Abstract
Brain metastasis as exclusion criteria in extensive-stage small cell lung cancer trials: a trend over decades
Highlights
Despite the introduction of cancer prevention, screening, and new treatment modalities, cancer remains the leading cause of human mortality in both men and women worldwide
Future studies need to ease eligibility regarding brain metastases (BMs) according to American Society of Clinical Oncology (ASCO)/Friends recommendations
We focused on the presence of BMs as an exclusion criterion in prospective clinical trials of extensive-stage small cell lung cancer (ES-Small cell lung cancer (SCLC))
Summary
Despite the introduction of cancer prevention, screening, and new treatment modalities, cancer remains the leading cause of human mortality in both men and women worldwide. To develop novel therapies and further improve outcomes, well-designed clinical trials recruit candidates in numerous clinical settings. They are intended to help physicians’ decision-making in future oncology patients, these trials are often restrictive in patient selection. Patients with unfavorable risk factors are not permitted to participate due to fear of safety risks, resulting in a lack of generalizability to the typical patient population. Patients in oncology clinics may not have the same clinical characteristics that are required for participation in trials, indicating potential discrepancies in patient populations between clinical trial and non-clinical trial settings. Due to lack of data in the trials, patients may develop unexpected outcomes with newly-developed treatments or be undertreated because of the fear of unknown risk
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