bluuebunny/crossref_metadata_2025 huggingface dataset:
Implementation and preliminary efficacy of a risk stratification system +/- patient-reported outcomes monitoring for patients with hospital-diagnosed advanced lung cancer.
Authors: Ray Emily Miller , Gentry Amanda , Ledenyi Madeleine , Elston Lafata Jennifer Elston , Sanoff Hanna Kelly , Mody Gita N
Published: June 2024

11095

Background: Risk stratification systems may improve quality of care for patients with advanced lung cancer (ALC) by identifying those at high risk of rehospitalization and directing them to supportive care. The purpose of this study was to evaluate the implementation and preliminary efficacy of a risk-based system, with/without electronic patient-reported outcome (ePRO) symptom monitoring, to trigger supportive care for patients with hospital-diagnosed ALC. Methods: In this single-site, non-randomized, pragmatic study, patients in an academic center with hospital-diagnosed ALC were stratified to low or high risk using an established tool. High-risk patients were referred to two-pronged supportive care: patient navigation and outpatient palliative care. Eligible patients were recruited for 3 months of ePRO symptom monitoring coupled with provider alerts. Healthcare utilization was assessed at 90 days post-discharge. Program feasibility and acceptability were assessed using percent of eligible supportive care referrals made and completed, enrollment rates in ePROs, ePRO completion, and notifications to providers of concerning symptoms. Preliminary efficacy was defined as percentage of concerning ePRO symptoms resulting in new clinical action and 90-day readmissions. Results: At the time of interim analysis, 49 patients had been assessed with 48/49 (98%) identified as high risk. Patients had a mean age of 66 years, and were non-Hispanic, 51% male, and 22% Black. Patient navigation referral (92%) and completion (88%) was high. Palliative care referral (89%) and completion (45%) was lower. 14/39 (36%) of eligible patients enrolled in ePRO symptom monitoring, with competing priorities or feeling overwhelmed as the primary reasons for non-participation. Patient-level ePRO completion ranged from 0-100% (mean 53%). Nearly all (97%) concerning symptoms were reported to the clinical team; 27% of these resulted in new clinical action. By 90 days, 16/37 (43%) had hospital readmissions. Conclusions: Patient navigation was feasible and acceptable in patients with hospital-diagnosed ALC. However, there are ongoing barriers to implementation of post-hospitalization ePRO symptom monitoring and palliative care. Additional evaluation is needed to understand the barriers and facilitators and to measure the impact of navigation on patient outcomes. Since nearly all patients met high-risk criteria, future programs will eliminate risk stratification and target all patients with hospital-diagnosed ALC. Clinical trial information: NCT05722847 . [Table: see text]
Relationship between cognitive and emotional domains of prognostic awareness with quality of life and psychological distress in patients with advanced cancer.
Authors: Greydanus Claire , Lavoie Mitchell W. , Temel Jennifer S. , Greer Joseph A. , Park Elyse R. , Jackson Vicki , El-Jawahri Areej , Amonoo Hermioni L.
Published: June 2024

11106

Background: Prognostic awareness, a measure of patients’ cognitive and emotional perception of their illness and prognosis, allows individuals to align their medical decision-making with their goals and values. Prior studies have shown mixed findings regarding the relationship between prognostic awareness with better quality of life (QOL) and less psychological distress in patients with advanced cancer. However, studies have not investigated whether it is the cognitive or the emotional aspects of patients’ awareness of their prognosis that are associated with QOL and psychological distress in patients with advanced cancer. Methods: We conducted a cross-sectional study of patients with metastatic solid malignancies not being treated for curative intent at a single academic center from 11/2019-6/2022. We used the Prognostic Awareness Questionnaire (PAIS) to measure the cognitive (i.e., the capacity to understand one’s prognosis characterized by the accurate perception that a cancer is curable or not) and emotional coping with prognosis (i.e., the capacity to emotionally process prognostic uncertainty and terminal prognosis). We used the Functional Assessment of Cancer Therapy-General (FACT-G), Hospital Anxiety and Depression scale (HADS), and the Peace, Equanimity and Acceptance in the Cancer Experience (PEACE) scale to measure, QOL, psychological distress, and acceptance of illness, respectively. We used multivariate regression models controlling for age, gender, and cancer type to assess the relationship between the cognitive and emotional prognostic awareness domains and patient-reported outcomes. Results: Overall, 632 participants (age 65 years (SD=11.3), 51% female, 76% married or living with a partner) were enrolled in the study. In multivariate models, higher cognitive understanding of prognosis was not associated with QOL (b=-2.134; p=0.069), psychological distress (i.e., anxiety: b=0.331; p=0.232 and depression; b=0.233; p=0.368), or peaceful acceptance of terminal illness (b=-0.045; p=0.838). However, emotional coping of prognosis was associated with better QOL (b=1.981; p<0.001), less anxiety (b=-0.516; p<0.001) and depression (b=-0.370; p<0.001) symptoms, and more peaceful acceptance of terminal illness (b=0.438; p<0.001). Conclusions: Patients’ emotional coping with their prognosis, rather than their cognitive understanding of their terminal prognosis, was associated with their QOL, psychological distress, and acceptance of their illness. These findings underscore the importance of examining prognostic awareness and its association with patient-reported outcomes by domains. We also highlight the need to develop supportive care interventions to promote effective coping strategies for patients after prognostic disclosure.
Impact of transitions of care nurse navigation on post-discharge follow-up.
Authors: Lo Celina , Miller Jackie , Csik Valerie Pracilio
Published: June 2024

