bluuebunny/crossref_metadata_2025 huggingface dataset:
Using SMS technology to improve quality of life and symptom management in the breast cancer patient population: A feasibility study.
Authors: Fulton Tracy , Lettkeman Laura , Buchholz Thomas A.
Published: June 2023

e13619

Background: Cancer patients experience a wide range of negative side effects/symptoms from chemotherapy and radiation including pain, dehydration, nausea/vomiting, and diarrhea/constipation. Symptoms are distressing and decrease the overall quality of life and increase unnecessary hospitalizations and emergency visits. Symptom management and quality of life may be improved by using Short Message System (SMS) texting in cardiac and diabetic patient populations. The technology may also decrease costs for unnecessary emergency department (ED) visits by breast cancer patients. The purpose of this study was to determine if an SMS texting service can improve quality of life by improving symptom management. A secondary purpose was to evaluate if texting decreases emergency visits by breast cancer patients. Methods: This IRB-approved, consented study implemented an SMS texting program for breast cancer patients. Participants received two texts per day during their chemotherapy treatment period (6 months), one text being informational regarding symptom management and the second was one of encouragement and inspiration. Participants were called bi-weekly to complete the Distress Thermometer for Patients (NCCN). ED visits and/or hospital admission rates for the sample were collected. An exit interview measured satisfaction with the program in quantitative measures and theme analysis for qualitative measures. Twenty patients participated in this study, with 13 included in the data analysis. Results: SMS texting provided a change in treatment for symptom management in 40% of patients. Overall satisfaction with the SMS program was at the 89th percentile. Almost all participants felt supported and cared for due to bi-weekly calls by the investigators. Only 10% of the participants visited the emergency department, which is lower than historical averages. Data concerning the distress thermometer proved to be non-informative. Conclusions: SMS texting is feasible and easily integrated into the care of breast cancer patients. Texting technology may provide engagement with the care team leading to changes and improvement in symptom management during chemotherapy treatment. Further study of texting technology providing interactive abilities for patient-reported outcomes is warranted.
Remote evaluation of NAVIFY Oncology Hub using clinical simulation.
Authors: Halligan Jack , Goh Ethan , Lo Ernest N. , Chabut Delphine , Prime Matthew Stewart , Ghafur Saira
Published: June 2023

e13622

Background: Clinical workflow is critical for the efficient and safe delivery of patient care. NAVIFY Oncology Hub is a clinical workflow solution that provides clinicians with a comprehensive view of a patient’s clinical journey and aims to enable effective and efficient care decisions in oncology care. This study explored the use of remote clinical simulation to assess the usability, efficiency, and cognitive burden associated with using NAVIFY Oncology Hub. Methods: Twenty seven (27) board-certified oncologists were recruited to participate in remote evaluation sessions conducted via teleconference. Participants were instructed to review and synthesize clinical information from 10 synthetic breast cancer cases using NAVIFY Oncology Hub (case order was randomized). After completing the exercise, participants answered a survey which included the system usability scale (SUS), Likert-scale questions designed for participants to self-report the efficiency of completing each task, and the NASA Task Load index (to assess cognitive burden). The survey and a short interview was also used to gather structured feedback on the solution, patient cases, and study methods. Results: NAVIFY Oncology Hub scored an “excellent” 82 on the system usability scale (SUS). Most participants (67%) indicated that they would be likely to use the solution in their clinical practice, with approximately half (48%) reporting they would recommend it to a colleague. The majority of participants (96%) said they were “a lot more efficient” or “somewhat more efficient” when using NAVIFY Oncology Hub to review patient information. The majority of participants (78%) felt it would be “significantly better” or “somewhat better” than their existing solution at facilitating patient discussion and coordinating care. On the NASA Task Load Index survey, the majority of participants (63%) required low or very low levels of mental demand, temporal demand, and effort to successfully complete tasks using NAVIFY Oncology Hub. The majority of participants (91%) felt the synthetic patient cases were either ‘very similar’ or ‘somewhat similar’ to cases seen in routine clinical practice, and that the tasks completed during the sessions were ‘very similar’ or ‘somewhat similar’ to their clinical practice. Conclusions: This novel clinical simulation study shows early evidence that NAVIFY Oncology Hub has high usability, potential to increase overall efficiency and reduce cognitive burden on oncologists compared to contemporary EHR systems. Clinical trial information: NCT05478135 .
Longitudinal MRI-based radiomic model to complement sentinel lymph node biopsy assessment after neoadjuvant chemotherapy in initially clinically node-positive breast cancer: A multicentre, diagnostic study.
Authors: Wang Kun , Zhu Teng , Huang Yuhong , Li Wei
Published: June 2023

