Galanis Evanthia, Buckner Jan C, Maurer Matthew J, Sykora Rene, Castillo René, Ballman Karla V, Erickson Bradley J
Division of Medical oncology, Mayo clinic, rochester, MN 55905, USA.
Neuro Oncol. 2006 Apr;8(2):156-65. doi: 10.1215/15228517-2005-005. Epub 2006 Mar 2.
Significant limitations are associated with the use of standard radiographic measurements as indicators of response in glioma therapy trials. The Response Evaluation Criteria in Solid Tumors (RECIST) were recently introduced in an attempt to standardize and simplify assessment of response to treatment in cancer clinical trials. However, their applicability in gliomas has been assessed in only a very small number of patients. Our aim was to validate radiographic response assessment in newly diagnosed glioma patients. Sixty-seven newly diagnosed glioma patients participating in nine North Central Cancer Treatment Group glioma trials were included; 565 MRI scans were analyzed. All scans were performed with the same technique. Kappa statistics were calculated to determine agreement between assessment methods. Cox proportional hazards analyses and time-dependent Cox models were used to assess the association between different measurement methods and overall survival. Results showed agreement between the one-dimensional (1D) and two-dimensional (2D) measurements both for T2 images and for gadolinium-enhanced images. Comparison of duration of response and time to progression as assessed by eight different methods showed similarity in response assessments by 1D, 2D, area, and volume gadolinium measurements. In contrast, time to progression was significantly shorter when assessed by 1D-T2 or 2D-T2 images as compared to area-T2 or volume-T2 images. This set of data indicates that RECIST could be used instead of 2D imaging for response assessment in newly diagnosed glioma trials. Overall, responses as determined by any tumor measurement method did not correlate with patient survival for either enhancing or nonenhancing tumors, although the small number of responders limits definitive conclusions. Time-dependent Cox models demonstrated that, in contrast to the case of nonenhancing tumors, progression as determined by 1D, 2D, area, and volume measurements in gadolinium-enhanced images was predictive of survival of patients with enhancing tumors.
在胶质瘤治疗试验中，将标准的影像学测量作为反应指标存在显著局限性。实体瘤疗效评价标准（RECIST）最近被引入，旨在使癌症临床试验中治疗反应的评估标准化和简化。然而，其在胶质瘤中的适用性仅在极少数患者中进行了评估。我们的目的是验证新诊断胶质瘤患者的影像学反应评估。纳入了67例参加北中部癌症治疗组9项胶质瘤试验的新诊断胶质瘤患者；分析了565次磁共振成像（MRI）扫描。所有扫描均采用相同技术。计算kappa统计量以确定评估方法之间的一致性。使用Cox比例风险分析和时间依赖性Cox模型来评估不同测量方法与总生存期之间的关联。结果显示，对于T2图像和钆增强图像，一维（1D）和二维（2D）测量之间具有一致性。通过八种不同方法评估的反应持续时间和进展时间的比较显示，1D、2D、面积和钆增强体积测量的反应评估具有相似性。相比之下，与面积-T2或体积-T2图像相比，通过1D-T2或2D-T2图像评估时，进展时间明显更短。这组数据表明，在新诊断的胶质瘤试验中，RECIST可用于替代2D成像进行反应评估。总体而言，尽管反应者数量较少限制了得出明确结论，但任何肿瘤测量方法所确定的反应与强化或非强化肿瘤患者的生存均无相关性。时间依赖性Cox模型表明，与非强化肿瘤的情况相反，钆增强图像中通过1D、2D、面积和体积测量所确定的进展可预测强化肿瘤患者的生存。
