bluuebunny/crossref_metadata_2025 huggingface dataset:
Cancer care service use intensity in Medicare Advantage versus traditional Medicare.
Authors: Mitchell Aaron Philip , Kalidindi Yamini , Feldman Roger , Carlin Caroline , Song Ge , Jung Jeah
Published: June 2024

11054

Background: Prior studies have found evidence of lower cost of care and preserved care quality among Medicare Advantage (MA) plans vs. traditional Medicare (TM). However, MA performance for patients with serious conditions such as cancer is yet to be explored. MA plans are incentivized to reduce expenditures, and the high financial cost (often with marginal clinical benefit) of chemotherapy might be an opportunity for savings. We compared service use intensity and quality between MA and TM cancer patients receiving systemic therapy. Methods: Medicare claims data and MA encounter records (including only MA contracts that had highly complete data), 2015-2019. We included patients with select major cancer types, and measured outcomes during a 6-month chemotherapy episode, defined by the date of systemic therapy initiation after a 1-year washout period. Service use intensity was measured in dollar terms using standardized Medicare prices. Quality measures included treatment-related emergency department (ED) visits and hospitalizations, avoidable ED visits, preventable hospitalizations, and overall survival. To estimate the association between MA enrollment and these outcomes, we used regression models with county-level fixed effects and inverse probability of treatment weighting to balance the MA and TM samples on patient demographics, cancer type, health-risk score, metastatic status, frailty, and area characteristics. We performed separate analyses by cancer type. Results: The study sample comprised 96,501 MA and 206,274 TM beneficiaries who had one of seven cancer types: breast cancer, chronic leukemia, colon cancer, lung cancer, lymphoma, multiple myeloma, and prostate cancer, and who initiated systemic therapy between 2016 and 2019. Estimated mean overall service use among MA enrollees was $62,599, compared to $71,317 for TM beneficiaries (-$8,718, p<0.01). A majority of the overall difference was accounted for by Part B-covered systemic therapy drugs ($20,691 in MA versus $25,723 in TM, difference -$5,032, p<0.01). Although MA enrollees received slightly cheaper drugs (-$277 per treatment day, p<0.01), the lower cost of systemic therapy was driven largely by a lower number of treatment days occurring per 6-month episode for MA enrollees (-1.06 days, p<0.01). MA enrollees had fewer treatment-related ED visits and hospitalizations (-2.5%, p<0.01 and -0.7%, p<0.01 respectively) but had more avoidable ED visits (+0.5%, p<0.01). There was no difference in survival or preventable hospitalizations. Results were similar within individual cancer types. Conclusions: MA enrollment is associated with reduced service utilization but not shorter survival among cancer patients receiving systemic therapy. Further research is needed into the mechanisms of these savings to identify areas where care may be delivered more cost-effectively without negatively impacting outcomes.
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.
Association of enrollment in Medicare Advantage plans versus fee-for-service in patients with a late-stage diagnosis of gynecologic cancer.
Authors: Zhang Elyse Xinyue , Ward Kevin C , Meisel Jane Lowe , Switchenko Jeffrey M. , Lipscomb Joseph
Published: June 2024

