bluuebunny/crossref_metadata_2025_split huggingface dataset:
EROS: Engendering reproductive health within oncologic survivorship—ECOG-ACRIN E1Q11 assessing discrepancy in clinician-patient importance of sexuality over 2 years post-cancer diagnosis.
Authors: Rao Shivani , Lee Ju-Whei , Hashim Sinan , Zaren Howard A. , Radeke Erika K. , Cella David , Fisch Michael Jordan , Wagner Lynne I. ,   EROS ECOG ACRIN E1Q11 Trial Group
Published: June 2024

e23197 Background: Cancer diagnosis and therapeutic interventions are associated with altered reproductive health including sexuality. Despite pertinence to quality of life, cancer management frequently precludes periodic assessments of sexual health. Methods: The EROS trial is a clustered randomized trial performed at 17 NCI Community Oncology Research Program (NCORP) sites (including 8 NCORP sites and 9 Minority/Underserved NCORP sites) from 2016-2023. Eligible subjects included reproductively capable women aged 15-55 with new cancer diagnosis. We report on an embedded observational study pertaining to oncosexuality. Perceived importance of patient’s sexuality maintenance was assessed for clinicians and patients on a 10-point Likert scale (1 = Not important; 10 = Extremely important). Mean and standard deviation were computed for value discrepancy (pairwise clinician-patient differential) by arm assignment and timepoint (baseline, 3-, 6-, 12- and 24-months). One-sample t-test was conducted with Bonferroni’s adjustment to evaluate cell mean of the value discrepancy against zero (α = 0.02). A mixed effect model analyzed intervention effect on value discrepancy over time, adjusting for baseline covariates (α = 0.05). Results: Mean patient importance rating within the intervention arm ranged from 8.39 (SD = 2.39) at baseline to 7.84 (SD = 2.86) at 24-month assessment; paired clinician value varied from 8.17 (SD = 2.57) to 7.77 (SD = 2.92), respectively. Within non-intervention arm, mean patient importance rating varied from 8.23 (SD = 1.95) at baseline to 8.68 (SD = 1.67) at 24-month assessment; paired clinician value ranged from 7.93 (SD = 1.86) to 8.15 (SD = 1.70). Mean clinician-patient value differentials with respect to arm assignment and timepoint were not significantly different from zero. A significant arm-by-timepoint interaction effect was noted (p = 0.0417). Post-hoc simple main effect analysis exhibited no intervention effect at any assessment timepoint. Conclusions: Data indicate high concordance of sexuality importance within oncologic clinicians and patients over the 2 years. Findings necessitate investigation to ensure management of sexual health matches level of importance to the cancer survivor. Clinical trial information: NCT01806129 .
Developing a manual clinical trials screening process in a diverse southern gynecologic oncology practice in the Deep South.
Authors: Klein Margaret , Pirzadah Humza , Magharehabed Yasmeen , Chapple Andrew G. , Castellano Tara , Jernigan Amelia 
Published: June 2024

e23209 Background: At this time, there is no standard clinical trial screening process or definition that has been adopted within Gynecologic Oncology. In our low resource, highly diverse Gynecologic Oncology patient population, we sought to create an equitable, adaptable, manual screening process that better reflected our patient population. Our objective is to describe our clinical trial screening process and our success in improving trial enrollment and a matched trial portfolio. Methods: An IRB-approved, QI project was implemented in July 2022 to evaluate trial access for Gyn Onc patients. First, screenable events were defined as: the start of one’s first scheduled visit, bi-monthly tumor boards, weekly pre-op meetings, and by keeping track of on a shared Epic list. Potential patients were those with a screenable event: new patients or diagnoses, regimen changes, progressions, and recurrences. Events were categorized into screen positive or screened no trial available. Screen positives were further categorized as screen fail, screen positive, enrollment failure, or enrolled. Data about patients was collected via weekly research team meetings. Monthly meetings occurred to review progress. This data was compared to trials available, number of patients with trail available, and those that enrolled. Reasons for enrollment fails were tracked to improve access and anticipate barriers. Results: Overall demographic data of patients was collected. The average age of participants was 60.67 years (SD = 13.45), and the average distance to a treatment center was 59.27 miles (SD = 137.43). Other demographics are presented in Table 1. For each month, the percentages of “screen no trial available (SNTA)” events and patients who screened positive and did enroll on trial were recorded. Over time, SNTA rates stayed stable, but enrollment increased. Patient preference accounted for 32.8% of enrollment fails (n = 42), pre-existing symptoms/conditions accounted for 23.4% (n = 30), and distance/location accounted for 21.1% (n = 27). During a time of high employee turnover in the summer months of 2023, there was a rise in enrollment fails due to staffing (n = 6, 4.7%). Conclusions: Through a collaborative quality initiative, we describe an effective process of clearly defining and tracking our patient population and ‘screenable events’ for which all patients are screened and offered trial participation if eligible. We show that we improved understanding of the patient population, built a clinical trial portfolio better matched to population served, exceeded national averages for enrolling patients on trials, and are moving toward improved number eligible over time. [Table: see text]
Creating and establishing a sustainable culture of clinical and translational research at an academic cancer center.