11126

Background: Poor discharge communication is among the primary causes of readmissions and many patients are lost to follow-up (F/U) post-discharge (PD). For newly diagnosed (DX) cancer patients, the coordination of care from inpatient (IP) to outpatient (OP) follow-up is critical. At the Sidney Kimmel Cancer Center in Philadelphia, we saw a no show (NS) rate of 6.6% for PD F/U appointments (Oct-Dec 2022) resulting from deficient communication. To improve the IP to OP transition for cancer patients, a Transition of Care Nurse Navigator (ToC NN) pilot was initiated to support patients discharged from Thomas Jefferson University Hospital (TJUH). The goal was to complete 80% of PD visits and reduce the NS rate by 20% by 12/31/23. Methods: The target population are patients that are newly DX solid tumor patients that will be discharged to home/rehab and need an OP Medical Oncology appointment. Through communication with hospitalists, IP Fellows/Residents, and/or Attendings, the ToC NN is referred eligible patients. The ToC NN visits patients during hospitalization or follows-up post-discharge to assess Health Related Social Needs and distress. PD F/U appointments are communicated during the initial contact along with information about the OP resources available and referrals are made based on patient interest/needs to social work, nutrition, or supportive medicine. All communication is documented by the EMR and the oncology care team is notified. The ToC NN follows up with the patient/patient’s family member 48-72 hours after hospital discharge to check in and do a symptom management call. Additional F/U calls are made as needed. The ToC NN serves as the patient’s point of contact (POC) from discharge to OP new patient visit (NPV) appointment. Results: The pilot exceeded the 80% goal of completion of PD visits. It revealed a 41.4% increase of PD NPV completion and a 21.9% decrease of NS rate from the 2022 to 2023 data. Conclusions: The ToC NN services showed significant impact in supporting patients transition from IP to OP. Our findings confirm having a contact after hospital discharge increases the completion of PD visits due to effective communication and support. [Table: see text]
Mutated KRASas a promising target in pancreas cancer: PURPLE registry data to inform real-world incidence and prognostic significance and to aid trial recruitment.
Authors: Lee Belinda , Tian Eric , Croagh Daniel , Harris Marion , Thomson Benjamin , Michael Michael , Loveday Benjamin , McLachlan Sue-Anne , Knowles Brett , Shapiro Jeremy David , Wong Rachel , Fox Adrian , Jennens Ross , Yong Tuck , Hodgson Russell , Houli Nezor , Ananda Sumitra , Lipton Larissa Rachel , Mendis Shehara Ramyalini , Gibbs Peter
Published: June 2024

11150

Background: With around 90% KRASmutation (mt) frequency, pancreatic ductal adenocarcinoma (PDAC) is considered the most RAS-addicted cancer. Despite guideline recommendations, genomic testing is not routine in all PDAC patients (pts) in Australia, due to unproven clinical impact. As more novel KRAS-direct therapeutics enter clinical trials, understanding the real-world frequency of individual mutations and prognostic significance, and facilitating trial recruitment are important goals, all of which can be supported by registry data. Methods: Data extracted from the PURPLE pancreatic cancer registry from 9 participating Australian cancer centres, between 2016-2022, was analysed to compare clinicopathological features, survival based on KRASmt status, and assess feasibility of the platform to identify and molecularly stratify patients for future clinical trials. Survival estimates were calculated using Kaplan-Meier curves and log-rank testing on SPSS (Macintosh v.29). Results: Of 721 PDAC routine care pts identified, next generation sequencing (NGS) was undertaken in 378/721 (52%). Median patient age was 68 years (range 52-83); 152 (40%) had resectable, 111 (29%) locally advanced and 115 (30%) metastatic disease. 57/378 (15%) were KRAS wildtype. Of 321 pts with a KRAS mt, codons 12,13, and 61 were the most common sites of mt, including G12D (45%), and G12V (30%), with lower frequencies of G12R (13%), Q61H (6%), G12A (3%), G12C (1%), and G13D (1%). Comparing KRAS wildtype to KRASmt pts, there was no difference in median age (68 vs 67, p=0.63), gender (male: 49% vs 60%, p=0.23), Charlson comorbidity index (p=0.30), or stage at first presentation (p=0.99). Overall KRAS wildtype pts were more likely to be ECOG PS 0 at diagnosis (p=0.01) and to receive at least 1 modality of treatment (p=0.004). For all pts, median overall survival (OS) in KRASwildtype versus KRAS mt pts was 29.0 months versus 19.7 months (p=0.007), and for the 115 metastatic pts 15.1 versus 10.4 months (p=0.28). Further analysis of the impact by disease stage and by individual RAS mt is underway. Conclusions: Registry based analysis informs understanding of KRAS mt status of PDAC in a community setting. Here, KRAS mt status was associated with worse OS outcomes, likely in part due to the association with ECOG PS and receiving less active treatment. With newer promising KRAS-targeted therapies becoming available in clinical trials, known RAS status will aid identification of trial candidates. The clinical utility of NGS and rationale for reflex testing in PDAC is increasing. Clinical Registry information (ACTRN12617001474347).
Therapy-related myeloid neoplasm risk score (TMNRS): A convenient clinical score for TMN risk assessment at presentation in adult patients (pts) with cancer.
Authors: Singh Abhay , Herr Megan , Mishra Rahul , Karia Rusina , Hahn Theresa , Thota Swapna
Published: June 2024

