Omar Elghawy, Reema Patel, Jason Xu, Jonathan Sussman, Bethany Horton, Varinder Kaur
{"title":"Enrollment Trends Among Patients with Melanoma Brain Metastasis in Active Clinical Trials.","authors":"Omar Elghawy, Reema Patel, Jason Xu, Jonathan Sussman, Bethany Horton, Varinder Kaur","doi":"10.1080/07357907.2024.2354809","DOIUrl":null,"url":null,"abstract":"<p><p>The CNS is a common site for distant metastasis and treatment failure in melanoma patients. This study aimed to evaluate the inclusion rate of patients with melanoma brain metastases (MBM) in prospective clinical trials. 69.3% of trials excluded MBM patients based on their CNS disease. In univariate analysis, trials not employing immunotherapy (<i>p</i> = 0.0174), inclusion of leptomeningeal disease (<i>p</i> < 0.0001) and non-pharmaceutical sponsor trials (<i>p</i> = 0.0461) were more likely to enroll patients with MBM. Thoughtful reconsideration of clinical trial designs is needed to give patients with MBMs access to promising investigational agents and improve outcomes for patients with MBM.</p>","PeriodicalId":9463,"journal":{"name":"Cancer Investigation","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Investigation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/07357907.2024.2354809","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/5/22 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
The CNS is a common site for distant metastasis and treatment failure in melanoma patients. This study aimed to evaluate the inclusion rate of patients with melanoma brain metastases (MBM) in prospective clinical trials. 69.3% of trials excluded MBM patients based on their CNS disease. In univariate analysis, trials not employing immunotherapy (p = 0.0174), inclusion of leptomeningeal disease (p < 0.0001) and non-pharmaceutical sponsor trials (p = 0.0461) were more likely to enroll patients with MBM. Thoughtful reconsideration of clinical trial designs is needed to give patients with MBMs access to promising investigational agents and improve outcomes for patients with MBM.
期刊介绍：
Cancer Investigation is one of the most highly regarded and recognized journals in the field of basic and clinical oncology. It is designed to give physicians a comprehensive resource on the current state of progress in the cancer field as well as a broad background of reliable information necessary for effective decision making. In addition to presenting original papers of fundamental significance, it also publishes reviews, essays, specialized presentations of controversies, considerations of new technologies and their applications to specific laboratory problems, discussions of public issues, miniseries on major topics, new and experimental drugs and therapies, and an innovative letters to the editor section. One of the unique features of the journal is its departmentalized editorial sections reporting on more than 30 subject categories covering the broad spectrum of specialized areas that together comprise the field of oncology. Edited by leading physicians and research scientists, these sections make Cancer Investigation the prime resource for clinicians seeking to make sense of the sometimes-overwhelming amount of information available throughout the field. In addition to its peer-reviewed clinical research, the journal also features translational studies that bridge the gap between the laboratory and the clinic.
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