11140

Background: In the United States, uterine cancer is the most common gynecologic (GYN) cancer; and ovarian cancer causes more deaths each year than any other GYN cancer. There are currently no recommended population-wide screening tests for ovarian or uterine cancer, which are heavily concentrated in older women. Medicare is the primary health insurer for 97% of Americans aged 65 years and older. This study is the first to examine the association between Medicare enrollment plan – Medicare Advantage (MA) versus fee-for-service (FFS) – and stage at diagnosis among older women newly diagnosed with ovarian or uterine cancer. Methods: Using the linked Surveillance, Epidemiology, and End Results (SEER) registries and Medicare enrollment data, we identified 101,193 women aged 65 years and older with newly diagnosed ovarian or uterine cancer between 2007-2019. We categorized patients into two groups: 1) those continuously enrolled in Medicare MA for six months prior to their diagnosis, through the diagnosis month, and the month following diagnosis; 2) those continuously enrolled in Medicare FFS within the same eight-month window. Late-stage was defined as “Distant” stage (with “Local” and “Regional” stages representing an earlier-stage diagnosis) using the SEER Summary Stage variable. The association between Medicare enrollment plan and stage was examined through multivariable logistic regression modeling that adjusted for sociodemographic characteristics. The influence of each predictor on the difference in the probability of late stage was summarized as an adjusted marginal effect (ME). Results: Among uterine cancer patients, 37% had MA insurance. Compared with Medicare FFS enrollees, the adjusted percentage of late-stage diagnosis was 0.6 percentage points (ppt) lower for MA enrollees (95% CI = -1.1-(-0.1); P<0.05). Notably, patients were more likely to have a late-stage uterine diagnosis if they were: non-Hispanic Black or Hispanic (vs. non-Hispanic White); age 75 and older (vs. between 65 -74); and residing in a lower SES neighborhood. Among ovarian cancer patients, 34% had MA insurance. We found no significant difference between Medicare MA and FFS enrollees in ovarian cancer stage at diagnosis. Of note, Non-Hispanic Black patients were significantly more likely to be diagnosed with late-stage disease compared to Non-Hispanic White, and likewise for patients aged 75 and older (vs. between 65-74). Conclusions: Among Medicare beneficiaries (age 65+) diagnosed with uterine cancer, those enrolled in an MA plan were significantly less likely to be diagnosed at a later stage. In similar analyses for ovarian cancer, there was no such MA - FFS difference in the probability of late-stage. As enrollment in Medicare Advantage plans continues to grow, it becomes increasingly important to identify whether there are significant outcome differences between MA and FFS plans.
Knowledge, attitudes, and current practices toward lung cancer palliative care management in China: A national survey.
Authors: Chen Mengting , Yu Huiqing , Zhang Junhui , Yang Hong , Yang Liejun , Tian Ling , Wang Sixiong
Published: June 2024

11143

Background: To demonstrate the status and differences in knowledge, attitudes, and practices (KAP) of lung cancer palliative care (LCPC) management, and to measure patient controlled analgesia (PCA) in cancer pain management in of China. Methods: A questionnaire on LCPC management was used in this study, which involved a total of 2093 participants from 706 hospitals in China. Seven major components make up the questionnaire, including chi-square tests or Fisher exact probabilities to measure the differences in KAP between hospitals grades. Comparing distributions of ordered data between groups was done using the Kruskal-Wallis H test or the Mann-Whitney U test. Multiple choice questions use multiple response cross analysis. Correlation was evaluated by the Spearman correlation coefficient. Results: 84.2% participants believed that anti-tumor therapy is equally important as palliative care. The satisfaction rate of participants from grade 3 hospitals, which was significantly higher than that of grade 2 and grade 1 hospitals (χ²=27.402, P=0.002). The most common symptoms requiring LCPC was pain. The major barriers toward to LCPC were “Patients and families are concerned about the safety of long-term use of palliative care related drugs”. The most common reasons for the use of PCA treatment were 31.1% participants thought “Patients with systemic application of large doses of opioids or adverse reactions to opioids that cannot be tolerated”. The top three barriers toward PCA treatment of cancer pain were (i) worry about adverse reactions of drug overdose, (ii) worry about opioid addiction, and (iii) increase of patients' economic burden. In the past 24 months, 33.9% of the participants had not participated in online or offline training related to palliative care of lung cancer. Conclusions: Chinese healthcare workers are in need of training for lung cancer palliative care and, in particular, for controlling cancer pain symptoms.
Breaking through barriers: Unraveling challenges in clinical trial participation among oncologic patients in a developing country.
Authors: Bushatsky Erika , Cândido Andressa Liz , Vasquez Quispe Daniel Agustin , Paiola Rafaela , Machado Barata Tavares Alessandra Cristina , Cruz Felipe Melo , Arruda Lilian Martins
Published: June 2024