11164

Background: tMNs are rare, albeit serious complication in cancer survivors. A tMN risk prediction model is currently not available, therefore we leveraged clinical information and history in a large population-claims database to devise the first tMN risk prediction model in adult cancer survivors. Methods: SEER-Medicare was used to analyze 970,390 adults aged 66-84 diagnosed with first primary cancer (FPC) from 2000-2011 (with follow-up through 2015), who survived ≥1 year. Medicare claims data classified individuals with a priori identified conditions. We focused on prostate, GI, breast, lung, and bladder (n=830,468) FPCs to develop a tMN risk prediction model. The population was divided into training and validation cohorts. Χ2 test identified risk factors associated with tMN. The tMN risk score (TMNRS) was created as a simple arithmetic sum of independent predictors of tMN weighted according to the adjusted odds ratio from logistic regression analysis. Pts were categorized into risk groups (Table) based on their TMNRS, which were tested in the validation cohort. Model performance was evaluated using ROC and c-statistics. Results: 87-96% of tMN developed within the first 10 years of FPC. Predictors of tMN included history of autoimmunity, infections, cardiovascular disease, granulocyte-colony stimulating factor, FPC stage, chemoradiotherapy exposure, age at FPC diagnosis, and sex. Training analysis distinguished survivors into distinct risk groups (table) with 10-year incidence of tMN ranging from 0.3% to 1.5% (prostate), 0.04% to 1.1% (GI), 0.2% to 1.4% (breast), 0.1% to 1.2% (lung) and 0.1% to 1.4% (bladder). The table summarizes the incidence of tMN and by risk category for each of the FPCs. After validation, the c-statistic ranged from 0.62-0.68. Conclusions: We utilized the largest SEER-Medicare cohort to date to develop a tMN risk model. The TMNRS captures several novel predictors and can be readily used in the clinic. This easy-to-use tool distinguishes cancer survivors into clinically relevant groups at risk of tMN development. This study lays the framework for screening and monitoring of pts at high risk of tMN. In future, we will leverage increasingly available molecular data to improve prediction performance of the model. Web-based calculator to be published with the manuscript/available at time of presentation. [Table: see text]
Surgical outcomes for non-small cell lung carcinoma by race and surgical facility types in the United States.
Authors: Singh Aditi , Nelson Cindy , Abdalla Ahmed
Published: June 2024

11167

Background: Successful outcomes of surgical treatment of cancer requires expertise and high-quality supportive services for surgical care. Previous studies have shown that case volume and availability of other in-house supportive services affect surgical outcomes. Latest studies have shown that this gap has now significantly reduced. Issues related to access, availability of funding for latest technologies and continuous medical education still exist and likely still impact the surgical outcomes. The objective of the study is to understand the impact of surgical center related factors on survival outcomes for cancer patients based on race and other demographic features. Methods: We conducted a retrospective analysis of patients diagnosed with Stage I-III Non-small cell lung cancer (NSCLC) between 2004 to 2020 using the National Cancer Database (NCDB). Patients were divided into 4 cohorts of NCDB assigned facility type (Community Cancer Program, Comprehensive Community Cancer Program, Academic/Research Program, Integrated Network Cancer Program). Racial and other demographic data was analyzed for each of the facility types. Differences in categorical variables were evaluated using a Chi-square test. Results: 298,393 adenocarcinoma and 129,144 squamous cell carcinoma patients underwent surgery for NSCLC between 2004-2020. 326,798 patients with clinical stages I-III were selected for the analysis. Most surgeries were performed at the academic/research programs and comprehensive community programs. Utilization of each facility type was uniform across all races. The 30-day mortality rate was lowest for the academic/research programs (Community Cancer Program 3.1%, Comprehensive Community Cancer Program 2.6%, Academic/Research Program 1.8%, Integrated Network Cancer Program 2.3%; p=0.000). 30-day mortality rate was higher for American Indian, Aleutian, or Eskimo racial subgroups amongst all age-groups at all the surgical facility types especially for Stage IIIB NSCLC (White: 6%, Black: 3.4%, American Indian, Aleutian, or Eskimo: 14.3%, p=0.006). For each race, the 30-day mortality rate was better at the academic/research programs. Females had lower 30-day mortality for all racial subgroups. Having private insurance was associated with the lowest 30-day mortality rate. This was noted for all races across all the facility types. Lower income status was associated with higher mortality rates across all facility types. This difference was statistically significant for white patients. Majority of patients had less than 10 days of length of stay at all the surgical facility types. Conclusions: Outcomes of NSCLC surgery are significantly better at academic/research programs where a higher number of procedures are performed and access to latest surgical technologies is available. Short-term mortality rates are higher for American Indian, Aleutian, or Eskimo racial subgroup.
Effect of real-time data-driven physician engagement on appropriate precision oncology testing.
Authors: Liu Ying , McLeod Howard L. , Schreier Jeff , Bhogal Nirmala , Clark Jordan , Thompson Eve , Rompicherla Arun , Little Gemma , McKenna Joshua , Ismail Anjum , Varghese Sarah , Slifko Bethany Michelle
Published: June 2024

