bluuebunny/crossref_metadata_2025 huggingface dataset:
Implementation of a rapid access multidisciplinary pathway to reduce health disparities in veterans with thoracic malignancies.
Authors: Wilcox Sabrina , Taylor Kate , Besko Melisa , Pirzadeh Mina
Published: June 2023

e18583

Background: Lung cancer has higher incidence and lower survival rates in Veterans compared to the general population. Previous investigation at our institution identified delays in care for veterans with new lung cancer diagnoses often due to patient factors including transportation, lodging, or too many appointments. Modifiable factors we aimed to improve included coordination and consolidation of care related to diagnostic work-up. We implemented a rapid access pathway (RAP), including a multidisciplinary panel of providers who review outside referrals for imaging concerning for thoracic malignancy with a goal of identifying appropriate invasive diagnostic work-up prior to initial consultation visit. Patients eligible had an initial telehealth visit and were offered a two-day consolidated diagnostic visit, with lodging. Methods: Retrospective chart review was conducted on veterans referred to the Veterans Affair Ann Arbor Healthcare System for lung cancer work-up and who were eligible for RAP from 10/2021- 12/2022. Data abstracted included veteran demographics, comorbidities, indication for initial imaging, tumor stage, and treatment rendered. Time intervals between abnormal image to multidisciplinary conference (T0), conference to telehealth consult (T1), telehealth consult to tissue diagnosis (T2), tissue diagnosis to treatment (T3), total time from abnormal image to treatment (T4) were calculated. Incidence and type of system delay (SD) versus patient delay (PD) was recorded with each care interval. Results: 306 new consults underwent multidisciplinary review; 20 were eligible for the RAP; 4 declined a consolidated visit. Sixteen Veterans at least partially completed the pathway by the time of analysis. 93% (n = 15) were male, 81% (n = 13) identified as White. Median age at referral was 74 and median Charleston-Comorbidity Index was 5, with 62% having mobility issues. 56% lived at least 50 miles from the Ann Arbor VA. Disease was detected by lung cancer screening in 56%, incidental finding in 37%, and symptom triggered in 6%. Median times to each interval were T0 13.5 days, T1 5.5 days, T2 28 days, T3 34 days and T4 70 days. SD was observed in 11% of patients; most commonly due to administrative scheduling changes. PD occurred in 35% of patients, often prior to diagnostic procedure or treatment initiation; most commonly due to a new hospitalization, patient wanting more time prior to treatment or declining work-up/treatment. Conclusions: Our aim was to expedite diagnosis and treatment of new potential lung cancers in Veterans by mitigating barriers commonly experienced in the healthcare system without compromising quality of care. All veterans who participated in all stages of the RAP received RAND guideline concordant care (time from abnormal image to treatment initiation < 98 days). Ongoing analysis will include clinical outcomes following RAP implementation.
Barriers to diversity in cancer therapy: Uncovering disparities in knowledge and interpretation of genetic testing among African Americans, and their direct implications for access to mutation-based therapies.
Authors: Lapidot Lena , Safran Michal , Bader Tzvia , Gaziel Avital
Published: June 2023

e18587

Background: African American cancer patients are disproportionately impacted by limited access to health education and resources, limiting their access to advanced care and clinical trials (CTs). In line, African Americans have the highest death rate and shortest survival of any racial/ethnic group in the US for most cancers. In this study we analyzed cancer patients’ knowledge of different parameters of their disease, including biomarker/mutational status knowledge which is vital for making informed treatment decisions. Methods: Leal (formerly, Trialjectory) is an AI-based platform that matches cancer patients to CTs based on a self reported medical profile. The profile includes parameters essential for CT matching including disease status, stage, biomarker/mutational status, treatment history, comorbidities and demographics. This study included a multi-racial sample cohort of 11,302 patients with advanced cancer who completed the questionnaire between 2019-2023. We characterized the general questionnaire completion rate and further focused on whether genetic testing was performed and on biomarker knowledge across varying clinical, demographic and racial/ethnic groups. Results: The general questionnaire completion rate was not affected by age, gender, or ethnic group. Genetic testing performance was associated with cancer types for which treatment guidelines recommend testing. There was no major difference in genetic testing performance between ethnic groups (Pearson’s Χ² = 0.05), with slightly lower rates in African Americans compared to other racial groups. A notable gap was found in the interpretation and reporting of test results across all races. Race and ethnic background had a significant impact on biomarker knowledge (Pearson’s Χ² < 0.0001), with African Americans having a profoundly lower probability of knowing/reporting their mutation status compared to other races/ethnic groups. Clinical trials that require the presence of certain mutations for a match were ranked lower on the matched CT list or were not matched at all for patients who failed to report their biomarker data. Conclusions: African Americans are less likely to know or interpret/report their mutation status compared to other races or ethnic groups. This disparity was not influenced by the completion rate of the questionnaire, suggesting that ethnicity is not a hindrance to accessing technology. Our results highlight a significant gap in access to information and education particularly in regards to biomarker knowledge, which play a crucial role in obtaining the most effective treatment or accessing mutation-specific targeted therapy within or outside of a CT. Addressing these disparities is imperative to ensure that cancer patients can make informed treatment decisions.
Implementation of a housing insecurity screening tool in patients with lung cancer.
Authors: Burns Laura , Young Sara , Jang Hyerim , Jani Chinmay , El Saman Radwan Amr , Al Omari Omar , Patel Mohini , Dudipala Harshitha , Buitron de la Vega Pablo , Kulke Matthew H. , Tapan Umit
Published: June 2023

