bluuebunny/crossref_metadata_2025 huggingface dataset:
One size does not fit all: Clinical trial investigator perspectives of disparities in racial/ethnic minority participation in oncology clinical trials.
Authors: Bransky Natalie Perle , Walling Anne M. , Klomhaus Alexandra M , Glaspy John A. , Garcia-Jimenez Maria De Lourdes
Published: October 2023

108

Background: Thirty years after the NIH Revitalization Act, racial/ethnic minority (REM) patients remain underrepresented in oncology clinical trials. Little is known about clinical trial investigator perspectives of REM participation in clinical trials. To our knowledge no published studies exist assessing differences in investigator perspectives based on their primary role in the clinical trial process. We hypothesized that differences exist in investigator perspectives regarding REM participation in oncology clinical trials based on having a more design-oriented (principal (PI)/co-investigator (co-I)) or recruitment-oriented role (sub-investigator (sub-I)). Methods: We conducted a cross-sectional, anonymous, pilot survey of oncology clinical trial investigators at an academic center. Over 5 weeks, 107 individuals received a survey assessing 6 domains about disparities in REM participation in clinical trials, including knowledge, attitudes, and prior training. Modified, previously validated items were used if possible. We performed a subset analysis of mid- and late-career investigators (>/= 10 years of experience) comparing those who opened at least 1 clinical trial in the past year as PI or co-I to those who did not (sub-I). Results: There were 60 respondents (56% response rate). Average time as a clinical trialist was 14 years (2-40). Average number of trials opened in the last year as PI/co-I was 4 (1-30). Among all respondents, 83% strongly agreed disparities exist in REM clinical trial participation and that lack of diversity is problematic (75%). Notably, 45% agreed this is a problem they cannot directly address. Among mid- and late-career investigators, those who opened at least 1 trial as PI/co-I were more likely to have received training about barriers/facilitators (OR=3.56; 95% CI=1.05, 12.04; p=.04) to REM clinical trial participation and about strategies for improving participation (OR=3.75; 95% CI=1.06, 13.29; p=.04). Despite this, they were more likely to endorse wanting help to improve in this area (OR=4.95; 95% CI=1.17, 21.02; p=.03). Conclusions: Our results suggest there is awareness among clinical trial investigators of disparities in REM clinical trial participation, but investigators do not feel they can directly address these. Investigators who are more involved in clinical trial design are more likely to want help to improve their ability to address disparities in REM trial participation despite being more likely to have received prior training on the topic. Our findings suggest training alone is inadequate support for investigators involved in designing clinical trials. More studies eliciting the needs of investigators with varying roles in the clinical trial process are needed to inform targeted interventions to enhance investigators’ self-efficacy for improving REM participation in clinical trials.
Improving clinical trial consent form readability through artificial intelligence.
Authors: Litt Henry Kazunaru , Greenstreet Akman Emma , Idossa Dame , Florez Narjust , Velazquez Manana Ana I.
Published: October 2023

