bluuebunny/crossref_metadata_2025_split huggingface dataset:
Examining knowledge of cancer-related family history in an urban underserved patient population.
Authors: Jones Monet , Ludi Daniel , Martinez Irann , Naylor Keith 
Published: June 2024

e22550 Background: An accurate assessment of family history of cancer is essential in assigning cancer risk, and in decision making regarding the timing and method of cancer screening. However, obtaining a complete and accurate cancer-related family history, including first- and second-degree relatives, is often challenging in underserved communities. Familial dynamics such as single parent households, kinship care, and estrangement may act as barriers to an individual’s knowledge of their family health history. Presently, Electronic Medical Record systems constrain users to a binary documentation of cancer history as either ‘yes’ or ‘no’. However, patients may be unaware or uncertain of their family’s cancer history. These unknowns are not captured, resulting in poor understanding of patient knowledge regarding their family history of cancer. Objective: To assess knowledge of cancer-related family history for first- and second-degree relatives among an urban underserved patient population. Funding source: The American Cancer Society. Methods: University of Illinois Health patients aged 45-75 years without a history of colorectal cancer, who received an order for colorectal cancer screening through fecal immunochemical testing or screening colonoscopy were eligible to participate. A total of 88 respondents completed a 23-item telephone survey assessing knowledge of their family cancer health history using a 5-point Likert scale. Surveys were administered in both English and Spanish languages. Results: Of the 88 survey participants, 50 (57%) were female, 54 (61%) were of black or African American race, and 31 (36%) were of Hispanic or Latino ethnicity. On a single-item question assessing overall knowledge of their cancer-related family history, 35 (39.7%) responded they know it well or very well, versus 13 (14.8%) with little or no knowledge. On knowledge of maternal cancer related history, 8 participants (9.1%) reported little or no knowledge of their mother’s cancer history, and 29 participants (33%) reported little or no knowledge of their maternal relatives’ cancer history. On knowledge of their father’s cancer history, 35 (39.8%) reported little or no knowledge of their father’s cancer history, and 48 participants (54.5%) reported little or no knowledge of their paternal relatives’ cancer history. Conclusions: This original research study addresses the current gap in understanding patient knowledge regarding familial cancer health history. Survey results demonstrate a striking discrepancy between respondent reported overall knowledge of cancer-related family history, and knowledge of their maternal and paternal cancer histories. Moreover, respondents reported increased knowledge of their mother’s versus father’s cancer history p < 0.0001. Improved recognition of unknown family history in first- and second-degree family members may improve cancer-risk assessment.
Adherence to cancer screening for patients with Li-Fraumeni syndrome: A report on our experience at Fred Hutchinson Cancer Center.
Authors: Bribiesca Rodriguez Josefine , Tatunay Kevin , Laurino Mercy Y , Dubard-Gault Marianne E 
Published: June 2024

e22553 Background: Li-Fraumeni syndrome (LFS) is a high-risk cancer predisposition syndrome where patients are at risk of developing multiple primary cancers, synchronous, and metachronous cancers in their lifetimes. Patients with LFS often serve as their own advocates to request and receive appropriate cancer screening as few clinicians have experience in caring for them and few clinics are adequately staffed to provide complex cancer screening coordination. Methods: Fred Hutchinson Cancer Center (Fred Hutch) is a large academic cancer care center associated with the University of Washington. In July 2020, Fred Hutch's clinical cancer genetic service launched a high-risk surveillance clinic for patients with hereditary cancer syndromes requiring services from multiple specialties. Our clinic has since helped patients with LFS receive coordinated cancer screening. Here we report on adherence to the Toronto protocol by reviewing patient demographic, cancer history and family history, and genetic records. Furthermore, we report on the number of visits, types of screening, and cancer diagnoses patients with LFS received since enrolling in the high-risk clinic. Results: A total of 112 patients with LFS were seen in the high-risk surveillance clinic between July 2020 and December 2023. Of these patients’ paths reviewed so far, 73 patients established with the clinic and received blood work and/or MRI imaging scans, and 42 were seen in at least one follow up visit. 2 patients with LFS were diagnosed with one or more new cancer diagnosis since enrollment, both have completed treatment, and both are without evidence of disease as of February 2024. Conclusions: The high-risk surveillance clinic was promptly utilized by patients with LFS for coordination of their complex cancer screening needs and to guide their next steps when triaging symptoms and concerns. While the clinic addresses a gap in cancer screening coordination, patients with LFS need wrap around care close to where they live which is difficult to accomplish in the Pacific Northwest.
The prevalence of RCTs in PARP and immune-checkpoint blockade combination trials: An appraisal of clinical evidence generation in oncology.
Authors: Olsen T. Anders , Saez-Ibanez Ana Rosa , Upadhaya Samik , Sharon Elad 
Published: June 2024

