Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Lancet Oncol. 2013 Sep;14(10):e407-16. doi: 10.1016/S1470-2045(13)70308-5.
Neurocognitive function, neurological symptoms, functional independence, and health-related quality of life are major concerns for patients with brain metastases. The inclusion of these endpoints in trials of brain metastases and the methods by which these measures are assessed vary substantially. If functional independence or health-related quality of life are planned as key study outcomes, then the reliability and validity of these endpoints can be crucial because methodological issues might affect the interpretation and acceptance of findings. The Response Assessment in Neuro-Oncology (RANO) working group is an independent, international, and collaborative effort to improve the design of clinical trials in patients with brain tumours. In this report, the second in a two-part series, we review clinical trials of brain metastases in relation to measures of clinical benefit and provide a framework for the design and conduct of future trials.
神经认知功能、神经症状、功能独立性和健康相关生活质量是脑转移瘤患者的主要关注点。脑转移瘤试验中包含这些终点以及评估这些措施的方法差异很大。如果功能独立性或健康相关生活质量计划作为主要研究结果，那么这些终点的可靠性和有效性可能至关重要，因为方法学问题可能会影响研究结果的解释和接受。神经肿瘤反应评估（RANO）工作组是一个独立的、国际性的、协作性的努力，旨在改善脑肿瘤患者临床试验的设计。在这篇报告中，是一个两部分系列中的第二部分，我们回顾了与临床获益衡量标准有关的脑转移瘤临床试验，并为未来试验的设计和进行提供了框架。
