景我们之前报道过,肿瘤 3D 体积生长率 (3DVGR) 分类可以帮助评估脑膜瘤患者的药物活性,使用三个主要类别和总共五个亚类:第 1 类:减少;第 1 类:减少;第 1 类:减少;第 1 类:减少;2:稳定或严重放缓;3:进展。EORTC-BTG-1320 临床试验是一项随机 II 期试验,评估曲贝替定治疗复发性 WHO 2 或 3 级脑膜瘤的疗效。我们的目标是评估 EORTC-BTG-1320 中 3DVGR 分类的判别价值。方法 纳入试验前至少进行过一次 MRI 检查的所有患者均被纳入。通过连续 MRI 评估 3D 体积,直至出现进展。2D 成像反应通过 MRI 改良麦克唐纳标准进行集中评估。临床获益定义为神经或功能状态改善或类固醇减少或停用。结果 纳入16名患者,中位年龄58.5岁。最佳 3DVGR 类别为:1、2A、3A 和 3B 分别为 2 名 (16.7%)、4 名 (33.3%)、2 名 (16.7%) 和 4 名 (33.3%) 患者。所有无进展生存期超过 6 个月的患者的最佳 3DVGR 1 级或 2 级。3DVGR 1 级和 2 级(组合)的中位总生存期为 34.7 个月,而 3 级为 7.2 个月 (p=0.061)。所有 1 类患者 (2/2)、75% 的 2 类患者 (3/4) 和仅 10% 的 3 类患者 (1/10) 均具有临床获益。结论 肿瘤 3DVGR 分类可能有助于识别脑膜瘤临床试验中治疗活动的早期信号。
更新日期:2024-03-06
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