11144

Background: Clinical trials are vital for advancing cancer research and treatment development, yet obstacles to participation impede progress, particularly in regions with limited clinical research awareness, such as Brazil. Methods: This study was conducted in a single cancer center in São Paulo, Brazil, between 2020 and 2022. A tailored questionnaire comprising demographic (age, gender, income) and barrier-related sections explored patient-related (10 questions), protocol-related (7 questions), and physician-related (5 questions) barriers. Results: Among 206 oncologic patients enrolled in the study, 43.7% were from the public healthcare system, and 56.3% had private insurance. Patients who self-declared as white were 59.7%, and those who self-declared as brown/black were 35.9%. Patient-related challenges included unfamiliarity with trial participants (84.6%), concerns about daily life disruptions (75.4%), and transportation difficulties (66.2%). Protocol-related obstacles involved fears of unknown side effects (62.3%), inability to choose treatment (47.6%), and potential assignment to a placebo group (46.8%). Physician-related barriers included communication issues, strained doctor-patient relationships (94.7%), and patient deference to doctors' decisions (55.4%). Higher-income patients and those in the public health system demonstrated greater clinical research awareness. Conclusions: The study emphasizes the critical role of patient education in overcoming barriers to clinical trial participation in oncologic patients. Furthermore, it underscores the necessity of addressing disparities among minority populations, such as non-white individuals with lower incomes, to transform clinical research and ensure universal access to newer therapies. Efforts should be directed towards inclusivity, bridging awareness gaps, and fostering a comprehensive understanding of the benefits of clinical trial participation for all cancer patients.
Timing of EGFR or ALK inhibitor initiation and survival among patients with advanced NSCLC.
Authors: Tanvetyanon Tawee , Chen Dung-Tsa , Gray Jhanelle E.
Published: June 2024

11148

Background: ALK or EGFR inhibitor is an ideal frontline treatment for patients with advanced non-small cell lung cancer (NSCLC) harboring targetable alteration in ALK or EGFR. However, in the real-world setting, frontline treatment may be delayed or unideal. For such patients, the magnitude of survival benefit when initiating ALK or EGFR inhibitor at a much later timepoint remains unclear. Methods: We utilized a nationwide electronic health record-derived, deidentified database collected from diverse oncology practices across the United States to investigate the timeliness of preferred targeted therapy (PTT), defined as osimertinib, lorlatinib, alectinib or brigatinib. Individualized data obtained from patients with stage IV NSCLC at diagnosis treated with PTT during 2018 to 2023 were analyzed. Timing of PTT initiation was modeled as time-varying covariate. Results: Data from 3250 patients were analyzed: 2640 patients (81%) with EGFR mutation and 610 patients (19%) with ALK rearrangement. The median time to PTT was 7 weeks from diagnosis with 26.4% of patients started PTT within 1 month. Landmark analyses using timepoints ranging from 1 to 12 months after diagnosis showed that at all timepoints, patients who had started on PTT had a significantly better survival than those who had not (Table). In a multivariable analysis, time to PTT ≤ 1 month from diagnosis was an independent predictor of survival: HR 0.74 (95% CI: 0.62-0.89), p=0.002. Prolonged time to PTT was significantly associated with advanced age, positive smoking status and genomic class being ALK as compared to EGFR. Conclusions: In this population-based analysis, an initiation of PTT occurring as late as at least 1 year from diagnosis still resulted in a significant survival benefit, though the magnitude of benefit appeared decreased as time passed. [Table: see text]
Differences in baseline characteristics and healthcare costs among insured patients with advanced cancer with vs without clinical trial participation.
Authors: Stockl Karen M , Morin Pamela , Reyes Carolina , Schroeder Brock , Certa Julia M , Tucker Jamie , Hostin Damon , Fox John Leonard
Published: June 2024

11154

Background: Despite concerted efforts to improve clinical trial participation (CTP), enrollment remains low. Perceived additional costs to the patient or health plan may be barriers to CTP; low biomarker testing rates may be another. This study assessed differences in characteristics of patients with CTP versus patients without CTP in an insured population with advanced cancer. Methods: A retrospective analysis was conducted using de-identified administrative claims data from commercially insured and Medicare Advantage (MA) enrollees in the Optum Labs Data Warehouse. Patients ≥18y with claims evidence of advanced cancer and systemic therapy between 01/01/2018 and 02/28/2022 were stratified into 2 groups: 1) with CTP: ≥1 claim with a CTP diagnosis (ICD10 Z00.6) and ≥1 claim with a Q modifier on or within 90 days after index date; and 2) without CTP: no claims with a CTP diagnosis or Q modifier. Patients with >1 primary cancer, T-cell therapy, or <360 days baseline or follow-up (unless death) enrollment were excluded. Biomarker testing, targeted therapy use, and healthcare costs per patient per month (PPPM) were assessed in the baseline period. Results: Of 61,490 patients identified, 1753 (3%) had CTP and 59,737 (97%) did not have CTP; 4% of commercial and 3% of MA patients had CTP. Most common tumor types were breast (27%; 2% had CTP), lung (16%; 3% had CTP), digestive tract (15%; 2% had CTP), and prostate (15%; 3% had CTP). Patients with CTP were younger and more frequently had documented biomarker test use in the baseline period than patients without CTP (Table). In unadjusted analyses, the CTP group had higher healthcare costs in the baseline period prior to CTP regardless of insurance type, driven by 51% higher systemic cancer therapy costs and 35% higher ambulatory visit costs. An ongoing propensity score matched analysis will evaluate the impact of CTP on cost of care in the follow-up period. Conclusions: Consistent with prior studies, the overall CTP rate among patients with advanced cancers was low (3%). Baseline costs (prior to CTP) were higher for patients that later enrolled in clinical trials than for patients without CTP. Further research is ongoing to assess differences in follow-up healthcare costs for patients with vs without CTP adjusting for baseline characteristics. [Table: see text]
Integration of a machine learning model-generated surgical risk score into the EHR and preoperative workflow.
Authors: Mahuron Kelly , Chen Chen , Carlin Cameron S , Seth Naini S. , Nelson Rebecca A. , Uranga Carolina , Lai Lily L.
Published: June 2024