e13623

Background: The high false-negative rate (FNR) of sentinel lymph node biopsy (SLNB) alone results in unnecessary axillary lymph node dissection (ALND) in initially clinically node-positive (cN+) breast cancer after neoadjuvant chemotherapy (NAC). This study aimed to reduce the FNR by establishing a longitudinal MRI radiomics-assisted SLNB model compared with SLNB alone. Methods: We established and tested a machine learning algorithm (RMLM) based on pre-NAC, post-NAC and longitudinal MRI radiomics features to detect axillary complete response (ypN0) to neoadjuvant chemotherapy in cN+ breast cancer. In total, 234 eligible patients who underwent SLNB and ALND were retrospectively recruited in the primary cohort (PC), 723 patients were in external validation cohorts (EVC) 1-3, and 81 patients from two multicentre prospective clinical trials (ClinicalTrials.gov, NCT03154749, NCT04858529) were enrolled in the prospective validation cohort (PVC). The U test and least absolute shrinkage and selection operator with tenfold cross-validation were used to select the most significant features. The specificity and FNR of RMLM-assisted SLNB were compared with those of SLNB alone. Results: In the primary (n=234 patients), external validation (n=723) and prospective validation sets (n=81), RMLM achieved excellent performance in detecting metastatic axillary lymph nodes (AUC=0.938 in the primary cohort, 0.842-0.913 in the external cohorts, 0.865 in the prospective validation cohort). RMLM-assisted SLNB achieved an FNR of 4.96% in PC, 5.83-8.08% in EVC1-3, and 9.09% in the prospective validation cohort. The removal of more than two SLNs combined with RMLM could further reduce the FNR to 2.78% in PC, 3.28-7.27% in EVC1-3, and 6.67% in the prospective validation cohort. Conclusions: RMLM combined with SLNB provides a potential tool to evaluate residual nodal disease after NAC and reduce unnecessary ALND.
Integrating technology to support data management abstraction of adverse events (AE) and concomitant medications (ConMed) from the electronic health record (EHR) to sponsor electronic data capture (EDC) systems using design thinking (DT) methodology.
Authors: Yuravlivker Leemor , Buckley Michael T. , Bouvier Nancy , Jeevarathnam Sundar , Lazan Steve , Panchal Renata , McKellop Mairi , Lengfellner Joseph M. , Terzulli Stephanie Lucia , Sabbatini Paul
Published: June 2023

e13624

Background: Manual abstraction of data from a site’s EHR to pharmaceutical sponsor’s EDC system is labor intensive and inefficient. To reduce the time and effort of this process for data managers (DM), a web-based application, Clinical Trials Data Hub (CTDH), was developed using Design Thinking methods. It extracts and consolidates AE and ConMed data from the EHR and displays it in a user friendly, automated, and consolidated view for easy entry into EDC forms. Methods: Following DT methodology to develop CTDH, we interviewed 12 DMs to identify data entry bottlenecks, and ideated solutions for what is now CTDH. To evaluate CTDH’s value, we built a functioning prototype using Splunk and conducted pilot A/B testing with 6 DMs for 2 use cases (Case I: basic easy to find ConMed linked to the AE, and Case 2: complex, where the ConMed linked to the AE was buried in a 33-page document) using their current workflow (A) versus CTDH (B) where a 5-minute training of CTDH occurred prior to testing. We hypothesized that CTDH would outperform current workflows across 3 primary outcomes: 1) correct data identification, 2) time to identify data, and 3) using a modified Single Ease Question (SEQ) rating scale to assess how difficult users found the task. This study was conducted in Jan-Aug 2022 at a large single-center cancer hospital. Results: DMs spend ~20 hours/week on data entry; the majority of which is spent searching the EHR for which ConMeds are associated with an AE. A/B testing results are noted in Table I (see below). Use case 2 showed that DMs using CTDH reduced the time to find one ConMed linked to an AE by 148%, saving ~5 minutes in one task. 5 of 6 participants preferred CTDH to existing clinical systems. Conclusions: Our findings suggest that CTDH allows DMs to 1) identify AE and ConMed data required for EDCs more quickly than in current workflow, 2) identify data more accurately to be entered in sponsor EDCs, and 3) perceive the task of identifying this data to be easier. CTDH reduces the time DMs spend searching clinical systems and documents and has the potential to save meaningful time per patient per study. CTHD will launch into production in May 2023. Digital tool product development using DT methodology has the potential to improve operational efficiency and the clinical staff user experience. This is particularly important in an industry that has struggled with burnout, cost containment, and high turnover. [Table: see text]
Continuous temperature monitoring: A systematic review of literature findings.
Authors: Phillips Ruth Anne , Bradley Sarah K. , Jani Janvi
Published: June 2023