109

Background: High literacy levels are needed to understand oncology clinical trial (CT) informed consent forms (ICF), which represents a barrier to enrollment of older adults and diverse populations. ChatGPT-4 is an artificial intelligence chatbot that responds to user prompts and can summarize large amounts of text. We tested whether ChatGPT-4 could simplify CT information from ICFs. Methods: On May 22, 2023, we searched clinicaltrials.gov for interventional, therapeutic, NIH-funded, CTs involving adults with the 14 most prevalent cancer types. Only CTs with available study protocols that were currently recruiting, “enrolling by invitation”, and “active not recruiting” were included. Trials that were diagnostic, preventative, or supportive were excluded. Publicly available ICFs from the resulting CTs were downloaded and analyzed. Using the ChatGPT-4 plugin askyourpdf.com, we asked ChatGPT-4 to review each ICF and answer 8 questions recommended by the NCCN for patients considering a CT in a 6th grade literacy level. Our prompt included the following 8 questions: “1) What are the treatments used in the clinical trial? 2) Has the treatment been used for other types of cancer? 3) What are the risks and benefits of this treatment? 4) What side effects should I expect and how will they be managed? 5) How long will I be in the clinical trial? 6) Will I be able to get other treatment if this doesn’t work? 7) How will you know if the treatment is working? 8) Will the clinical trial cost me anything?” Reading level (readability) was assessed for both the ICFs and ChatGPT-4’s question responses using the validated Flesch-Kincaid (FK), Gunning Fog (GF), and SMOG indices using the online Readable App. Data was summarized with descriptive statistics and t-test was used to compare text reading levels between ICFs and ChatGPT-4’s answers. Results: Our search yielded 83 therapeutic oncology CTs, of which 70 had publicly available ICFs. ChatGPT-4 successfully analyzed 66 of the 70 ICFs (94.3%). The mean text reading levels of its answers were 6.2 (95% CI: 5.9-6.5), 8.6 (95% CI: 8.2-8.9), and 9.2 (95% CI: 8.9-9.4) based on FK, GF, and SMOG indices, respectively. Of 70 ICFs, 54 (77.1%) contained text that could be evaluated for readability analysis and were included in the analysis. The mean text reading levels was 7.9 (95% CI: 7.7-8.1), 9.3 (95% CI: 9.1-9.6), and 10.5 (95% CI: 10.2-10.8) based on FK, GF, and SMOG indices, respectively. ChatGPT-4’s text responses had a significantly lower reading level compared to ICFs text for all three readability indices (FK: p<0.01, GF: p=0.02, SMOG: p<0.01). Conclusions: ChatGPT-4 presented key information from oncology CT ICFs at a 6th to 9th grade reading level, which was significantly lower than the original ICFs. While further studies are needed to assess ChatGPT-4’s accuracy, this study shows its potential as tool for improving patients’ understanding of oncology CTs.
Cancer screening and socioeconomic insecurity in FQHCs: The COVID-19 pandemic and state Medicaid expansion.
Authors: Star Jessica , Yabroff Robin , Han Xuesong , Shi Kewei Sylvia , Jemal Ahmedin , Bandi Priti
Published: October 2023

112

Background: Previous studies reported improvements in multiple care quality measures, including cancer screening, in patients served in federally qualified health centers (FQHCs) located in Medicaid expansion states compared to non-expansion states. However, the COVID-19 pandemic disrupted delivery of routine primary care. Little is known about whether the COVID-19 pandemic disrupted or worsened cancer screening and socioeconomic insecurity in FQHC patients. Methods: Data on breast, cervical and colorectal cancer screening, and socioeconomic insecurity (food insecurity, financial strain, and lack of transportation to care) were obtained from the 2020 and 2021 Uniform Data System (UDS), a national report of care delivered by FQHCs. To balance clinic characteristics, the inverse probability of treatment weighting method was employed. Using a propensity score, the probability of being in a state that expanded Medicaid as of January 1, 2020, was measured. Clinics were then weighted conditional on the proportion best served in a language other than English and privately insured as well as rural location and which funding streams were received from section 330 of the Public Health Service Act. A weighted generalized estimating equation adjusted for random clustering of FQHCs within state with a Poisson distribution produced the prevalence ratios. Results: Between 2020-2021, approximately 2700 and 1300 clinics reported on cancer screening and socioeconomic insecurity. In 2020 and 2021, FQHCs in Medicaid expansion states had a higher patient screening prevalence for colorectal (2020: aPR: 1.16, 95% CI: 1.1-1.23; 2021: 1.13, 1.07-1.19) and breast (2020: 1.1, 1.05-1.17; 2021: 1.09, 1.03-1.14) cancer compared to clinics in non-Medicaid expansion states. Additionally, patient food (2021: 0.59, 0.36-0.97) and financial (2020: 0.57, 0.38-0.86; 2021: 0.58, 0.41-0.82) insecurity prevalence was lower in clinics in Medicaid expansion v. non-expansion states. Conclusions: State Medicaid expansion status was associated with higher cancer screening and lower socioeconomic insecurity within FQHCs during the COVID-19 pandemic. It remains an important policy intervention for vulnerable populations to receive care and mitigate disparities.[Table: see text]
Diagnostic delay among young women with breast cancer.
Authors: Fleshner Katherine , Quan May Lynn , Yang Flora , Xu Yuan ,   RUBY Site Investigators
Published: October 2023

