bluuebunny/crossref_metadata_2025_split huggingface dataset:
Measuring the long commute: Experiences of a multi-ethnic cohort of patients enrolled in a financial reimbursement program for cancer clinical trials.
Authors: Medina Sheyla P , Zhang Sylvia , Nieves Elena , Dornsife Dana , Johnson Robert G. , Spicer Darcy V. , Borno Hala 
Published: June 2022

e18568 Background: Financial reimbursement programs (FRP) aim to address patients’ out-of-pocket expenses associated with clinical trial participation. The study aims to explore patients’ experience in therapeutic clinical trials (TCT) after enrollment in FRP at two academic medical centers in California and identify barriers and opportunities to improve TCT participation. Methods: From May 2019 to January 2020, adult patients with a diagnosis of cancer and eligible for a TCT were recruited from oncology clinics. Eligible participants for the FRP had a household income ≤ 700% of the current HHS Poverty Guidelines. Semi-structured interviews were conducted in patients’ preferred language. Qualitative analysis was performed comparing experiences by site and by preferred language. An iterative process of coding was used to identify themes on interview transcripts. Results: 53 patients were interviewed (20, UCSF; 33, USC). Median age was 59 (IQR 46 - 65) and 59% were female. Nearly half (49%) identified as Latinx/Hispanic compared to 32% Non-Hispanic White, 10% Asian, 4% Black, 1% Native American, and 4% Other. A third were non-English speakers (68% English, 26% Spanish, 6% Korean/Other), 42% had a college education or more, and 55% were retired/unemployed. The majority of patients (66%) had metastatic disease. Patients described their commute to the TCT sites which involved complex logistics and commute time ranging from one hour to 4.5 hours as well as numerous out-of-pocket costs. Prominent barriers to TCT participation included financial toxicity, fears of the process itself or the low likelihood of cure, and systemic factors affecting enrollment. Despite these barriers, most patients would participate in a TCT regardless of financial hardship. Patients proposed modifications to TCTs including decentralization, recruitment strategies, education and peer counseling as well as vouchers and established rates for out-of-pocket expenses. While English-speaking patients were varied on willingness to discuss financial concerns with their doctors, the majority of non-English speakers reported that they would speak with their physician about financial concerns associated with treatment. Conclusions: Patients’ experiences with TCTs demonstrate a combination of financial and logistical stressors that may be lessened by financial reimbursement programs. FRPs have the potential to address inequities in clinical trial access among vulnerable populations.
Factors influencing the initiation of adjuvant endocrine therapy in patients with Estrogen receptor-positive ductal carcinoma in situ: A single institution experience.
Authors: Farag Fady , Levy Julia , Cole John T. 
Published: June 2022

e18569 Background: Ductal carcinoma in situ (DCIS) is a non-obligate precursor to invasive ductal breast cancers. The aim of treatment in DCIS is to prevent local recurrence as almost half of recurrences can be invasive. Few studies have specifically addressed how provider recommendation and patient’s demographic factors contribute to medication initiation in women with DCIS. The objective of this study is to evaluate whether disparities exist pertaining to prescription of adjuvant hormonal therapies. Methods: This single-center retrospective study included 111 patients diagnosed with DCIS between 2020 and 2021. Data collected included race, type of insurance, prescribing providers, and socioeconomic status. We used zip codes to identify the poverty levels in these areas as published in the United States Census Bureau and stratified the patients into quartiles accordingly. Chi-Square statistics were used to calculate significance levels. Results: The average age was 62.8. 63 (56.8%) patients received adjuvant hormonal therapy, and 48 (43.2%) did not. White patients comprised 53.1% of the population, while African Americans were 45%. Among the white patients, 52.5% took hormonal therapy, while 62% of African Americans received hormonal treatment. Majority had Medicare insurance (49.5%), or a commercial insurance (42.3%). 62% of Medicare patients received hormonal therapy and 52.5% of commercial insurance users received adjuvant treatment. 34% lived in areas with the percentage below poverty line greater than 21.9%, 27% lived in areas with the percentage below poverty line between 16.4-21.9%, 38.7% % lived in areas with the percentage below poverty line between 10.6% and 16.4%, and 9% lived in areas with the percentage below poverty line was less than 10.6%. Providers were grouped into either breast oncologist or general oncologists. Breast oncologists prescribed hormonal treatment to 56.8% of their patients, and general oncologists to 56.7% of their patients. There was no statistical significant correlation between the intake of hormonal therapy and race (P = 0.6), insurance (P = 0.5), socioeconomic (P = 0.58) or providers (P = 0.99). Conclusions: In this single-center study, we didn’t find that patients’ demographics or providers influenced the decision to initiate adjuvant hormonal therapy in DCIS.