e13625

Background: Recent studies have determined continuous temperature monitoring (CTM) identifies fever up to 12 hours earlier than intermittent temperature monitoring in patients with neutropenic fever. In 2010, Van Vliet showed CTM enabled the early administration of antibiotics. Verma and colleagues (2021) reported that self-monitored temperature taking was frequently inaccurate. Nessle et al. (2022) observed 2 instances of fever, associated with bloodstream infections, detected by CTM 5 hours and 12 hours earlier than oral temperature. CTM records 8,640 data points in 24 hours versus the current standard of care (SOC), which typically measures up to 6 data points in 24 hours. The increased frequency of data collection presents a comprehensive picture of the patient’s status which enables earlier detection in trends or patterns of fever. As a result, earlier medical evaluation and prompt administration of antibiotics has led to improved patient care and outcomes. Methods: A literature review was executed to determine the validity of evidence available related to CTM utilization in both oncology and other high-risk therapeutic areas. Levels of evidence were assigned based on the design, methodology, validity, and applicability of the studies. Journal impact scores were added to support findings and implementation into real-world practices. A table was created to organize the data, including level of evidence, journal impact score, and study results. Results: This review of the literature included 17 documents related to CTM. Levels of evidence for CTM include 4 documents with Level 1 and 5 documents with Level 2 evidence. The journal impact scores found 6 of the 17 documents to be above 5. Overall, the study results showed a positive correlation between the use of CTM and earlier fever detection. Conclusions: CTM use has grown in recent years; however, there is still a need for randomized controlled trials to observe health economic, and clinical outcomes. CTM allows for earlier detection of fever, improving patient outcomes over SOC in high-risk patients. CTM should be considered a clinical decision tool to enhance current vital sign monitoring, thereby improving neutropenic patient care.
A deep learning system to predict origins for cancers of unknown primary using cytological images from hydrothorax and ascites.
Authors: Tian Fei , Sun Lin , Wei Na , Liu Wei , Li Xiangchun , Chen Gong
Published: June 2023

e13628

Background: Cancer of unknown primary (CUP) origin is still a mystery in the field of tumor diagnosis, which is difficult to be diagnosed by conventional imaging methods. The aim of this study is to develop a deep learning based method to assist pathologists in determining the origin of malignant hydrothorax and ascites using cytological images. Methods: By curating cytology images of hydrothorax and ascites from 42682 cases at three hospitals, we developed a deep-learning-based method -Tumor Origin diffeRentiation for Cytological Histology (TORCH)- for diagnosis of malignancy and prediction of tumor origin. We examined its performance on three individual test sets (n=12799). We compared TORCH with a panel of four pathologists on 496 cases that were randomly selected from test sets. Area under the receiver operating characteristic curve (AUROC) was used as the primary classification metric. Metrics including accuracy, sensitivity, specificity, precision and negative predictive value were used to measure the efficacy of TORCH versus pathologists. A score system was used to evaluate and compare the performance between our AI model and pathologist experts. Attention heatmap was used to interpret model prediction results. Results: TORCH model reached an overall micro-average one versus rest auroc of 0.957(95% CI: 0.955-0.959). On the three test sets, TORCH achieved an AUROC of 0.964 (95% CI 0.957-0.972), 0.947 (0.940-0.953), and 0.988 (0.985-0.993) in the diagnosis of cancer and 0.947 (0.942-0.952), 0.957 (0.953-0.960) and 0.972 (0.968-0.976) in localization of tumor origin, respectively. For primary tumor origin prediction, TORCH achieved an overall top-1 accuracy of 79.2% and top-3 accuracy of 98.5%. On three test sets, the top-1 accuracy was 75.7%, 79.4%, and 85.0% respectively. Compared with pathologists, TORCH demonstrated a better prediction efficacy (1.665 ± 0.677 vs. 1.265 ± 0.555; P <0.001). The mean diagnostic score of junior pathologists assisted with TORCH was also remarkably higher than the previous one (1.326 ± 0.728 vs. 1.101 ± 0.824; P <0.001). The comprehensive accuracy of attention heatmaps capturing main area of isolated tumor cells was 87.3% (95% CI: 81.9-92.8%). Conclusions: TORCH model was able to provide relatively accurate diagnosis of malignancy and prediction of tumor cell origin in hydrothorax and ascites. It can be used as an effective ancillary method to aid clinicians in allocating personalized therapy and improving patients’ prognosis.
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.
Complicating breast cancer treatment: Reasons patients present to the ED.
Authors: Hsiung Jayla , Taneja Kamil , Patel Karan , Benedict William , Sprankle Kenyon , Diaz Michael J. , Cohen Jules A.
Published: June 2023

