bluuebunny/crossref_metadata_2025_split huggingface dataset:
Black patient representation in anti-cancer drug development.
Authors: Karol Alexander B. , Paredes Rodrigo , Fujiwara Yu , Argulian Anna , Joshi Himanshu , Galsky Matt D. 
Published: May 2024

e13680 Background: Black patient enrollment in cancer clinical trials is critical to improving the generalizability of trial results and advancing an understanding of potential differences in drug efficacy and safety in underrepresented populations. Prior research indicated that in 2018, Black patients comprised ~2.5% of accruals to phase III trials in oncology (1). Here, we probed whether the representation of Black patients has increased in contemporary trials. Methods: We systematically searched the clinicaltrials.gov database to review racial demographics for phase III clinical trials. These trials evaluated systemic anti-cancer therapies in adult patients between October 28th 2013, and October 28th 2023. Studies were excluded if they did not include racial demographic information. The demographics of the trials and cancer subtypes were recorded. 19-year domestic cancer specific prevalence data was obtained from United States Cancer Statistics as a reference to evaluate the representation of Black patients in the included clinical trials. P-values were calculated with a chi-squared test. Results: 436 trials met criteria for review and 238 trials, enrolling 115,969 patients, met our inclusion criteria. Among these patients, 72,471 (62.5%) were White, 1,895 (1.6%) were Black, 31,996 (35.9%) were from another race. Systemic therapies explored included: immunotherapy (99 trials, 41.6%), targeted therapy (110 trials, 47.9%), chemotherapy (17 trials, 7.6%), and other therapies (7 trials, 2.9%). Black patients were underrepresented in phase 3 trials across the vast majority of tumor types (Table). Sub-group analysis revealed significantly increased Black clinical trial representation in trials beginning enrollment in 2019-2022 versus 2013-2018 (2.3% vs 1.8%, p=0.02). Conclusions: Adult Black patients are significantly under-represented (<2%) in modern oncology trials. However, there has been a significant increase in Black enrollment since 2019. Ongoing efforts are needed to ensure optimal representation of Black patients in oncology trials. 1. Tharakan, Cancer, 2021. [Table: see text]
Integrating social drivers of health screening into ambulatory cancer care.
Authors: Jones Tessa , Snow Alison , Aryeh Brittany , Liu Mark , Smith Cardinale B. , Mazor Melissa 
Published: May 2024

e13692 Background: Despite the known impact of social drivers of health (SDOH) on cancer related outcomes, the integration of SDOH screens into routine oncology clinical practice is scarce and suboptimal. Recent findings indicate feasibility of integrating these tools, yet data is limited in how to develop and implement the screens to address unmet SDOH related needs. This study aims to provide an overview of the development and integration of a SDOH screener and referral system into clinical workflow and describe the patients who completed and didn’t complete the survey. Methods: The 17-item Quality of Life and Support (QOLS) survey was based on evidence-based SDOH questionnaires, co-created with our community board, and built into the Mount Sinai Tisch Cancer Center EHR, Epic. The survey is sent out via the patient portal 7 days prior to patients’ second oncology appointment, with repeat measures every 90 days. Surveys are available in English and Spanish and evaluate SDOH needs such as transportation, food insecurity, employment, social support, financial strain, stress, and depression. If survey answers indicate need for additional support the case is ‘escalated’ to social work, chaplaincy, or family care coordinator depending on the area of need. We used descriptive statistics to describe patients who completed versus didn’t complete the survey. Of those completed, we also describe the SDOH trigger and frequency of ‘escalation’. Results: Between June 2022 - December 2023, 10,655 patients were assigned 25,353 surveys across 5 sites. 37% of the assigned surveys were completed.A total of 6,179 individuals completed at least one survey. The average number of surveys completed was 2. Of the completed surveys, 43% were completed before the appointment date. Of completed surveys, 21% were escalated to social work, 8.5% to chaplaincy, and 1.3% to family care with the most frequent reasons for escalation being distress, financial strain, and transportation. A significant relationship was found between Race (Pearson chi2 = 107.9 p < .000) and Ethnicity (Pearson chi2 = 58.8, p<.000) and survey completion with differences due primarily to White and non-Hispanic White completion vs non-completion. Notably, Black and Hispanic individuals are completing the survey in the same proportion as those receiving it. Conclusions: This study shows successful integration of a SDOH screen into ambulatory cancer care which allows for systematic referrals to SDOH resources. [Table: see text]
Ethnic disparities in breast cancer: A comprehensive analysis of socio-demographic and clinical characteristics among African American, Hispanic, and Caucasian women.
Authors: Proskuriakova Ekaterina , Aryal Barun Babu , Shrestha Dhan , Adams Megan , Valencia Stephanie , Varsani Akshay , Sakhuja Anuradha , Jasaraj Ranjit Babu , Kovalenko Iuliia , Verda Larissa , Khosla Paramjeet Grewal 
Published: May 2024

