背景:对于软脑膜转移(LM)患者的临床神经学评估,尚无有效的工具。然而,疾病过程中的临床检查指导医疗管理,是临床试验反应评估的一部分。因为神经影像学可能并不总是由于快速的临床恶化而获得,LM的临床神经学评估至关重要,标准化对于最大限度地减少评估者的分歧很重要。
方法:RANO-LM组启动了一个两步流程,旨在改善和规范LM患者的临床评估。我们在此报告第一步:建立共识记分卡。工作组举行了9次虚拟会议,以定义有关神经系统评估的一般建议以及应进行测试的选定感兴趣领域。
结果:选择了十四个神经症状和体征领域:意识水平,认知,恶心和呕吐,愿景,眼球运动,面部力量,听力,吞咽,演讲,肢体力量,肢体共济失调,走路,膀胱肠功能。对于每个项目,关于如何执行评估的明确说明提供了0和2之间的评分标准。患者的一般临床状况和类固醇的使用情况,止痛药,和抗催吐剂应该记录在案。以前的脑转移或癌症治疗的神经系统后遗症应在基线评估时进行评估;当症状或体征可能与LM以外的其他疾病有关时,应指定。
结论:已建立了用于临床评估的经修订的NANO-LM共识记分卡。该提案的国际前瞻性验证研究目前正在进行中(NCT06417710)。
BACKGROUND: There are no validated tools for the clinical
neurological assessment of patients with leptomeningeal metastases (LM). However, clinical examination during the course of the disease guides medical management and is part of response assessment in clinical trials. Because neuroimaging may not always be obtained owing to rapid clinical deterioration, clinical
neurological assessment of LM is essential, and standardization Is important to minimize rater disagreement.
METHODS: The RANO-LM group launched a 2-steps process, aiming at improving and standardizing the clinical assessment of patients with LM. We report here on the first step: the establishment of a consensus scorecard. The task force had 9 virtual meetings to define general recommendations on
neurological assessment and selected domains of interest that should be tested.
RESULTS: Fourteen domains of
neurological symptoms and signs were selected: level of consciousness, cognition, nausea and vomiting, vision, eye movement, facial strength, hearing, swallowing, speech, limb strength, limb ataxia, walking, bladder bowel functions. For each item, a clear instruction on how to perform the assessment is provided with scoring criteria between 0 and 2. The general clinical status of the patient and use of steroids, pain medications, and anti-emetics should be documented.
Neurological sequelae from previous brain metastases or cancer treatment should be rated at the baseline evaluation; it should be specified when symptoms or signs may be related to a condition other than LM.
CONCLUSIONS: A revised NANO-LM consensus scorecard for clinical assessment has been established. An international prospective validation study of the proposal is currently ongoing (NCT06417710).