Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA.
Department of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, MA.
J Clin Oncol. 2023 Jun 10;41(17):3160-3171. doi: 10.1200/JCO.22.01579. Epub 2023 Apr 7.
The Response Assessment in Neuro-Oncology (RANO) criteria are widely used in high-grade glioma clinical trials. We compared the RANO criteria with updated modifications (modified RANO [mRANO] and immunotherapy RANO [iRANO] criteria) in patients with newly diagnosed glioblastoma (nGBM) and recurrent GBM (rGBM) to evaluate the performance of each set of criteria and inform the development of the planned RANO 2.0 update.
Evaluation of tumor measurements and fluid-attenuated inversion recovery (FLAIR) sequences were performed by blinded readers to determine disease progression using RANO, mRANO, iRANO, and other response assessment criteria. Spearman's correlations between progression-free survival (PFS) and overall survival (OS) were calculated.
Five hundred twenty-six nGBM and 580 rGBM cases were included. Spearman's correlations were similar between RANO and mRANO (0.69 [95% CI, 0.62 to 0.75] 0.67 [95% CI, 0.60 to 0.73]) in nGBM and rGBM (0.48 [95% CI, 0.40 to 0.55] 0.50 [95% CI, 0.42 to 0.57]). In nGBM, requirement of a confirmation scan within 12 weeks of completion of radiotherapy to determine progression was associated with improved correlations. Use of the postradiation magnetic resonance imaging (MRI) as baseline scan was associated with improved correlation compared with use of the pre-radiation MRI (0.67 [95% CI, 0.60 to 0.73] 0.53 [95% CI, 0.42 to 0.62]). Evaluation of FLAIR sequences did not improve the correlation. Among patients who received immunotherapy, Spearman's correlations were similar among RANO, mRANO, and iRANO.
RANO and mRANO demonstrated similar correlations between PFS and OS. Confirmation scans were only beneficial in nGBM within 12 weeks of completion of radiotherapy, and there was a trend in favor of the use of postradiation MRI as the baseline scan in nGBM. Evaluation of FLAIR can be omitted. The iRANO criteria did not add significant benefit in patients who received immune checkpoint inhibitors.
反应评估神经肿瘤学（RANO）标准广泛应用于高级别胶质瘤临床试验。我们将 RANO 标准与更新的修改版（改良 RANO[mRANO]和免疫治疗 RANO[iRANO]标准）进行比较，以评估这些标准在新诊断的胶质母细胞瘤（nGBM）和复发性胶质母细胞瘤（rGBM）患者中的表现，并为计划中的 RANO 2.0 更新提供信息。
通过盲法读者评估肿瘤测量和液体衰减反转恢复（FLAIR）序列，以使用 RANO、mRANO、iRANO 和其他反应评估标准确定疾病进展。计算无进展生存期（PFS）和总生存期（OS）之间的 Spearman 相关性。
纳入 526 例 nGBM 和 580 例 rGBM 病例。在 nGBM 和 rGBM 中， RANO 和 mRANO（0.69 [95%CI，0.62 至 0.75] 0.67 [95%CI，0.60 至 0.73]）之间的 Spearman 相关性相似。在 nGBM 中，要求在放疗完成后 12 周内进行确认扫描以确定进展与相关性提高相关。与使用放疗前 MRI 相比，使用放疗后 MRI 作为基线扫描与相关性提高相关（0.67 [95%CI，0.60 至 0.73] 0.53 [95%CI，0.42 至 0.62]）。评估 FLAIR 序列并不能提高相关性。在接受免疫治疗的患者中， RANO、mRANO 和 iRANO 之间的 Spearman 相关性相似。
RANO 和 mRANO 显示 PFS 和 OS 之间具有相似的相关性。在放疗完成后 12 周内，确认扫描仅对 nGBM 有益，并且在 nGBM 中，倾向于使用放疗后 MRI 作为基线扫描。可以省略 FLAIR 的评估。在接受免疫检查点抑制剂治疗的患者中，iRANO 标准没有显著获益。