e13698 Background: Despite advancements in breast cancer therapy leading to a decline in mortality rates within certain ethnic populations, there exists a concerning trend of increasing cancer incidence among African American (AA) and Hispanic women. This persistent rise highlights the urgent need to explore and comprehend the socio-demographic and breast cancer characteristics specific to these populations. Methods: We assembled a 10-year database of women diagnosed with breast cancer in the community hospital in Chicago. After excluding minority ethnic groups, specifically AA, Hispanic, and Caucasian cohorts were included in this study, comprising 786 patient records analyzed. Results: The distribution revealed a predominance of AA patients at 49.7%, Hispanics at 42.1%, and Caucasians at 8.14%. Noteworthy differences across the three ethnic groups were observed in age categories at cancer diagnosis, BMI categories, family history of first-degree relatives with breast cancer, marital status, smoking habits, menopausal status, and alcohol use at the time of diagnosis (p < 0.05). Within the molecular subtypes, 14.5% were identified as triple-negative breast cancer (TNBC), with a higher prevalence of 18.7% among the AA subgroups. 19.6% of patients had advanced disease, proportion was higher in AA ethnic group (22.8%; p = 0.83) compared to other ethnicities. Breast conservative procedures were prevalent in almost half of the patient population on average (52.1 %), with a slightly higher frequency of mastectomies noted in the Hispanic patient group (44.1%, p < 0.05). In logistic regression analysis, compared to the reference AA ethnicity, Hispanics exhibited higher odds of having HER-2 positive breast cancer (OR 1.74; CI 1.04 – 2.94; p < 0.05), as did Caucasians (OR 2.35; CI 1.05 – 5.04; p < 0.05). Conclusions: In summary, our study underscores substantial socio-demographic and breast cancer characteristic differences among AA and Hispanic populations compared to Caucasians, revealing notable ethnic disparities in breast cancer. Despite these variations, our findings highlight promising healthcare equity, with comparable access to surgical and chemotherapy interventions across ethnicities. TNBC demonstrates molecular heterogeneity and a higher prevalence among AA women, contributing to significant racial disparities.
Utilization of circulating tumor DNA (ctDNA) testing by race and ethnicity in more than 135,000 patients.
Authors: Davis Andrew A. , Bucheit Leslie A , Zhang Nicole , Pretz Christopher , Strickler John H , Chachoua Abraham , Wise David R , Wong Kwok-Kin , Aviki Emeline Mariam , Zhang Tian , Qin Qian , Clemens Keelia M. 
Published: May 2024

e13702 Background: Studies have shown low rates of tumor genomic profiling in the metastatic population and disparities in cancer care have been observed across races, ethnicities, and ages. We aimed to better understand how ctDNA is being utilized across race, ethnicity, and age in common cancer types using a real-world (RWE) clinicogenomic database. Methods: GuardantINFORM is an RWE database that aggregates de-identified records from ctDNA testing (Guardant360), and aggregated payer claims from which race, ethnicity, age, cancer type and setting (academic/community) were extracted from 2021-2023 using the patients’ first test. Common cancers with biomarker/targeted therapy opportunities were included. Rates of ctDNA testing by race were assessed for non-Hispanic (NH) White, Black, and Asian/pacific islander (PI) and separately for Hispanic ethnicity. ctDNA testing rates were compared to recent CDC Wonder incidence using previously published methods (PMID: 36658153) and to tissue-based testing rates (PMID: 33106634) using t-test and Fisher’s Exact Test (significance: p < 0.05). Results: There were no significant differences in sex, setting (academic/community), or age ( > 65, 50-65 years) for each group compared to the overall cohort (p > 0.2). ctDNA testing occurred most frequently in NH White (71.5%) followed by NH Black (12.1%), Hispanic (9.1%), and NH Asian/PI (4.7%); rates were comparable to published tissue-based rates (White: 76%, Black: 7%, Asian: 6%, N/A for Hispanic; p = 0.97). Controlling for incidence, ctDNA testing rates were significantly less-than-expected for 75% (6/8) of cancers in NH White, 37.5% (3/8) of cancers in both NH Black and Asian/PI, and 100% (8/8) of cancers in the Hispanic cohort (Table 1). Conclusions: In this large clinicogenomic database, Black and Asian patients had higher than expected rates of ctDNA testing, while Hispanic patients had lower rates. While the representation of Black patients is encouraging, ongoing efforts are needed to improve availability and frequency of testing, particularly for Hispanic patients. [Table: see text]
Overcoming racial and ethnic disparities in clinical trial enrollment real world evidence from an NCI-Designated Cancer Center in a minority majority county.
Authors: Lee Frank , Valerin Jennifer Brooke , Dayyani Farshid 
Published: May 2024

