bluuebunny/crossref_metadata_2025_split huggingface dataset:
CancerX: A national public-private partnership to boost innovation in the fight against cancer.
Authors: Goldsack Jennifer C , Konya Stephen , Young Catharine , Robinson Edmondo J , Mohan Santosh 
Published: June 2023

e13637 Background: In early 2022, President Biden reignited the Cancer Moonshot, setting new national goals to cut the death rate from cancer by at least 50% over the next 25 years and improve the experience of people and their families living with and surviving cancer. In its first year, the reignited Cancer Moonshot announced over 25 new programs, policies, and resources in pursuit of these goals. In February 2023, to mark the one-year anniversary of the new national goals, the Cancer Cabinet – the expert and interagency body responsible for setting the Cancer Moonshot agenda across government agencies – announced three new actions, including the launch of CancerX - a public-private partnership (PPP) to act as a national accelerator to boost innovation in the fight against cancer. Methods: Leveraging foundational work of Moffitt Cancer Center, the U.S. Department of Health and Human Services (HHS), the Digital Medicine Society (DiMe), and Moffitt Cancer Center have come together to establish and lead CancerX as an open, collaborative public private partnership effort to rapidly accelerate the pace of cancer innovation in the US. This builds on momentum of prior successful multi-stakeholder collaborations led by these founders to advance digital innovation to reduce the incidence and burden of cancer for all people. This multi-stakeholder success will characterize CancerX, with additional organizations driving innovation in the fight against cancer participating across initiatives. Results: To speed the development and optimize the impact of innovative solutions across the continuum of cancer care – including prevention, detection, treatment, and transitions in care – CancerX is comprised of three key initiatives: 1) Pre-competitive evidence generation: a rolling series of multi-stakeholder efforts will develop evidence, best practices, toolkits, and value models to drive the success of the mission. 2) Accelerator: This program will provide mentorship, education, and exposure to funding and clinical partnership opportunities to a start-up cohort aligned with the mission. 3) Demonstration projects: These implementation projects will pilot novel, mission-aligned approaches to demonstrate their value and sustainability for scale to drive broad adoption. Conclusions: CancerX provides a structure for organizations whose missions are aligned with the Cancer Moonshot goals to rapidly advance innovative solutions for success at scale. Through a multi-pronged approach focused on 1) commoditizing best practices and aligning incentives, 2) coordinating access to research, mentorship, resources, and other collaborative opportunities, and 3) demonstrating success in practice to drive broad adoption, this PPP will reduce the incidence and burden of cancer for all people.
Altmetrics of breast cancer clinical trials’ subgroup analysis: A systematic review.
Authors: Odeh Nada Wael , Alzubi Marah , Alrawabdeh Jawad , Al Zyoud Muntaser , Hamadneh Yazan , Al Hadidi Samer 
Published: June 2023

e13640 Background: Sharing findings of clinical trials using the internet and social media is increasing. Altmetric attention scores are instantaneous evaluations of the influence and popularity of science in a variety of media, such as news, blogs, and different social media platforms. Altmetrics’ distributions and trends for subgroup analyses were not previously investigated. Our study aimed to characterize altmetrics of the studies reporting subgroup analyses of breast cancer clinical trials and to assess the association between altmetrics and other characteristics of publications. Methods: We performed a systematic review of all published secondary analyses of breast cancer clinical trials form Jan 2020 until Feb 15, 2022. 1491 secondary analysis of solid malignancies were identified of which 287 were related to breast cancer. The altmetric scores for the included studies were obtained from a website named Bookmarklet for Researchers on the 12th of Feb 2023. Pearson’s correlation, Independent Samples t test, the one-way analysis of variance (ANOVA), and Chi-Square test were utilized to identify associations between a number of the studies’ characteristics and altmetrics. Statistical analysis was completed using SPSS Statistics. Results: Altmetric scores were captured for 211 (73.5%) of the 287 included publications. The median score was 4 (IQR 2-19). The captured altmetric scores ranged from 1 to 882. Around 45% of the included studies were first-authored by women and pharmaceutical companies funded approximately 35%. Both gender and funding source did not show any effect on the altmetric scores. Higher altmetric scores ( > = 4) were associated with authors who reported conflicts of interest (COI) (P = 0.001), studies published in 2015 or after (P = 0.003), papers published in journals with higher impact factors (P < 0.001), and publications with a higher number of authors (P = 0.019). Conclusions: Higher number of authors, presence of COI, higher impact factor of the publishing journal, and a publication year of 2015 or after are associated with higher altmetric scores in subgroup analyses of breast cancer-based clinical trials. Given the observational nature of secondary analysis and possible inaccurate conclusions, caution must be entertained when interpreting their findings.