11163

Background: We previously developed a machine learning model (MLM) that accurately predicts postoperative complications (POC) for cancer inpatients. As laborious manual entry of patient data is a barrier for risk calculator use, and risk constantly changes depending on clinical status, we sought to integrate our MLM into the electronic health record (EHR) and preoperative workflow as a readily available surgical risk score (SRS) that is generated using real-time data. Here, we report on the integration process and survey results regarding its functionality and impact on patient care. Methods: A MLM that predicts severe POC (CD Grade ≥3) for cancer inpatients undergoing same-hospitalization operations was previously developed using EHR data. To integrate our MLM into the Epic EHR, we developed a real-time infrastructure (RTI) using the cloud-based platform Azure. EHR data is inputted to RTI and processed in real-time to generate model outputs. These outputs are then sent back to the EHR through the Epic Cognitive Computing Platform to generate each patient’s specific SRS. The SRS is dichotomized as “high” or “low” risk based upon a previously determined threshold and is displayed as a “Best Practice Advisory (BPA)” when a surgical case request is entered. In addition to the automated BPA, the SRS is sent to the primary surgeon as an InBasket Case Message. To elicit feedback of our EHR-integrated SRS, a survey was distributed to surgical providers at our institution. Results: After integration of our MLM into the EHR preoperative workflow, 185 surgeries were completed between November 16, 2021 to July 31, 2023. The 30-day severe POC rate was 27.6%, and our MLM had precision of 44.7% and recall of 74.5%, resulting in AUROC of 0.78 and AUPRC of 0.53. 35 surgical providers (40% primary surgeons, 34% surgical fellows, 26% advanced practice providers) from the divisions of surgical oncology, colorectal surgery, and gynecologic oncology completed our survey in July 2022 and July 2023. 28 (80%) of providers stated that they have interacted with the SRS through either BPA or InBasket Case Messages. Of these providers, 21 (75%) strongly agreed or agreed that the SRS was visible at appropriate times, and 18 (64%) strongly agreed or agreed that the SRS contains relevant information to assess surgical risk. 8 (29%) strongly agreed or agreed that the SRS was used to facilitate preoperative discussion. The 2023 survey additionally asked whether the SRS impacted the decision to operate; among providers who had interacted with the SRS, 4 (36%) strongly agreed or agreed with this statement. Conclusions: Integration of a real-time, MLM-generated SRS into the EHR and preoperative workflow can be successfully performed. While our integrated SRS is visible to surgeons and contains risk assessment felt relevant to the operation, the impact of the SRS on clinical care and decision making remains unclear.
Effect of combination of genomic variation–based machine learning and clinical pathology on accurate diagnosis of tumors: Lung adenocarcinoma and lung squamous cell carcinoma.
Authors: Gu Weiguang , Wang Haitao , Zhuang Mengxia , Hao Qing , Wang Zhizheng , Liu Wenjin , Lu Leilei , Dong Xiaowei , Pang Fei , Qin Hongli , Wang Kai
Published: June 2024