e13708 Background: Significant racial and ethnic disparities continue to persist in clinical trial enrollment. Specifically, Asian and Hispanic individuals are severely underrepresented compared to their census estimates and make up as little as 1% and 6% respectively of all clinical trial enrollments [PMID: 35875251]. This limits the generalizability of clinical trials and consequently the application of novel therapeutics for diverse populations. This observational study looks at enrollment demographics at the University of California, Irvine (UCI) with an emphasis on minority participation in clinical trials. We hypothesized that minorities would be underrepresented in our enrollment population. Methods: The UCI Chao Family Comprehensive Cancer Center (CFCCC) is located in Orange County (OC), CA, a minority-majority county. Enrollment data from clinical trials was collected from 2015-2023 through the CFCCC clinical research database. Demographics were compared to data provided by the NIH SEER reports in both OC and United States. Results: Between 2015-2023, 2315 individuals across 3 UCI Health facilities were enrolled. Demographics were as follows: White, Asian, Black, American Indian/Alaska Native, mixed/unknown race (66.4%/20.1%/2.4%/0.7%/0.7%/ 9.3%). Non-Hispanic vs Hispanic ethnicity (77.8%/20.6%). Female vs Male sex (47.6%/52.3%). Age <70 vs >70 years (78.6%/21.4%). Low Income/Health Professional Shortage Areas (HPSA) vs non-Low Income/HPSA (44.9%/55.0%). Study Phase: Phase I/II (39.2%), Phase II (28.0%), Phase III (29.3%), Phase II/III (3.0%), and Phase IV (0.3%). Study sponsor: Industry (61.2%), Investigator initiated (23.5), Cooperative group (14.9%), other (0.3%). Most notably, the Asian enrollment (20.1%) and Hispanic enrollment (20.6%) exceeded demographic representation of Asians (15.6%) and Hispanics (17.3%) in OC. Conclusions: Our results demonstrate that accrual of minorities is feasible across all types of clinical trials. These findings suggest that minorities are not inherently less likely to enroll in clinical trials. A clinical trial portfolio mirroring the catchment area might improve accrual of minorities. Enrollment based on race/ethnicity and trial phase/sponsor will be presented at the meeting.
Influence of patient awareness and health disparities on early identification of neutropenic sepsis risk.
Authors: Kolyvas Emily , O'Farrell Aislinn , Sanderson Hannah , Wilson Anna , Melesi Gini , Crispin Ortuzar Mireia , Ahmad Saif 
Published: May 2024

