bluuebunny/crossref_metadata_2025_split huggingface dataset:
Financial toxicity during pediatric cancer therapy: A qualitative analysis.
Authors: Ohlsen Timothy James Daeeun , Hale Malika R , Larson Anika J , Jones Salene M. W. , Wilkinson Fred , Ko Linda K , Chow Eric Jessen , Desai Arti D 
Published: June 2024

11056 Background: Childhood cancer treatment may often result in adverse financial consequences—also termed financial toxicity (FT)—for patients and families. Limited research has specifically examined mechanisms and drivers of FT salient to pediatric oncology. Methods: Using a phenomenological approach, we conducted in-depth interviews with a purposive sample of English- and Spanish-speaking parents of children receiving treatment for cancer at our institution. Parents were interviewed 6-18 months after a first cancer diagnosis, a period chosen to balance accumulation of financial challenges after treatment initiation with minimal recall bias. Interviews were coded by 3 investigators using an inductive, open-ended approach. We performed thematic analysis of interview transcripts focused on elucidating the main components of FT and relationships between them, identifying ameliorating and exacerbating factors, and exploring the impact of FT on patient and family well-being. We organized relationships between themes into a conceptual framework. Results: We interviewed 21 parents (86% mothers, 59% >40 years old, 33% non-Hispanic White, 47% college-educated, 42% of those reporting had a household income of $50-100k, equal proportions above/below this). We identified 5 themes. Four themes pertained to primary elements of FT: (1) increased out-of-pocket spending, often related to additional caregiving and household coordination needs; (2) reduced income, primarily from employment changes inadequately covered by paid leave; (3) new material hardship, with families unable to afford costs of living when previously able to do so; and (4) elevated psychological distress regarding finances. We also identified an additional theme pertaining to response behaviors directed at managing FT, effects of which could be positive (“adaptive behaviors”), negative (“maladaptive behaviors”), or mixed. Response behaviors included reducing discretionary spending, selling off assets, skipping meals, requesting money from strangers, and rummaging through discarded items. Several exacerbating and ameliorating factors pertinent to the development of FT emerged, including household location, composition, wealth, employment flexibility, resource provision, and duration and severity of treatment. Parents provided perspectives regarding policies or interventions to mitigate FT, such as toolkits to better connect families with financial resources and extended paid family leave. Conclusions: Families of children with cancer face a wide range of financial toxicity throughout treatment, and many of these experiences differ considerably from those of adult patients. Many families reported substantial impact and unmet needs. These findings will help inform the design of quantitative measures specific to pediatric cancer and identify unique targets for intervention development and policy change for children with cancer.
In search of strategies to mitigate financial toxicity in survivorship care: A survey of 347 head and neck cancer survivors.
Authors: Shih Ya-Chen Tina , Brauer Eden , Ganz Patricia A. 
Published: June 2024

11060 Background: High costs of cancer treatment exert substantial financial toxicity for patients undergoing treatment. Growing literature suggests lasting financial toxicity (FT) after treatment completion. This calls for the development and integration of mitigating strategies in survivorship care to reduce FT; thereby improving the overall well-being of survivors. Methods: Cross-sectional survey data from 347 head and neck cancer survivors were analyzed to explore the relationship between FT and potential targets for intervention. We measured FT using the COmprehensive Score for financial Toxicity (COST, v1), and defined severe, moderate, and mild-to-no FT as having COST score ≤13, 14 to 25, and ≥26, respectively. The survey also collected information on demographics, quality of life, work and activity impairment, and cancer care coordination (CCC) communication and navigation subscales. We conducted logistic regression to examine which COST item is most predictive of severe FT, and mediation analysis using structural equation model to explore potential targets for interventions to reduce FT. Results: The average age of respondents was 65.5 yrs (SD=11.3). 334 completed COST; 6.3%, 22.2% reported severe and moderate FT, respectively. Study cohort included 20% diagnosed within 2 yrs, 45% 3-4 yrs and 35% ≥5 yrs; the proportion of patients reporting severe FT did not decrease by year since diagnosis (6%, 5.3%, and 7.7%, respectively, P=0.73). Of the 11 items in COST, financial stress was most predictive of severe FT. Survivors who rated financial stress as “very much” or “quite a bit” were 92.8 (P=0.02) times more likely to have severe FT. Higher financial stress was significantly associated with being < age 65, having higher comorbidity score, lower CCC-navigation score, higher activity impairment; navigation and activity impairment are potentially actionable. None of these four variables were statistically significantly associated with severe FT. Mediation analysis showed financial stress has strong mediation effect on severe FT, and survivors with low CCC-navigation scores and high activity impairment were 3.2 times (95% CI: 1.3 – 7.8; P=0.01) and 2.5 (95% CI: 1.1 – 5.2; P=0.02) more likely, respectively, to report high financial stress. Survivors with high financial stress were significantly more likely to be interested or very interested in receiving resources covering financial issues compared to those without (63.4% vs 17.8%, P<0.01). Conclusions: Survivorship care that incorporates interventions designed to improve coordination and navigation and decrease activity impairment can potentially mitigate FT for cancer survivors through reducing their financial stress. The Centers for Medicare and Medicaid Services began paying for navigation services in 2024, opening the opportunity to integrate these interventions into covered navigation services.
Oral cancer drug repositories: Challenges and solutions.
Authors: Sharath Medha , Huntington Scott F. , Halene Stephanie , Abdelghany Osama 
Published: June 2024