e18601

Background: Patients with lung cancer experiencing housing insecurity are known to have longer time to biopsy, more missed appointments, and other delays in treatment as compared to their peers with stable housing. Methods: A single-institution retrospective chart review was performed at our safety-net academic institution. Patients with a new diagnosis of primary lung cancer from January 2015 through December 2020 who responded to the housing insecurity screening tool were included. Patients who screened positive received a print-out of housing resources or referral to a patient navigator. All characteristics except molecular testing were analyzed using multivariate logistic regression with housing status as the dependent variable. Molecular testing was analyzed separately via a Chi-Square test of independence given molecular testing was indicated for only a subset of patients. Results: Of the 423 patients, 264 (62%) reported housing insecurity. Compared to patients with stable housing, patients with housing insecurity received molecular testing when indicated at comparable rates, had similar time from first biopsy to initiation of treatment, and had similar insurance status (Table 1). Patients with stable housing were more likely to be White (OR 1.65, 95% CI 1.09 -2.50). Conclusions: Although existing data shows patients with housing insecurity experience delays in treatment, our findings suggest that provision of equitable access to care with targeted interventions to reduce housing insecurity may help reduce such disparities, which often affect minoritized racial groups disproportionately. [Table: see text]
Impact of neighborhood disadvantage on stage at diagnosis and outcomes in women diagnosed with breast cancer.
Authors: Harris Alexandra A , Szabo Aniko , Kamaraju Sailaja , Cheng Yee Chung , Burfeind John D. , Chitambar Christopher R. , Chaudhary Lubna Naaz
Published: June 2023

e18603

Background: Low socioeconomic status (SES) has been associated with higher incidence of high-risk breast cancer and poorer outcomes. However, previous studies have inconsistent definitions of SES. Using a more comprehensive definition of SES via the Neighborhood Atlas, which calculates one's relative level of Neighborhood Disadvantage (ND) using 17 variables from American Community Survey and US Census data, may address this problem. We aimed to determine if higher level of ND is associated with later stage breast cancer at diagnosis and/or higher five-year recurrence rates. Methods: We performed a retrospective chart review study of 418 women that were diagnosed with breast cancer in 2015 within the Froedtert Health System in WI. Data collected included: patient characteristics (age, race, BMI, menopausal status, genetic status), tumor characteristics (tumor size, nodal status, metastases, ER/PR/HER2 status, histology, grade, date of diagnosis, self- detected vs. abnormal mammogram), treatments received (surgery, radiation, chemotherapy, endocrine therapy), and outcomes (type of recurrence, date of recurrence, date of death if applicable, last follow-up, etc.). Patient home addresses at the time of diagnoses were geocoded and inputted into the Neighborhood Atlas Mapping Tool to obtain 2015 ND values. Spearman’s rank correlation was used to evaluate the association between ND and TNM stage at diagnosis. Cox regression was used to evaluate the effect of ND on cause-specific hazard of recurrence. Significance value of < 0.05 was utilized. Results: The average age at diagnosis was 60 years and most women were post-menopausal (74%). Most patients had ER and/or PR-positive cancer (82% and 72% respectively) and 15% had HER2-positive disease. The average tumor size was 1.3cm (range 0-10). Node positive disease was seen in 104 women (25%) and 20 women (4.8%) had distant metastatic disease at diagnosis. Only 24 (5.7%) patients experienced disease recurrence within five years of diagnosis. The average National ND value was 36 (range of 4 to 100). ND was not significantly associated with stage at breast cancer diagnosis (p = 0.37) or five-year recurrence rates (p = 0.19). Conclusions: The average National ND value was not significantly associated with stage at breast cancer diagnosis or five-year recurrence rates. It is important to consider our study population demographics in the context of these results. The average National ND value was low at 36 which suggests an unequal representation of those living in disadvantaged areas compared to those living in more advantaged areas. Additionally, we were unable to draw strong conclusions on effects of ND on patient outcomes due to low number of recurrences seen. Future studies with larger sample size are likely needed to capture the possible impact of ND on patient outcomes.
Real-world treatment patterns of non-small cell lung cancer in an Indian hospital.
Authors: Miyasato Gavin , Kasivajjala Vamsi Chandra , Misra Mohit , Kumar Kiran , Shah Chitrang , Friedman Howard S
Published: June 2023