11168

Background: Precision medicine is a paradigm shift in healthcare: 24% of all FDA approvals are precision medicines, with 67% of new approvals relying on companion or complementary testing or on diagnostics prior to clinical use. Yet a recent publication indicates that approximately 64% of potentially eligible patients could be lost due to various clinical practice gaps along patient journey (Sadik et al JCO 2022). Low prevalence biomarker testing is proven to be one of the critical determinants of missed therapy, potentially due to poor physician awareness. The increasingly advanced machine learning (ML) and natural language processing (NLP)-based ability to label, analyze, and segment data can be utilized to monitor and influence testing behavior in real-time. We hypothesize that a real-time data-driven physician-targeted digital engagement can increase biomarker testing rate and in turn enhance patient identification for precision therapies. Methods: Unstructured real-world, real-time biomarker testing reports were collected from 494 laboratories across the US. These testing reports were first curated, labeled and extracted via ML and NLP-based technologies to allow data analysis and reveal testing behavior. Suboptimal testing behavior was defined as no requisition of the selected novel biomarker as part of the diagnostic workups. Physicians who identified as having suboptimal testing behavior were selected as candidates to receive a personalized digital engagement over a 4-week period. The digital engagement's purpose was to raise clinical awareness towards the novel biomarker testing. The follow-up testing behavior was analyzed again over laboratory reports collected from 26-weeks’ time after the initial engagement. Results: 822 physicians were identified with suboptimal testing behavior and selected to receive 4 weeks' follow-up digital engagement. 271 out of 822 (33%) recipients were successfully engaged shown as open and read the digital communication. 42 (~15%) physicians reacted to the communications and ordered the new test at least once during this period. The initial 4 weeks' engagement was observed to be the most impactful, when 23 out of the 42 (~55%) physicians ordered the novel biomarker test for the first time.71 new therapy-eligible patients were identified via data-driven targeted physician digital engagement during the 26 weeks’ follow-up period. Conclusions: This study illustrates the value of data in influencing or reinforcing testing behaviors and emphasizes the value of data-driven physician-targeted digital engagement in addressing clinical practice gaps which in turn, drive patient identification to match potential eligible precision therapies.
New-onset atrial fibrillation, cardiovascular outcomes and all-cause mortality in patients with newly diagnosed cancer: A large population-based matched cohort study.
Authors: Mukherjee Diptasree , Walsh Declan , Alqahtani Saleh A , Krishnan Arunkumar
Published: June 2024

11184

Background: Studies have shown an association between atrial fibrillation (AF) and cancer, but the relationship is incompletely studied. there is also a paucity of data regarding the specific association between cancer type and AF risk . Notably, the longitudinal associations of new-onset AF with adverse cardiovascular (ACV) outcomes in Newly Diagnosed Cancer Patients remain unclear. Thus, through a comprehensive nationwide population-based study, we assessed the associations between new-onset AF and subsequent risks of ACV events and all-cause mortality. Methods: This large retrospective cohort study was conducted using the TriNetX database and included adults (>18 years) with any new cancer diagnoses. We performed 1:1 propensity score matching (PSM) for demographics, BMI, nicotine dependence, comorbidities, cancer type, and medications to similar controls as cancer patients without AF. The primary outcome was new ACV events like heart failure (HF), major adverse cardiovascular events (MACE; coronary artery intervention myocardial infarction, or unstable angina), ischemic heart disease (IHD), and cerebrovascular events (CVE; cerebral infarction, carotid intervention, stroke, transient ischemic attack. The secondary outcome was all-cause mortality. Sensitivity analysis assessed statistical robustness. Hazard ratios (HR) were calculated to compare group outcomes. Results: Among the new diagnoses, 52,606 developed AF, and 374,959 remained AF free during the follow-up. After PSM, both cohorts (51,567 each) were well-matched. The mean follow-up duration was 4.8 (± 2.7) years. Among newly diagnosed cancer patients, those with incident AF had higher risk of MACE (HR 1.56; 95% CI 1.49–2.16), HF (HR 3.10; 95% CI 2.76–4.36), IHD (HR 1.68; 95% CI 1.41–2.01), CVE (HR 2.93; 95% CI 2.13–4.04), and all-cause mortality (HR 2.56; 95% CI 1.89–3.78) compared with those without incident AF. We noted a higher incidence rate during the initial months after the diagnosis of AF for both sexes. During the first year, the association with any ACV events (men: HR 2.78, 95% CI, 1.85–3.20; women: HR 1.81, 95% CI, 1.31–2.67) was more substantial than that following AF diagnosis for both sexes. New ‐onset AF was strongly associated with metastatic cancer. In sensitivity analysis, we excluded individuals with <1 year of follow-up results were consistent, and all statistically significant associations remained unchanged. Conclusions: cancer patients who developed AF had significantly higher risks of subsequent adverse cardiovascular events and greater all-cause mortality. AF was strongly associated with metastatic disease. Our findings highlight the importance of strategies for AF prevention to mitigate macrovascular complications in all newly diagnosed cancer patients.
Comparative analysis of actionable gene reporting in targeted panels versus comprehensive NGS testing for solid tumor samples.
Authors: Duong Chaugiang , Puentes Roisin , Montgomery Nathan , Lyle Derek , Lopez-Diaz Fernando J.
Published: June 2024

