bluuebunny/crossref_metadata_2025_split huggingface dataset:
Enrollment representation of age, race, and ethnicity in ovarian cancer registrational clinical trials (2010-2020): An evaluation by the U.S. Food and Drug Administration.
Authors: Yang Felice , Huang Yue , Lerro Catherine , Liu Wei , Fiero Mallorie , Feng Zhou , Kanapuru Bindu , Patel Timil , Amiri-Kordestani Laleh , Ison Gwynn , Fashoyin-Aje Lola A. , Kluetz Paul , Singh Harpreet , Rivera Donna 
Published: June 2023

e18527 Background: Ovarian cancer is the fifth leading cause of cancer mortality among U.S. women. Because clinical trials have historically not been demographically representative of real-world patients, an understanding of the extent of disparities is an important step in addressing them. We aimed to evaluate the representation of older adults and racial and ethnic minorities in trials for ovarian cancer drugs. Methods: We conducted a pooled analysis of all trials that were submitted to the U.S. Food and Drug Administration (FDA) from January 1, 2010 to December 31, 2020 in support of marketing applications for epithelial ovarian, fallopian tube, or primary peritoneal indications. Demographic data (age, race, and ethnicity) for adult participants were analyzed alongside incident ovarian cancer case data (diagnosis between 2010 and 2019) from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program. Enrollment to Incidence Ratio (EIR) is reported and defined as the percentage of participants divided by percentage of U.S. incident ovarian cancer cases. An EIR between 0.80-1.20 indicates adequate representation; <0.80 or >1.20 indicates underrepresentation or overrepresentation, respectively. Participants with race or ethnicity categories reported as unknown or missing, or insufficient for calculation were not included in this analysis. A sensitivity analysis was conducted to evaluate the exclusion of trials enrolling only BRCA+ participants. Results: The analysis included 8,211 participants enrolled across 15 clinical trials. Age was available for all participants; race/ethnicity was not reported for 16.3% of participants. With increasing age, EIR decreased (Table). Non-Hispanic (NH) White participants had the highest EIR of all racial/ethnic groups, while NH Black and Hispanic participants had the lowest EIR. Results were similar when excluding trials enrolling only BRCA+ participants. Conclusions: Adults aged ≥75, NH Black, and Hispanic participants were underrepresented in registrational trials for new ovarian cancer therapies. To enhance understanding of the correlation between age, race, and ethnicity, further analyses are necessary. Prospective measures are essential, as discussed in recent FDA guidances, to enroll an adequately representative population in ovarian cancer clinical trials.[Table: see text]
The UC san diego health suspicion of cancer clinic.
Authors: Vaidya Poorva , Cutting Elena R. , Kato Shumei , Mitchell William M. , Heyman Benjamin Michael , Gold Kathryn A. 
Published: June 2023

e18528 Background: Physicians at UC San Diego Moores Cancer Center (MCC), like at many major cancer centers in the United States, are subspecialized by tumor type. Patients with symptoms concerning for cancer, but without a diagnosis, often face challenges in establishing care with an oncologist, which can potentially lead to delays in diagnosis and treatment. Methods: At our institution, we created a Suspicion of Cancer (SOC) clinic for referral of patients who have symptoms concerning for cancer, but without a definitive diagnosis of malignancy. The purpose of the clinic is to facilitate establishment of a diagnosis and access to an oncologist in a timely manner. We created an order for referral in our electronic medical record system that enables any provider to refer to patients to the SOC clinic. Once a referral is placed, a hematologist-oncologist or medical oncologist reviews the case and approves the patient for an appointment with the SOC clinic. Results: Between January 2022 and November 2022, we received 107 unique referrals to the SOC clinic. The average age of referred patients was 64 years, with 50 (46.7%) females and 57 (53.3%) males. Thirty-four (31.2%) referrals were from primary care doctors, 23 (21.5%) from hospital medicine, 22 (20.6%) from emergency medicine, 15 (14.0%) from medical subspecialties or neurology, 11 (10.3%) from surgery or surgical