e18604

Background: The circumstances regarding lung cancer in India are similar to many countries around the world – it is one of the most commonly diagnosed cancers with many treatment options available. India, however, relies heavily on an out-of-pocket healthcare payment model in which patients are often directly responsible for the majority of these treatment costs. This paradigm makes many of the newer generation of medications financially inaccessible for most Indians. In this research, we aimed to understand the current treatment patterns of non-small cell lung cancer (NSCLC) from an analysis of Indian hospital data, as a way to contextualize the real-world treatment situation. Methods: Electronic Medical Record (EMR) data was sourced from a major cancer hospital located in India’s national capital region. Using the Querent health analytics platform, EMR data across 5 years (2017-2022) were analyzed. Demographics, disease characteristics, and treatment patterns were identified through a combination of structured and unstructured data including data from registration, laboratory, radiology, diagnosis, procedure, pharmacy, and clinical notes. Results: 1,227 unique patients with NSCLC were observed in the hospital over five years, with an average (SD) duration of observation time of 12.1 (15.4) months. The patients were, on average (SD), 59.0 (11.2) years old and were more likely to be male (69.4%). Most patients were in later cancer stages, with a distribution of I (3%), II (2%), III (13%), and IV (82%). Among those with metastatic NSCLC, 773 (76%) received cancer treatment at the hospital, with 52% receiving surgery, 5% radiotherapy, and 88% anti-cancer medication. The most commonly administered medications were chemotherapies (carboplatin (52%) and pemetrexed (38%)). Targeted therapies were administered in 55% of patients. Conclusions: Only about half of all metastatic NSCLC patients received targeted cancer therapy. This proportion pales in comparison to targeted therapy utilization rates observed in the US and Europe, indicating the need to address the affordability issues that hamper patient access to these medications. Increased adoption of advanced therapeutics could lead to improved outcomes for many patients in India.
Oncology financial advocacy services guidelines: Results of a Delphi study.
Authors: Boehmer Leigh , Kajdic Hodzic Rifeta , Harvey Allison , Doherty Meredith , Gentry Sharon , Kirch Rebecca A , Nelson Krista , Mangir Christina , Santiago Angie , Schneider Lori , Plotkin Elana
Published: June 2023

e18606

Background: At least half of people with cancer experience financial toxicity1 but financial advocacy has emerged as a promising intervention to mitigate it. How cancer programs and practices screen for financial toxicity among patients and the types of services they offer vary greatly. Standardization is needed to evaluate the outcomes and impacts of financial advocacy. Therefore, the Association of Community Cancer Centers (ACCC) Financial Advocacy Network set out to develop Oncology Financial Advocacy Services Guidelines (hereafter “the Guidelines”) to address this gap. Methods: To conduct this original, non-clinical trial research, ACCC convened a task force of seven multidisciplinary experts in financial advocacy to oversee a modified Delphi study. The task force assembled a panel of 49 experts, who represented oncology financial advocacy staff, multidisciplinary cancer care team members, financial advocacy subject matter experts, as well as patients and patient advocates. Based on a literature review and qualitative input from panelists, the task force drafted a list of 44 potential guidelines. In early 2022, panelists completed two rounds of anonymous voting, determining if each statement should not be a guideline, be a minimum guideline, or be an enhanced guideline. Consensus was set at 75% agreement. Results: The panel reached consensus that 43 statements should be guidelines. One guideline was rated minimum, while another 17 trended toward being considered minimum (60%-74% agreement among panelists). The panel rated one guideline as enhanced, with two others trending toward being enhanced. Twenty-two guidelines did not reach consensus one way or another on being minimal vs. enhanced. Conclusions: The Guidelines are publicly available in a report that includes implementation considerations extracted from Delphi panelists’ comments and task force input. Half of guidelines did not reach consensus on whether they are minimum or enhanced, reflecting the diversity of current financial advocacy practice and a need to develop greater standardization in the field. ACCC is taking several next steps to advance research and quality practice using the Guidelines, including collaborative policy development, assessment tools, and the creation of valid metrics and accountability measures.
Association of food insecurity with reduced cancer screening rates.
Authors: Shah Mohammed Masoom , Islam Shahidul , Braunstein Marc Justin
Published: June 2023

e18609

Background: Social determinants of health, including access to adequate food and nutrition, may influence many aspects of healthcare, including cancer screening. This study explored the associations between food insecurity and cancer screening. Methods: A retrospective analysis was conducted using the National Health Interview Series from 2021 to capture contemporary events. Based on scaled questionnaires, food security was stratified into either food secure or insecure, and then subgrouped into high, marginal, or low security (i.e. most insecure). Associations were made with rates of having at least one screening test. Relationships between variables were evaluated using Chi-Square and Cochran-Armitage trend tests. Logistic regression models were used to find factors associated with cancer screening. Results: Patients included in analyses included: 19,916 for colon, 15,293 for cervical, and 8,589 for prostate cancer screening. Those with food insecurity had significantly lower rates of cancer screening than those with food security across all 3 cancer screens, including for colon (51.3% vs. 61.8% p < 0.0001), cervical (78.1% vs. 85.2% p < 0.0001), and prostate (36.0% vs. 51.5%, p < 0.0001). This was similar when comparing low, marginal, and high food security, respectively, for colonoscopies (50.1% vs. 52.6% vs. 61.8%, p < 0.0001), cervical cancer screening (78% vs. 78.2% vs. 85.1%; p < 0.0001), and prostate-specific antigen testing (31.2% vs. 41.2% vs. 51.5%; p < 0.0001). Other social determinants were analyzed, including insurance type (public vs. private), age, and race. Patients with public health insurance had lower screening rates across all three cancers compared to those with private insurance (p < 0.0001). Lower food security was linked with younger age (p < 0.0001), and Black patients were disproportionately affected by food insecurity compared to other races (p < 0.001). Adjusted for covariates, low food security, minority racial groups, and public insurance were associated with lower odds of cancer screening. Conclusions: Individuals with self-reported food insecurity were found to have lower cancer screening rates than those who were food secure. Further analysis of demographic and clinical information revealed associations between low food security status and public health insurance, younger age, and Black race. These data suggested that measures can be taken to address food insecurity in these populations that appear to be most vulnerable to lacking appropriate cancer screening. [Table: see text]
Who is getting screened? Estimating uninsured and underinsured women utilizing NBCCEDP screening program in a high insurance state.
Authors: Haynes David , Borrero Maria , Idossa Dame , Roach Lauren , Haas Mckenna
Published: June 2023