11185

Background: The landscape of actionable genes significantly influences clinical decisions in cancer diagnosis, prognosis, and treatment planning. In a clinical context, the selection of NGS panels hinges on striking a balance among informative data, insurance coverage, and the preferences of patients and healthcare providers. Molecular pathology reference laboratories commonly employ large-scale next-generation sequencing (NGS) testing, curating smaller, disease-specific targeted panels. This study investigates the prevalence of unreported actionable genes in real-world clinical samples subjected to disease-specific panels. Methods: We analyzed SNV/InDel DNA variants in 795 clinical solid tumor samples using the Illumina TSO 500 platform for comprehensive NGS panel testing of 517 genes. Comprehensive NGS panel-tested samples were intersected with disease-specific targeted NGS panels for breast (54 genes), brain (62 genes), colorectal (36 genes), and lung (44 genes). An artificial filter was applied to align targeted panels with patient disease. Variants were classified based on pathogenicity, and benign variants were filtered out. Detected variants were assessed for actionable mutations as defined by the FDA recognized OncoKB actionable gene database criteria. Additionally, 1484 lung patient samples tested with a lung-specific targeted panel were de-identified and unmasked to the comprehensive NGS tumor profiling to investigate the prevalence of actionable alteration beyond those covered by the disease-specific panel. Results: The study revealed that 3.2% of breast, 0% of brain, 66.2% of colorectal, and 2.7% of lung samples had additional actionable mutations undisclosed by the targeted panels. The number of actionable genes beyond those included in the targeted panels were 14 for breast, 2 for brain, 25 for lung, and 41 for colorectal cancer. This underscores the importance of comprehensive testing to fully capture each patient tumor’s actionable mutation profile. Conclusions: Our findings detect masked actionable mutations in down-sampled targeted panels and highlight the need for comprehensive testing to accurately identify actionable mutations in various cancer types. Reporting actionable mutations can significantly influence clinical decision-making, emphasizing the importance of NGS test selection in routine molecular diagnostics as well as the impact of integrating comprehensive NGS testing.
Impact of chemotherapy-induced peripheral neuropathy permanence on patients' preference to discontinue chemotherapy.
Authors: Jun Yerial , Tao Xueting , Chen Ciao-Sin Chelsea , Griggs Jennifer J. , Kidwell Kelley M. , Hertz Daniel Louis
Published: June 2024

12046

Background: Chemotherapy-induced peripheral neuropathy (CIPN) diminishes patients’ functional ability and quality of life; approximately 40% of patients experience CIPN symptoms 3 years after treatment. Due to the absence of effective CIPN treatments, ASCO guidelines recommend discontinuing chemotherapy in patients experiencing intolerable CIPN symptoms. Little is known about patient’s preference to continue or discontinue chemotherapy when experiencing CIPN, and whether the potential permanence of CIPN symptoms affects this decision. The objective of this prospective observational study was to determine the effect of CIPN symptom permanence on patients’ preference to discontinue chemotherapy. Methods: Patients receiving taxane and/or platinum chemotherapy for breast or colorectal cancer were enrolled in a prospective observational clinical study. Patients reported their CIPN severity using the EORTC CIPN20 patient-reported outcome questionnaire at the start of each treatment cycle. At the same time, patients were asked if they would prefer to continue or discontinue chemotherapy treatment under the hypothetical scenario that their current CIPN symptoms would be temporary or permanent. A generalized linear mixed effects model was used to determine the effect of CIPN severity, permanence, and other clinical variables on a patient’s decision to discontinue (vs. continue) chemotherapy treatment. Results: A total of 66 patients completed data collection at least one time, of whom 55 (83%) had breast cancer, 12 (18%) had metastatic disease, and 52 (79%) received a taxane. The odds a patient would prefer to discontinue chemotherapy treatment if their CIPN symptoms would be permanent (vs. temporary) were nearly 30 times greater (odds ratio (OR)=30.15, 95% confidence interval (CI): 15.73-57.79, p<0.001, Table). There was a statistical trend toward preferring to discontinue chemotherapy treatment as CIPN symptom severity increased (OR=1.09, 95% CI: 1.00-1.19, p=0.063). Conclusions: The potential for CIPN symptoms to be permanent has a huge effect on whether patients want to continue or discontinue chemotherapy treatment. Additional data is needed on the incidence and predictors of permanent CIPN. More importantly, shared decision-making tools that convey the risk of permanent CIPN, and the potential risk of discontinuing chemotherapy treatment, are needed to facilitate patient-centered treatment decisions so that each patient with cancer achieves their personal treatment goals. [Table: see text]
Physical activity and dexamethasone for cancer related fatigue: A preliminary placebo controlled randomized control trial.
Authors: Yennu Sriram , Valero Vicente , Smaglo Brandon George , Overman Michael J. , Dasari Arvind , Wolff Robert A. , Raghav Kanwal Pratap Singh , Barcenas Carlos Hernando , Busaidy Naifa Lamki , Fellman Bryan M. , Basen-Engquist Karen , Tripathy Debashish , Bruera Eduardo
Published: June 2024