Trends and characteristics of potentially preventable emergency department visits among patients with cancer in the US.
Authors: Alishahi Tabriz Amir , Turner Kea , Hong Young-Rock , Powers Benjamin Daniel , Lafata Jennifer Elston 
Published: June 2023

e13643 Background: An initial step to reducing emergency department (ED) visits among patients with cancer is to identify the characteristics of patients visiting the ED and examine which of those visits could be prevented. The objective of this study was to explore nationwide trends and characteristics of ED visits and examine factors associated with potentially preventable ED visits and unplanned hospitalizations among patients with cancer in the US. Methods: This cross-sectional study used data on ED visits from the National Hospital Ambulatory Medical Care Survey from January 1, 2012, to December 31, 2019; US Cancer Statistics reports were used to estimate new cancer cases each year. Frequencies and trends of ED visits by adult patients (aged ≥18 years) with cancer were calculated. The primary outcome was potentially preventable ED visits (using the Centers for Medicare & Medicaid Services definition), and secondary outcomes were hospitalizations and the immediacy of the ED visits. Multivariable logistic regression analyses were performed to examine the associations of patient, hospital, and temporal factors with potentially preventable ED use and ED use resulting in hospitalization. Results: Among 854911106 ED visits, 35510014 (4.2%) were made by patients with cancer (mean [SD] age, 66.2 [16.2] years); of those, 55.2% of visits were among women, 73.2% were among non-Hispanic White individuals, 89.8% were among patients living in a private residence, and 54.3% were among Medicare enrollees. A total of 18 316 373 ED visits (51.6%) were identified as potentially preventable, and 5 770 571 visits (21.3%) were classified as high acuity. From 2012 to 2019, potentially preventable ED visits increased from 1 851 692 to 3 214 276. Pain (36.9%) was the most common reason for potentially preventable ED visits. The number of patients who visited an ED because of pain increased from 1 192 197 in 2012 to 2 405 849 in 2019 (a 101.8% increase). Overall, 28.9% of ED visits resulted in unplanned hospitalizations, which did not change significantly over time (from 32.2% in 2012 to 26.6% in 2019; P = .78 for trend). Factors such as residence in a nursing home (odds ratio, 1.73; 95% CI, 1.25-2.41) were positively associated with having a potentially preventable ED visit, and factors such as the presence of more than 1 comorbidity (odds ratio, 1.82; 95% CI, 1.43-2.32) were positively associated with having an unplanned hospitalization. Conclusions: In this study, 51.6% of ED visits among patients with cancer were identified as potentially preventable, and the absolute number of potentially preventable ED visits increased substantially between 2012 and 2019. These findings highlight the need for cancer care programs to implement evidence-based interventions to better manage cancer treatment complications, such as uncontrolled pain, in outpatient and ambulatory settings.
Alternative trastuzumab dosing schedules and association with health care greenhouse gas emissions.
Authors: Strohbehn Garth William , Jacobson Sofia , Kacew Alec , Knoebel Randall W. , Hsieh Po-Hung , Ratain Mark J. 