e13668

Background: Breast cancer is a very common cancer that provides a significant amount of stress on patients’ lives. These patients can have many cancer-related complications, which lead them to present to the ED. However, few studies have identified common reasons for these patients to present to the ED and factors associated with high risk of admission. Methods: We utilized the 2006-2012 Nationwide Emergency Department Sample to identify the common primary diagnoses of breast cancer patients in the ED. A multivariate logistic regression was used to identify characteristics that were significantly associated with a higher chance of inpatient admission. A p-value less than 0.05 was considered significant. Results: Between 2006 and 2012, 2,160,701 breast cancer patients presented to the ED. Most patients were at least 80 years old (53.0%), female (99.1%), Medicare beneficiaries (64.4%), of the highest income quartile (26.2%), living in the South (36.8%), presented to non-trauma hospitals (52.7%), and presented to metropolitan non-teaching hospitals (44.8%). Most patients were admitted (53.1%). The most common primary diagnoses of breast cancer patients were chest pain (5.4%), urinary tract infection (3.3%), pneumonia (3.1%), secondary malignancy (3.0%), and cardiac arrhythmia (3.0%). The primary diagnoses associated with the highest risk of inpatient admission are the following: septicemia (odds ratio: 39.4, 95% confidence interval (CI): 33.8-45.9,p < 0.001), femur fracture (OR:19.1, 95% CI: 16.6-22.0,p < 0.001), secondary malignancy (OR:17.7, 95% CI: 16.2-19.4,p < 0.001), acute cerebrovascular disease (OR:5.8, 95% CI:5.3-6.3,p < 0.001), pneumonia (OR:4.9, 95% CI:4.7-5.2,p < 0.001), and complication of previous surgical or medical therapy (OR:2.2, 95% CI:2.0-2.3,p < 0.001). Primary diagnoses associated with a lower risk of admission are the following: contusion (OR:0.06, 95% CI:0.06-0.07,p < 0.001), abdominal pain (OR:0.14, 95% CI:0.13-0.15,p < 0.001), and connective tissue disorder (OR:0.17, 95% CI:0.16-0.19,p < 0.001). Interestingly, patients that paid with Medicaid (OR:0.84, 95% CI:0.79-0.89,p < 0.001) or private insurance (OR:0.89, 95% CI:0.86-0.93,p < 0.001) were less likely to be admitted. Furthermore, uninsured patients were also less likely to be admitted (OR:0.52, 95% CI:0.48-0.57, p < 0.001). Conclusions: Breast cancer patients frequently present to the ED for many reasons, with septicemia and femur being the most severe diagnoses. Physicians should keep these risk factors in mind to prevent these complications and reduce patient stress.
Association of patient age and insurance status with in-hospital mortality for patients with lung cancer.
Authors: Hsiung Jayla , Taneja Kamil , Patel Karan , Metz Kevin , Chen Steven , Benedict William , Wolfe Jared , Diaz Michael J. , Cohen Jules A.
Published: June 2023