e18617

Background: The National Breast and Cervical Cancer Early Detection Program's (NBCCEDP) mission is to improve access to mammography and other health services for underserved women. Research has shown that this national program has improved access to mammography services. However, there is limited research describing the total number of individuals eligible to utilize these services. Howard et. al., described women eligible for NBCCEDP services at the state level. Hughes et. al. have improved upon this with the introduction of geographic small-area estimation techniques that allow us to estimate individuals below the census tract level. Our work builds upon Hughes et. al., by accounting for variations in uninsured and insurance status. Methods: We used a geospatial small area estimation technique, spatially adaptive filters, to calculate standardized incidence ratios describing the utilization rate of NBCCEDP services in Minnesota. The American Community Survey (2010-2014) data describing the insurance status was integrated into the spatially adaptive filters to account for the likelihood that an individual is uninsured. Results: We tested three models that integrate insurance status by age, sex, and race/ethnicity. Our composite model, which adjusts for all three insurance statuses, improves our estimates by reducing estimation error by 95%. We estimate that 49,914 uninsured and underinsured women are eligible to receive services within the state of Minnesota. In addition to an improved state estimate, we also provide estimates at county level to better understand the uptake of these services. Conclusions: This analysis addresses a significant gap in the literature by including secondary datasets that allow for a more accurate prediction of both the underlying population eligible to receive services and calculation of utilization rates to address programmatic goals. Spatially adaptive filters are not restricted to a specific administrative unit and insurance status provides a better screening utilization estimate.
Examining experiences of African American patients with breast cancer in a multidisciplinary survivorship clinic.
Authors: Uelk Madeleine , Chervinko Nazzara , Louthen Cathy Grace , Patel Arpan , Robinson Patricia A. , Fujiu Kathleen
Published: June 2023

e18621

Background: Breast cancer (BC) is the most commonly diagnosed cancer in women. More effective therapies have led to improved survival rates, yet, the survival benefit is not shared across all patient (pt) populations, with worse breast cancer outcomes among African American (AA) pts. The American College of Surgeons has mandated that accredited sites have a cancer survivorship program. At the Cardinal Bernardin Cancer Center (CBCC), there remain disparities in access and utilization of the survivorship clinic, especially by AA BC survivors. Of the 385 new BC analytic cases CBCC treated between March 1, 2020, and March 1, 2021, 72 of these were AA pts. Unfortunately, less than 10% of AA BC pts who received curative intent therapy attended the CBCC Survivorship Clinic. As part of the "Bringing Quality Care Training to Komen’s African American Health Equity Initiative" in collaboration with ASCO, CBCC remodeled its survivorship program into a multidisciplinary clinic staffed by medical oncology, oncologic psychology, genetic counselor, nutritionist and social worker in order to provide comprehensive care to pts following diagnosis and treatment. Methods: The CBCC team performed the following: construction of a process map outlining the current pathway for referring pts to the survivorship clinic; creation of a fishbone cause and effect diagram highlighting factors contributing to poor utilization of the clinic; implementation of faculty surveys to assess reasons for lack of referral to survivorship clinic; development of pt experience surveys; and identification of countermeasures. Tumor registry identified BC pts by stage, race, and ethnicity. Results: Review of the CBCC BC registry showed a low attrition rate among 72 AA pts, with only 1.4% (n = 1) of AA pts diagnosed at CBCC treated elsewhere. AA pts made up a disproportionate number of stage IV diagnoses comprising 40% (n = 8). Surveys demonstrated the following reasons for poor utilization of the survivorship clinic by faculty in order of descending importance: providers felt they were providing survivorship care to their pts; pts declined referral due to appointment fatigue; lack of understanding to make referral; no outcomes data to support survivorship clinics; pt misunderstanding the purpose; fear of losing the pt; pt financial burden. Pt surveys (n = 20) showed high pt satisfaction, with an average rating of 4.8 out of 5 for overall care. Conclusions: Lack of utilization of the cancer survivorship clinic among AA BC pts leads to inefficient application of resources, decreased survivorship care, reduced pt experience, and diminished opportunity for survivorship education and increased health literacy. Paths for the future include increased faculty and pt education, faculty engagement, designated scheduler for survivorship clinic, and increased promotional and marketing work.
Patients with breast cancer and the threat of septicemia.
Authors: Taneja Kamil , Patel Karan , Diaz Michael J. , Chandragiri Sahas , Hsiung Haley , Cohen Jules A.
Published: June 2023