e23006 Background: PARP-inhibitors were developed to promote lethal genomic instability in cancers with homologous recombination repair (HRR) defects, ultimately receiving approval for patients with BRCA gene mutations. At the tumor microenvironment, DNA instability is linked to higher expression of immune activating signals such as PDL1. PDL1 is one of the primary targets for immune-checkpoint inhibitors (ICIs), receiving approval for numerous cancer types. In-vitro studies support mechanisms of possible synergy for PARP and ICIs in combination. Despite both therapy classes being available to oncologists for nearly a decade, the clinical benefit for these agents together remains unclear. Our study aims to appraise the global clinical trial landscape for trials testing combination PARP and PD1/PDL1 regimens. Methods: Search terms for all known approved or unapproved PD1/PDL1 and PARP inhibitors associated with trials registered on the National Library of Medicine’s website, clinicaltrials.gov, were included in the cohort as long as one interventional arm administered both agents. Qualitative and quantitative trial data features were collected from the Cancer Research Institute (CRI) Immuno-Oncology Intelligence Database and complemented with manually sourced information from trial registries and publications. Contribution of Effect (COE) was defined as trials with two or more arms that compare our combination regimen of interest to PARP or an ICI alone. The presence of randomization, eligibility for randomized-controlled trial (RCT) status as well as COE was determined by three reviewers separately with disagreements settled by committee decision. Results: In total, we found 188 clinical trials that enrolled 39,268 patients. A minority of 17 trials were phase I not considered as RCTs, leaving 37,827 patients across 171 trials for enrollment in phase II trials and beyond. Of these 171 trials, 80 (47 %) were single-arm studies without active comparator. Forty-nine (29%) used randomized assortment, 40 (23%) met criteria for an RCT and 33 (19%) met criteria for RCT with COE. In total, these 33 trials enrolled 14,803 patients. Of the 33, 17 (10%) enrolled patients with cancers that are approved for PARP blockade by the FDA and 11 (6%) employed genetic testing for HRR defects. Sponsorship ranged from 16 trials by industry, 6 by cooperative oncology group, 6 by academic institutions and 5 by the National Cancer Institute. Conclusions: Our study results highlight that the global clinical trial apparatus directs significant resources and patients towards trials with lower standards of evidence generation. Across sponsor types, there was a considerable number of trials that met the rigor of an RCT with COE. These findings show both promise and areas of improvement within the trial landscape to generate evidence relevant to the use of PARP and ICIs in combination.
The impact of end-of-life quality metrics on date of death and hospice documentation over time.
Authors: Deepak Divya , Mills Lydia , Indurlal Puneeth , Turnwald Brian , Sun Jian , Weber Dana , Garey Jody S. 
Published: June 2024

e23009 Background: Patient experience and quality of care at the end of life (EOL) have become increasingly important for Oncology providers with the shift to value-based care (VBC). Medicare VBC programs such as the Oncology Care Model (OCM) and Enhancing Oncology Model (EOM) encourage care transformation and use quality measurement to drive EOL quality improvements. Timely and accurate documentation allows practices to evaluate their own performance and continuously improve care transformation efforts. We studied documentation trends in the electronic health record (EHR) and compared them with Medicare claims to evaluate the impact quality metrics had on ensuring accurate practice documentation. Methods: Best practices were established, and continuous education was provided to enable capture and recording of key EOL data in the EHR beginning in July 2016. Patient level date of death (DOD) and hospice enrollment (HSP) data were provided by CMS during the OCM (July 2016 - June 2022) for 14 participating practices in The US Oncology Network (The Network). We obtained corresponding DOD and HSP data from the EHR and compared documentation trends between systems. Statistical analysis was performed for increasing/decreasing trends using the Mann Kendall test. Results: There were statistically significant increases in EHR DOD (19.37% increase, p value 0.02) and HSP (18.93% increase, p value 0.002) documentation from 2016 -2022. All practices had an average year over year increase of 16.40% in HSP documentation (range 11.94% - 18.93.%) and 16.24% increase in DOD documentation (range 6.49% - 19.37%). The median increase from 2016 to 2022 in documentation of DOD was 68% (range 37% - 92%) and HSP was 48% (range 12% - 83%) for all practices. Conclusions: As an epitome of the Hawthorne effect, EOL quality metrics drive clinical documentation improvements with DOD and HSP, further accelerated by continuous education and the establishment of best practices. Improved clinical documentation aids care transformation and quality improvement, creating a positive feedback loop. The impact of quality measurement on other structured and unstructured documentation in the EHR is apt for further exploration. CMMI Disclaimer: The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of CMS. The authors assume responsibility for the accuracy and completeness of the information contained in this document. [Table: see text]
Examining global and gender disparities in high-impact evidence synthesis on lung cancer: A 2000-2024 analysis of Cochrane Library.
Authors: Bhat Vivek , Bellur Shreyas S , Kumar Abhishek , Kaushik Sharanya , Ozair Ahmad , Walia Harneet Kaur , Ahluwalia Manmeet Singh 
Published: June 2024