subspecialties, and 1 (0.93%) that was self-referred. Thirty (28.0%) patients already had definitive diagnosis of malignancy from either our institution or an outside institution, while 77 (72.0%) did not have a diagnosis at time of referral. Of the 107 referrals, 21 (19.6%) did not follow up with a medical oncologist or hematologist-oncologist within our health system. Reasons for not following up included insurance status, establishing care elsewhere, failed attempts to contact patients, or no shows to established clinic appointments. One patient was already established with a hematologist-oncologist within the MCC prior to referral. Eighty-six (80.4%) patients were seen in new consultation by a medical oncologist or hematologist-oncologist at our institution. After referral, the average time to consultation with a medical oncologist or a hematologist-oncologist was 15.3 days. In the 77 cases without diagnosis at time of referral, 39 (50.6%) underwent biopsy, while 38 (49.4%) were deemed to not require biopsy or declined biopsy. Twenty-five (32.5%) patients were diagnosed with cancer and 52 (67.5%) either did not have biopsy or had a negative biopsy. Ninety-two (86.0%) of the 107 referred patients were alive at time of analysis, while 15 (14.0%) were deceased. Conclusions: The MCC SOC clinic offers a referral pathway to expedite diagnosis and access to care for new oncology patients. In continuing to collect data related to the above outcomes, we hope to identify barriers to the delivery of oncologic care and improve patient outcomes.
Diversity, equity, and inclusion (DEI) champions: Lessons learned and implications for future programming to support cancer clinical trials.
Authors: Figueroa-Moseley Colmar , Gansauer Lucy , McDermott Jessica Dreger , Espinoza Gutarra Manuel Ricardo , Nagaraj Gayathri , Robinson Patricia A. , Bangs Rick , Caban-Holt Allison 
Published: June 2023

e18529 Background: Improving diversity and representativeness in SWOG Cancer Research Network (SWOG) clinical trials is critical for addressing disparities in prevention, detection, treatment, supportive care, and mortality among patients with cancer diagnosis. Understanding the needs of underrepresented groups (URGs) and building relationships and trust between these populations and researchers can help overcome barriers to study recruitment. SWOG developed a formal organization structure to provide evidence-based guidance for increasing diverse representation in SWOG research. Methods: Funded through a grant from Genentech and the Hope Foundation, SWOG developed a methodology and field guide to improve representativeness in clinical trials. This methodology includes analyzing the current clinical trial portfolio, reviewing study sites and inclusion/exclusion criteria, refining protocol and accrual plans to be more inclusive, implementing changes, and sharing findings with study teams and communities. Five DEI Champions were selected to work with 5 research committees including Gastrointestinal, Lung, Breast, and Genitourinary Cancers and Multiple Myeloma to identify action plans. The Champions provided tools, evidence, and strategies to implement SWOG’s DEI methodology, provided countermeasures for studies not meeting prespecified enrollment benchmarks, and analyzed and reported participation across the SWOG clinical trial portfolio. Champions, study teams, and committees all implemented strategies and structure for research program modifications and policies. Results: Four of the 5 research committees showed significant improvements in infrastructure and implementation of DEI. Factors that improved DEI within SWOG research committees included a willingness of the committee to engage in DEI work; the infrastructure in place to support the implementation of DEI; the tumor sites being studied, and cross-committee collaborations on research protocols (Veterans, Patient Advocacy, Recruitment & Retention, and Palliative & Support Care). Conclusions: The DEI Champion role is an important strategy that engages cancer researchers and staff in DEI improvement activities and improves infrastructure and recruitment of URGs to clinical trials. Further research is needed to determine the impact of DEI champions on cancer clinical trial participation.
Point-of-care isoenzyme type M2 pyruvate kinase quick stool test for the detection of gastric cancer in Rwanda: A pilot study.
