Background: Chordoma is a rare bone cancer with limited treatment options. Clinical trials are crucial for developing effective therapies, but their success depends on including diverse patient populations. The objective of this study was to systematically evaluate the reporting of racial, ethnic, and socioeconomic diversity in United States clinical trials exploring treatment for chordoma. Methods: A literature search was conducted through PubMed/Medline, Cochrane, Epistemonikos, and ClinicalTrials.gov databases for published US chordoma trials up until 19 August 2024. The data collected included trial characteristics and racial and ethnic data, as well as socioeconomic indicators when available. Methodological Index for Non-Randomized Studies (MINORS) and Revised Cochrane Risk-of-Bias Tool for Randomized Trials (RoB2) analyses were adopted to assess the methodological quality. The N-1 Chi-squared (χ2) test was implemented to compare the reported racial and ethnic data with the most recent US Census Bureau data. Results: Five trials involving 111 patients (median age: 63 years; 34% female) were included. Four studies (80%) were single-arm non-randomized studies with one study (25%) having a high methodological quality and three (75%) having a moderate quality based on the MINORS analysis. Most patients (91%,n= 82) were White/Caucasian, representing a proportion which was significantly higher than the reported 75% in the US population (p= 0.0005). Black/African American patients (2%,n= 2) were significantly underrepresented compared to the 14% in the US population (p= 0.0015). Regarding ethnicity, Hispanic/Latino patients (7%,n= 6) were significantly underrepresented compared to the 20% in the US population (p= 0.0021). No measures of socioeconomic status were reported. Conclusions: This systematic review highlighted the need for improved racial and ethnic diversity in chordoma trials and the better reporting of socioeconomic data. The underrepresentation of minority groups may obscure potential disparities in disease incidence, treatment access, and clinical outcomes.
背景：脊索瘤是一种罕见的骨癌，治疗选择有限。临床试验对于开发有效疗法至关重要，但其成功取决于纳入多样化的患者群体。本研究旨在系统评估美国脊索瘤治疗临床试验中种族、民族和社会经济多样性报告情况。方法：通过PubMed/Medline、Cochrane、Epistemonikos和ClinicalTrials.gov数据库检索截至2024年8月19日已发表的美国脊索瘤试验。收集的数据包括试验特征、种族和民族数据，以及可获得的社会经济指标。采用非随机研究方法学指数（MINORS）和修订版Cochrane随机试验偏倚风险评估工具（RoB2）评估方法学质量。使用N-1卡方检验将报告的种族和民族数据与美国最新人口普查数据进行比较。结果：共纳入5项试验，涉及111名患者（中位年龄：63岁；女性占34%）。四项研究（80%）为单臂非随机研究，根据MINORS分析，其中一项研究（25%）方法学质量较高，三项（75%）质量中等。大多数患者（91%，n=82）为白人/高加索人，该比例显著高于美国人口中报告的75%（p=0.0005）。黑人/非裔美国人患者（2%，n=2）的比例显著低于美国人口中的14%（p=0.0015）。在民族方面，西班牙裔/拉丁裔患者（7%，n=6）的比例显著低于美国人口中的20%（p=0.0021）。未报告任何社会经济状况指标。结论：本系统综述强调脊索瘤试验需要提高种族和民族多样性，并改进社会经济数据的报告。少数群体的代表性不足可能掩盖疾病发病率、治疗可及性和临床结果方面的潜在差异。
肿瘤(癌症)患者之家