117

Background: Breast cancer in women under 40 is uncommon, but often presents with greater disease burden and worse survival compared to the post-menopausal population. Given its infrequence, it is not well-understood how young patients initiate contact with care and how they are investigated prior to establishing the diagnosis. Whether young women experience diagnostic delay and whether it might impact survival is unclear. We aimed to describe the presentation of breast cancer among women <40 and to understand the diagnostic timeline using patient-reported outcomes. Methods: We evaluated patients in the Reducing the Burden of Breast Cancer in Young Women (RUBY) cohort, a pan-Canadian study recruiting women <40 with breast cancer at the time of diagnosis. Five online surveys detailing demographics, medical/family history and the diagnostic journey, distributed by e-mail at the time of recruitment, were used. All subjects who completed the surveys from 2015-2022 were included. A “patient delay” was considered >4 weeks from onset of symptoms to first contact with the healthcare system. A “system delay” was considered >3 weeks from presentation to first investigation, based on Canadian Partnership Against Cancer screening guidelines. Analysis was conducted using descriptive statistics. Results: There were 1148 patients included for analysis. Median age (IQR) was 37 (33.9, 39.0). Eighty-nine percent of patients had a symptom prompting assessment, of which most had a palpable mass (77.3%), and 27.7% had a painful mass. The median (IQR) number of weeks that patients waited was 2.0 (1.0, 8.0), and 364 patients (31.7%) experienced a patient delay. Most patient delays were attributed to lack of awareness of associated symptoms: 27.7% of patients were not concerned about their symptom and 3.9% were falsely reassured by practitioners. Other reasons included difficulty accessing timely care (3.6%; 37 patients) and conflicting priorities (2.1%; 21 patients). One hundred sixteen patients (10.1%) experienced a system delay. When asked about perceived timeliness of diagnosis, only 248 patients (24.4%) felt their time to assessment was not fast enough. Conclusions: The majority of young women with breast cancer present with palpable, often painful masses. A significant proportion of women experienced a patient delay, suggesting opportunities for increased education regarding presentation of early-onset breast cancer; After presentation to care, most women were investigated in a timely manner.
Empowering women’s health: Opportunity to bridge breast cancer screening to lung cancer screening.
Authors: Khalifeh Yara , Beirat Amir F. , Aljaras Razan , Alhaffar Dana , Karkash Ahmad , Hajj Ali Adel , Hanna Nasser H. , Ajrouch Ali
Published: October 2023

121

Background: Lung cancer (LC) is the leading cause of cancer-related death for women in the United States (US). It surpasses the combined mortality rate of breast, cervical and ovarian cancers. Early detection of LC at stage I increases the 5-year survival rate to 80%. Lung Cancer Screening (LCS) is an effective tool for early detection. However, while 78% of women over 50 in the US undergo Breast Cancer Screening (BCS), only 6% of eligible women receive LCS. Methods: This is a retrospective study of all women diagnosed with primary LC presenting to Indiana University Simon Comprehensive Cancer Center from January 2019 to December 2020. We collected sociodemographic characteristics and information related to smoking history, LCS and BCS. We excluded patients with a prior history of lung or breast cancer who were under surveillance, and those with unknown smoking history. We assessed the BCS and LCS eligibility and utilization according to the U.S. Preventive Services Task Force latest recommendations. We also determined the utilization of LCS in women who have received BCS. Results: Among the 307 women who met the eligibility criteria, 87.6% were white, 51.8% had a Medicare insurance, 41.7% were ever-smoker, and 64.5% had advanced stages of LC (Stage II-Stage IV). Approximately half of our cohort was eligible for LCS, but only 20% received LCS. On the other hand, 72% were eligible for BCS and 58% of them underwent BCS. Among women who received BCS and were eligible for LCS, only25% underwent LCS. The median time from BCS to LC diagnosis was approximately 2.2 years. Among the 178 women who received BCS within one year prior to LC diagnosis, 27% underwent LCS. Among the remaining women who did not have LCS,66.7% of women were already in a later stage (Stage II-IV) at the time of LC diagnosis. Conclusions: Our study demonstrates that majority of women, who met the eligibility criteria for BCS and LCS, received BCS but not LCS prior to their LC diagnosis. This shows that despite the potential mortality benefit, LCS is still underutilized. Receiving LCS at the time of BCS can provide a valuable opportunity to increase LCS participation among eligible women and the potential of diagnosing LC at earlier stages.
Racial and geographic disparities in the use of molecular testing among older Medicare beneficiaries with lung cancer.
Authors: Qin Xuanzi , Chen Jie
Published: October 2023