Using a standard implementation science framework to improve clinical trial enrollment for a community Tennessee oncology center.
Authors: Jain Neha M , Lammers Philip Edward , Savona Michael R. , Osterman Travis John , Goorha Salil 
Published: June 2022

e18586 Background: Recommendations for clinical trial consideration are ubiquitous across all cancers. However, it is challenging to identify patients from underrepresented communities and offer them opportunities to enroll in clinical trials due to a multitude of reasons including social determinants of care, distance from clinical resources, lack of resources, etc. As part of the Leukemia & Lymphoma Society (LLS) Influential Medicine Providing Access to Clinical Trials (IMPACT) study, Vanderbilt-Ingram Cancer Center (Nashville, TN) partnered with Baptist Cancer Center (BCC, Memphis, TN) to improve accrual of trials for patients with Hodgkins lymphoma. BCC has an active NCI Community Oncology Research Program (NCORP) grant with 12 affiliated sites spread across Arkansas, Tennessee, and Mississippi and provides care for underrepresented minority, and underserved communities. Methods: We chose the Consolidated Framework for Implementation Research (CFIR), as a conceptual model to guide assessment of the existing process and inherent opportunities. We created a secure REDCap survey to identify timepoints in the existing clinician workflow and research sites that provide the best opportunities to discuss clinical trials with the patient. Retrospective data was collected for 67 patients diagnosed with Hodgkins lymphoma, who received care at six sites affiliated with BCC. A manual chart review was performed to extract data from the electronic medical record. Results: We observed that 73% of the patients from 2 sites already had an established diagnosis of Hodgkins lymphoma at the time of referral to the medical oncologist. By contrast, only 33% of patients from the remaining 4 sites had an established diagnosis at the time of referral. In these cases, the diagnosis was established after pathological testing ordered by the oncologist was performed. Conclusions: Using our analysis, we identified 2 sites from a large healthcare network that would benefit greatest from implementing pre-screening for clinical trials before the first visit with a medical oncologist. Further, we determined that efforts/resources for trial screening at the remaining 4 sites would be best served after pathological evidence of disease was established. Clinical trial enrolment is a multi-step process and needs substantial human and financial resources. Implementation science interventions can help to guide judicious use of resources while improving patient care in rural and underserved communities.[Table: see text]
Disparities in pegasparagase-induced toxicity in Hispanic patients with acute lymphoblastic leukemia.