Authors: Kumar Parvesh , Cross Chad L. , Baker Ken , Hildebrandt Gerhard 
Published: June 2024

e23220 Background / Objectives: At the Ellis Fischel Cancer Center (EFCC) at the Univ. of Missouri (MU) School of Medicine (SOM), our recent (2016 - 2020) accurals to interventional oncology clinical trials (CT) have been suboptimal. Hence, the EFCC research leadership undertook a number of initiatives since 2021 to improve the function and productivity of the oncology CT enterprise. The objective of our retrospective review was to determine the impact of our initiatives including improving enrollments to clinical trials. Methods: These major programmatic initiatives have included the following: (1) CT portfolio analysis; (2) faculty survey to assess concerns/ needs related to enrollment; (3) Development of a "One-Pager" list of open CT; (4) Working with faculty leader "champions"; (5) Increasing the number of clinical research staff; (6) Initiation of a monthly "Clinical Trials Working Group (CTWG)" to monitor enrollment to clinical trials, troubleshooting obstacles to accruals and on-going CT portfolio analysis and adjustments; (7) Development of multi-disciplinary "Disease Working Groups" (DWGs) in Breast, GU, GYN-Onc., Lung, GI and CNS cancers to establish a Protocol Review & Monitoring System (PRMS) with the objective of aligning our clinical trials with our patient population; (9) Initiation of a monthly “Investigator Education Workshop” (IEW) to educate our faculty on the conduct of investigator initiated CT and pharma sponsored CT; (10) Initiation of a "Top Enrolling Ceremony" to honor the top enrollers to clinical trials. Results: The analysis of our CT portfolio revealed that in both December 2020 and May 2021, more than half [i.e., 52% (n = 17/33 and n = 13/25, respectively] of our CT had never enrolled a patient in the lifetime of the protocol. Since the implementation of the PRMS in late 2021, we have observed a continual decrease in the status of those clinical trials with “never” any enrollments from a historical average of 52% to 34% in January 2022, to 32% in January 2023 and to 28% in October 2023, p = 0.0173. In addition, implementation of the PRMS also had an immediate significant impact such that only 53% of all of the protocols reviewed by the Protocol Review and Monitoring Committee were approved in 2021 vs. a historical average of 75% from 2018 - 2020. Moreover, between 2021 and 2023, an average total of 82 patients were enrolled to interventional oncology clinical trials vs. the historical average of 42 patients per year from 2016- 2020, representing an overall increase of 95% p = 0.0004. Conclusions: The development and establishment of the PRMS within the last 3 years has had a very positive impact on our clinical trial enterprise at the EFCC by reducing active clinical trials that are not suitable for our patient population and significantly increasing our enrollment to interventional oncology clinical trials. For 2024, we will continue our implementation of the PRMS at the EFCC.
Development and preliminary validation of a platform for systematic, unbiased pre-screening of non-small cell lung cancer (NSCLC) across three community oncology practices.
