Regine William F, Schmitt Frederick A, Scott Charles B, Dearth Chantel, Patchell Roy A, Nichols R Charles, Gore Elizabeth M, Franklin R Lee, Suh John H, Mehta Minesh P
Department of Radiation Oncology, University of Maryland Medical System, Baltimore, MD 21201, USA.
Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1346-52. doi: 10.1016/j.ijrobp.2003.09.023.
A multi-institutional trial was conducted by the Radiation Therapy Oncology Group (RTOG) to test the feasibility of performing a test battery consisting of five neurocognitive measures and a quality-of-life instrument in patients with brain metastases.
The major eligibility requirements included histologic proof of a primary malignancy, measurable single or multiple brain metastases, Zubrod performance status of 0-1, neurologic function status of 0-2, and "certification" for administration of neurocognitive assessments. This certification process required either attendance at an RTOG neurocognitive assessment training workshop or review of an instructional video, followed by submission of an audiotape of mock/simulated test sessions for central review. The test battery included the following measures: the Mini-Mental Status Examination, Hopkins Verbal Learning Test, Verbal Fluency/Controlled Word Association Test, Ruff 2 and 7 test, Trailmaking Test, and Profile of Mood States-Short Form. The primary objective of this trial was to establish whether patients were able to complete this test battery. Compliance was defined as successful completion of a test measure. The test battery was to be administered just before, at completion of, and 1 month after whole brain radiotherapy to 37.5 Gy at 2.5 Gy/fraction once daily. Fifty-nine patients were enrolled in the trial.
The patient characteristics included 32% > or =65 years; 44% with Zubrod performance status of 0; and 81% with multiple brain metastases. The overall compliance rate for administration and completion of the five neurocognitive measures and a quality-of-life instrument before treatment, at treatment completion, and 1 month after treatment was > or =95%, > or =84%, and > or =70%. The most common causes of noncompliance were patient-related factors (e.g., performance status or inability to understand test instructions) and not institutional error.
Neurocognitive evaluation of patients with brain metastases in a multi-institutional and cooperative group setting is feasible using the test battery and certification process used in this study. This battery and certification process will be incorporated into future RTOG brain tumor trials.
放射肿瘤学组（RTOG）开展了一项多机构试验，以测试对脑转移瘤患者进行由五项神经认知测量和一项生活质量工具组成的测试组合的可行性。
主要入选标准包括原发性恶性肿瘤的组织学证据、可测量的单发或多发脑转移瘤、Zubrod体能状态为0 - 1、神经功能状态为0 - 2，以及神经认知评估管理的“认证”。该认证过程要求要么参加RTOG神经认知评估培训工作坊，要么观看教学视频，随后提交模拟测试环节的录音带以供集中审核。测试组合包括以下测量：简易精神状态检查表、霍普金斯言语学习测验、言语流畅性/控制词语联想测验、鲁夫2和7测验、连线测验，以及简式情绪状态剖面图。本试验的主要目的是确定患者是否能够完成该测试组合。依从性定义为成功完成一项测试测量。测试组合将在全脑放疗至37.5 Gy（每次2.5 Gy，每日一次）之前、完成时以及完成后1个月进行。59名患者入组该试验。
患者特征包括32%年龄≥65岁；44%的Zubrod体能状态为0；81%有多发脑转移瘤。治疗前、治疗完成时以及治疗后1个月，五项神经认知测量和一项生活质量工具的总体管理和完成依从率分别≥95%、≥84%和≥70%。最常见的不依从原因是患者相关因素（如体能状态或无法理解测试说明），而非机构失误。
使用本研究中所用的测试组合和认证过程，在多机构合作组环境中对脑转移瘤患者进行神经认知评估是可行的。该测试组合和认证过程将纳入未来的RTOG脑肿瘤试验。