Authors: Riano Ivy , Shikama Felicien , Mukanumviye Marie Solange , Ingabire Zainab , Nyampinga Dyna , Forbes Victoria , Chamberlin Mary D. , Aberra Hanna 
Published: June 2023

e18530 Background: Isoenzyme type M2 pyruvate kinase (M2-PK) can only be detected in gastrointestinal (GI) tumors. Detection of M2-PK on a small, portable platform with minimal training required, could offer a streamlined approach for the diagnosis of GI cancers especially in low-income countries (LIC's). We evaluated the feasibility of M2-PK stool test to detect gastric cancer in Rwanda. Methods: Participants with GI symptoms were screened and scheduled for upper endoscopy during the 5th Annual Rwanda Endoscopy Week. Participants who underwent gastric biopsy and provided a stool sample were enrolled. Three Rwandan medical centers participated. ScheBo M2-PK Quick test (Biotech AG, Giessen, Germany) was used to test fecal tumor M2-PK. Study approval was obtained from Dartmouth Health, UConn Health, and University of Rwanda IRB's. Descriptive statistics were estimated. Study is currently enrolling patients to reach the desired sample size (N = 110). Results: A total of 35 patients were consented; 26 patients did not have a biopsy, 1 did not provide a stool sample, 1 was lost to follow-up, and 7 were analyzable. 57.1% were male (n = 4) and 42.9% females (n = 3) with ages ranging from 50 to 71 years old. Males accounted for 66.6% of the cases of gastric cancer (n = 2). The most predominant symptoms reported were dyspepsia (66.7%), and weight loss (33.3%). Among those with hemoglobin levels available the mean was 8.63 g/dL (SD ± 0.71). Only one patient completed staging imaging with CT scans. Two patients with positive M2-PK stool tests had a proven diagnosis of gastric cancer (100%). One of them had a diagnosis of GIST. There was only 1 confirmed gastric adenocarcinoma in 5 patients with a negative M2-PK stool test, yet two patients were told to repeat the endoscopy procedure. Conclusions: A point-of-care (POC) quick stool test to screen gastric cancer is feasible in Rwanda. Study participation interest was high among Rwandan patients. Due to a lack of flexible endoscopes in LIC's, screening is restricted to patients living near regional or urban endoscopy centers, which contributes to the growing prevalence of gastric cancer and health disparities. Cancer control programs in LIC's can be implemented and maintained iteratively with realistic expectations and interventions tailored to the local population, its cultural values, and economic infrastructure. Thus, an emerging POC M2-PK stool test can triage patients to early medical attention when suspected gastric cancer.
Readability and understandability of instruments for collecting patient-generated data (PGD).
Authors: Chiodi Camila Kelly , Arvis Johanna , Martin Elise , Barbier Aude , Di Meglio Antonio , Jacob Guillemette , Menvielle Gwenn , Everhard Sibille , Guillemin Francis , Luis Ines Maria Vaz Duarte , Franzoi Maria Alice B 
Published: June 2023

e18534 Background: PGD are crucial to inform and optimize cancer care. These may include patient-reported outcomes measures (PROMs), patient-reported experience measures (PREMS), or patient preferences information (PPI). The increasing use of PGD has led to the need for the adaptation of instruments to different languages and cultures. Recent data has brought attention to the additional need to consider patients’ ability to understand written information included in PROMs. Low health literacy is associated with higher risk for quality-of-life deterioration and generates disparities, including underrepresentation in cancer research. Aiming at improving equity and representation, we evaluated readability and understandability of nine French-language PROMs that are currently used in a contemporary cohort of breast cancer survivors. Methods: Readability of PROMs was assessed using the Flesh Reading Ease Score (FRES), the Gunning’s Fog Index (FOG), and the FRY graphics (yielding a mean score representing the n. of school years required to understand the respective text). Readability was considered ideal if mean score ≤6th grade level and acceptable if between 6-8th grade. Understandability was evaluated using the Patient Education Materials Assessment Tool (PEMAT, range 0-100%, higher scores corresponding to easier understandability) and defined as ideal if PEMAT ≥ 80%. Plain-language best practice was met if both readability and understandability were ideal. The Evaluative Linguistic Framework for Questionnaires (ELF-Q) provided additional qualitative elements to assess understandability. Two native French speakers, including a patient representative, independently evaluated each PROM. An additional independent assessment was requested if discordance. Results: None of the 9 PROMs evaluated had ideal readability scores, and only 1 had an acceptable score. Understandability ranged from 55-91%, and only 3 PROMs had ideal scores. None of the instruments met the definition of plain-language best practice. ELF-Q identified points for improvement in several dimensions of the PROMs (Table). Conclusions: The use of comprehensive linguistic and cultural frameworks during the development and translation of self-reported PGD instruments may improve experience and engagement of patients with lower literacy and foster equity and representation in cancer cohort studies. [Table: see text]
A funder-based comparison of global oncology research led by NCI-designated cancer centers: Results from the 2021 global oncology survey.