e18622

Background: A very dangerous complication that can occur in breast cancer patients is septicemia. However, there are not many large scale studies that have demonstrated patient and hospital factors associated with higher risk of this complication in breast cancer patients. Methods: We utilized the 2006-2012 Nationwide Emergency Department Sample to identify breast cancer patients that presented to the emergency department (ED) with a primary diagnosis of septicemia. A multivariate logistic regression was used to identify characteristics that were significantly associated with a higher chance of septicemia. A p-value less than 0.05 was considered significant. Results: Between 2006 and 2012, 2,160,701 breast cancer patients presented to the ED. Out of these patients, 39,164 (1.8%) presented to the ED with a primary diagnosis of septicemia. Most patients were at least 80 years old (61.5%), female (98.9%), Medicare beneficiaries (73.8%), of the highest income quartile (28.6%), living in the South (34.3%), presented to non-trauma hospitals (51.5%), and presented to metropolitan non-teaching hospitals (46.0%). Factors associated with the highest risk of septicemia in breast cancer patients are the following: Medicaid patients (odds ratio (OR): 2.0, 95% Confidence Interval (CI): 1.6-2.6, p < 0.001), Medicare patients (OR: 2.0, 95% CI: 1.6-2.5, p < 0.001), private insurance patients (OR: 1.7, 95% CI: 1.4-2.1, p < 0.001), living in the West (OR: 1.5, 95% CI: 1.3-1.7, p < 0.001), living in the Northeast (OR: 1.3, 95% CI: 1.1-1.5, p < 0.001), presenting to a metropolitan non-teaching hospital (OR: 1.2, 95% CI: 1.1-1.4, p = 0.03), and presenting to a metropolitan teaching hospital (OR: 1.3, 95% CI: 1.1-1.5, p = 0.003). Almost all breast cancer patients with septicemia were admitted (97.6%), discharged the same day (1.0%), or transferred to a short-term hospital (0.7%). Amongst patients that were admitted, most patients were discharged (34.4%), transferred to a skilled nursing facility or intermediate care facility (29.8%), or died (16.2%). Risk factors associated with increased risk of dying in septicemia patients are the following: living in the Northeast (OR: 1.4, 95% CI: 1.2-1.8, p = 0.001), presenting to a metropolitan teaching hospital (OR: 1.3, 95% CI: 1.0-1.7, p = 0.046), and living in the South (OR: 1.2, 95% CI: 1.0-1.5, p = 0.045). Conclusions: After correcting for patient and hospital characteristics, a patient’s insurance status, the hospital’s region, and the hospital’s teaching status are intimately related to a breast cancer patient's risk to develop septicemia. Furthermore, hospital region and teaching status are also associated with a breast cancer patient’s risk of dying from septicemia. This suggests that a patient’s access to resources is critical for their risk of developing cancer-related complications.
Clinical utility of an international multidisciplinary virtual tumor board for fibrolamellar carcinoma.
Authors: Kent Paul , Tasse Jordan C. , Schadde Erik , Kato Tomoaki , Humar Abhinav , Fisher Oliver M. , Dixon Matthew , Yamashiro Darrell , Cornelius Albert , Royall Nelson Andrew , Kim Thomas , Friedland Julie C. , Stuhlmiller Timothy Joseph , Awawda Alaa , Sabates Alanis , Shapiro Mark Adam , Ellison Jessica , Stockwell Tom
Published: June 2023

e18624

Background: Fibrolamellar carcinoma (FLC) is a rare liver cancer with approximately 1500 new cases per year, worldwide. The lack of expertise locally often incurs significant travel for patients (pts). Virtual consults have improved access to expertise but identifying the best experts for an ultra-rare condition is difficult for pts and families and multidisciplinary tumor boards of experts offer better clinical guidance. Foundations and advocacy groups play a vital role in navigation and support for pts with rare cancers. Methods: Pts with FLC and their local treating oncologists were engaged by the FibroFighters Foundation and offered a multidisciplinary virtual tumor board (VTB) review. Each VTB included the local treating oncologist, a patient advocate, a molecular pharmacologist, and international experts in the clinical management of FLC including at least one medical oncologist, one radiation oncologist, one interventional radiologist, and one surgical oncologist. Each VTB reviewed the pts’ clinical history and relevant imaging and discussed surgical, radiological, and systemic approaches. Pts consented to the observational research protocol XCELSIOR ( NCT03793088 ) to enable longitudinal clinical summaries to be prepared and for outcomes to be annotated. Results: Between August 4th 2022 and February 9th, 2023, the VTB held a total of 71 discussions for 59 unique pts (12 discussed more than once): 12 new diagnoses, 28 relapses, 14 treatment failures, and 5 ongoing care. Median age at diagnosis of pts was 18 years (range 6-44 years). Pts were seen at 44 institutions/practices across 22 states and 4 countries (USA, Australia, Switzerland, and the Netherlands). A total of 36 unique treatment regimens were discussed, with 21 unique consensus top-ranked options delivered to treating oncologists. The most common consensus options included regimens of gemcitabine, lenvatinib, and nivolumab (13), interventional radiology (IR, 11), surgical resection (6), and a regimen of gemcitabine, oxaliplatin, and lenvatinib (6). The primary team implemented the VTB recommendations 60 times out of 71 (85%): change in systemic therapy (33), IR (11), continue current regimen (11), surgery (6), radiation oncology (2). Conclusions: This is the first demonstration of a patient-focused international multidisciplinary VTB for FLC. The high rate of recommendation adoption by local treating oncologists suggests this is a valuable service to improve patient care. Outcomes are being collected prospectively in a master observational research protocol to better define clinical utility.
Patterns of diversity in cancer clinical trial enrollment at a New York City academic health system, 2018-2022.
Authors: Rodriguez-Russo Carlos , Chadha Manjeet , Cocco Jennifer , Goodman Karyn A.
Published: June 2023