Authors: Campbell Fontaine Annette , McAneny Barbara L. , Tucker Valerie , Koontz Michael Zach , Trotter Chardria , Paulson Joseph , Svedman Christer , Pan Alexander , Peguero Julio Antonio , Campos Luis T. 
Published: June 2024

e23230 Background: With a rapidly increasing number of candidate drugs and clinical trials in oncology, efficiency in clinical trial execution has become a primary focus area for innovation. Currently, fewer than 5% of oncology patients enroll in clinical trials, and data suggests a lack of diversity in clinical trial patient populations compared to the broader patient demographic. To address these issues, we developed a systematic unbiased pre-screening platform for all patients. This approach holds the promise of hastening clinical trials by enhancing the identification of eligible patients and concurrently promoting diversity among those invited to participate in these trials. Methods: A framework for use of EMR ingested data and standardized abstraction of select 160 variables was developed for patients with NSCLC. An algorithm based on 7 key eligibility criteria was developed to generate an automated assessment of eligibility for a presumed trial. Abstracted data was compared to a medical oncologist’s assessment (gold standard) and the automated tool was validated by comparing eligibility assessment before each visit with that of a medical oncologist. Results: Three community oncology practices in the US participated. Source data-verified values for histology, ECOG PS, treatment history, line of therapy, and current metastatic status were available for > 90% of patients in real-time. Tumor NGS testing rates for actionable alterations exceeded 75%. From Oct 23, 2023 to Jan 14, 2024, 786 NSCLC pts had MD visits. Preliminary validation of the automated tool in 79 patients revealed concordant classification in 76/79 pts (96.2%). Sensitivity, specificity, PPV and NPV were > 90%. Concordance for all variables was 98% between the abstractor and medical oncologist. Conclusions: A platform for systematic, unbiased pre-screening of patients for clinical trials in NSCLC has been developed to support and facilitate oncology sites without imposing financial or resource burdens or affecting routine clinical workflow. Preliminary validation supports high performance. Updated validation data will be presented in the meeting. The high levels of data completeness and quality, including NGS testing rates that are substantially higher than what has previously been reported in community centers, underscore their suitability as clinical trial sites.
Clinical outcomes of patients receiving venetoclax and hypomethylating agents for AML in academic and academic-community partnerships.
Authors: Pham Natalie , Lantz Jeffrey , Jones Caroline , Kundu Debamita , McCann Nicholas , El Chaer Firas , Reed Daniel , Keng Michael Kenneth 
Published: June 2024

e23235 Background: Prior studies have reported improved outcomes for acute myeloid leukemia (AML) in academic over nonacademic settings potentially due to the availability of multidisciplinary teams, clinical trials and increased resources (1,2). Our institution has partnered with community practices to further evaluate this disparity. In this study, we analyzed treatment outcomes when nonacademic centers partnered with academic centers to treat AML using a regimen of venetoclax and a hypomethylating agent. Methods: We reviewed 92 patients with newly diagnosed AML treated with venetoclax and either decitabine or azacitidine at an academic center (n = 57) or community practice with academic center support (n = 35). When partnering with the community, patients received the first cycle of therapy at an academic center. Before discharge, our team completed financial screening, scheduled follow up appointments and provided prescriptions. The primary objective was to evaluate the overall response rate (ORR) with a secondary evaluation of differences in chemotherapy management and complications. Results: Patients in the academic setting tended to have more adverse risk disease (80.7% vs. 74.3%, p = 0.36) according to the European LeukemiaNet (ELN) (table). The overall survival (OS) of all patients was 10.7 months (95% CI 9.4-15.7) with no significant difference between the groups. The ORR was similar between the community and academic settings (40.0% vs. 36.8%, p = 0.46). The complete remission (CR) rate was 11.4% in the community versus 19.3% in the academic setting (p = 0.67), and the CR rates were improved in the academic group versus the community after cycle 2 (12.9% vs. 0%, p = 0.72) and cycle 3 (25.0% vs. 0%, p = 0.46). Adverse events were comparable, except for increased rates of fatigue (80.7 vs. 54.3%, p = 0.01) and diarrhea (33.3 vs. 11.4%, p = 0.04) in the academic setting. Conclusions: Contrary to prior studies, our evaluation and ongoing partnerships support the transition of AML treatment to a community setting with academic consultation. Although there were some differences in adverse events, the OS and ORR were similar. Furthermore, this study did not identify any significant safety concerns that could prevent patients from receiving this regimen in either setting. Our goal is to continue evaluating this partnership, as we design prospective studies to improve the care of this patient population. 1. Giri S et al. OS of AML Treated at Academic Center Vs Nonacademic Center. Blood 2015. 2. Halpern AB et al. Practice patterns & outcomes for adults with AML. Hematol Am Soc 2020.[Table: see text]
Results of a quality improvement program to increase complete lung cancer biomarker testing rates by focusing on system, physician, and other factors associated with adverse health outcomes.