Published: June 2023

e13644 Background: Climate change due to greenhouse gas (GHG) emissions by humans imperils health. Health care is a major source of GHG emissions and thus reducing health care’s environmental impact should be a global priority. GHG emissions associated with the production and administration of cancer drugs, as well the downstream societal costs in human health terms, are undescribed. The extent to which a given cancer drug’s dosing frequency and duration impact GHG emissions is unknown. Methods: Using trastuzumab for HER2-positive breast cancer as a use case, we conducted a case-control simulation study of single, U.S. academic medical center data to estimate the expected reductions in GHG emissions with three alternative dosing strategies (6-month adjuvant treatment duration, extended-interval dosing, and both) using streamlined life-cycle analysis. We estimated the per-patient relative reduction in GHG emissions expected to occur with each of the alternative dosing strategies and, in exploratory analysis, the societal health costs ( e.g., disability-adjusted life-years [DALYs] and excess mortality per kg CO2) associated with therapy-related GHG emissions, using conventional versus alternative dosing strategies. Results: Adoption of 6-month adjuvant trastuzumab reduced expected per-patient GHG emissions in the adjuvant setting by 10%. Adoption of both 6-month adjuvant trastuzumab and pharmacokinetically-supported every 4-week trastuzumab dosing reduced GHG emissions by 4.5%, 18.7%, and 14.6% in the neoadjuvant, adjuvant, and metastatic settings, respectively. An estimated 8.1 DALYs and 4.6 excess lives are lost annually worldwide as a result of U.S.-based administration of conventionally dosed trastuzumab. Adoption of alternative dosing in the U.S. is estimated to enable avoidance of approximately 1.5 DALYs and 0.9 excess lives lost annually. Conclusions: Alternative dosing strategies, suggested to be noninferior by pharmacokinetic and clinical evidence, are estimated to reduce the societal health costs imposed on bystanders that arise from cancer care’s environmental impact. Environmental impact and its resultant societal health costs should be considered in clinical trial design, re-interpretation of previously conducted trials, regulatory decision-making, and health technology assessments of both new and existing cancer therapies.
Is there a harmonised standard to oncology trial data provision in data sharing initiatives?
Authors: Hopkins Ashley Mark , Modi Natansh , Sorich Michael J. 
Published: June 2023

e13645 Background: Over the past decade the pharmaceutical industry has invested considerably in data sharing infrastructures to support independent researcher access to clinical trial individual-participant data (IPD), facilitating novel secondary analyses and the development of predictive models/simulation tools. Data sharing also helps in informing trial design and can accelerate the development of new therapies. To facilitate a data sharing ecosystem achieving these visions, researchers need to be able to access data, and when they do so, optimally, the data needs to be provided in a harmonised format that supports the research. Methods: In 2021 an audit confirmed 91 (of 203) clinical trials supporting medicines approved by the FDA in the last 10 years for the treatment of solid tumours as eligible (‘in scope’) for independent IPD request. This study reports on data provision for a planned clinical trial IPD meta-analysis summarising adverse events and therapeutic outcomes for new anticancer medicines according to race and sex. For the trials shared upon request, we report the heterogeneity in provisions of IPD and supporting documents. Results: Following SAP submission, the team obtained IPD packages from 76% (69 of 91) of requested trials – this includes data from 13 companies in a pooled cohort of over 40000 patients treated with new medicines against solid tumours. Time to data provision ranged from 117 to 312 days. In the IPD packages of 7 trials, overall survival or progression-free survival data were redacted, while for 9 trials there were partial redactions to adverse event data. For 3 trials, race data was removed, and for 1, sex was removed. Age was provided as a categorised variable in 17 trials. Weight was removed from 10 trials, and performance status was removed from 2. For 19 trials no clinical study report was provided, for 4 trials the data dictionary was missing, for 18 trials there were no data derivation specifications, while 5 IPD packages did not contain files orientating to anonymisation. Conclusions: While there is room to improve and standardize data sharing principles and procedures, overall, the acquired IPD was observed as a significant and high-quality resource for future scientific discovery. Future research could consider evaluating the ability to access data from non-industry trial sponsors, and strategies to harmonise data sharing practices between companies.