Authors: Garton Elise M. , Eldridge Linsey , Cira Mishka K. , Frank Allison , Loehrer Patrick J. , Duncan Kalina 
Published: June 2023

e18535 Background: Equitable global cancer research partnerships are key to reducing the global burden of cancer, which disproportionately affects low-and middle-income countries (LMICs). One indicator of equitable partnerships is the inclusion of LMIC investigators in global cancer research. In 2021 the National Cancer Institute (NCI) conducted a survey of the 71 NCI-Designated Cancer Centers about their global oncology activity. The survey results highlight cancer centers' non-NIH funded global cancer research, training, and capacity-building projects and complement data about global cancer research funded by the National Institutes of Health (NIH). This analysis presents NIH and non-NIH funded global oncology research led by cancer centers stratified by collaborator income class. Methods: NCI designed and fielded an online survey to cancer center global oncology contacts and principal investigators of research projects from July 2021 through January 2022. Data about NIH grants were sourced from internal NIH systems. Income classes are defined by the World Bank and analysis was conducted in Microsoft Excel and Python. A two proportion Z test was used to test for differences in collaborator income class between NIH grants and non-NIH funded projects. Results: Ninety-four percent (67/71) of cancer centers responded to the survey. Forty-seven cancer centers reported 257 global oncology projects with named international collaborating institutions in 2021. Comparatively, 69 cancer centers held 688 NIH cancer research grants with international collaborating institutions in 2021. These projects and grants had collaborators in 111 countries, including 72 LMICs. Projects and grants were stratified by whether they had collaborators only in high-income countries (HICs), only in LMICs, or in both HICs and LMICs, as shown in Table 1. Non-NIH funded global oncology projects were significantly more likely than NIH grants to have only LMIC collaborators (p = 0.0006) or both HIC and LMIC collaborators (p < 0.0001). Conclusions: While the inclusion of LMIC collaborators in research does not guarantee an equitable partnership nor effective research, it is one indicator of these efforts. The results of the global oncology survey demonstrate that cancer centers are committed to conducting research in LMICs and with LMIC institutions, and they are more likely to collaborate with LMIC institutions when supported by a non-NIH funder or by institutional funds. Further analysis is recommended to understand the extent to which research collaboration indicates equitable partnership, and the barriers and facilitators to collaboration posed by different funding sources. [Table: see text]
Treatment adherence and clinical outcomes of osimertinib (Osi) among ethnic-minority patients (pts) with EGFR-mutated NSCLC.
