Chua Alfredo V, Delmerico Jennifer, Sheng Haiyang, Huang Xin-Wei, Liang Emily, Yan Li, Gandhi Shipra, Puzanov Igor, Jain Prantesh, Sakoda Lori C, Morrow Gary R, Ambrosone Christine B, Kamen Charles, Yao Song
Department of Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Department of Biostatistics, State University of New York at Buffalo, Buffalo, NY.
JCO Oncol Pract. 2025 Mar;21(3):408-417. doi: 10.1200/OP.24.00033. Epub 2024 Aug 22.
Minoritized racial/ethnic groups are historically under-represented in cancer clinical trials, which may be exacerbated in recent trials on immune checkpoint inhibitors (ICIs). We examined the representation and reporting of the racial/ethnic composition of participants in clinical trials on ICIs.
We examined English full-text trials on ICIs published from 2007 to 2022. Information on trial characteristics and racial/ethnic composition of participants was extracted from published papers or ClinicalTrials.gov. Differences in participation by publication year, ICI agent, and cancer site were analyzed. Enrollment-incidence ratio (EIR) was calculated to compare the proportion of minoritized racial/ethnic group patients in US-based trials against age-adjusted cancer incidence data available for the US population. An EIR > 1 signified over-representation, whereas an EIR <1 signified under-representation.
Of the 471 trials examined, racial composition was unreported in 146 (31%), whereas Hispanic/Latinx ethnicity was unreported in 278 (59%). Only 30 (6%) trials reported race/ethnicity-specific results. In US-only trials (n = 174), White patients were over-represented (EIR, 1.20 [95% CI, 1.17 to 1.22]), whereas Hispanic/Latinx patients were the most under-represented (EIR, 0.35 [95% CI, 0.24 to 0.48]), followed by Black/African American patients (EIR, 0.66 [95% CI, 0.54 to 0.79]). Subgroup analyses consistently indicated over-representation of White patients across publication years (EIR, 1.19-1.24), ICI classes (EIR, 1.16-1.23), and cancer sites (EIR, 1.11-1.31), whereas Hispanic/Latinx patients were consistently under-represented. An upward trend of trial representation and reporting was observed for all minoritized racial/ethnic groups over time (trend values ≤.05).
Disparities in the representation and reporting of minoritized racial/ethnic groups persist in recent trials on ICIs, necessitating collaborative efforts for improved diversity and equitable cancer treatment access.
少数族裔群体在癌症临床试验中的代表性历来不足，在近期关于免疫检查点抑制剂（ICI）的试验中，这种情况可能会加剧。我们研究了ICI临床试验参与者种族/族裔构成的代表性和报告情况。
我们研究了2007年至2022年发表的关于ICI的英文全文试验。从已发表的论文或ClinicalTrials.gov中提取试验特征和参与者种族/族裔构成的信息。分析了按发表年份、ICI药物和癌症部位划分的参与差异。计算入组发病率比（EIR），以比较美国试验中少数族裔患者的比例与美国人群可获得的年龄调整癌症发病率数据。EIR>1表示代表性过高，而EIR<1表示代表性不足。
在471项试验中，146项（31%）未报告种族构成，278项（59%）未报告西班牙裔/拉丁裔族裔。只有30项（6%）试验报告了种族/族裔特异性结果。仅在美国进行的试验（n = 174）中，白人患者代表性过高（EIR，1.20[95%CI，1.17至1.22]），而西班牙裔/拉丁裔患者代表性最低（EIR，0.35[95%CI，0.24至0.48]），其次是黑人/非裔美国患者（EIR，0.66[95%CI，0.54至0.79]）。亚组分析一致表明，在各发表年份（EIR，1.19 - 1.24）、ICI类别（EIR，1.16 - 1.23）和癌症部位（EIR，1.11 - 1.31）中，白人患者代表性过高，而西班牙裔/拉丁裔患者始终代表性不足。随着时间的推移，所有少数族裔群体的试验代表性和报告呈上升趋势（趋势值≤.05）。
在近期关于ICI的试验中，少数族裔群体在代表性和报告方面的差异仍然存在，需要共同努力以提高多样性和公平获得癌症治疗的机会。