e18630

Background: Mitigation of cancer clinical trial (CT) enrollment disparities is increasingly prioritized in healthcare, but disparity metrics are inconsistently published by individual health systems. We aimed to assess health-system-level trends in CT enrollment by race, ethnicity, sex, and treatment location (network vs main hospital) during the COVID-19 pandemic, as well as to evaluate county-level disparities in CT accrual fraction (AF) over a five-year period. Methods: This was a cross-sectional study of the population enrolled on therapeutic cancer CTs in a New York City academic health system (AHS) from 2018-2022. Demographics were descriptively analyzed and compared with most recent public NCI-reported therapeutic trial accrual data. New York County 5-year cancer incidence was estimated for each demographic subgroup using age-adjusted cancer incidence rates from public SEER/NPCR data and US Census data. Primary endpoint was AF, defined as proportion of patients accrued relative to cancer incidence. Results: Of 2,533 patients enrolled on CTs over the 5-year period, 51% were White, 18% Black, 17% Hispanic, 9.8% Asian, 0.08% American Indian/AK Native, 0% Pacific Islander, and 3.9% Multiple/unknown race; 47% were female. Minority accrual proportion was higher than that of NCI accrual data (45% vs 25%, p =< 0.001). Annual enrollment fell from maximum 571 patients in 2019 to 457 in 2020, then increased to 499 by 2022. Meanwhile, the proportion of minority enrollment increased to a peak of 49.2% in 2020 and fell to 45% in 2022. Female enrollment of 49% in 2018 decreased to 42% in 2021, increasing sharply to 51% in 2022. On multivariate analysis, Black and Asian patients were more likely to be enrolled after the start of the pandemic than White patients (ORs 1.3, 95% CI 1.1-1.6; 1.4, 1.03-1.8). Black, Asian, and female patients were more likely to be enrolled at network hospital locations than White or male patients, respectively (ORs 1.9, 95% CI 1.3-2.7; 2, 1.2-3.1; 14, 8.6-21). Relative to county-level estimated cancer incidence, Black patients had a higher AF than White patients (0.96% vs 0.77%, OR 1.3, 95% CI 1.1-1.4), while Hispanic patients had a lower AF (0.55%, OR 0.72, 95% CI 0.64-0.8). Women had a lower AF than men (0.66% vs 0.74%, OR 0.9, 95% CI 0.83-0.97). Conclusions: Minority accrual at this AHS was higher than nationally reported. Despite decreased total accrual numbers in 2020 due to the COVID-19 pandemic, high accrual diversity was maintained. County-level AF disparities among women and Hispanic patients suggest opportunities for improvement in community outreach, and greater diversity of clinical trial enrollees at network hospitals may reflect successful outreach to the communities they serve.
Barriers to implementing expanded access programs in oncology: A multidisciplinary perspective.
Authors: Fu Sherry , Muquith Maishara , Williams Erin Fenske , Anderson, Jr Larry D. , Zhang Tian , Beg Shaalan
Published: June 2023