Authors: Lee Matthew , Miao Emily , Zhang Chenxin , Xue Xiaonan , Tuckman Steven , Halmos Balazs , Cheng Haiying 
Published: June 2023

e18536 Background: Osimertinib (Osi) is widely used in the management of patients with EGFR-mutated NSCLC but there is limited data on the treatment adherence and clinical outcome of Osi in ethnic minorities. This study aims to evaluate race/ethnicity, adherence and other demographic, socioeconomic and clinical factors of patients with NSCLC treated with Osi. Methods: A retrospective cohort study of a total of 102 patients with EGFR mutated NSCLC that were prescribed Osi from 1/1/16-12/31/22 with 46 patients within Montefiore’s own specialty pharmacy system with updated claims data. Adherence was measured using two methods with medication possession ratio (MPR) and proportion of days covered (PDC). Primary endpoint was overall survival (OS) along with secondary endpoints of progression-free survival (PFS) and treatment duration from the start of Osi, compared minority vs non-minority using log-rank testing and survival analysis with cox proportional models. Results: A median follow-up time of 10.5 months (mons), median age of 69 years old and 34.8% self-reported as Non-Hispanic Black (NHB), 45.6% as Hispanic (H), 10.9% as non-Hispanic White (NHW) and 8.7% non-Hispanic Asian. Treatment adherence did not differ between Blacks vs non-Blacks or Hispanics vs non-Hispanics using both MPR or PDC. The median out of pocket cost for our pts after financial assistance and insurance was around $80 (USD). Compared to non-Hispanics, Hispanics had similar OS, PFS and treatment duration. However, compared with Non-Blacks, Blacks had inferior PFS (p=0.021) and borderline significance of worse OS (p=0.052) and shorter duration of Osi (p=0.068). Further results are summarized in the table. Conclusions: Our study demonstrates that treatment adherence did not differ among minority vs. non-minority patients. However, unlike Hispanics who had similar survival to non-Hispanics, Blacks had inferior PFS, OS and shorter duration of Osi compared to Non-Blacks. This warrants further research on the underlying mechanisms to help improve patient care and outcome while undergoing Osi treatment especially in Black pts. [Table: see text]
Impact of ethnicity and insurance on adverse effects and treatment outcomes related to immune checkpoint inhibitors at a safety net hospital.
Authors: Mahadevia Himil , Eidenschink Benjamin , Harry Stephanie Sarita , Kujtan Lara Ann 
Published: June 2023

e18538 Background: Clinical trials have shown efficacy and safety of immune checkpoint inhibitors (ICI) in the treatment of various malignancies. However, trial populations often do not adequately represent patient populations in the real-world. We report immune related adverse effects (IRAEs) among patients with various malignancies, diverse ethnicities, and government sponsored insurance or uninsured, as well as treatment outcomes of ICIs in metastatic non-small cell lung cancer (mNSCLC). Methods: A retrospective study of adult patients with malignancy, who received ICI or ICI plus chemotherapy from January 1, 2015 to January 1, 2020 was conducted at a safety net hospital. Data was collected from electronic medical records with IRB approval. IRAEs were identified and categorized according to CTCAE v5.0. 1-year overall survival (OS) and median duration of ICI therapy (mDT) were calculated for mNSCLC patients. Results: We reviewed 121 patients: 49% were African American (AA), 40% were white and 11% were other ethnicities. Medicaid/Medicare (M/M) was the primary insurance for 83% of patients, 6% had commercial insurance and 11% were uninsured. The median duration of follow-up was two years. IRAEs occurred in 37% of patients; hypothyroidism was the most common (7.5%), and none led to death. The incidence of grade 2 or higher IRAEs was lower in AA (25.4%) compared to in whites (32.6%), with treatment discontinuation rates of 5% in AA versus 16% in whites. Among mNSCLC patients, AA and other ethnicities had a decreased 1-year OS of 37% and 22% respectively, compared to 48% in whites. The mDT was 8.3 months for AA and 3 months for other ethnicities, compared to 13.2 months for whites. 40% of M/M patients with mNSCLC were alive at 1 year; none of the uninsured patients were alive at 1 year. The mDT was higher in M/M patients (6 months) than uninsured patients (3.5 months). Conclusions: Ethnicity and insurance coverage may influence the incidence of IRAEs and treatment outcomes with ICI. AA had a lower incidence of IRAEs compared to whites. However, minority populations with mNSCLC had decreased survival compared to whites. mNSCLC patients with M/M had better OS than uninsured patients. Minorities and uninsured patients spent less time on ICI compared to other patients. IRAEs are a significant burden and further study of the use of ICIs in diverse populations is warranted.[Table: see text]