e13711 Background: Neutropenic sepsis (NS) is a life-threatening condition predominantly affecting immunosuppressed cancer patients undergoing cytotoxic chemotherapy. Recognition of the associated symptoms and swift action in response is critical. Timely administration of antibiotics within the first hour of symptom onset is the gold standard of care, with each hour of delay associated with an 8% rise in mortality. Health disparities further compound this challenge by affecting patient access to healthcare. This study aimed to understand the intricacies of NS awareness amongst patients receiving chemotherapy and their caretakers, and to identify demographic and socioeconomic factors shaping this understanding. Methods: Inclusion criteria included current/prior chemotherapy patient/caregiver, any cancer type, age > 18. Structured interviews were conducted by 52 North (n=15) to obtain qualitative information around NS understanding. In collaboration with the Macmillan Cancer Support, a focused online survey utilizing a 5-point Likert scale was used with 252 respondents in the United Kingdom to date. Participant consent was obtained. Results: Findings from the interviews underscored the relationship between non-adherence to NS guidelines and factors including income, socioeconomic status, and other features impacting behavior. Survey participants included: male:female – 29:219, ages 20-80+ (63.2% 51-70), patient:caregiver – 218:34. Only 160/248 (64.5%) of individuals agreed or strongly agreed that they understood NS while 65/248 (26.2%) disagreed or strongly disagreed and 23/248 (9.2%) were neutral. NS symptoms such as fever were reported by 213/252 (84.5%) of respondents, however only 87/213 (40.8%) sought medical advice in less than 1 hour, 71/213 (33.3%) waited over 1 hour, and 28/213 (13.1%) did not seek advice. Individuals reporting greater NS understanding were more than twice as likely to seek help in less than 1 hour (47.9% vs 19.6%; 68/142 vs 10/51). Individuals with salaries >£40K vs <£40K (~$50K) were more likely to seek help less than 1 hour after symptoms (42.5% vs 36%; 34/80 vs 33/91). Conclusions: This study reveals a compelling association between comprehension of NS and likelihood to seek treatment within the recommended 1-hour timeframe. Furthermore, higher income emerges as a factor influencing the promptness of seeking treatment. These insights highlight the critical issue of delayed care due to a lack of understanding, exacerbated by socioeconomic disparities. This study emphasizes the urgent need for enhanced education targeting at-risk groups. By addressing knowledge gaps and socioeconomic barriers, there exists a tangible opportunity to mitigate NS-related mortality in patients undergoing chemotherapy. Subsequent studies will extend these data to include the United States, to compare analysis of barriers to care in different geographic locations.
Racial disparities in the intervention trials in colon cancer.
Authors: Vyas Abhinav , Kaur Dania , Savani Saloni , Shahzad Moazzam , Singh Rohit , Yadav Udit , Mushtaq Muhammad Umair , Batra Akshee 
Published: May 2024

e13718 Background: Colorectal cancer (CRC) is the third-leading cancer worldwide and racial minorities bear a disproportionate burden of this disease. Methods: We searched the clinicaltrials.gov database for all the completed clinical trials conducted on adult patients until 2023 in the United States. In intervention trials, we manually abstracted data on the racial distribution of enrollees, phases, tumor histology, intervention type, and year of completion. We divided interventions into chemotherapy, radiotherapy, surgery, immunotherapy, behavioral, diagnostic tests, and others. To quantify the racial disparity, we calculated the enrolment ratio (ER) as the observed ratios of racial participation in the study compared to the prevalence in colorectal cancer per the 2009-2019 Surveillance, Epidemiology and End Results (SEER) database. We also conducted subgroup racial enrollment based on clinical trial and type of intervention. Results: We identified 394 studies, of which 252 studies (64%) had racial distribution published, including 138814 participants. Most studies were phase 2 trials (168), followed by phase 1/2 trials (49) and phase 3 studies (43). The racial breakdown included 88677 White participants (63.9%), 23230 were African Americans (16.7%), 9963 were Asians (7.1%), 4398 were of other races (3.2%), and 12546 were of unknown race (9.0%). The frequency of including racial data was 100% in Phase 1 studies, 56.5% in Phase 2, 58.1% in Phase 3, and only 16% in Phase 4. A total of 185 were immunotherapy trials, out of which 63 studied chemotherapies, radiotherapy and/ or surgery along with immunotherapy. Racial enrolment data was reported in 68.6 %, 58% and 59.3% in immunotherapy, chemotherapy, and radiotherapy interventions respectively. The ERs of whites, blacks, and Asians were 0.8, 1.3, and 0.9, respectively (Table). However, ER in subgroups with specific interventions, such as chemotherapy, immunotherapy, and radiotherapy, were 0.5, 0.4, and 0.6, respectively. Conclusions: African Americans are underrepresented in CRC intervention trials. Equal access and tailored strategies for cultural and linguistic differences are needed for fair participation. [Table: see text]
Expansion of outreach to native Hawaii and Pacific Islander communities to increase breast cancer screening and clinical trial awareness in underserved and rural Oahu.
Authors: Chun Kirsten , Tran-Dang Mai-Phi , Cornett Patricia , Braun-Inglis Christa M , Fukui Jami Aya 
Published: May 2024