12050

Background: Despite high frequency and significant impact on quality of life, there are limited treatment options available for cancer related fatigue (CRF) in patients with advanced cancer. The primary aim of the study was to determine the feasibility (adherence, safety, and satisfaction) of the combination therapy, physical activity (PA) plus Dexamethasone (Dex); and PA plus placebo (Pl) for CRF. The secondary aim was to explore the effects of PA+Dex, and PA+Pl on CRF as assessed by Functional Assessment of Cancer Illness Therapy–fatigue (FACIT-F). Methods: In this phase 2, randomized, double blind, placebo controlled trial, patients with advanced cancer with CRF ≥ 4/10 on Edmonton Symptom Assessment Scale were eligible. Patients were randomized to standardized PA for 4 weeks plus either 4mg of Dex (PA+Dex arm), or Pl (PA+PL arm) BID for the first 7 days. Changes in FACIT-F scores from baseline to Day 8, and Day 29 were assessed. Other outcomes included change in quality-of-life scores. Results: A total of64 (89%) patients were evaluable. The median (IQR) changes in FACIT-F scores at Day 8 and Day 29 from baseline were 9 (2,16), P< 0.001; 5.75 (0,12.5), P=0.015 for PA+ Dex arm, and 3.5 (-2.13, 10), P=0.054; 6.50 (2.5, 15.5), P=0.006 for PA+ Pl arm respectively. Exploratory Linear Mixed Model (LMM) analysis showed significant treatment effect of PA +Dex, with treatment having improvement of 5.63 units for FACIT-F scores (95% Cl 1.74,9.52), P=0.005. Effect sizes for improvement of FACIT-F scores at Day 8 and Day 29 were -3.49, -2.43 in PA+Dex arm; and -1.93, -2.72 in PA+Pl arm, respectively. Effect sizes for change in fatigue related symptoms and quality of life scores as assessed by Patient-Reported Outcome Measurement Information System-Fatigue T-scores, Multidimensional Fatigue Symptom Inventory-Short Form total, and Functional Assessment of Cancer Therapy -General scores at Day 8, and Day 29 in PA+ Dex arm were 2.93 (P=0.005), 2.82 (P=0.005); 2.27 (P=0.023), 2.68 (P=0.007); -2.39 (P=0.017), -3.26 (P=0.001) respectively. Adherence to Dex and Pl were 91% and 92%, respectively, Satisfaction rates with PA+Dex and PA+Pl arms were 98% and 79%, respectively. There was no significant difference in grade ≥3 adverse events between the two arms (P = 0.36). Conclusions: Satisfaction, and tolerability to the combination therapy, and medication adherence was excellent.PA + Dex significantly improved CRF at day 8 and 29. The improvement was sustained 3 weeks after discontinuation of Dex. Further larger studies are justified. Clinical trial information: NCT03583255 .
Association of lung cancer-associated cachexia with the metastatic spread to pleura.
Authors: Sekula Bartosz , Szymanski Pawel , Konkel Magda , Zielińska Alicja , Altobelli Gioia , Szewczykowski Mikołaj , Naczk Edmund , Dróżka Magdalena , Rzyman Witold , Dziadziuszko Rafal , Skrzypski Marcin Tomasz
Published: June 2024

12095

Background: Cancer-associated cachexia (CAC), a major contributor to mortality in patients with non-small cell lung cancer (NSCLC), is characterized by alterations in body composition. Here, we explore the associations between body composition changes and the pattern of lung cancer metastatic spread. Methods: Computer tomography (CT) images from cancer diagnosis and recurrence were used to quantify subcutaneous and visceral adipose tissue (SAT, VAT) and skeletal muscle (SKM) tissue areas at the 3rd lumbar vertebrae level, using an DAFS AI-based software, Voronoi Analytics, in 101 NSCLC pts, who relapsed after surgical treatment of the primary tumor at the Medical University of Gdansk Hospital. The decrease in SKM, SAT and VAT of more than 5% or 10% at cancer relapse was compared with the pattern of cancer recurrence. Results: The median time to recurrence after primary tumor resection was 1.6 years (0.4–6.4 years). There were 38% local or regional recurrences, 59% distant recurrences, and 13% second primary lung cancers. Among the cases with distant recurrence, there were 19% brain recurrences, 22% pleural metastases, 34% lung metastases, 17% bone metastases, and 11% cases of liver relapse. More than one site of distant recurrence occurred in 51 (50%) of patients. Loss of > 5% of SKM, SAT and VAT occurred in 61%, 33% and 41% respectively. Loss of >5% or >10% of SKM was associated with the pleural metastases at the time of cancer recurrence, ( P < 0.001). Median muscle loss was –11.6% for patients with pleural relapse and –5.3 % for patients with other metastatic locations ( P < 0.001). There were no significant associations between other body composition changes and the pattern of recurrences, tumor histology or age. Conclusions: NSCLC relapse to the pleura after surgical treatment of the primary tumor, appears to be associated with a decrease in the skeletal muscle compartment. This finding may inform the design of the future studies aiming to investigate molecular correlates of sarcopenia and cancer-associated cachexia.
Role of military physicians in cancer screening practices: The DEPISTmed study.
Authors: Helissey Carole , Peyrottes Arthur , Venturelli Maxence , Pautas Marie , Audisio Marie-Anne , Picchi Hugo , Le Roy Audrey , Barhli Aline , Schernberg Antoine
Published: June 2024

