METHODS: An electronic search was conducted for all NSCLC clinical trials published between 2010 and 2020 with included words \"carcinoma, non-small cell, lung\" and \"non-small cell lung cancer.\" Studies from PubMed, Cochrane, and SCOPUS were included and were uploaded into Covidence to assist with systematic review. All articles were screened by two separate individuals and reviewed for location, study type, cancer stage, field of study of the research team, and percentage of females included. Student\'s t-test was used to compare the means of males and females.
RESULTS: Across the 269 studies that met inclusion criteria, fewer females than males were enrolled (38.7% vs. 61.1%; p < 0.0001). Compared with studies from 2010 to 2015, those from 2016 to 2020 had greater representation of females (36.7% vs. 41.4%, p = 0.0091, respectively). Both nonsurgical and surgical studies enrolled fewer female than male patients (38.1% vs. 61.7%, p < 0.0001; 43.1% vs. 57.2%, p = 0.0002, respectively). Clinical trials from the USA had the least difference between sexes with an average of 46.7% females enrolled. Less females compared with males were enrolled in early-stage NSCLC (37.6% female vs. 62.6% male, p < 0.0001) and late-stage NSCLC trials (37.6% female vs. 62.0% male, p < 0.0001).
CONCLUSIONS: Despite recent improvement, there continues to be significant underrepresentation of females compared with males in NSCLC clinical trials.
方法:对2010年至2020年发表的所有NSCLC临床试验进行了电子搜索,其中包含“癌,非小细胞,“肺”和“非小细胞肺癌”。“来自PubMed的研究,科克伦,和SCOPUS被纳入并上传到Covidence以协助进行系统评价.所有文章都由两个独立的人进行了筛选,并审查了位置,研究类型,癌症阶段,研究团队的研究领域,包括女性的百分比。学生t检验用于比较男性和女性的均值。
结果:在符合纳入标准的269项研究中,登记的女性少于男性(38.7%vs.61.1%;p<0.0001)。与2010年至2015年的研究相比,2016年至2020年的研究中女性的比例更高(36.7%vs.41.4%,分别为p=0.0091)。非手术和手术研究招募的女性患者少于男性患者(38.1%vs.61.7%,p<0.0001;43.1%vs.57.2%,分别为p=0.0002)。来自美国的临床试验在性别之间的差异最小,平均有46.7%的女性参加。与男性相比,女性在早期非小细胞肺癌中的比例较低(女性占37.6%,62.6%男性,p<0.0001)和晚期非小细胞肺癌试验(37.6%女性与62.0%男性,p<0.0001)。
结论:尽管最近有所改善,在NSCLC临床试验中,与男性相比,女性的代表性仍然显著不足.