Abstract

Objectives: Clinical trials inform standard clinical guidance for the treatment of gynecologic cancers, and minority recruitment is critical to reducing racial disparities. Our study’s primary objective was to describe how race and ethnicity were represented within publications selected as high-quality clinical evidence for the preferred systemic treatment regimens of endometrial cancer by the National Comprehensive Cancer Network (NCCN). Our secondary objective was to compare the race/ethnicity distribution among clinical trial participants to the CDC reported rates of endometrial cancer among Black and Hispanic patients between the years 1999 and 2017. Methods: NCCN Clinical Practice Guidelines for Uterine Neoplasms, Version 4.2021, were used to identify the studies cited to support the preferred agents for the systemic treatment of endometrial cancer. We excluded nontherapeutic studies, those reported in abstract only, and studies that evaluated regimens for cancers other than endometrial carcinoma. Race and ethnicity data were manually abstracted and pooled among studies reporting these data. We compared the distributions of race and ethnicity observed in these studies with that of incident cancer cases in the U.S. using the Chi-square test. National cancer statistics were obtained from CDC’s U.S. Cancer Statistics database (1999-2017). Results: A total of 13 references were cited as the data for systemic treatment of endometrial cancer by the NCCN. Ten studies of 1,280 patients met the inclusion criteria and were reviewed for race and ethnicity data (Figure 1). The majority of the studies were phase II trials. Only four publications (40%), with 706 patients, reported on race and/or ethnicity with highly variable language regarding race and ethnicity categories. Of these four studies, one included multiple non-colorectal cancers, including endometrial; however, race and ethnicity were not specified for the 13 endometrial cancer patients; thus, the study was excluded from further analysis. Of the remaining 664 patients, 49 identified as Black or African American, representing 7.4% of trial participants that reported on race. In contrast, the CDC data suggests that 9.9% of women with endometrial cancer identify as Black or African American (p<0.001). Only two studies described participants as Hispanic or Latino. Of the 589 patients enrolled in these studies, 18 patients (3.2%) identified as Hispanic or Latino, compared with 7.6% of women diagnosed with cancer in the US (p<0.001). Objectives: Clinical trials inform standard clinical guidance for the treatment of gynecologic cancers, and minority recruitment is critical to reducing racial disparities. Our study’s primary objective was to describe how race and ethnicity were represented within publications selected as high-quality clinical evidence for the preferred systemic treatment regimens of endometrial cancer by the National Comprehensive Cancer Network (NCCN). Our secondary objective was to compare the race/ethnicity distribution among clinical trial participants to the CDC reported rates of endometrial cancer among Black and Hispanic patients between the years 1999 and 2017. Methods: NCCN Clinical Practice Guidelines for Uterine Neoplasms, Version 4.2021, were used to identify the studies cited to support the preferred agents for the systemic treatment of endometrial cancer. We excluded nontherapeutic studies, those reported in abstract only, and studies that evaluated regimens for cancers other than endometrial carcinoma. Race and ethnicity data were manually abstracted and pooled among studies reporting these data. We compared the distributions of race and ethnicity observed in these studies with that of incident cancer cases in the U.S. using the Chi-square test. National cancer statistics were obtained from CDC’s U.S. Cancer Statistics database (1999-2017). Results: A total of 13 references were cited as the data for systemic treatment of endometrial cancer by the NCCN. Ten studies of 1,280 patients met the inclusion criteria and were reviewed for race and ethnicity data (Figure 1). The majority of the studies were phase II trials. Only four publications (40%), with 706 patients, reported on race and/or ethnicity with highly variable language regarding race and ethnicity categories. Of these four studies, one included multiple non-colorectal cancers, including endometrial; however, race and ethnicity were not specified for the 13 endometrial cancer patients; thus, the study was excluded from further analysis. Of the remaining 664 patients, 49 identified as Black or African American, representing 7.4% of trial participants that reported on race. In contrast, the CDC data suggests that 9.9% of women with endometrial cancer identify as Black or African American (p<0.001). Only two studies described participants as Hispanic or Latino. Of the 589 patients enrolled in these studies, 18 patients (3.2%) identified as Hispanic or Latino, compared with 7.6% of women diagnosed with cancer in the US (p<0.001).

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