P17.02.B BMSCOPE: A SCOPING REVIEW TO CHART THE EVOLVING CLINICAL STUDY LANDSCAPE IN BRAIN AND LEPTOMENINGEAL METASTASIS

Abstract

BACKGROUND 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 BM/LM clinical studies published globally between 2010 and 2023. MATERIAL AND METHODS Eleven electronic databases were searched on 21 June 2021, with an updated search on 21 February 2023. Clinical studies were included if they involved the investigation of a therapeutic intervention in patients with BM and/or LM, and a reported patient outcome. Study-level data was extracted by study authors, including study type, date of publication, country of data collection, number of BM/LM patients in study, primary tumour type and type of therapeutic intervention RESULTS 48222 studies were identified from the electronic search and 4921 unique studies were eligible for analysis, with increasing numbers of studies (and international collaborations) through the study period. 627 of these publications were clinical trials. Over the study period there was a shift towards later stage clinical trials, predominantly trials of systemic therapy that included BM/LM patients. Despite this, only 29.2% reported intracranial-specific outcomes. CONCLUSION In this comprehensive analysis of the BM/LM literature, we chart the evolving landscape of studies involving this previously clinically excluded population. Given the increasing clinical research activity, particularly late-stage systemic therapy trials, it is imperative that consideration is given to the intracranial activity of new investigational agents. Wider adoption of standardised reporting of intracranial-specific endpoints will facilitate evaluation of intracranial efficacy