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Clinical Trial Eligibility Criteria and Recently Approved Cancer Therapies for Patients With Brain Metastases

Brain metastases cause significant morbidity and mortality in patients with advanced cancer. In the era of precision oncology and immunotherapy, there are rapidly evolving systemic treatment options. These novel therapies may have variable intracranial efficacy, and patients with brain metastases re...

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Autores principales: Tan, Aaron C., Boggs, Drexell H., Lee, Eudocia Q., Kim, Michelle M., Mehta, Minesh P., Khasraw, Mustafa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8761732/
https://www.ncbi.nlm.nih.gov/pubmed/35047397
http://dx.doi.org/10.3389/fonc.2021.780379
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author Tan, Aaron C.
Boggs, Drexell H.
Lee, Eudocia Q.
Kim, Michelle M.
Mehta, Minesh P.
Khasraw, Mustafa
author_facet Tan, Aaron C.
Boggs, Drexell H.
Lee, Eudocia Q.
Kim, Michelle M.
Mehta, Minesh P.
Khasraw, Mustafa
author_sort Tan, Aaron C.
collection PubMed
description Brain metastases cause significant morbidity and mortality in patients with advanced cancer. In the era of precision oncology and immunotherapy, there are rapidly evolving systemic treatment options. These novel therapies may have variable intracranial efficacy, and patients with brain metastases remain a population of special interest. Typically, only patients with stable, asymptomatic and/or treated brain metastases are enrolled in clinical trials, or may be excluded altogether, particularly in the setting of leptomeningeal carcinomatosis. Consequently, this leads to significant concerns on the external validity of clinical trial evidence to real-world clinical practice. Here we describe the current trends in cancer clinical trial eligibility for patients with brain metastases in both early and late phase trials, with a focus on targeted and immunotherapies. We evaluate recent newly FDA approved therapies and the clinical trial evidence base leading to approval. This includes analysis of inclusion and exclusion criteria, requirements for baseline screening for brain metastases, surveillance cerebral imaging and incorporation of trial endpoints for patients with brain metastases. Finally, the use of alternative sources of data such as real-world evidence with registries and collaborative studies will be discussed.
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spelling pubmed-87617322022-01-18 Clinical Trial Eligibility Criteria and Recently Approved Cancer Therapies for Patients With Brain Metastases Tan, Aaron C. Boggs, Drexell H. Lee, Eudocia Q. Kim, Michelle M. Mehta, Minesh P. Khasraw, Mustafa Front Oncol Oncology Brain metastases cause significant morbidity and mortality in patients with advanced cancer. In the era of precision oncology and immunotherapy, there are rapidly evolving systemic treatment options. These novel therapies may have variable intracranial efficacy, and patients with brain metastases remain a population of special interest. Typically, only patients with stable, asymptomatic and/or treated brain metastases are enrolled in clinical trials, or may be excluded altogether, particularly in the setting of leptomeningeal carcinomatosis. Consequently, this leads to significant concerns on the external validity of clinical trial evidence to real-world clinical practice. Here we describe the current trends in cancer clinical trial eligibility for patients with brain metastases in both early and late phase trials, with a focus on targeted and immunotherapies. We evaluate recent newly FDA approved therapies and the clinical trial evidence base leading to approval. This includes analysis of inclusion and exclusion criteria, requirements for baseline screening for brain metastases, surveillance cerebral imaging and incorporation of trial endpoints for patients with brain metastases. Finally, the use of alternative sources of data such as real-world evidence with registries and collaborative studies will be discussed. Frontiers Media S.A. 2022-01-03 /pmc/articles/PMC8761732/ /pubmed/35047397 http://dx.doi.org/10.3389/fonc.2021.780379 Text en Copyright © 2022 Tan, Boggs, Lee, Kim, Mehta and Khasraw https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Oncology
Tan, Aaron C.
Boggs, Drexell H.
Lee, Eudocia Q.
Kim, Michelle M.
Mehta, Minesh P.
Khasraw, Mustafa
Clinical Trial Eligibility Criteria and Recently Approved Cancer Therapies for Patients With Brain Metastases
title Clinical Trial Eligibility Criteria and Recently Approved Cancer Therapies for Patients With Brain Metastases
title_full Clinical Trial Eligibility Criteria and Recently Approved Cancer Therapies for Patients With Brain Metastases
title_fullStr Clinical Trial Eligibility Criteria and Recently Approved Cancer Therapies for Patients With Brain Metastases
title_full_unstemmed Clinical Trial Eligibility Criteria and Recently Approved Cancer Therapies for Patients With Brain Metastases
title_short Clinical Trial Eligibility Criteria and Recently Approved Cancer Therapies for Patients With Brain Metastases
title_sort clinical trial eligibility criteria and recently approved cancer therapies for patients with brain metastases
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8761732/
https://www.ncbi.nlm.nih.gov/pubmed/35047397
http://dx.doi.org/10.3389/fonc.2021.780379
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