Authors: Boulter Alexis Chen , Sovich Justin Lin , Kainthla Radhika , Sadeghi Navid , Jones Amy Little 
Published: June 2022

e18590 Background: Hispanic individuals experience the highest incidence of acute lymphoblastic leukemia of any racial or ethnic group in the United States. While Hispanic individuals are known to have disproportionately increased mortality and higher therapy-related toxicity rates in ALL, there is a paucity of data regarding ethnic differences in rates of toxicity related to pegasparagase, a backbone of ALL treatment regimens. In our safety-net hospital system, we sought to evaluate disparities in rates of pegasparagase-induced hepatotoxicity between Hispanic and non-Hispanic patients. Methods: Pegasparagase infusions administered in adult ALL patients from 2011-2020 at Parkland Memorial Hospital in Dallas, Texas, were identified using the electronic medical record. Retrospective review of demographic, clinical, and socioeconomic data was conducted. For each infusion, dosing, timing, transaminase trends, and toxicity data were gathered. Statistical analysis was completed with Excel Analysis ToolPak and R Statistical Software. Accounting for baseline characteristics (age, BMI, sex, metabolic comorbidities, and baseline hepatic function), multiple linear regression models were constructed for peak transaminase and bilirubin levels. ANOVA testing, adjusted R2 values, and AIC were utilized to compare the contribution of race, ethnicity, and socioeconomic variables to modeling. Results: 47 individual patients received pegasparagase during the study period with 196 infusions evaluated. The mean age was 30 years, 29% were female and 73.4% white Hispanic. There were 64 grade 3-4 pegasparagase-related toxicities (54 hepatotoxicity, 4 pancreatitis, 6 thrombosis). 83.3% of grade 3-4 hepatotoxicity events were in Hispanic patients, and 16.7% in non-Hispanics. The median time from infusion to grade 3-4 toxicity was 18 days. Hispanic ethnicity was significantly associated with severe hepatoxicity (P = 0.0004). An interaction was identified with insurance status and primary language which significantly strengthened the impact of ethnicity and race on hepatotoxicity severity (P = 0.005, P = 0.02). Conclusions: In our safety-net population, Hispanic ethnicity was associated with significantly higher grades of hepatotoxicity when compared to non-Hispanic patients. Uninsured status and primary Spanish language use were not only independently associated with increased toxicity but also strengthened the effect of Hispanic ethnicity on the severity of liver dysfunction related to pegasparagase. These findings propose that Hispanic patients may benefit from closer monitoring during treatment with pegasparagase-containing regimens and highlight the need for further studies to improve risk-stratification of Hispanic patients when selecting ALL therapy.
Utilization and financial coverage of blood based next generation sequencing for solid tumors: A study from Augusta-Georgia.
Authors: Lampkin Erica , Karki Nabin Raj , Matosz Sabrina , Casey Mycal , Leurinda Christian , Abdel Karim Nagla Fawzy 
Published: June 2022

e18592 Background: There is an increasing trend of integrating molecular profiling to devise treatment plans for solid malignancies. Tumor testing for specific clonal abnormalities is being supplanted by broad multigene panel testing from blood specimen, aptly labelled liquid biopsy. Due to varying utility across malignancies in differing contexts and issues of access and affordability, their adoption is not uniform. We attempt to characterize the pattern of utilization across tumor types and financial coverage schemes in an academic cancer institute in southeastern United States. Methods: All blood based next generation testing samples ordered by providers affiliated to Georgia Cancer center between January 1, 2017, and December 31, 2021, via Guardant platform for all solid tumors was included in this analysis. Guardant360 and Guardant360CDx assays tested for upto 83 cancer related genes in circulating cell-free DNA in patients of solid tumors. Primary cancer diagnosis, insurance information and turnaround time was obtained from Guardant. Results: 296 tests were sent from January 1, 2017, through December 31, 2021. The total number of tests performed in year 2017, 2018, 2019, 2020 and 2021 were 1, 3, 28, 99 and 165 respectively. Billing information was available for all cases, clinical information was available for 262 cases. Average turnaround time was 8.5 days overall. 221 Guardant360 was sent with average turnaround time of 10 days. 41 Guardant360CDx was sent with average turnaround time of 7 days. The frequency of malignancies in the order of dimensioning frequency were lung 50.7%, prostate 12.1%, breast 6.9%, kidney 3.8% and colorectal 3.4%. The remaining 22.1% comprised of pancreatic, melanoma, glioblastoma, and bladder malignancies. The test was covered by private insurance/employee health plan in 53.4% (158/296), Medicare in 31.1% (92/296) and Medicaid in 10.5% (31/296) (table). 4.7% (14/296) qualified for free of charge testing (financial indigent) and 0.3% (1/296) were self-pay (table). Conclusions: There is an increase in the utilization of liquid biopsy to perform comprehensive genomic analysis. The distribution of tumor types is not entirely explained by the incidence and availability of targeted therapies for each type. Private insurers accounted for most of the tests being done. The disparities in utilization of this platform across different tumor types and payment models deserve further exploration. T[Table: see text]
Enrollment disparities in non-Hodgkin lymphoma clinical trials.
