ACRIN 6677/RTOG 0625

<p>RTOG 0625/ACRIN 6677 is a multicenter, randomized, phase II trial of bevacizumab with irinotecan or temozolomide in recurrent glioblastoma (GBM). This study investigated whether early posttreatment progression on FLAIR or postcontrast MRI assessed by central reading predicts overall survival (OS).</p><h4>METHODS:</h4><p>Of 123 enrolled patients, 107 had baseline and at least 1 posttreatment MRI. Two central neuroradiologists serially measured bidimensional (2D) and volumetric (3D) enhancement on postcontrast T1-weighted images and volume of FLAIR hyperintensity. Progression status on all posttreatment MRIs was determined using Macdonald and RANO imaging threshold criteria, with a third neuroradiologist adjudicating discrepancies of both progression occurrence and timing. For each MRI pulse sequence, Kaplan-Meier survival estimates and log-rank test were used to compare OS between cases with or without radiologic progression.</p><p>Two sets of XLS spreadsheets (ACRIN-DSC-MR-Brain TCIA Anonymized and ACRIN-DSC-MR-Brain-HB TCIA Anonymized) are needed in order to obtain the entire clinical data set for this collection. The file sets are a random sample of ACRIN 6677 participants divided into 2 groups. Group 1/ACRIN-DSC-MR-Brain TCIA Anonymized: a 75% random sample; Group 2/ACRIN-DSC-MR-Brain-HB TCIA Anonymized: a 25% random sample initially held for testing/validating algorithms trained on the 75% sample.  Both are available via the clinical download button.</p><h4>RESULTS:</h4><p>Radiologic progression occurred after 2 chemotherapy cycles (8 weeks) in 9 of 97 (9%), 9 of 73 (12%), and 11 of 98 (11%) 2D-T1, 3D-T1, and FLAIR cases, respectively, and 34 of 80 (43%), 21 of 58 (36%), and 37 of 79 (47%) corresponding cases after 4 cycles (16 weeks). Median OS among patients progressing at 8 or 16 weeks was significantly less than that among nonprogressors, as determined on 2D-T1 (114 vs 278 days and 214 vs 426 days, respectively; P < .0001 for both) and 3D-T1 (117 vs 306 days [P < .0001] and 223 vs 448 days [P = .0003], respectively) but not on FLAIR (201 vs 276 days [P = .38] and 303 vs 321 days [P = .13], respectively).</p><h4>CONCLUSION:</h4><p>Early progression on 2D-T1 and 3D-T1, but not FLAIR MRI, after 8 and 16 weeks of anti-vascular endothelial growth factor therapy has highly significant prognostic value for OS in recurrent GBM.</p>

RTOG 0625/ACRIN 6677是一项多中心、随机、II期临床试验，旨在评估贝伐珠单抗联合伊立替康或替莫唑胺在复发性胶质母细胞瘤（GBM）中的应用。本研究旨在探究早期治疗后的FLAIR或对比增强MRI的进展情况，由中心阅片评估，是否可预测总生存期（OS）。

方法：在123名入组的患者中，有107名患者有基线MRI和至少一次治疗后MRI。两名中心神经放射学家连续测量了对比增强T1加权图像上的二维（2D）和体积（3D）增强以及FLAIR高信号体积。所有治疗后MRI的进展状况均采用Macdonald和RANO影像阈值标准确定，并由第三位神经放射学家对进展发生时间和时间上的差异进行裁定。对于每个MRI脉冲序列，使用Kaplan-Meier生存估计和log-rank检验来比较有无影像学进展的病例的总生存期（OS）。

为了获取此收集的完整临床数据集，需要两套XLS电子表格（ACRIN-DSC-MR-Brain TCIA匿名化和ACRIN-DSC-MR-Brain-HB TCIA匿名化）。这些文件集是ACRIN 6677参与者的随机样本，分为两组。组1/ACRIN-DSC-MR-Brain TCIA匿名化：75%的随机样本；组2/ACRIN-DSC-MR-Brain-HB TCIA匿名化：最初保留的25%随机样本，用于在75%样本上训练的算法的测试/验证。两者均可通过临床下载按钮获取。

结果：在2个化疗周期（8周）后，97名患者中的9名（9%）、73名患者中的9名（12%）和98名患者中的11名（11%）分别出现了2D-T1、3D-T1和FLAIR的影像学进展，而在4个周期（16周）后，80名患者中的34名（43%）、58名患者中的21名（36%）和79名患者中的37名（47%）出现了相应的进展。在8周或16周进展的患者中，中位OS显著低于无进展患者，在2D-T1上分别为114天和278天（P均小于.0001），在3D-T1上分别为117天和306天（P小于.0001）以及223天和448天（P等于.0003），但在FLAIR上并未观察到差异（201天和276天[P等于.38]以及303天和321天[P等于.13]）。

结论：在8周和16周抗血管内皮生长因子治疗后，2D-T1和3D-T1上的早期进展，而非FLAIR MRI，对复发性GBM的总生存期具有高度显著的预后价值。