Central nervous system disease in phase III studies for advanced HER2 positive breast cancer: A review



Bhogal, Talvinder ORCID: 0000-0003-3297-9957, Cameron, David and Palmieri, Carlo ORCID: 0000-0001-9496-2718
(2022) Central nervous system disease in phase III studies for advanced HER2 positive breast cancer: A review. BREAST, 63. pp. 85-100.

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Abstract

<h4>Importance</h4>The introduction of human epidermal growth factor receptor 2 (HER2) directed therapy has transformed the outcomes of patients with advanced breast cancer (BC). However, HER2 positive breast cancer has a predilection for the central nervous system (CNS) which is associated with significant morbidity and mortality. Understanding the intracranial activity of novel HER2 directed agents is key to developing treatments as well as possible preventative strategies for HER2-positive CNS disease.<h4>Observations</h4>Using protocols and data from published phase III clinical trials for locally advanced/metastatic HER2-positive breast cancer since the licensing of single agent trastuzumab for advanced BC we review the central nervous system related aspects. This includes CNS related entry criteria, use of baseline and on study cross-sectional imaging of the CNS and protocol and non-protocol defined CNS end points and reported data.<h4>Conclusions</h4>and Relevance: This review found heterogeneity between studies with regard to the entry criteria, use of CNS imaging and reported end points within the pivotal phase III studies. Based on these data, a standardisation of both entry criteria and end points with regard to the CNS should be developed and applied to future studies of HER2-positive advanced BC. Such an approach would enable the generation of comparable data and allow a meaningful analysis of different treatment approaches with regard to the CNS. This in turn would allow the development of the most optimal treatment approaches for HER2 positive CNS disease and ultimately the development of preventative strategies.

Item Type: Article
Uncontrolled Keywords: Brain metastasis, Breast cancer, HER2
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Clinical Directorate
Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User: Symplectic Admin
Date Deposited: 23 May 2022 08:57
Last Modified: 18 Jan 2023 21:01
DOI: 10.1016/j.breast.2022.03.013
Open Access URL: https://doi.org/10.1016/j.breast.2022.03.013
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3155327