e13669

Background: In 2022, the National Cancer Institute estimated that more than 240,000 individuals will be diagnosed with lung cancer. Furthermore, over 130,000 patients will die. To help minimize this death rate, it is important to identify death risk factors. Methods: We utilized the 2006-2012 Nationwide Emergency Department Sample to identify risk risk factors for death in lung cancer patients. A multivariate logistic regression was used to identify patient and hospital characteristics that were significantly associated with a higher chance of in-hospital death. The top 20 primary diagnoses of these patients were included in the analysis to take into account the reason to visit the ED. A p-value less than 0.05 was considered significant. Results: During this time period, 1,344,817 lung cancer patients presented to the emergency departments (ED) across the US. The majority of patients at least 70 years old (50.8%), male (51.1%), Medicare beneficiaries (67.5%), of the lowest income quartile (28.1%), living in the South (40.3%), presented to non-trauma hospitals (54.3%), and presented to metropolitan non-teaching hospitals (43.3%). Out of the 1,344,817 lung cancer patients that presented to the ED, 6.1% died in the hospital. The primary diagnoses associated with increased mortality are the following: respiratory failure (odds ratio (OR): 9.05, 95% confidence interval (CI): 8.47-9.67, p < 0.001), septicemia (OR: 8.46, 95% CI: 7.98-8.97,p < 0.001), acute cerebrovascular disease (OR: 3.04, 95% CI: 2.71-3.35,p < 0.001), secondary malignancy (OR: 2.00, 95% CI: 1.88-2.13,p < 0.001), pulmonary heart disease (OR: 1.97, 95% CI: 1.75-2.20,p < 0.001), and pneumonia (OR: 1.90, 95% CI: 1.80-2.01, p < 0.001). Patients at least 70 years old (OR: 3.09, 95% CI: 1.72-5.53, p < 0.001), males (OR: 1.28, 95% CI: 1.24-1.32,p < 0.001), and uninsured patients (OR: 1.29, 95% CI: 1.15-1.46, p < 0.001) are patient groups at higher risk for in-hospital mortality. 5 primary diagnoses associated with decreased risk of death are the following: fluid/electrolyte disorder (OR: 0.81, 95% CI:0.70-0.93), p = 0.003), central nervous system disease (OR: 0.76, 95% CI: 0.640.91, p = 0.002), arrhythmia (OR: 0.74, 0.65-0.83, p < 0.001), anemia (OR:0.68, 95% CI: 0.55-0.83, < 0.001), complication related to previous surgery of medical therapy (OR:0.64, 95% CI:0.51-0.80, < 0.001), and chronic obstructive pulmonary disease (OR: 0.45, 95% CI: 0.39-0.62, p < 0.001). Conclusions: Older, uninsured, and male lung cancer patients are at high risk for in-hospital mortality. Patients presenting to the ED with respiratory failure and septicemia are at the highest risk for mortality.
Knowledge gaps and educational needs for common cancer therapy-related cardiovascular toxicities and related drug interactions.
Authors: Kaspari Sarah , Moore Heather , Beavers Craig , Hayes Sarah Maryon , Peterson Kristen , Yaseen Israa , Skersick Preston , Truitt Kelsey , Casselli Stephen , Rodgers Jo Ellen E.
Published: June 2023

e13672

Background: Unprecedented growth in novel oncolytic agents has led to an increase in the complexity of cancer management, including cancer therapy-related cardiovascular toxicities (CTR-CVTs) and related pharmacodynamic (PD) and pharmacokinetic (PK) drug-drug interactions (DDIs). The intent of this survey is to assess the landscape of CTR-CVTs including health care provider (HCP) educational needs. Methods: A 20-question survey was distributed to HCPs primarily specializing in cardiology, oncology, hematology and cardio-oncology. The survey was distributed on email listservs of targeted organizations, including the International Cardio-Oncology Society. In addition to demographics, the survey assessed CTR-CVTs and related DDIs encountered. Perceived knowledge gaps were also assessed. Data was analyzed and summarized utilizing descriptive statistics. Results: Of 220 survey respondents, 46% were pharmacists and 54% were other HCPs ( > 80% physicians). Respondents predominately practiced in North America (59%) or Europe (20%), with the majority at academic medical centers (65% academic, 35% community) and primarily specializing in cardiology (71%, cardiology, 26% oncology, 14% hematology). Types of malignancies managed were primarily solid tumors (74%), however hematological malignancy management was also common ( > 60%). All HCPs reported encountering the following CTR-CVTs most commonly: cancer therapy-related cardiac dysfunction (CTRCD) (88%), hypertension (HTN) (79%) and thromboembolic disease (71%). Overall, pharmacists reported managing CTR-CVTs less frequently than other HCPs, especially regarding atrial fibrillation/flutter, coronary artery disease/vasospasm and bradycardia/AV block. The most common cardio-oncology-related PD DDIs encountered were CTRCD and QT prolongation/Torsades de Pointes (QTP/TdP). The most frequently managed cardio-oncology-related PK DDIs included antiarrhythmic agents, direct-acting oral anticoagulants and antiplatelet agents. All HCPs reported greatest comfort managing anthracycline/HER2 targeted therapy-associated CTRCD and least comfort managing arsenic-associated QTP. Immune checkpoint inhibitor-associated myocarditis (74%), immune modulator-associated thrombosis/thrombotic events (64%), Bruton tyrosine kinase inhibitor associated bleeding (58%) and atrial fibrillation (55%) were ranked of highest educational need. Overall, responses for PD/PK DDIs and educational recommendations were similar between pharmacists and other HCPs. Conclusions: This survey provides insight on the most commonly encountered CTR-CVTs and related DDIs as well as knowledge gaps of HCPs managing CTR-CVTs. These specific areas should be targeted for future educational initiatives to optimize the cardiovascular care of patients with cancer.