Authors: Heron Dwight Earl , Blair Jean , Francis Jawad Elias , Stoeppler-Biege Kristina , Simpson Lijo , Stapp Jeremy , Kim Joseph 
Published: June 2024

e23249 Background: Complete biomarker testing (CBT) is an underutilized standard of care for patients with advanced lung adenocarcinoma, but limited tissue samples may lead to incomplete testing. Especially if quantity is not sufficient (QNS) requiring additional samples, a prolonged time-to-initiation of treatment (TTT) has been shown to negatively impact clinical outcomes. Bon Secours Mercy Health (BSMH) Youngstown, Ohio reviewed biomarker testing data and found: 1) only 41% of patients received CBT, and 2) in the case of QNS when liquid biopsies were utilized, the time from diagnosis to results took an average of 42 days. BSMH worked in collaboration with OncoLens and Q Synthesis to address these issues and reduce the TTT. To our knowledge, there is also no data on interventions that can increase CBT across large health systems and simultaneously tackle both physician and other factors associated with known health disparities. Methods: A multidisciplinary team developed a new workflow for patients diagnosed with advanced NSCLC. The pilot involved collecting both tissue and blood at the time of needle biopsy and working with a single reference lab for testing. Physicians and nurses in radiology and pulmonology were in-serviced on the new workflow. As patients were being prepared for a biopsy procedure, nurses collected two tubes of blood for liquid biopsy. After the procedure, both the tissue and blood were sent to pathology and if pathology confirmed an advanced NSCLC diagnosis, both samples were sent to the reference lab for testing. The lab developed a new process to hold blood and test it only when the tissue was QNS. If QNS, tissue testing for PD- L1 was prioritized, and additional biomarker tests were completed with the blood sample. If tissue quantity was sufficient, unused blood was discarded. The lab charged for a single test regardless of whether the test was performed on tissue and/or blood. Results: The QI project ran from Sept 2021 - Dec 2022 and achieved four improvements: 1) a 39.6% increase in CBT in patients with advanced NSCLC (80.6% post-intervention), 2) a decrease of 15.7 days from diagnosis to complete liquid biopsy test results (27.2 days post-intervention, 3) increased CBT rates across all but one physician by an average of 55% (-5% to 220%), and 4) increased CBT by 8% in females and patients with Medicare, Medicaid or other noncommercial/underinsured/uninsured payors. Conclusions: This QI project demonstrated that CBT of advanced NSCLC can be improved by programs that are tailored to large health systems and individual physicians. Gains are also seen in patient populations at risk of adverse outcomes.
Questionnaire survey and analysis of drug clinical research implementation capabilities of breast cancer treatment departments in Chinese hospitals.
