Metastatic Disease

Mapping Intimacies ◽

10.1093/med/9780197512166.003.0107 ◽

2021 ◽

pp. 962-966

Author(s):

Akanksha Sharma ◽

Alyx B. Porter

Keyword(s):

United States ◽

Lung Cancer ◽

Brain Tumors ◽

Brain Metastases ◽

Renal Cell ◽

The United States ◽

Neurologic Complication ◽

Cancer Type ◽

Primary Malignancy ◽

Intracranial Metastases

Intracranial metastases are the most common brain tumors in adults and outnumber primary brain tumors by 10 to 1. Nearly 200,000 patients are affected every year in the United States, and these metastases have become the most common neurologic complication of cancer. Intracranial metastases are occurring with increased frequency as a result of improved therapies for systemic cancers that extend survival. Most patients with brain metastases have lung cancer as the primary malignancy, followed in frequency by breast, melanoma, renal cell, and thyroid cancers. The prognosis when brain metastases are detected differs on the basis of the underlying cancer type.

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The enrollment status of patients with brain metastases in metastatic renal cell carcinoma: A query of clinicaltrials.gov.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e16070 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e16070-e16070

Author(s):

Tri Cao Le ◽

James Brugarolas

Keyword(s):

United States ◽

Renal Cell Carcinoma ◽

Brain Metastases ◽

Cell Carcinoma ◽

Metastatic Renal Cell Carcinoma ◽

Renal Cell ◽

The United States ◽

Cns Metastases ◽

Exclusion Criteria ◽

Cns Metastasis

e16070 Background: Clinical trials routinely exclude patients with brain metastases in metastatic renal cell carcinoma (mRCC). However, the degree to which such patients are excluded has not been documented. Routine exclusion of such patients limits applicability of trial results and obfuscates potential benefit in this subpopulation. This study aims to systematically determine the status of central nervous system (CNS) disease exclusion, with or without leptomeningeal disease, in clinical trial enrollment in interventional studies of mRCC. Methods: ClinicalTrials.gov was systematically queried to characterize the CNS exclusion criteria among open, interventional trials in mRCC. Results: Of 121 open trials, 29 (24%) strictly excluded patients with CNS metastasis. 69 trials (57%) enrolled patients with CNS metastasis with contingencies (i.e. prior CNS-directed local therapy, and/or lack of neurologic symptoms). Two trials (2%) enrolled patients with CNS metastasis without exception. 21 trials (17%) did not specify enrollment criteria with respect to CNS disease. In multivariate analysis of the effect of trial phase, location, sponsor, treatment type, and histologic subtype on CNS exclusion criteria, only location had a statistically significant effect. Trials performed exclusively within the United States had higher odds of excluding patients with CNS metastases than global trials (OR = 8.889, 95% CI: 1.405-56.251, p = 0.023) or trials performed exclusively outside of the United States (OR = 2.778, 95% CI: 1.054-1.758, p = 0.053). Conclusions: Due to the high rate of exclusion of patients with brain metastases in mRCC, many trial results cannot be reliably generalized to this subpopulation. Consideration should be given to looking at the effect of new systemic therapies on patients with CNS metastases to clarify benefit or harm in this subpopulation.

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