Abstract 817P
Background
Emerging evidence suggests pharmacogenomic differences between ethnic groups contributes to disparate treatment effects in cancer patients treated with systemic anti-cancer therapies (SACT). It is important to understand the representation of ethnic minority groups in research, and how this relates to patient outcomes. This systematic review compared participation of ethnic minority groups in contemporary gynae-oncology RCTs of SACT, and described the global distribution of research sites.
Methods
Medline, Embase and ClinicalTrials.gov databases were systematically searched. Phase II & III RCTs of SACT for ovarian, cervical, endometrial, vaginal and vulvar cancers of any stage, published 01/11/2012-01/11/2022 and reporting ethnicity were included. SACT licensed at time of search were eligible. Studies of non-systemic agents, vaccines, radiotherapy or surgery alone were excluded. Outcomes were recruitment by ethnicity and location of research sites. Recruitment by ethnicity was extracted, participation calculated for each group and compared by indication, trial phase and publication period, as well as to incidence in real-world populations. PRISMA guidance was used to report results.
Results
26 RCTs met inclusion criteria. 17,041 patients participated; 79.8% (13,595) were “Caucasian”, 9,1% (1552) “Asian”, 3.7% (630) “Black/African American”, and 6.1% (1,031) “Other/Unknown”. The remaining 1.3% (233) comprised other groups. “Caucasian” patients were over-represented in RCTs for each disease indication, and recruited at a higher rate to phase II than phase III RCTs. “Black/African American” patients recruited at a lower rate to phase III than phase II RCTs.Of 26 studies, 20 were conducted in multiple countries, 5 only in the US, and 1 only in Italy. Of 5478 sites, 4,390 (80.1%) were located in North America or Europe, 187 (3.4%) in East Asia, and 901 (16.5%) in other regions. Notably, no sites were located in Africa or South Asia.
Conclusions
Ethnic minorities are under-represented in contemporary gynae-oncology RCTs. Efforts must be made to include ethnic minority patients to ensure findings are generalisable to real-world populations.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
K. Man: Financial Interests, Institutional, Research Funding: UK National Institute for Health and Care Research, Hong Kong Research Grant Council, CW Maplethorpe Fellowship, European Commission Framework Horizon 2020 , Innovation and Technology Commission of the Government of the Hong Kong Special Administrative Region; Financial Interests, Personal, Funding: IQVIA Ltd. S. Nicum: Financial Interests, Personal, Advisory Board: GSK, AstraZeneca; Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca, Clovis; Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Stocks/Shares: GSK; Financial Interests, Institutional, Funding: AstraZeneca. All other authors have declared no conflicts of interest.
Resources from the same session
648P - Medium to long-term effects of the COVID-19 pandemic on colorectal cancer diagnosis and management in Italy: Preliminary findings from an updated analysis of the real-world multicenter COVID-DELAY study
Presenter: Alessandro Parisi
Session: Poster session 11
649P - The genomic landscape of appendiceal adenocarcinoma (AA) revealed by 855 whole exome sequences (WES)
Presenter: Michael White
Session: Poster session 11
650P - Genomic profiling of small bowel adenocarcinoma: A pooled analysis
Presenter: Thomas Aparicio
Session: Poster session 11
651P - DCF versus doublet chemotherapy as first-line treatment of advanced squamous anal cell carcinoma: A multicenter propensity score matching study
Presenter: Christophe Borg
Session: Poster session 11
726P - Circulating cell-free DNA-based biomarkers as a new tool for prognosis and surveillance of adrenocortical carcinoma
Presenter: Cristina Ronchi
Session: Poster session 11
727P - Clinical outcome of anlotinib (A) and tislelizumab (T) in metastatic adrenocortical carcinoma(mACC): A one-arm single-center experience
Presenter: HAO LI
Session: Poster session 11
728P - Brain metastases in advanced thyroid carcinoma: Clinical and molecular characteristics and outcomes
Presenter: Thais Megid
Session: Poster session 11
729P - Prognostic significance of nodal micrometastases in patients with non-functioning pancreatic neuroendocrine tumors (NF-PanNETs): A survival analysis from a prospective observational study
Presenter: Valentina Andreasi
Session: Poster session 11
730P - The outcome of combine radioligand and CAPTEM therapy in patients with advanced, unresectable, progressive GEP-NET
Presenter: Jaroslaw Cwikla
Session: Poster session 11