Towards the improvement of breast cancer management based on EUSOMA quality indicators: Insights from a 15-year institutional experience.
Authors: Paulina Lugo , Campoverde Leticia , Bautista Valeria , Saenz Samantha , Caicedo Andres 
Published: June 2023

e13662 Background: Breast cancer (BC) is the most common female malignancy and the leading cause of cancer-related deaths among women worldwide. Quality indicators (QIs) are evidence-based measures in healthcare used to track and improve patient care. In 2010, the European Society of Breast Cancer Specialists (EUSOMA) identified several quality indicators that could be adopted by breast cancer dedicated institutions. These QIs allow standardized clinical performance and quality assurance for BC care. We assessed the compliance of EUSOMA QIs published in 2017 by the Hospital de los Valles (HDLV), an Ecuadorian private institution, as a tool to assess BC management. This is the first project in Ecuador and South America that evaluates breast cancer quality indicators. The importance of this project is to create a foundation to identify areas for the improvement of breast cancer care in Ecuador. Methods: Women between 20 and 80 years of age with a histopathological diagnosis of BC and surgically treated at HDLV between 2007 and 2022 were included and analyzed in compliance with the updated EUSOMA QIs (2017). Exclusion criteria: male patients, breast cancer cases diagnosed by core biopsy only and without surgical excision, previous chemotherapy exposure. The number of cases meeting each criteria for EUSOMA QIs is expressed as percentages. Results: 137 women with breast cancer were included for analysis. Based on available information and resources, we were able to assess 14 out of the 34 QIs proposed by EUSOMA. Six indicators reached the minimum standard suggested by EUSOMA: 3 out of 7 QIs for diagnosis, 2 out of 3 for surgical and locoregional treatment, and 1 out of 4 for surgical and quality of life. Standards in triple diagnosis, waiting time, and surgical approaches were accomplished, while standards for surgical over-treatment and simultaneous reconstructive surgery did not meet standards. Conclusions: The lack of data about treatment, follow-up, and low access to standardized procedures limited the number of QIs assessed. This study marks a milestone towards continuous BC care improvement and indicates the need for local QIs and their regional implementation.
Pattern of molecular testing among US veterans with gastrointestinal cancers: A single center experience.
Authors: Shikdar Sufana , Gentry Christopher , Nicholson Alisha , Sawh Ravindranauth 
Published: June 2023

e13663 Background: In response to the rising global burden of cancers, the Veterans Health Administration's (VHA) National Precision Oncology Program (NPOP) supports the use of molecular testing (MT) among veterans. The Oklahoma City (OKC) VHA is serving patients with cancer in both rural and urban areas by implementing the standard practice of precision oncology testing across our diverse patient population. Identification of molecular biomarkers can facilitate treatment selection and trial access for veterans. Here we report real-world practices of physicians caring for veterans with gastrointestinal (GI) cancers namely gastroesophageal (GE), pancreatobiliary (PB) and colon cancers at OKC VHA and determine the degree to which molecular data is being utilized to prognosticate or alter clinical management. Methods: Patients presenting to the OKC VHA with metastatic GE, PB and colon cancer from June 2020 to September 2022 were included in the study. Data was collected retrospectively, including patient demographics, clinical characteristics, mutational data, actionability (OncoKB), and treatment recommendations. The primary outcome was the percentage of tumor sequencing performed, and actionable alteration annotated by the OncoKB database therapeutic evidence level. Results: 101 veterans were diagnosed with metastatic GI cancers (GE 18.8%, PB 28.7% and colon 52.4%), of which 82 samples (81.2%) were submitted for MT. The cohort was male-dominant (98%) with a median age of 69.5 years, and 46.5% of the veterans were from rural Oklahoma. Time from test order date to test result availability was 11.7 days. 25.7% (n=26) had at least one likely oncogenic mutation according to the OncoKB database, and 12.8% of them (n=13) were changed to FDA-approved targeted medications. The most common aberrant genes were TP53, KRAS, HER2, and MSI-H. Statistically significant differences were seen in the level of evidence by cancer group. In multivariate logistic regression, patients with colon cancer were most likely to receive MT (OR, 45.5 95% CI 2.27, 27.0 for colon over PB; OR 14.7 95% CI 2.27, 29.6 for GE over PB). Provider level (fellow vs faculty) and distance from the VHA (urban vs rural) were not associated with MT. Conclusions: Our study indicates clinical implementation of precision oncology is feasible across the VHA healthcare system, including rural veterans. Further analysis of this large cohort of patients will help to address gaps in MT for veterans with GE and PB cancers. The study also highlights the importance of MT to guide clinical trial enrollment and identify investigational drug opportunities among veterans.[Table: see text]
Effect of national multidisciplinary tumor boards on diagnostic stratification and therapeutic management in cancers of unknown primary.
