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• W2977480246 abstract "Sexual and gender minority (SGM) patients, which include lesbian, gay, bisexual, transgender and queer/questioning (LGBTQ+) patients, are increasingly recognized as a diverse cancer patient population with unique risks, outcomes and disparities.1 To better understand SGM-specific considerations in cancer care, as well as determine rates of SGM participation in prospective research more broadly, ongoing efforts aim to promote reporting of SGM status in oncologic trials.2 We therefore sought to determine rates of SGM reporting and SGM patient exclusion among randomized controlled trials (RCTs) in oncology to date.3 We identified RCTs in clinical oncology through a search of the ClinicalTrials.gov website. Institutional board review of the study was not required as all data were publically available without identifying patient-specific information. The ClinicalTrials.gov website was queried using the following search parameters: Terms: “cancer”; Status: excluded “Not yet recruiting”; Phase: Phase 3; and Study Results: “With Results.” This yielded 1,239 trials; these were then screened for cancer-specific RCTs addressing a therapeutic intervention, resulting in identification of 764 trials, with years of enrollment between 1991 and 2017. The earliest peer-reviewed publication of a trial's primary endpoint (PEP) served as the primary publication. SGM reporting (or lack thereof) was based on review of both ClinicalTrials.gov and the primary publication. Information regarding enrollment criteria was collected from ClinicalTrials.gov, the primary publication, and the study protocol if available. Two individuals independently screened trials and collected data. Of 764 trials, none reported SGM status, including LGBTQ+ status. Similarly, no trial provided information regarding patients with nonbinary gender. The total combined enrollment for all analyzed trials was 462,449 patients. Of these, only two patients were listed as having gender “not reported” or “unknown,” and the remainder were classified as “male” or “female.” Trial enrollment criteria were then examined for both explicit and implicit exclusion of SGM populations.3 Only one trial (0.13%) included exclusionary language; this trial (NCT00895011) was an industry-funded study examining the effects of avanafil on postprostatectomy erectile dysfunction, where the PEP was directly related to penile–vaginal intercourse.4 We describe a complete absence of SGM status reporting among oncologic RCTs to date. SGM-specific cancer care, though an academic area of study still in its infancy, is a topic of growing interest in the oncology community.5, 6 Data to date suggest that SGM cancer patients have unique barriers to cancer care1, 2, 6; outcomes and toxicity profiles across disease sites may also differ based on SGM status.1, 7, 8 Additionally, trial access equity for SGM patients must be improved given known disparities among this patient population.1 Therefore, inclusion of SGM patients within cancer clinical trials and reporting on their specific outcomes is imperative. The National Institutes of Health Sexual and Gender Minority Research Office (SGMRO) has issued recent guidance encouraging clinical investigators to ensure inclusion of SGM populations, and report on both SGM status and outcomes.2 Reporting of SGM status, a substantial barrier to SGM-related cancer research, has been mandated by the Affordable Care Act as well as subsequent missives from the federal branch in the United States.9, 10 While these efforts to encourage SGM status data collection and reporting have only emerged over the last decade, our data provide a reference point for future investigation into whether cancer clinical trials are rising to meet this challenge. Additionally, a low incidence of SGM-exclusionary language was found among cancer trial enrollment criteria overall. However, the sole trial with exclusionary language was one of only seven studies (14%) in our trial cohort with a PEP addressing sexual toxicity. This parallels previous data demonstrating a 15% rate of exclusionary language among sexual function endpoint trials more broadly (noncancer-specific).3 Exclusion of SGM patients from cancer clinical trials has the capacity to widen existing care disparities for SGM patients, and hinder trial access.1, 3, 9 SGM exclusion also prevents advancing understanding of SGM-specific cancer care considerations. Investigators must remain vigilant in avoiding exclusionary enrollment criteria, especially for trials with sexual toxicity endpoints. Our study, the first to describe SGM reporting and exclusion among cancer trials, highlights both the current dearth of data as well as opportunities for the future. Through initiatives such as those led by the SGMRO, we hope that the oncology community will work to better understand and address the needs of the SGM cancer patient population. Yours sincerely Ethan B. Ludmir Andres F. Espinoza Amit Jethanandani Timothy A. Lin Walker Mainwaring Austin B. Miller Prajnan Das" @default.
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• W2977480246 date "2019-11-01" @default.
• W2977480246 modified "2023-09-30" @default.
• W2977480246 title "Reporting and exclusion of sexual and gender minorities in cancer clinical trials" @default.
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• W2977480246 doi "https://doi.org/10.1002/ijc.32700" @default.
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