Department of Radiology, Brigham and Women's Hospital, Boston, Massachusetts. Center of Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.
Center of Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.
Clin Cancer Res. 2016 Feb 1;22(3):575-81. doi: 10.1158/1078-0432.CCR-14-3040. Epub 2015 Oct 21.
The RANO criteria have not been assessed using outcome data from prospective trials. We examined the radiologic data of patients with recurrent glioblastoma from the randomized phase II trial (AVF3708g) to determine the effect of including T2/FLAIR evaluation as per RANO criteria on measurements of objective response rates (ORRs) and progression-free survival (PFS) compared with assessment based on contrast enhancement (Macdonald criteria).
The ORRs and median PFS were determined using the RANO criteria and compared with those obtained using the Macdonald criteria. Landmark analyses were performed at 2, 4, and 6 months, and Cox proportional hazard models were used to determine the associations between OR and progression with subsequent survival.
The ORRs were 0.331 [95% confidence interval (CI), 0.260-0.409] and 0.393 (95% CI, 0.317-0.472) by RANO and Macdonald criteria, respectively (P < 0.0001). The median PFS was 4.6 months (95% CI, 4.1-5.5) using RANO criteria, compared with 6.4 months (95% CI, 5.5-7.1) as determined by Macdonald criteria (P = 0.01). At 2-, 4-, and 6-month landmarks, both OR status and PFS determined by either RANO or Macdonald criteria were predictive of overall survival [OS; hazard ratios for 4-month landmark (OR HR = 1.93, P = 0.0012; PFS HR, 4.23, P < 0.0001)].
The inclusion of T2/FLAIR assessment resulted in statistically significant differences in median PFS and ORRs compared with assessment of solely enhancing tumor (Macdonald criteria), although OR and PFS determined by both RANO and Macdonald criteria correlated with OS.
尚未使用前瞻性试验的结果数据来评估 RANO 标准。我们检查了来自随机二期试验（AVF3708g）的复发性胶质母细胞瘤患者的放射学数据，以确定根据 RANO 标准包括 T2/FLAIR 评估对客观缓解率（ORR）和无进展生存期（PFS）的测量的影响，与仅根据增强对比（Macdonald 标准）进行评估相比。
使用 RANO 标准确定 ORR 和中位 PFS，并将其与 Macdonald 标准获得的值进行比较。进行了 2、4 和 6 个月的里程碑分析，并使用 Cox 比例风险模型来确定 OR 和进展与后续生存之间的关联。
根据 RANO 和 Macdonald 标准，ORR 分别为 0.331（95%置信区间[CI]，0.260-0.409）和 0.393（95%CI，0.317-0.472）（P <0.0001）。使用 RANO 标准，中位 PFS 为 4.6 个月（95%CI，4.1-5.5），而使用 Macdonald 标准为 6.4 个月（95%CI，5.5-7.1）（P=0.01）。在 2、4 和 6 个月的里程碑处，无论是 RANO 还是 Macdonald 标准确定的 OR 状态和 PFS 都与总生存相关[OS；4 个月里程碑的风险比（OR HR=1.93，P=0.0012；PFS HR，4.23，P<0.0001）]。
与仅评估增强肿瘤（Macdonald 标准）相比，纳入 T2/FLAIR 评估会导致中位 PFS 和 ORR 出现统计学上的显著差异，尽管 RANO 和 Macdonald 标准确定的 OR 和 PFS 与 OS 相关。