Authors: Jacquin Nicolas , Kamal Maud , Bieche Ivan , Dupain Célia , Guillou Isabelle , Rouleau Etienne , Masliah-Planchon Julien , Tlemsani Camille , Blons Helene , Marisa Laetitia , Blanc Pierre , Wong Jennifer , Saintigny Pierre , Boyault Sandrine , Allory Yves , Vincent-Salomon Anne , Cockenpot Vincent , Selves Janick , Le Tourneau Christophe , Watson Sarah 
Published: June 2023

e13666 Background: With the increasing complexity of current diagnostic investigations, the integration of clinical, pathological and genomic characteristics is crucial for the management of patients (pts) with cancers of unknown primary (CUP). A national multidisciplinary tumor board (NatCUPMTB) was created in July 2020 in France to discuss the diagnostic and therapeutic management of CUP pts. The objective of this study was to evaluate the diagnostic, prognostic and therapeutic impact of NatCUPMTB after 30 months of activity. Methods: This was a multicenter retrospective study with prospective follow-up. All pts discussed at least once in the NatCUPMTB between July 2020 and January 2023 were included. Pts and tumors characteristics, pathological and genomic analyses including WGS, WES and RNAseq performed on the two PFGM2025 (French Genomic Medecine Plan 2025) national large-scale sequencing platforms, NatCUPMTB conclusions, and follow-up were collected. Results: 151 pts were included. The median age at diagnosis was 58 yo, 55% were female, and the median number of metastatic sites at diagnosis was 2. The median time between diagnosis and first MTB presentation was 4 months (1-20). At the time of analysis, NatCUPMTB conclusions and long-term follow up were available for 92 pts. MTB investigations enabled to identify a likely primary origin in 53/92 (58%) pts, the most frequent being renal carcinoma (N=9) cholangiocarcinoma (N=6) and lung carcinoma (N=6). For 16/53 (30%) pts, MTB diagnoses were based on the combination of clinical, pathological and genomic investigations. NatCUPMTB recommended a personalized therapeutic strategy in 54/92 patients (59%). After a median follow-up of 11.2 months, the median overall survival (OS) was 17.4 months from diagnosis and 10.1 months from the 1st MTB presentation. Pts for which the MTB had a diagnostic impact had increased OS from 1st MTB presentation compared to pts with no diagnostic orientation (14.5 vs 4.4 months, p=0.0007). Moreover, pts having received a treatment following MTB recommendation (based on likely origin or targetable alteration) had increased OS from 1st MTB presentation compared to pts having received other treatments (14.5 vs 4.4 months, p=0.003). Conclusions: NatCUPMTB provides significant diagnostic and therapeutic benefit in pts with CUP. Early presentation of pts at NatCUPMTB as soon as CUP diagnosis is suspected should be recommended.