Authors: Lan Bo , Xuenan Peng , Ma Fei 
Published: June 2024

e23257 Background: Clinical research competence determines the quality of clinical research and the reliability of research findings and is vital in the development of new antitumor drugs and the diagnosis and treatment of breast cancer. Our study aimed to explore the clinical research implementation capabilities of breast cancer treatment departments in China and to analyze the differences among regions, departments and different hospital classifications. Methods: This was a department-based cross-sectional study conducted in the form of electronic questionnaires in China from 7th August to 31st August 2023; this study was initiated by the breast cancer expert committee of the National Cancer Center (NCC). The questionnaire was designed on the Wenjuanxing platform. Our study was conducted among the first batch of breast cancer standardized diagnosis and treatment quality control pilot centers, which includes 200 hospitals selected by the NCC on the basis of the level of breast cancer diagnosis and treatment, surgery volume and other factors. The centers cover 30 provinces, and all of them are tertiary-level general hospitals or cancer hospitals. Results: A total of 127 questionnaires from 122 hospitals were ultimately included in the analysis. Medical personnel involved in the clinical research of 118 (92.9%) departments received good clinical practice (GCP) training. A total of 89.3% (109/122) underwent centralized institutional review board (IRB) review. The steps of the approval process from research initiation to completion lasted 2-4 weeks or longer. The majority of departments initiated or participated in 2 or fewer clinical research projects over the past year. Among the differences between different departments, the Department of Medical Oncology had a better qualification profile and process and greater number of initiated and participated clinical studies than did the Department of Surgical Oncology. There were more patients enrolled in registered clinical trials in specialized cancer hospitals than in general hospitals (50 and below, 50-200, and more than 200 patients from specialized cancer hospitals vs. general hospitals: 39.1%, 52.2%, and 8.7% vs. 76.9%, 16.4%, and 6.7%, respectively; p = 0.001). For needs and problems, most of the departments were strongly willing to undertake clinical research and receive professional training; the most common problem in the process of conducting studies was patient recruitment. Conclusions: Most departments generally exhibited complete capabilities for implementing clinical research. Improvements in implementation efficiency, quality and quantity of research and patient recruitment are still needed. Professional training and communication, as well as the recommendation and implementation of clinical research, are required in future development.
Esophageal cancer in the United States: A 21-year mortality analysis (1999-2020).
Authors: Farooq Muhammad Zain , Kamal Usama , Jamil Adeena , Fatima Eeshal , Khurram Abiha , Khan Zoha , Kamdi Zainab , Ahmed Sana , Jaglal Michael Vishal 
Published: June 2024

e23258 Background: Esophageal cancer (EC) is the sixth leading cause of cancer-related deaths in the United States, with a mere 20% survival rate in the first five years, making it a significant public health concern. Considering the lack of comprehensive evaluations of mortality trends that are undergoing substantial transformations on a global scale, this study aims to provide an update on the mortality rates of esophageal cancer and its trends in the United States. Methods: The mortality trends among adults with EC were analyzed using data from the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiological Research (CDC WONDER) database, where EC was presented as a contributing or the underlying cause of death. Code C15 “Malignant Neoplasms of Esophagus” in the International Classification of Disease, tenth revision (ICD-10) was used to identify the data. Crude and age-adjusted mortality rates (AAMRs) per 100,000 people were extracted. Annual percent changes (APCs) in AAMRs with 95% CI were obtained using joint point regression analysis across different demographic (sex, race/ethnicity, and age) and geographic (state, urban-rural, and regional) subgroups. Results: Between 1999 and 2020, 309,725 documented deaths were attributed to esophageal cancer. The overall AAMR decreased from 1999-2020 (6.69 to 5.68). Males had higher consistently higher AAMRs than females (10.96 vs. 2.24). NH White had the highest overall AAMR (6.88), followed by NH Black (6.46), NH American Indian (4.95), Hispanic or Latino (3.31), and NH Asian or Pacific Islander (2.57). CMRs also increased with advancing age and were greatest in individuals over the age of 85 years. AAMR also varied by region (overall AAMR: Midwest: 7.18; Northeast: 6.75; South: 6.07; West: 5.76), and non-metropolitan areas had higher AAMR (non-core areas: 7.09; micropolitan areas: 7.19) than metropolitan areas (large central metropolitan areas: 5.75; large fringe areas: 6.33). The states in the upper 90th percentile of esophageal cancer-related AAMR were Vermont, District of Columbia, West Virginia, Ohio, New Hampshire, and Maine, and exhibited an approximately two-fold increase in AAMRs, compared to states falling in the lower 10th percentile. Conclusions: Over the last two decades, there has been an overall decline in mortality related to EC in the United States. However, demographic and geographic discrepancies in EC-related mortality persist, necessitating additional exploration and development of specifically directed treatments.