Mitchell Cancer Institute, University of South Alabama, Mobile, AL 36604, USA.
Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
Gynecol Oncol. 2020 Jun;157(3):729-732. doi: 10.1016/j.ygyno.2020.03.002. Epub 2020 Mar 13.
It is important to develop effective therapies in minorities to ensure equity in cancer care. Underrepresentation of minorities in early phase trials may cause therapies that are effective only in majority populations. We evaluated minority participation in gynecologic oncology phase 1 clinical trials.
In peer-reviewed published articles of gynecologic oncology phase 1 clinical trials from years 1985 to 2018, we manually abstracted racial distribution of enrolled participants, cancer type, and year published. We calculated expected and observed ratios of racial participation on the basis of age-adjusted cancer incidence for race from the United States Centers for Disease Control and Prevention.
We identified 357 articles of phase 1 trials (total, 9492 participants), including 213 articles on ovarian cancer (60%). Racial distribution of participants was available in 84 articles (23%) that included 2483 participants (26%): 1950 white (79%), 140 black (5%), and 393 other participants (16%). Other nonwhite races exceeded black enrollment in 46 of 84 trials (55%) that listed race. Enrollment of black participants was less than expected from disease incidence for ovarian (incidence-to-enrollment ratio, 18.5; P < .001), endometrial (3.6; P < .001), and cervical cancer (6.8; P < .001). No phase 1 study met expected enrollment for black participants. Frequency of black participants decreased 1.8-fold from 1995 to 1999 (8 of 70 participants [11%]) to 2015-2018 (55 of 892 participants [6%]; P < .025).
Major racial underrepresentation exists in gynecologic oncology phase 1 clinical trials. Enrollment of more black participants is needed to achieve racial equity.
为确保癌症治疗的公平性，在少数族裔中开发有效的治疗方法非常重要。少数族裔在早期临床试验中的代表性不足可能导致仅对多数人群有效的治疗方法。我们评估了少数族裔在妇科肿瘤学 1 期临床试验中的参与情况。
在 1985 年至 2018 年发表的妇科肿瘤学 1 期临床试验同行评审文章中，我们手动提取了入组参与者的种族分布、癌症类型和发表年份。我们根据美国疾病控制与预防中心的年龄调整后种族癌症发病率，计算了基于种族的预期和观察到的参与率。
我们确定了 357 篇 1 期试验文章（共 9492 名参与者），其中包括 213 篇卵巢癌（60%）的文章。在 84 篇（23%）包括 2483 名参与者（26%）的文章中，可获得参与者的种族分布：1950 名白人（79%）、140 名黑人（5%）和 393 名其他参与者（16%）。在列出种族的 84 项试验中，有 46 项试验中其他非白色种族的入组人数超过了黑人（发病率与入组人数比，18.5；P<.001）。黑人参与者的入组人数低于卵巢癌（发病-入组比，18.5；P<.001）、子宫内膜癌（3.6；P<.001）和宫颈癌（6.8；P<.001）的发病率。没有 1 期研究符合黑人参与者的预期入组人数。黑人参与者的比例从 1995 年至 1999 年（8 名参与者中的 11%）下降到 2015 年至 2018 年（892 名参与者中的 55%），下降了 1.8 倍（P<.025）。
妇科肿瘤学 1 期临床试验中存在严重的种族代表性不足。需要招募更多的黑人参与者，以实现种族公平。