125

Background: The National Comprehensive Cancer Network (NCCN) guidelines recommend comprehensive molecular testing for newly diagnosed patients with metastatic non-small cell lung cancer (mNSCLC). However, the uptake of the next-generation sequencing (NGS) tests for NSCLC was low due to lack of insurance coverage. In 2018, the Centers for Medicare & Medicaid Services issued a national coverage determination to cover diagnostic laboratory tests using NGS for Medicare beneficiaries with advanced cancer. It is important to understand the current uptake of the NGS tests among older Medicare beneficiaries with lung cancer and examine the potential racial and geographic disparities in the use of NGS tests. Methods: From the random 20% sample of all Medicare beneficiaries, we selected Medicare beneficiaries who were 66 years and older and newly diagnosed with lung cancer in 2020. We excluded beneficiaries who were ever diagnosed with breast, colorectal, endometrial, lung, or prostate cancer before 2020 and beneficiaries who died in 2020. We further restricted our sample to those with a full year of Medicare Part A and B coverage and no month of Medicare Advantage coverage. We identified molecular testing for our lung cancer cohort using Medicare carrier and outpatient claims. We used two linear probability models to examine the relationship between race and the receipt of any molecular tests among all lung cancer patients (N=9,229), and the relationship between race and the receipt of panel tests among those received any molecular tests (N=1,842). We adjusted for age at the beginning of 2020, sex, Medicaid enrollment (low-income), geographic region, and common pre-existing chronic conditions (Alzheimer’s and related dementia, heart failure, chronic kidney disease, chronic obstructive pulmonary disease, diabetes, depression, ischemic heart disease, and arthritis). Results: Among 9,229 older lung cancer patients newly diagnosed in 2020, 1,842 (19.96%) of them received molecular tests. Among those 1,842 who received molecular tests, 709 (38.49%) of them received NGS tests, and the rest received single-gene tests only. In our regression analyses, we found Asian patients were 12.5-percentage point more likely to receive any molecular tests compared to White patients. Among those received any tests, Hispanic patients were 16.0-percentage point less likely to receive NGS tests over single-gene tests compared to White patients. We also found those residing in the South and the West were less likely to receive NGS tests over single-gene tests than those residing in the Northeast. Conclusions: Given the guideline recommendation and proportion of new mNSCLC cases among all new lung cancers, there was likely underuse of NGS tests. There were also racial and geographic disparities in the use of NGS tests.
Awareness of biomarker test timing and purpose in patients with non-small cell lung cancer (NSCLC).
Authors: Mohindra Nisha Anjali , Trosman Julia R. , Houseknecht Stefanie , Feliciano Josephine Louella , Sacks Ruth Lauren , Souter Benjamin , Waugh Wendi , Martin Jeremiah , Woodyard Jennifer , Schmidt Laura , Chang Cara , Rediske Anna , Zavala Sonia , Lycan Thomas William , Martin Nikki A. , Lile Ashley , Boehmer Leigh , Weldon Christine B.
Published: October 2023

138

Background: Biomarker testing is necessary for optimal 1st line treatment selection in advanced NSCLC. Patient understanding of timing and purpose of biomarker testing is imperative for patient engagement in care but is challenging to achieve (1). The 4R Oncology model of patient self-management and timely care delivery has been shown to improve patient knowledge of timing/sequence of care in breast cancer (2) but has not been studied in NCLSC in relation to biomarker testing. 4R is being implemented at 5 centers (3 community and 2 academic) in NSCLC. We report baseline assessment of patient awareness of biomarker testing timing and purpose to inform 4R implementation. Methods: Pre-implementation surveys of patients with advanced NSCLC at 5 centers Aug – Dec 2022. Metrics are listed in Table. Results: Survey response rate: 46% (65/142). Respondents were 65% White, 42% high school educated or less, 46% with annual income ≤$30K. While all patients were aware of receiving non-biomarker tests, >40% were not aware of receiving biomarker testing (Table). About half knew why or how long they need to wait for results, but only 29% received this information from providers. Of those tested, the majority reported provider discussions of biomarkers or therapy selection and were clear about results or therapy selection. Awareness (eg, knowing to wait for results before therapy) was associated with receiving printed NSCLC materials (45% vs 7%, p<.01), education above high school (69% vs 41%, p=.03) and income >$30K (67% vs 32%, p=.01). Willingness to wait for test results was associated with knowing how to prepare for treatment while waiting (89% vs 46%, p<.01). Race did not impact these metrics. Conclusions: Considerable gaps exist in patient awareness of timing and purpose of biomarker testing. We refined the 4R model to emphasize biomarker timing in printed visual material, facilitate patient-provider discussions and engage patients in health maintenance while waiting for results. We revised 4R to a lower literacy level. Results will be reported when available. (1) Martin, Oncol Issues, 2022. (2) Trosman JCOOP 2021.[Table: see text]
Implementation of a national cancer subspecialist virtual consult pilot in an integrated health system.
Authors: Kolevska Tatjana , Brasfield Farah M , Kotak Dinesh , Presti Joseph , Harzstark Andrea , Carney Jennifer Fu , Rabrenovich Violeta , Riley-Bowen Megan , Hendricks Tiffany , Glinsky Isabel , Le Michele , McKinney Mishellene
Published: October 2023