Authors: Boisclair Stephanie , Sandoval-Sus Jose David , Kolitz Jonathan E. , Rhodes Joanna Meehan 
Published: June 2022

e18594 Background: Disparities in cancer clinical trials limit the real-world reproducibility of their results while remaining inapplicable to excluded patients (pts) like those living with chronic viral infections. Non-Hodgkin lymphoma (NHL) has an incidence distributed heterogeneously among races and is associated with chronic viral infections such as HIV, Hepatitis B (Hep B) and Hepatitis C (Hep C). Given these epidemiological characteristics, we assessed demographic representation in NHL clinical trials to identify areas for improvement. Methods: Clinicaltrials.gov was queried for NHL trials and specified for completed, interventional, phase 2, 3 & 4 trials, with results and with recruitment in the US. Trials including malignancies other than NHL, with enrollment outside of the US or lacking reported demographics on clinicaltrials.gov or trial publications were excluded. SEER 21 and the 2020 US census were used to calculate incident cases for each specified subgroup. Enrollment fraction (EF) was defined as the number of trial enrollees divided by the estimated US cases in each subgroup. We compared EF between subgroups utilizing odds ratios (OR) with p-value < 0.05 deemed significant. Results: Of 176 trials meeting criteria, 64 (36.4%) reported ethnicity and 79 (44.9%) reported race. EF of Black, Asian/Pacific Islander, American Indian and Hispanic (HSP) pts were significantly lower compared to White and non-HSP pts (Table). Racial minorities were less likely to be enrolled in relapsed/refractory trials (OR 0.31 - 0.57 p < 0.008) compared to White pts but all were equally likely to be enrolled in front-line trials. HSP pts had a lower EF compared to non-HSP pts in both relapsed/refractory and front-line trials (OR 0.57, 0.46 p < 0.0001). Black and HSP pts were also less likely to be enrolled in hematopoietic stem cell transplant (HSCT) trials (OR 0.27, 0.74, p < 0.003). Women had a significantly lower EF compared to men (Table). 150 trials had inclusion/exclusion criteria specific for chronic viral infections: 141 (94%) excluded pts with HIV, 108 (72%) with chronic Hep B and 103 (69%) with Hep C. Conclusions: Our study demonstrates underrepresentation of not only women, but also of Black, Asian/Pacific Islanders, American Indian and HSP pts in NHL trials, especially in relapsing/refractory and HSCT trials. Moreover, pts living with chronic viral infections are systematically excluded by trial criteria. It is essential that trials reporting on safety, toxicity and efficacy represent the true patient population to limit ascertainment bias and improve external validity of results.[Table: see text]
Are we providing adequate information? patient-specific clinical trial information at NCI-designated cancer center websites.