11063 Background: Frequent drug shortages and high out-of-pocket costs due to inadequate and unaffordable insurance coverage hinder access to oral chemotherapy. Amidst this, oral cancer drugs estimated a mean of $4290/patient are wasted due to dose modification, discontinuation or death[Lam M. et al, JAMA Oncol. 2023;9(9):1238-1244]. To combat this discrepancy, multiple states have passed laws establishing drug repositories that collect unused oral cancer medications and redistribute them to patients in need. ASCO has also endorsed these programs, even advocating for open distribution systems allowing donations from individuals. Methods: We analysed statewise cancer drug repositories(source:National Conference of State Legislatures) and communicated with representatives from programs including SIRUM, RemediChain and I-DROP Coalition. We used a mixed methods approach to examine the breadth and functioning of these programs. Results: 28 out of the 44 states with laws establishing prescription drug repositories operate state-run drug recycling programs (Updated September 2023). However, only 14 states (California, Florida, Iowa, Michigan, Minnesota, Montana, Nebraska, Nevada, Ohio, Pennsylvania, Tennessee, Utah, Washington and Wisconsin) have provisions for donation of cancer medications, or for creation of separate cancer drug repositories. Other nonprofits like RemediChain and SIRUM function at a national level, covering 47 states and Washington D.C. between them. Conversations with 3 such programs revealed multiple obstacles that limit the effectiveness of drug recycling. All 3 programs reported inadequate donations, ranging from 2-3 donations/month in a state level program (I-DROP) to 1-10 donations/day in a larger national level program (RemediChain). 3/3 programs received more donations of unused pills from patients or their families than from pharmacies/health facilities. All 3 surveyed programs reported limited and inconsistent supply of donated drugs; expiration of drugs before redistribution; lack of demand for specialty drugs and unavailability of common oncology drugs that patients request since these drugs are less likely to go unused. All surveyed programs mentioned struggling with funding and staffing. Notably, all 3 repositories stressed that informing patients about recycling options right at the beginning of treatment was crucial to improve donation rates; and that expanding repository donor and recipient coverage could increase the chances of successfully redistributing drugs. Conclusions: Improving awareness amongst providers and patients, campaigning for federal funding and increasing the scale of coverage by expanding repository programs to all states and allowing interstate transfer of drugs could address current challenges to drug recycling. This would limit wastage of expensive medication while reducing financial burden on patients and improving access to life saving treatment.
Healthcare spending after a cancer diagnosis among working-aged adults.
Authors: Parsons Helen M. , Perraillon Marcelo C , Clark Roxanne , Bradley Cathy J , Greenwald Samuel , Zhao Jingxuan , Yabroff Robin 
Published: June 2024

11071 Background: The cost of cancer care has increased dramatically over the past decades, increasing the financial burden on patients. However, current estimates of healthcare spending and out-of-pocket burden rely heavily on data from older populations, which may not reflect contemporary treatment patterns in working-aged adults given the rise in use of novel therapies and increased incidence at younger ages. Methods: We used the 2012-2021 Colorado Central Cancer Registry linked to the All-Payer Claims Database to identify adults aged 22-63 newly diagnosed with cancer. We examined median health plan payments and out-of-pocket spending across the most common insurance and cancer types in six months after diagnosis. Results: Among 20,460 individuals newly diagnosed with cancer, the median total spending in the six months after diagnosis was $60,123 for those insured by private fee-for-service (FFS) plans and $26,326 for those insured by Medicaid. The majority of spending was for medical care. Among individuals insured by private FFS plans, those with lymphoma had the highest total median spending at $125,892, followed by lung ($99,823), breast ($87,121), leukemia ($86,776), and colorectal cancer ($76,273). Although total spending was markedly lower among those insured by Medicaid, individuals with leukemia ($52,591) and lymphoma ($46,787) experienced the highest median spending. Out-of-pocket spending was substantially higher for the privately insured ($3,751 or approximately $625/month) across all cancer types, and highest for lymphomas ($4,262), breast ($4,706) and colorectal ($4,216) cancers. Conclusions: Total healthcare spending after a cancer diagnosis is significant in the working-aged population and creates a substantial out-of-pocket burden, even among those privately insured. [Table: see text]
Impact of clinical response and AEs on health-related quality of life (HRQoL) in patients (pts) with R/R large B-cell lymphoma (LBCL): Pooled data from 4 lisocabtagene maraleucel (liso-cel) trials.
Authors: Johnson Patrick Connor , Abramson Jeremy S. , Shi Ling , Li Yeran , Eliason Laurie , Guo Shien , Liu Fei Fei , Gordon Leo I. 
Published: June 2024