e22502

Background: Cancer poses a significant health challenge within the military population, impacting both medical and economic aspects, as well as military operations. Despite the potential benefits of early cancer detection, adherence to organized and individual screenings remains below 50%. The pivotal role of military physicians, especially within military forces, in cancer prevention and screening is crucial.The main objective was to investigate the professional practices of military physicians in cancer screening, aiming to understand their perceptions, practices, and the role of screening in their daily routines. Methods: A prospective, observational, non-interventional cohort study was conducted, utilizing anonymous self-assessment questionnaires among military physicians practicing in army or joint military medical centers. Criteria for inclusion involved physicians engaged in patient care, including the performance of medical check-ups. Demographic data, perceptions, declared practices, and primary prevention measures were assessed through secure electronic questionnaires. Results: Between June 1, 2023, and September 30, 2023, 169 practitioners were included, with 51% were female. The median number of visits per practitioner was 400 (range 150-600). The study revealed a heightened concern among military physicians regarding cancer screening, particularly for breast, colon, and testicular cancers, with over 78% of practitioners expressing a significant level of concern (range: 59-90%). However, our investigation exposed disparities in clinical examinations and the prescription of additional tests, specifically within organized screenings among unit physicians. Less than 7% utilized recommendation sheets. Conclusions: Military physicians express a genuine concern for cancer screening, indicating the periodic medical check-up as an opportune moment for imparting screening information. The study highlights limitations such as the need for dedicated training, availability of materials, and optimizing patient care pathways. This research sheds light on the critical role of military physicians in cancer screening and provides insights into the challenges and opportunities for improving screening practices within military healthcare settings. The findings underscore the importance of targeted interventions to enhance adherence to screening guidelines and strengthen cancer prevention efforts within the military healthcare system.
A randomized trial of dietary modification with exercise in women who are class 2 obese with non-metastatic breast cancer.
Authors: Feinstein Trevor , Bowman Isabelle , Hoffman Catherine , Wellons Allison , Smith Jackie , Latham Valarie
Published: June 2024

e22542

Background: As overweight and obesity increases worldwide, associated risks of breast cancer parallel. A higher body mass index (BMI) has been linked with at least seventeen types of solid tumors, including 9% of all breast cancer cases. Weight gain post-diagnosis is associated with greater morbidity and may increase cancer recurrence risk by 30-40%. Exercise and diet modifications carry potential to lower risk of recurrence. Herein, we report a 6-month pilot study at Piedmont Fayette Hospital in women with nonmetastatic breast cancer with diet modification. Methods: Women with non-metastatic breast cancer, class 2 obesity were recruited to participate in a six-month pilot study at the Thomas F. Chapman Family Cancer Wellness Program at Piedmont Fayette Hospital. Following consent, participants were randomized into either: ARM 1- Dietary coaching including Caloric Counting/Food Tracking with Exercise Coaching ARM 2- Dietary coaching including Carbohydrate Cycling/Intermittent Fasting/Caloric Counting/Food Tracking with Exercise Coaching. The primary goal of this pilot study is to evaluate and compare the feasibility and preliminary efficacy of two weight loss interventions. Results: As of December 2023, 20 patients were enrolled in the dietary modification study. 11 patients completed 6 months of dietary modification. Of the 11 evaluable patients, 6 were randomized to arm 1 and 5 patients were randomized to arm two, table 1. There was not a substantial weight loss in arm 1 at 6 months. However, patients on arm 2 had a median 17-pound weight loss. Conclusions: Although this was a small pilot study performed at the community hospital, we were able to demonstrate dietary modification is feasible in women with nonmetastatic breast cancer and class II obesity. Furthermore, carbohydrate cycling, and intermittent fasting seemed to be a more effective method at weight loss over calorie restriction. We plan to further expand this pilot study to other Piedmont Wellness Centers. [Table: see text]
Perceptions of multi-cancer early detection (MCED) screening tests among underrepresented populations.
Authors: Cong Ze , Ross Melissa , Mulnick Sarah , Samuelson Ashley , Chung Karen
Published: June 2024

e22546

Background: Cancer is the second leading cause of death, with higher death rates observed among racial and ethnic minorities and individuals of lower income. MCED tests detect a shared cancer signal in plasma cell-free DNA. Beyond clinical/direct economic benefits, MCED may offer additional benefits (emotional, social, and/or behavioral) associated with a no cancer signal detected (NCSD) result, which might differ depending on socioeconomic status. This study aimed to explore the value of a NCSD result from the perspective of underrepresented individuals from the US general population. Methods: Qualitative interviews informed a cross-sectional online survey administered to adults aged 40-80 years without a cancer diagnosis within the last 5 years and not on cancer treatment. Soft quotas ensured a sample representative of the US population by age, gender, race, and ethnicity. The survey asked about the perceived value of a NCSD result from a hypothetical MCED test and collected sociodemographic and clinical information. Results were summarized descriptively. Results: The 1073 participants were 53% female, mean age 58 years (SD = 11), 67% non-Hispanic white, 12% non-Hispanic Black/African American, 12% Hispanic, 9% other or multiple races, 32% retired and 42% had less than a college degree. Regardless of income or race/ethnicity, nearly all participants (96-98%) viewed a NCSD result as somewhat or very valuable and anticipated maintaining or improving health behaviors (98-100%) and the majority expected positive emotional impacts (66-74%). However, minority groups were more likely than white participants to anticipate making lifestyle changes after a NCSD result (44-58% vs. 28%), increasing behaviors such as: exercising (61-75% vs. 47%), seeking health-related educational material (39-52% vs. 26%), eating healthy (58-78% vs. 47%), receiving vaccines (44-49% vs. 35%), maintaining/increasing adherence to recommended cancer screenings (22-29% vs 33% / 68-74% vs. 66%), and attending doctor visits (43-65% vs. 40%). Minorities also reported being more certain they would increase these behaviors than white participants. Lower to middle household income ( < $120,000) was associated with more positive impacts to self-care and monitoring health, relief, and happiness, and less fear, concern, anxiety, and stress after a NCSD result versus those with an income ≥$120,000. Conclusions: Regardless of income level or race/ethnicity, a negative MCED test result provides additional value to the US general population beyond traditional clinical benefits, has positive impacts on psychological/emotional health, and could promote adherence to or increase preventive healthcare behaviors. Importantly, racial/ethnic minorities and those of low to mid income anticipated greater positive impacts, specifically to preventive health behaviors with a negative MCED result.
Influence of family caregivers on clinical trial decisions: Results from a qualitative study.
Authors: Blackstone Eric , Loue Sana , Daly Barbara J. , Dorth Jennifer Anne , Brandt Patricia T. , Mazanec Susan R.
Published: June 2024