e13725 Background: Multiple barriers exist in the enrollment of racial and ethnic minority groups into breast cancer screening and clinical trials. Such barriers include the lack of knowledge, mistrust, and access. To increase participation of rural-dwelling Native Hawaiian/Pacific Islanders (NHPI) and other underserved minority groups in breast cancer screening and clinical trials, a pilot project was developed to augment community engagement, provide education, and gain insights into the cancer screening/clinical trial process. Our objective was to engage rural Oahu's underserved communities in breast cancer screening and facilitate enrollment into the Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients of Breast Cancer Trial (TMIST) utilizing a team comprising of a cultural congruent and gender concordant Community Health Educator (CHE) and medical oncology health care provider. Methods: We reviewed the community activities over the course of a year. The CHE facilitated outreach by speaking at numerous church events and other community gatherings. Results: Participants did not respond favorably to surveys on social determinants of health. Common reasons for their reluctance included lack of perceived importance and medical mistrust. When discussing verbiage that was intimidating or confusing such as clinical trial protocol consent language, TMIST study participants conveyed a strong sense of dehumanization. Conclusions: A total of 93 women were screened for the TMIST clinical trial. Of those, 13 were enrolled in TMIST and 31 participants received mammograms. Participant insight highlighted the importance of education using culturally sensitive language and community engagement to combat the lack of knowledge and mistrust. Continued development of education materials centered around community involvement will improve the accrual of NHPI participation in breast cancer screening/clinical trials. We hope this project established a basis for equity in communities with low breast cancer screening and clinical trial participation rates. We intend to build upon the community partnerships forged during this pilot project.
Navigating the intersection: Exploring racial disparities in major cardiovascular and cerebrovascular events among patients with hepatocellular carcinoma.
Authors: Uttam Chandani Kanishka , Agrawal Siddharth Pravin , Raval Maharshi , Siddiq Sajid , Nadeem Ahmed , Chintakuntlawar Ashish V. 
Published: May 2024

e13740 Background: Hepatocellular carcinoma (HCC) ranks as the 6th most common cancer and as the 3rd leading cause of cancer-related mortality. With immunotherapy improving survival rates, the relevance of major adverse cardiovascular and cerebrovascular events (MACCE) is increasing. We aim to explore the racial disparities in MACCE among patients with HCC, thus leading to a better understanding of the interplay of these conditions with social determinants of health. Methods: Using ICD-10 codes, patients with HCC were identified from National Inpatient Sample 2019 database. We included all-cause in-hospital mortality (ACIHM), acute myocardial infarction (AMI), atrial fibrillation (AF), cerebrovascular accident (CVA), and sudden cardiac death (SCD) as MACCE for the outcomes. Baseline characteristics including demographics, comorbidities; and MACCE outcomes were compared using chi-square for categorical or ANOVA for continuous data (statistical significance determined as p-value <0.05) and results were stratified based on patient’s races. Results: Out of the total sample size of 89,615 patients admitted with a diagnosis of HCC, 60.14% (53,895) were White, 13.67% (12250) were Black, 15.64% (14015) were Hispanic, 6.48% (5805) were Asian/Pacific Islander, 0.8% (720) were Native American, while 3.27% (2930) belonged to other ethnicities. There were significant racial differences in comorbidities with hypertension being most prevalent in Black patients (42.53%), diabetes mellitus in Native American patients (45.14%) and dyslipidemia in Asian/Pacific Islander patients (32.39%). When compared to White patients, ACIHM was the significantly higher in Black patients with adjusted odds ratio (aOR) of 1.305 (95% CI 1.123-1.517, p=0.001), Asian/Pacific Islander patients with aOR 1.271 (95% CI 1.024-1.578, p=0.03) and Other races patients with aOR 1.578 (95% CI 1.2-2.076, p=0.001). AF was significantly lower in all races when compared to White patients. CVA was significantly higher in Black patients with aOR 1.654 (95% CI 1.329-2.059, p<0.001) compared to White patients. SCD was significantly higher in Asian/Pacific Islander patients with aOR 2.22 (95% CI 1.364-3.612, p=0.001) when compared to White patients. https://docs.google.com/document/d/1wM_b0jmNjChKEfpyj5SL6HmSKEhDo0N3X5H76jC-w0I/edit?usp=sharing Conclusions: In patients with HCC, Asian/Pacific Islander patients had higher ACIHM and SCD while Black patients had higher ACIHM and CVA as compared to White patients. This study highlights the importance for development of healthcare strategies stratified by race which may aid to mitigate the higher risk of MACCE in certain races. Further research involving possible genetic influences and social determinants of health contributing to poorer outcomes in people of color becomes imperative.