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- Title
Clinical Trial Eligibility Criteria and Recently Approved Cancer Therapies for Patients With Brain Metastases.
- Authors
Tan, Aaron C.; Boggs, Drexell H.; Lee, Eudocia Q.; Kim, Michelle M.; Mehta, Minesh P.; Khasraw, Mustafa
- Abstract
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.
- Subjects
UNITED States. Food &; Drug Administration; MENINGEAL cancer; CLINICAL trials; CANCER patients; CANCER treatment; CANCER-related mortality; LEGAL evidence
- Publication
Frontiers in Oncology, 2022, Vol 11, p1
- ISSN
2234-943X
- Publication type
Article
- DOI
10.3389/fonc.2021.780379