11105 Background: Four liso-cel clinical trials in R/R LBCL (TRANSCEND NHL 001, PILOT, OUTREACH, and TRANSFORM) demonstrated a favorable clinical profile with high response rates (73%–80%) and positive changes in HRQoL after treatment. This analysis pooled data across 4 trials to assess the impact of clinical response and AEs on HRQoL. Methods: The EORTC QLQ-C30 and EQ-5D-5L were used to assess HRQoL repeatedly at prespecified time points up to Day 730. Six clinically relevant domains (EORTC QLQ-C30 global health status/quality of life [GHS/QoL], physical functioning, cognitive functioning, fatigue, pain, and the EQ-5D-5L visual analog scale [VAS]) were analyzed in liso-cel–treated pts pooled across trials with HRQoL scores at baseline and postbaseline visits. Linear mixed-effects regression models examined changes in HRQoL over time, with clinical response status and AEs as time-varying covariates, adjusting for relevant baseline and other time-varying factors. Trends in HRQoL change up to Day 730 over time were examined by cytokine release syndrome (CRS) and neurological events (NE) occurring ≤ 30 days after infusion. Results: The analysis included 368 and 372 pts for EORTC QLQ-C30 and EQ-5D-5L VAS, respectively. Achieving a clinical response (CR or PR) was associated with significant HRQoL improvement versus stable disease (SD) or PD in all 6 domains (Table). Meaningful improvement occurred ≤ 30 days after achieving CR or PR for all domains except cognitive functioning, where improvement occurred ≤ 90 days, and was sustained across remaining follow-up visits. CRS and NEs were associated with HRQoL worsening in selected domains; however, pts who experienced CRS or NEs ≤ 30 days after infusion recovered to levels of pts without the AE by Day 60 and maintained thereafter. Conclusions: Among liso-cel–treated pts with R/R LBCL, positive clinical response was associated with meaningful and sustained improvement in nearly all HRQoL domains. CRS and NEs may negatively impact certain HRQoL domains but are temporary. As liso-cel has demonstrated high response rates and a manageable safety profile across studies, these findings further support the pt-reported benefits of liso-cel for R/R LBCL. [Table: see text]
Improving quality of oncology (onc) documentation and enhancing structured data collection using a standardized onc note template.
Authors: Folstad Matthew , Augustine Arun , Hollnagel Fauzia , Carroll Cibele , Saner Ashleigh , Pier Jeff , Lavitschke Michael , Kleinschmidt Peter , Twedt Heidi , Tevaarwerk Amye Juliet , Emamekhoo Hamid 
Published: June 2024

11128 Background: To improve documentation quality in Medical Onc outpatient clinics, a standardized template was created. In this template we embedded: 1. An Epic SmartForm to collect structured data (SD) about patient, disease, and response status at each encounter. Minimal Common Oncology Data Elements (mCODE) compatible SD elements were used to enhance interoperability. 2. Several clinically impactful quality metrics (QM) selected based on the Quality Onc Practice Initiative (QOPI) guidelines. In this analysis, we aim to assess how template use impacted documentation quality. Methods: 113,376 outpatient encounters occurred between 01/2018 – 12/2022 (41 providers: 35 physicians, 6 APPs). The template go live was 3/19/2019. 2,520 randomly selected encounters were manually reviewed. Distinct documentation of 8 items served as QMs (Table). Of note, using the template was voluntary and data entry in the embedded form is not mandated. Documentation of each QM was compared between notes authored with/without template. For each note, a completeness score was calculated based on total number of QMs present/note. Categorical comparisons were made using chi-squared or Fisher’s exact tests. Numerical/continuous values were summarized using means and standard deviations. A template “user” was defined as a provider using the template in >10% of encounters after go live. This QI project was exempted by IRB. Results: 154/2520 encounters were excluded after manual review (visits not for solid tumor malignancy). The template was used in 38.7% (917/2366) of the reviewed notes. Cancer diagnosis was documented in >99.8% of notes regardless of template use. Template use was associated with increased documentation of 7 QMs (Table). Documentation overall completeness improved from 62% to 90% with a very large effect size (Table). Template use positively correlated with female gender and fewer years since last training (p<0.001). In the subgroup of notes written by “users” (21 physicians, 4 APPs), individual QM and overall completeness scores improved with template use (p<0.001). Conclusions: Template use profoundly improved QM documentation (statistically significant and clinically meaningful) by Onc clinic providers. This strategy enhances mCODE compatible structured data collection and semantic interoperability between systems, strengthening the available real-world data (RWD) in EHR. [Table: see text]
Enhancing inpatient chemo/immunotherapy stewardship: A novel scoring rubric approach to optimize utilization and reduce costs.
Authors: Bhardwaj Aarti Sonia , Lyublinsky Jessica , Sheng Tianxiang , Jain Priya , Thomas Robert , Smith Cardinale B. 
Published: June 2024