e18632

Background: Expanded access (EA) is a pathway to make investigational drugs available to patients in need but who are unable to join a trial. Despite the rapid approval time for expanded access requests by the Food and Drug Administration, EA protocols ( > 1 patient) and single-use EA have limited utilization due to barriers affecting physicians, pharmacists, and clinical research office staff. We examined factors limiting the broad implementation of EA at an NCI-designated comprehensive cancer center. Methods: Semi-structured interviews were conducted with oncologists (5), pharmacists (2), and research operations leadership (1) involved with applying for and facilitating expanded access at our institution. Interviews were transcribed verbatim and grouped into themes by 2 independent coders. Results: At our institution, recent EA requests for adult patients with cancer involved anti-viral and CAR-T therapies. Participants agreed that increased EA utilization benefits patients and potentially the institution, provided the workflow is not burdensome. Major barriers include gaps in physician knowledge of institutional processes and lack of response from drug sponsors on ability to supply drug. For EA protocols ( > 1 patient), there was lack of reimbursement for time and resources, particularly for regulatory coordination and pharmacy services, which often competed with clinical trial needs. EA requests are part of standard clinical care but may require reporting patient-level data to sponsors and resources similar to a clinical trial. This contributes to unclear delineation of roles between research and clinical staff, which delays communication with the pharmacy and adverse event reporting to sponsors. Across all departments, there was a desire for a centralized office or dedicated individual to support EA processes. Conclusions: Oncology professionals recognize the benefit of EA for patients with cancer. However, utilization is limited by various challenges including lack of clearly defined roles and financial support. Suggested improvements include establishing a centralized resource at the institutional level to streamline workflows. External parties such as industry, payers and advocacy groups can also enhance EA activity through defined protocols and resources for administrative support.
Rural communities and health professional shortage areas (HPSA) and access to immune effector cellular therapy and lymphoma/myeloma clinical trials.
Authors: Ahmed Nausheen , Wesson William , Pal Mudaranthakam Dinesh , Mushtaq Muhammad Umair , Abdallah Al-Ola A. , Lutfi Forat Umair , Baranda Joaquina Celebre , Abhyankar Sunil H. , McGuirk Joseph , Hoffmann Marc
Published: June 2023

e18633

Background: The National Health Service Corps (NHSC) has created a shortage designation to identify medically underserved communities. HPSA (Health Professional Shortage Areas) designation identifies an area, population, or facility with inadequate access to healthcare resources such as primary care. Rural-urban continuum codes (RUCC) classify U.S. census tracts using urbanization, population density, and daily commuting. Additionally, there are racial, ethnic, and geographic disparities in enrollment on therapeutic cancer clinical trials. Chimeric antigen receptor T cell (CAR T) therapy has been at the forefront of immune effector cell therapy (IEC) for lymphoma and myeloma. However, it is delivered at specialized centers, and access to specialty centers is known to be a challenge due to financial and geographic barriers. At our institution, trials for CAR-T cell therapy in lymphoma and myeloma are conducted by the IEC disease working group (DWG), while non-IEC trials are conducted by the lymphoma/myeloma DWG. We hypothesized that patients from HPSA and rural communities and HPSA had lower access to IEC and non-IEC trials for lymphoma and myeloma . Methods: Patients enrolled between 1/1/2015 – 2/6/2023 on IEC and non-IEC interventional trials with treatment were included. Disease types included lymphoma (Follicular lymphoma, high-grade B cell lymphoma, diffuse large B cell lymphoma) and myeloma were included. The hypothesis was tested through a t-test. Results: There were 667 total subjects. 503 (75.4%) were non-IEC and 96 (14.3%) were IEC clinical trial participants. The majority in both groups were male (52.7%), White (74.8%), non-Hispanic (86%) .Only 69 (10.3%) pts were from rural areas and 223 (38.9%) were from HPSA communities When stratifying based on RUCC (Table), there is significantly higher rural accrual for IEC trials compared to non-IEC trials. Hispanics from rural areas were lower. There were no African Americans (AA) from rural areas. Conclusions: There is low representation of patients from HPSA and rural communities for IEC and non-IEC lymphoma and myeloma clinical trials. The ethnic and racial inequity in access and enrollment to lymphoma/myeloma trials are pronounced in rural and HPSA communities. Strategies to improve clinical trial enrollment of the underserved rural and HPSA populations is an area of unmet need and will benefit minorities and patients from lower socioeconomic status. [Table: see text]
The impact of novel therapies on disparities in survival outcomes for metastatic cancers.
Authors: Degeling Koen , Zebrowska Karolina , Banuelos Rosa C. , Rizzo Evelyn J. , Belk Kathy W. , Schneider Gary
Published: June 2023