11174

Background: Non-small cell lung cancer (NSCLC) is the most prevalent form of lung cancer, with lung adenocarcinoma (LUAD) and lung squamous cell carcinoma (LUSC) being the predominant subtypes. Given the significant differences in treatment approaches and clinical outcomes between LUAD and LUSC, accurate identification of these pathological subtypes prior to treatment initiation is crucial. Methods: This study aimed to enhance the diagnostic accuracy for LUAD and LUSC by integrating a machine learning artificial intelligence (AI) model with the expertise of pathologists. The AI model was trained and validated on a cohort of 10,693 and 5,571 cases from the OrigiMed database, each confirmed by at least three pathologists. Targeted sequencing of 450 cancer-related genes was performed. Results: Analysis of the validation set demonstrated an overall accuracy of 89.2% across 28 tumor types, with individual accuracies ranging from 22.2% to 100%. For the top one prediction, the AI model achieved an accuracy of 82.7% for LUAD and 67.9% for LUSC. However, when considering the top three predictions, the accuracy significantly increased to 92.1% for LUAD and 93.0% for LUSC. To further validate the diagnostic capability of the AI model, a large sample of 4,531 LUAD cases and 207 LUSC cases from 4,502 patients was collected for comparative analysis with pathologists' diagnoses. The results indicated that 87.9% of LUAD cases and 83.6% of LUSC cases were consistent with the AI model's diagnosis, while 4.9% of LUAD and 9.7% of LUSC cases showed discrepancies. To investigate these inconsistencies, a subset of 30 LUAD cases and 16 LUSC cases was selected for re-evaluation by independent pathologists. Four poorly differentiated cases from the discrepancy group were ultimately diagnosed as 2 LUADs and 2 LUSCs, supporting the initial AI diagnosis. For instance, Patient 40 was initially diagnosed with LUSC; however, the AI system identified the pathology as LUAD, which may be attributed to the detection of the KIF5B-RET fusion. This diagnosis was subsequently corroborated by an additional pathologist who observed gland-like structures and ambiguous solid mass formations within the tumor tissue, consistent with LUAD histopathology. Conclusions: In summary, we have presented a machine learning AI model that leverages next-generation sequencing (NGS) technology for the auxiliary diagnosis of cancer. By applying this AI model to diagnose LUAD and LUSC and comparing it with the diagnoses made by human pathologists, we have demonstrated that the integration of pathological diagnosis and AI machine learning can significantly enhance and even surpass the diagnostic capabilities of human physicians. This advancement holds great potential in improving the accuracy of tumor diagnosis and the precision of treatment.
Rethinking the impact of pretransplant malignancy on eligibility for double lung transplantation (DLT): An analysis of 23,291 recipients.
Authors: Woo Wongi , Kim Hye Sung , Bharat Ankit , Chae Young Kwang
Published: June 2024

11180

Background: The outcomes for double lung transplant recipients with a history of pretransplant malignancy (PreTM) have not been extensively studied in a large, multicenter database. Given the rising need for transplants among older patients with a history of cancer and the improving outcomes of DLT, this study aimed to analyze recipient outcomes in the modern era. Methods: This study evaluated the United Network for Organ Sharing (UNOS) registry for adult DLT performed between 2005 and 2023. Patients with a history of previous or multi-organ transplants, and those with donors who had a history of malignancy, were excluded. Propensity-score matching was used to compare patients with or without PreTM. Posttransplant malignancies (PostTM) were classified into cutaneous and non-cutaneous types. The primary outcomes were overall and PostTM-free survival. Results: Of the 23,291 DLT recipients, 1,870 recipients (8.0%) had a history of PreTM, which was classified into twelve types. Patients with PreTM experienced worse overall (HR 1.20 [95% CI 1.12-1.29], p<0.001) and PostTM-free survival (HR 1.32 [95% CI 1.24-1.41], p<0.001). After propensity-score matching for age, sex, and race, the differences in overall survival between the two groups were diminished (HR 1.05 [95% CI 0.97-1.13], p=0.229). Although PostTM-free survival was still worse in the PreTM group, this difference was not observed after excluding cutaneous PostTM (HR 1.06 [95% CI 0.99-1.15], p=0.116). The incidence of PostTM of the same PreTM type among patients with PreTM was 13.5% (253/1870), which was not higher than the incidence of de novo PostTM incidence among patients without PreTM (p=0.633). Conclusions: Patients with PreTM show similar overall survival rates after DLT as those without PreTM, despite a higher incidence of PostTM, mainly cutaneous. Importantly, there is no increased risk of the original cancer type recurring in PreTM patients compared to the risk of de novo malignancy. These findings highlight the necessity for a more nuanced evaluation of transplant candidacy to prevent premature exclusion of PreTM patients from potentially life-saving surgeries. [Table: see text]