Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27.
CNS metastases are the most common cause of malignant brain tumours in adults. Historically, patients with brain metastases have been excluded from most clinical trials, but their inclusion is now becoming more common. The medical literature is difficult to interpret because of substantial variation in the response and progression criteria used across clinical trials. The Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) working group is an international, multidisciplinary effort to develop standard response and progression criteria for use in clinical trials of treatment for brain metastases. Previous efforts have focused on aspects of trial design, such as patient population, variations in existing response and progression criteria, and challenges when incorporating neurological, neuro-cognitive, and quality-of-life endpoints into trials of patients with brain metastases. Here, we present our recommendations for standard response and progression criteria for the assessment of brain metastases in clinical trials. The proposed criteria will hopefully facilitate the development of novel approaches to this difficult problem by providing more uniformity in the assessment of CNS metastases across trials.
中枢神经系统转移是成年人中最常见的恶性脑肿瘤病因。历史上，脑转移患者被排除在大多数临床试验之外，但现在越来越多地将他们纳入其中。由于临床试验中使用的反应和进展标准存在很大差异，医学文献很难解读。神经肿瘤脑转移反应评估（RANO-BM）工作组是一个国际性的多学科努力，旨在制定用于脑转移治疗临床试验的标准反应和进展标准。以前的努力集中在试验设计的各个方面，例如患者人群、现有反应和进展标准的差异，以及在将神经学、神经认知和生活质量终点纳入脑转移患者试验时所面临的挑战。在这里，我们提出了用于评估临床试验中脑转移的标准反应和进展标准的建议。希望这些标准建议通过在临床试验中对中枢神经系统转移的评估提供更大的一致性，为解决这一难题提供新的方法。