e18635

Background: Real-world data have suggested that increases in overall survival (OS) for metastatic cancers over time have been driven by improvements in the groups of patients who already had the highest survival outcomes. To further investigate these identified trends, this research aimed to quantify how novel therapies for metastatic cancers impact disparities in OS outcomes. Methods: Novel therapies for metastatic breast (mBC), metastatic colorectal (mCRC), and metastatic non-small cell lung (mNSCLC) cancer, approved by the United States Food and Drug Administration (FDA) in the last 8 years based on data from phase III randomised controlled trials (RCTs), were identified. For each cancer type, 3 novel therapies were selected with inclusion based on the availability of published Kaplan-Meier data for OS, at least 100 patients in each arm of the corresponding RCT, and OS reaching less than 30% at the end of the RCT follow-up period. For each cancer type and for the novel therapies and comparator therapies separately, the published OS data were replicated from the Kaplan-Meier data and pooled using weights based on sample sizes to ensure each therapy contributed equally to the analysis. Parametric survival modelling was performed to address censoring. The disparity in OS was defined by the absolute difference between groups with the highest and lowest survival, with groups defined by stratifying OS in either 2 or 5 groups. The impact of the combined novel therapies was determined based on the change in OS disparity relative to the combined comparators. A probabilistic analysis was performed to quantify the impact of parameter uncertainty on the outcomes. Results: Novel therapies increased disparities in OS across the 3 cancers. For mBC, the disparities in OS increased by 5.4 (95%-confidence interval: 0.9; 9.9) months, which equates to a 23.0% increase from 24.2 to 29.6 months if OS was stratified in 2 groups, and by 13.9 (1.4; 26.6) months; 25.0% from 57.1 to 71.1 if OS was stratified in 5 groups. For mCRC, disparities increased by 2.8 (1.4; 4.2) months; 37.6% from 7.5 to 10.3 months and by 6.3 (2.9; 9.8) months; 38.9% from 16.5 to 22.8 months, for stratification based on 2 and 5 groups, respectively. For mNSCLC, disparities increased by 10.2 (3.3; 17.3) months; 33.6% from 31.0 to 41.3 months and by 19.5 (4.0; 35.5) months; 31.5% from 63.2 to 82.7 months, for stratification based on 2 and 5 groups, respectively. Conclusions: OS outcomes for recent FDA-approved drugs for metastatic cancers suggest that these novel therapies increase disparities in OS between the patient groups with the highest and lowest OS relative to their comparator therapies in RCTs. Although evidence in terms of these disparities is important, further research using (real-world) individual patient data is warranted to assess how, for example, socioeconomic variables affect the impact of therapies on health disparities among patient groups.
Repetitive presentations of phase II and III trials involving systemic therapies in gastrointestinal (GI) malignancies at international meetings in the past few years.
Authors: Barbosa Malu , Ferreira Artur Rodrigues , Coelho Ricardo Lima , Muniz Pamela Carvalho , Souza Camila Brambilla , Neto José Ap. Tristão , Cascelli Fanny , Costa e Silva Matheus , Peixoto Renata D'Alpino
Published: June 2023

e18638

Background: The American Society of Clinical Oncology (ASCO) and the European Society of Medical Oncology (ESMO) annual meetings as well as their GI dedicated meetings (ASCO GI and ESMO GI) have the premise to accept abstracts for oral presentations that have not been previously presented. Methods: We conducted a review of all 220 abstracts involving phase II or III trials of systemic therapies that have been presented orally from June 2019 to January 2023 at ASCO, ASCO GI, ESMO and ESMO GI meetings to evaluate the incidenceof repetitive presentations of the same trial in different meetings as well as their relationship to pharmaceutical industry sponsorship. ANOVA test was used to compare means between different groups and p values of ≤ 0.1 were considered significant. Results: Overall, 20,9% of accepted oral abstracts from phase II or III trials were replicated during the 4-year time frame. Of them, 39% were phase II, 61% phase III, 72% pharma sponsored, 39% included developing countries, and 59% were positive. The association of industry sponsorship and study positivity indicated a variation of up 3,55 appearances (p 0,017) in the number of times this research was orally presented. Conclusions: Our findings suggest that almost 20% of oral abstracts involving systemic therapies in GI cancers are presented more than once at relevant meetings, especially those with positive results and sponsored by pharma. Our study highlights the need for a more effective oral abstract selection system in oncology meetings.
Barriers and facilitators to enrolling in a cancer clinical trial financial reimbursement program.
Authors: Nguyen Vivian , Ramos Elizabeth , Dornsife Dana , Johnson Robert G. , Miller Erin , Jones Mallorie , Uribe Daniela , Wileyto E. Paul , Vonderheide Robert H. , Guerra Carmen
Published: June 2023

e18641

Background: Cancer clinical trial (CCT) participants often have significant out-of-pocket expenses. These expenses may disproportionately burden lower income participants. To increase access to CCTs, the Lazarex Cancer Foundation (LCF) created the Improving Patient Access to Cancer Clinical Trials (IMPACT) Program, a financial reimbursement program for out-of-pocket travel and lodging expenses. This study was designed to evaluate the barriers and facilitators to enrolling and participating in the IMPACT Program. Methods: This qualitative study consisted of semi-structured interviews with a subset of CCT participants at the Abramson Cancer Center (ACC) of the University of Pennsylvania who enrolled in the IMPACT Program and consented to this study. The interview focused on barriers and facilitators of enrolling in the program and suggestions for improving enrollment. The interviews were analyzed using grounded theory methods of analysis. Results: From May 2021 to January 2023, 75 patients enrolled in the program and 31 patients participated in the interview (57% Female, 93% White, Median Age (SD) = 66.0 years (13.6)). The most common cancers represented in this population were hematological, gastrointestinal, and breast cancers (37.3%, 16.0%, and 13.3%, respectively). The table shows the reported barriers and facilitators of enrolling in IMPACT. The most commonly cited barriers were related to the process of enrollment (participants wished to be contacted earlier before accruing expenses) and patient barriers (technology access and privacy concerns). The most common facilitator to enrollment was receiving assistance and explanation from ACC IMPACT coordinators. Participant suggestions for improving enrollment in IMPACT include earlier introduction of the program to potential clinical trial participants during the informed consent process and offering navigation services for cancer center resources. Conclusions: Out-of-pocket expenses related to clinical trials can be addressed through financial reimbursement programs. To optimize the benefit of these programs, it is ideal to enroll patients at the time of informed consent, establish IMPACT coordinators, and use technology to streamline the enrollment and submission process. [Table: see text]