e23021 Background: Most cancer-related deaths occur in low-middle-income countries (LMICs), yet LMICs are underrepresented in global oncology research. Women have also historically been underrepresented in clinical literature. High-impact evidence synthesis influences guidelines and practice worldwide, so equitable authorship can ensure that issues presented are applicable globally. The Cochrane Library is a repository of high-impact systematic reviews that can be authored from all over the world. So, we aimed to analyze the representation of LMICs and women in the authorship of lung-cancer-related Cochrane Reviews. Methods: From the topic 'Lung and Airways' in the Cochrane Library, we included all studies related to lung cancer, published till February 2, 2024. We extracted the authors’ national affiliations, categorizing them into LMICs and non-LMICs based on the 2023 World Bank income classifications. Collaboratives/ groups were considered as a single entity. Following this, we manually captured at least one webpage for each author showing their gender or gender pronouns. For authors whose gender could not be determined via manual search, we used Gender-API, an artificial intelligence-based software, to determine their gender based on their name and country. Authors with < 90% certainty of gender on Gender-API were categorized as unknown. Results: We included 42 reviews that had 233 authors, including three group authors. United Kingdom (22.32%; n = 52/233), followed by Australia (16.31%; n = 38/233), Spain (13.3%; n = 31/233), China (9.01%; n = 21/233) and France (6.87%; n = 16/233) were the most represented countries. There were no authors from LMICs. Manually, we ascertained gender for 85.04% (n = 194/228) of authors, and overall, for 94.74% (n = 216/228). Women constituted 42.6% (n = 92/216) of all authors. They were, however, better represented as first authors (50%; n = 19/38) and corresponding authors (54.05%; n = 20/37). Conclusions: Despite suffering the brunt of cancer, LMICs had no representation in lung-cancer-related Cochrane reviews. While authorship had a male preponderance overall, women were well represented as first and corresponding authors. Addressing authorship disparities in global oncology literature, via mentorship and capacity building, can improve its applicability and utilization.
Enrollment of older adults in clinical trials for oncology indications, 2010-2020: An evaluation by the FDA.
Authors: Yang Felice , Lerro Catherine C. , Feng Zhou , Akinboro Oladimeji , Curley Richard , Dilawari Asma Ali , Fiero Mallorie , Huang Yue , Ison Gwynn , Kanapuru Bindu , Leong Ruby , Liu Wei , Patel Timil , Suzman Daniel L. , Kluetz Paul Gustav , Singh Harpreet , Rivera Donna 
Published: June 2024

e23029 Background: Underrepresentation of older adults (≥65 years) in clinical trials may limit important evidence for regulatory and clinical decision-making. Prior FDA analysis1 demonstrated underrepresentation of older adults in oncology clinical trials. With recent efforts to encourage inclusion of older adults, we evaluated representation in clinical trials using updated data. Methods: This analysis used patient-level data from pivotal trials supporting approvals of new drugs and biologics, and expanded indications from 2010-2020 for cancers with high incidence in the U.S. population and older adults: breast (BC), colorectal (CRC), non-small cell lung (NSCLC), prostate (PC), chronic myeloid leukemia (CML), and multiple myeloma (MM). Age distribution of trial participants compared to incident cases from the NCI SEER Program was analyzed using the Enrollment to Incidence Ratio (EIR). For each cancer-age group, EIR is the percentage of trial participants divided by percentage of incident cases. Previously established EIR categories of < 0.8, 0.80-1.20, and > 1.2 indicate under-, adequate, and over-representation, respectively. Results: The analysis included 86000 participants in 152 trials. Adults >65 yrs were underrepresented in BC trials. Adults >75 yrs were underrepresented in BC, CRC, NSCLC, CML, and MM trials (Table 1). Conclusions: Despite slight variation across cancers, adults >75 yrs appeared to be underrepresented in clinical trials, excepting PC. Given heterogeneity in the natural history by cancer site, incidence may not best represent age distribution of the intended use population for all trials. Further evaluation using prevalence as a comparator may provide additional insights. Additionally, results may be affected by clinical factors such as stage; however, comparison is limited by SEER data element availability. Planned sensitivity analyses such as stratification by drug class and line of therapy may further elucidate enrollment patterns. References: Singh H, Kanapuru B, Smith C, et al: FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the U.S. Food and Drug Administration. Journal of Clinical Oncology 35:10009-10009, 2017. [Table: see text]
Assessing the relevance and requirement of a prostate cancer passport: A patient-centric survey.
Authors: Aslam Razia , Shah Syed Muhammad Bilal , Hadi Danial , Mc Cann Aoife , Barron Emma 
Published: June 2024