e23023

Background: Family caregivers are key stakeholders in cancer clinical trial decisions who have been overlooked in previous research. Caregivers play a critical role in supporting patients during clinical trial participation, yet there is little consensus regarding how they should be included in informed consent. Clinical trial staff communicate regularly with patients and caregivers during consent and throughout trial participation, making their perspectives vital to understanding the role caregivers play in these decisions. Methods: This qualitative study identifies the roles caregivers play in cancer trial decision-making, influential factors from the caregiver perspective, and practices of clinical trial staff regarding caregiver inclusion in consent. Patients who were offered a clinical trial at a midwestern comprehensive cancer center were asked to identify a caregiver to participate. Clinical trial staff were recruited via email invitation. We conducted focus groups with caregivers and trial staff, followed by semi-structured interviews with caregivers. Caregivers were asked about attitudes towards research, experiences with trial consent, and their role in decision-making. Trial staff were asked how they included caregivers in consent and attitudes towards their involvement. Transcripts were coded, then analyzed with NVivo using content analysis. Results: Focus groups consisted of 9 caregivers and 10 clinical trial staff, then 15 caregivers completed interviews. Caregiver themes included promoting patient autonomy, influential factors, and burdens of trial participation. Trial staff themes were approaches to caregiver inclusion, navigating challenging situations, and the need for training. Caregivers viewed their role as supporting patient understanding and deferring to the patient as final decision-maker. Hope for therapeutic benefit, oncologist endorsement, and practical barriers (e.g. cost, distance) were influential. Trial staff viewed caregivers as highly influential and encouraged their involvement in consent despite occasional challenges such as family disagreement and undue influence. Conclusions: Early communication with caregivers when offering a trial is vital due to their influential role in decision-making. Clinical trial staff would benefit from training on best practices for inclusion of caregivers, including communication, managing emotions, mediating disagreement, and where to refer caregivers for support. Researchers should consider caregiver burden and potential sources of caregiver support during trial design to minimize barriers to participation.
Comparison of standard charges for complex proton therapy among Medicare Prospective Payment System (PPS) –exempt and –non-exempt cancer centers.
Authors: Cargill Kasey , Feder Noah Maxwell , Wilhite Tyler , Skinner Heath Devin , Wilke Christopher , Mowery Yvonne Marie
Published: June 2024

e23039

Background: Proton therapy is one of the most expensive treatment modalities offered to cancer patients, and only 44 proton therapy centers are operational in the U.S. Of those, 5 are Medicare Prospective Payment System (PPS)-exempt and are reimbursed based on their reported costs rather than predetermined prices. These PPS-exempt cancer centers set their adjusted payment rates to reflect the expense required for providing specialized care. We hypothesized that PPS-exempt centers would have higher rates for complex proton therapy delivery compared to non-exempt centers. Methods: We obtained online standard charge files for 44 proton therapy centers in the U.S. We used the CPT code 77525, the per fraction technical charge billed for complex proton treatment delivery, to extract the gross price (base charge for service), de-identified minimum and maximum negotiated price (lowest/highest charge negotiated with third-party payers), and cash price (charge for cash payment of service) per fraction of complex proton therapy. Prices were compared between PPS-exempt and non-exempt proton therapy centers using Wilcoxon/Kruskal Wallis test with a p-value < 0.05 considered significant. Results: Of the 44 proton therapy centers, 39 (88.6%) had publicly available standard charge files, and 5 (11.4%) are private practice not required to provide a standard charge file. Five of the 39 (12.8%) centers are PPS-exempt, and the remaining 34 (87.2%) are PPS non-exempt. Four (80%) PPS-exempt centers had their gross price, minimum and maximum negotiated price, and cash price available in their standard charge file for CPT 77525, while 23 (67.6%) PPS non-exempt centers had their gross price and cash price listed and 19 (55.9%) had the minimum and maximum price available. The median gross charge per fraction for complex proton treatment delivery was $8,035.25 (IQR $7,022.00-$9,427.50) at PPS-exempt versus $6,434.00 (IQR $5,213.00-$12,350.00) at PPS non-exempt centers. The median minimum price was $656.47 (IQR $178.04-$1,353.23) at PPS-exempt versus $1,294.70 (IQR $734.20-$2,267.46) at PPS non-exempt centers. The median maximum price was $8,120.10 (IQR $5,576.40-$11,529.86) at PPS-exempt versus $5,814.00 (IQR $4,830.00-$9,524.70) at PPS non-exempt centers. The median cash price was $5,360.65 (IQR $2,979.51-$6,897.08) at PPS-exempt versus $4,170.40 (IQR $2,828.00-$5,640.00) at PPS non-exempt centers. Conclusions: In summary, 80% of PPS-exempt and 67.6% of PPS non-exempt centers had publicly available standard charge files. Median charges for PPS-exempt centers are higher for gross charge, maximum price, and cash price, however did not meet statistical significance. [Table: see text]