11130 Background: Most inpatient chemo/immunotherapy (IC) is not reimbursed because of the diagnosis-related group code structure for reimbursement. We implemented the use of a novel objective scoring rubric to guide and automate IC stewardship at an academic cancer center to decrease the inappropriate use of IC especially at the end of life. Methods: We created a scoring rubric for non-formulary IC that includes type and phase of trial, FDA/NCCN approvals, performance status, line, and goal of therapy. Clinicians enter these criteria in a Redcap form which automatically calculates a score which is then verified by 2 disease specific physicians and a clinical pharmacist. If the threshold score is not met, IC is not approved for administration. IC that is on formulary and standard of care is automatically approved. We compared post-implementation year 1 (1/2022-8/2022) to post-implementation year 2 (1/2023-8/2023) on two primary outcomes: drug cost and utilization. Comparisons were assessed using the Wilcoxon Signed-Rank Test. Results: There was a total of 74 requests with 12% not approved in 2022 compared to 96 with 14% not approved in 2023. We compared the median values of the number of times each non-formulary IC was dispensed from January to August in both 2022 (median=6) and 2023 (median=2), p= 0.01. In 2022 the median of average monthly IC drug charges was $$840730 compared to $434586 in 2023 (p= 0.02). In 2022 the median of average monthly ICI drugs was($91651) compared to $55368.35 (p= 0.25) for 2023. The total annual charge of IC decreased by 44% from 2022 to 2023 with the total annual charge of immune checkpoint inhibitors decreasing by 26% (Table). Conclusions: Implementation of a novel objective scoring rubric for IC stewardship effectively reduced inappropriate administration, as evidenced by a significant decrease in the number of times non-formulary IC was dispensed and a substantial reduction in drug charges. The total annual charge of IC significantly decreased by 44% showing a sustained improvement over a 2 year period. This approach offers a promising strategy to optimize resource utilization and ensure appropriate utilization of IC, particularly in patients nearing the end of life. Further studies are warranted to evaluate the long-term impact of this intervention on patient outcomes and healthcare costs.[Table: see text]
Examining the relationship between ECOG performance status and immunotherapy outcomes: Insights from real-world data analysis.
Authors: Chernet Rachel , Desai Devashish , Rajendran Rahul , Bixby Amber , Faso Susan , Wallace Josh , Nasr Michel R , Jamaspishvili Tamara , Basnet Alina 
Published: June 2024

11131 Background: The impact of Eastern Cooperative Oncology Group Performance Score (ECOG) on immunotherapy (IO) outcomes is intricate, as historically clinical trials have primarily enrolled patients with ECOG scores of 0 or 1. The National Comprehensive Cancer Network (NCCN) advises against administering IO to patients with ECOG scores of 2 or higher. However, conflicting findings from research studies and variations in real-world clinical practice complicate this relationship. Our study aims to elucidate the association between ECOG status and the outcomes of immunotherapy. Methods: Data collected from SUNY Upstate Medical University treated cancer patients who underwent immunotherapy and chemotherapy was used for analysis. The Kaplan-Meier method and Cox regression were used to analyze survival probability based on therapy, age, and ECOG. Results: Of 813 patients included in the study, 46.99% (n=382) received immunotherapy. 51.85% (n=421) were females. The mean age was 64.1 years in IO group and 67.7 years in non-IO/chemo group. 52.5% (n=187) of patients who were ≤ 64 years received IO compared to only 42.7% (n=195) of patients who were ≥ 65 years (p=0.005). 48.6% (n=118) of patients with ECOG score 0 received IO, while only 40.5% (n=72) patients with ECOG score of ≥3 received IO (p=0.279). Patients who received IO with ECOG score of ≥3 had higher probability of survival compared to other groups (p<0.0001). While, in non-IO group, patients with ECOG 0 had higher probability of survival compared to ECOG 3 (HR 1.773, 1.209 – 2.600). There was no difference in overall survival in patients receiving IO based on age categories (p=0.2627, HR 1.148, 0.901 – 1.462). Conclusions: Our findings suggest that relying solely on ECOG status to determine eligibility for immunotherapy may be overly restrictive. Patients with significant comorbidities could still derive benefits from immunotherapy. Further investigation is warranted to comprehensively assess the influence of ECOG status on immunotherapy outcomes.