最近的研究对脑转移（BM）或软脑膜转移（LM）患者应被排除在全身治疗临床试验之外的观点提出了挑战。这项范围界定研究总结了 2010 年至 2023 年间发表的 BM/LM 临床研究。MEDLINE、CINAHL、CAB Abstracts、PsycINFO、Cochrane Library、HINARI、International Pharmaceutical Abstracts、PubMed、Scopus、Web of Science 和 EMBASE 电子数据库于 21 日进行了检索2021 年 6 月。更新检索于 2023 年 2 月 21 日进行。符合条件的研究应涉及对 BM 和/或 LM 实体瘤患者的治疗干预研究以及报告的患者结果。提取的研究级别数据，包括研究类型、发表日期、地理位置、研究中的 BM/LM 患者数量、原发肿瘤类型和治疗干预类型。4921 项独特研究符合分析条件。主要发现是 BM/LM 临床研究正在全球范围内扩展，包括观察性研究和临床试验。尽管随着时间的推移，全身治疗试验的比例逐渐提高，但大多数试验仍然不包括有症状的患者，并且缺乏 BM/LM 特定终点的报告。在全球范围内，BM/LM 临床研究存在更多国际合作的趋势。对 BM/LM 文献的分析描绘了涉及这一先前被排除的人群的研究不断发展的格局。鉴于临床研究活动不断增加，特别是涉及后期全身治疗试验，必须适当考虑新研究药物的颅内活性。更广泛地采用颅内特定终点的标准化报告将有助于评估相对颅内疗效。© 作者 2024。由牛津大学出版社代表神经肿瘤学会出版。

Recent studies have challenged the notion that patients with brain metastasis (BM) or leptomeningeal metastasis (LM) should be excluded from systemic therapy clinical trials. This scoping study summarises the BM/LM clinical studies published between 2010 and 2023.MEDLINE, CINAHL, CAB Abstracts, PsycINFO, Cochrane Library, HINARI, International Pharmaceutical Abstracts, PubMed, Scopus, Web of Science, and EMBASE electronic databases were searched on 21 June 2021. An updated search was performed on 21 February 2023. Eligible studies should involve investigation of a therapeutic intervention in solid tumour patients with BM and/or LM and a reported patient outcome. Extracted study-level data, included study type, publication date, geographical location, number of BM/LM patients in study, primary tumour type and type of therapeutic intervention.4921 unique studies were eligible for analysis. The key finding is that BM/LM clinical research is expanding globally, both observational studies and clinical trials. Despite the shift over time towards a higher proportion of systemic therapy trials, the majority still do not include patients with symptomatic disease and lack reporting of BM/LM specific endpoints. Globally, there has been a trend to more international collaboration in BM/LM clinical studies.This analysis of the BM/LM literature charts the evolving landscape of studies involving this previously excluded population. Given the increasing clinical research activity, particularly involving late-stage systemic therapy trials, it is imperative that due consideration is given to the intracranial activity of new investigational agents. Wider adoption of standardised reporting of intracranial-specific endpoints will facilitate evaluation of relative intracranial efficacy.© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Neuro-Oncology.