Authors: Velazquez Manana Ana I. , Idossa Dame , Meza Kelly Jasmin , Rodriguez Vargas Juan J. , Duma Narjust 
Published: June 2022

e18602 Background: Disparities persist in the recruitment and enrollment of diverse populations to cancer clinical trials (CT). Barriers to CT participation are numerous and include structural inequities that limit access, stringent eligibility criteria, financial barriers, provider bias, and patient knowledge. While national societies recommend patient educational materials should be written ≤6th grade reading level, most CT online information available is complex. We evaluated the accessibility, readability, and content of patient-specific CT information from NCI-designated cancer center websites (CCW). Methods: We conducted a qualitative review of CT information in 64 clinical NCI CCW. We reviewed each CCW’s patient-specific CT information to evaluate content, reading level, and navigation. Readability was evaluated using validated measures [i.e., Flesch-Kincaid Grade Level (FKGL), Gunning Fog Index (GFI), Coleman-Liau Index (CLI), and Simple Measure of Gobbledygook (SMOG) Grade Level] and an average readability score. Data was summarized using descriptive statistics. Results: Most CCW made CT information easily accessible, 62 had a CT-specific website of which 61% required only 1-click from the homepage and 5% required ≥3 clicks. Common patient-specific information included definition of CT (89%), CT phases (66%), guidance on how to decide if you should enroll in a CT (59%), risks and benefits of participation (53%), informed consent (48%), and financial considerations (30%). Only 16% of CCW contained CT information for patients with limited or no English proficiency (14% Spanish, 8% Chinese). CT educational content required a reading level of ≥10th grade (Table). 44% of websites included links to outside educational resources, such as the NCI. None of the websites included CT-specific supportive resources (i.e., transportation, navigation, financial assistance, etc.). Most CCW included a CT search bar (77%), yet when searching for a specific cancer type (i.e., breast cancer) 53% yielded a top search result that was disease agnostic or for a different cancer type. 72% included CT descriptions, 58% their eligibility criteria, and 29% included pre-screening forms or links to CT-specific inquiries. Conclusions: Most NCI designated CCW contain CT information at a high literacy level with suboptimal search options and very limited resources/information in other languages. Our findings highlight missed opportunities to develop and advertise CT-specific supportive services and to disseminate CT education materials that meet the literacy and language needs of the increasingly diverse US population.[Table: see text]
Successful biosimilar adoption in oncology: strategic approach to system standardization.
Authors: Limvorasak Suwicha , Dobbs Crystal Leung , Kim James , Posadas Edwin Melencio , Teaford Hilary , Diniz Marcio A. , Rogatko Andre , Vinson Bruce , Sakamoto Leanne , Patel Vipul , Figlin Robert A. , Shane Rita , Reckamp Karen L. 
Published: June 2022

e18605 Background: In the United States, therapeutic substitution with oncologic biosimilars offer opportunities to reduce the rising costs of cancer care while improving access to safe and effective treatment. Current challenges include integration into clinical practice, state laws for biosimilar interchangeability and payer reimbursement policies. Methods: We developed an approach to standardize biosimilar utilization across our oncology enterprise by leveraging the electronic health record to integrate with clinical algorithm pathways and financial information. Institutionally preferred biosimilars drugs were selected through the oncology Pharmacy & Therapeutics committee as part of the formulary process. Physicians were permitted to opt-out of substitution within the electronic order sets. Patients were divided into two groups based as 1) main medical center 2) affiliated sites to assess feasibility of the enterprise-wide substitution, defined as an 80% compliance rate at the main medical center and a 75% compliance rate at the affiliates sites. This provided a minimum detectable difference of 5.7% and 8.9%, respectively using an exact one-sided Binomial test with 80% of power at 2.5% significance level with Sidak correction. Results: Between January and December 2021, a total of 811 cancer patients who initiated treatment with bevacizumab, rituximab or trastuzumab were identified, of whom 535 were eligible for this analysis (age 18-96; 61% female, 39% male). The overall substitution rate to biosimilars was 83% (76%-97%) compared to baseline of 55%, representing a 51% improvement. The conversion rate was higher at the main medical center compared to the affiliated sites (85% vs. 81%). Among 92 patients who did not have substitution to biosimilars, the most common reasons were off-label indication (35%), patient assistance program (17%), payer preferred alternative brand (15%) and clinician preferred reference brand (12%). Four patients (< 1%) were not converted due to infusion reactions possibly related to biosimilars. Based on the wholesale acquisition cost, we estimate reduction in direct spending of $1.2 million per month or an average 23% cost savings. Conclusions: This real-world data suggest use of an integrated electronic health record to standardize biosimilar utilization in oncology and reduce costs. This approach leverages existing infrastructure for successful biosimilar adoption in oncology while preserving quality and safety.[Table: see text]