e23037 Background: Prostate cancer, a prevalent malignancy among men worldwide, necessitates a multifaceted approach to its management, encompassing diagnosis, treatment, and post-treatment care. The absence of a consolidated and accessible cancer information for prostate cancer patients prompts an exploration into the necessity and potential benefits of a dedicated Prostate Cancer Passport. This survey-based study seeks to elucidate patient perspectives and assess the demand for it. Methods: We Surveyed prostate cancer patients attending St James Hospital Medical Oncology OPD and day ward. The survey methodology integrated a diverse cohort of individuals representing varying demographics, encompassing age groups and socio-economic backgrounds. Questions were structured to gauge patient awareness, preferences, and perceived benefits associated with the adoption of a Prostate Passport. The survey was structured to gauge patient awareness levels regarding existing health record systems, preferences for a specialized Prostate Cancer Passport, and anticipated benefits associated with its implementation Furthermore, the survey seeked to elucidate potential concerns, barriers to adoption, and the anticipated impact on patient-provider interactions. Results: The survey’s findings indicate a significant interest among participants in the implementation of a specialized platform like the Prostate Passport, with more than 65% expressing enthusiasm about its potential benefits in improving healthcare management. However, 20% of patients reported not receiving any prostate cancer information booklet from their healthcare providers. Additionally, 30% of participants expressed dissatisfaction with communication with their medical team, while over 40% lacked confidence in their understanding of prostate cancer. Nevertheless, concerns related to data security were raised by more than 25% of patients, and approximately 23% identified potential barriers to adoption, such as interoperability with existing healthcare systems and ease of access across different healthcare settings. However, concerns regarding data security were highlighted by over 25% of patients and about 23% of patients identified interoperability with existing healthcare systems, and ease of access across various healthcare settings as potential barriers to adoption. Conclusions: The survey outcomes offer valuable perspectives on the distinct requirements and preferences of individuals facing prostate cancer. This data is crucial for customizing the Prostate Cancer Passport's design and functionalities to effectively cater to those needs. Our initial iteration of the prostate cancer passport has been completed and will be distributed to our oncology patients in the upcoming week. We plan to conduct a feedback survey in six months to gather insights and further enhance the passport based on user experiences.
CAR T-cell therapies: Measuring the growing need for increasing long-term safety protocols.
Authors: Faroun Yacoub , Winkelman Daniel F. , Gambone Nicholas , Angelastro Patrick 
Published: June 2024

e23047 Background: The CAR T-Cell market has grown significantly over the last five years with six products in the U.S. market covering a range of cancer types (DLBCL, FL, MCL, MM, ALL). The number of transplant centers certified for CAR T-Cell administration has also grown from 142 centers in Q4 2020 to 200 in Q4 2023. The FDA is currently investigating the safety of CAR T-Cell therapies due to the threat of secondary malignancies. CAR T-Cell patients are treated at advanced treatment centers but after they have completed therapy, they are often referred back to their original specialist for long-term monitoring. The purpose of this research is to measure if referring Oncologists have the information required to safely manage CAR T-Cell patients. Methods: This study followed market research best practices. The study was based on a survey of the BrandImpact panel of Oncologists who refer patients and a CAR T-Cell Panel of Oncologists who administer CAR T-Cell therapies. Results: The majority of referring Oncologists (61%) report they could use more information about CAR T-Cell therapies. When asked on an unaided basis what type of information they require, the most common request was for additional safety information (57%). At the same time, one-third of Oncologists treating CAR T-Cell patients at the advanced centers feel that there needs to be improved knowledge of the long-term safety aspects of CAR T-Cell therapies. When they resume monitoring CAR T-Cell patients, they would like to better understand the relevant long-term side effects and how they differ from the short-term side effects. Conclusions: Oncologists who refer CAR T-Cell patients report that they need more information; mainly around safety/side-effects. Of the Oncologists administering CAR T-Cell therapies, one-third feel there needs to be improved knowledge of the long-term safety issues. Consideration should be given to improving the level of educational information provided on this topic to improve CAR T-Cell patient outcomes. [Table: see text]