143

Background: Over 65,000 new cancer patients are diagnosed nationally each year at Kaiser Permanente (KP), with 12.7 million members in 9 states and the District of Columbia. KP developed the Cancer Expert Review Program (the Program) to connect oncologists with cancer subspecialists across the enterprise. The Program provides consultation and a chart note viewable by the patient within 2 business days. Methods: The Program was piloted from October 2022 to June 2023 for medical oncology patients with breast, gastrointestinal (GI), genitourinary (GU), sarcoma, thoracic, hematology, central nervous system (CNS), melanoma, head & neck, and gynecologic oncology (GYN) diagnoses or a need for molecular/genomic testing. Medical oncologists from Hawaii, Georgia, and Southern California submitted requests for virtual consults to designated cancer subspecialists using HealthConnect, KP’s EPIC system. Consulting physicians had direct access to the medical records for each patient, including pathology and imaging. Oncologists informed patients of the service and discussed the rendered opinion as part of shared decision-making. Implementation outcomes of feasibility and acceptability were evaluated. Providers were surveyed about perceptions of the service using an internally developed questionnaire. The time from consult request to completion was measured. Results: 108 consults (67.5%) were provided by individual subspecialists, while 22 consults (14%) were reviewed by multiple experts or a multidisciplinary team. 140 consults (87.5%) were completed within 2 business days. Of the 44 oncologists who requested a consult, 12 responded to a physician survey. 85% of physicians rated satisfaction with the service as “satisfied” or “extremely satisfied”. 75% said the advice helped to develop the treatment plan. Half of physicians reported the advice changed the original treatment or approach either “somewhat” or “to a great extent.” Half of physicians indicated that if this internal program were not available, they would have referred their patient to a non-Kaiser Permanente provider for a consultation. Conclusions: Implementation of a national cancer subspecialist virtual consult pilot within an integrated health system demonstrated the feasibility and acceptability of timely expert consults with high physician satisfaction. The Program facilitates subspecialist care in collaboration with the patient’s trusted general oncologist, keeping care close to home.Additional research is needed to understand the long-term implementation and quality outcomes of the Program.[Table: see text]
Who goes first? Patterns of cancer drug approvals across four major regulatory authorities: EMA, FDA, Health Canada, and PMDA.
Authors: Warner Jeremy Lyle , Mishra Sanjay , Hadfield Matthew James , Gyawali Bishal , Cowan Andrew , Khaki Ali Raza , Gage Samantha , Lythgoe Mark
Published: October 2023

149

Background: New anticancer therapies have led to substantial improvements in prognosis across many cancers. Commercial access to a drug is not possible until the drug has received regional regulatory authority market authorization. In prior work (1), we found that European Medicines Agency (EMA) drug approvals frequently lagged US Food and Drug Administration (FDA) approvals from 2010-2019. Here, we expand the analytic time period to 2004-2023 and include two additional regulatory agencies – Health Canada (HC) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Methods: Drugs with an anticancer indication and first global approval from 2004-2023 were preliminarily identified. Only drugs with an approval by all 4 regulators were included. For each drug, the first and last regulator’s initial approval dates were determined, and the interval between first and last approval was calculated. For drugs approved by all 4 regulators within 1 year (y), it was further determined whether they were considered first-in-class. Results: 209 drugs met the preliminary criteria, and 98 (47%) had approvals by all 4 regulators. The FDA was most commonly the first to approve (84 drugs), followed by PMDA (9 drugs), then EMA (5 drugs); HC was never first to approve. 43 of the FDA-first approvals (51%) were by the accelerated approval (AA) pathway; none of the EMA-first approvals were on the conditional marketing pathway. PMDA was most commonly the last to approve (62 drugs), followed by HC (21 drugs), the EMA (14 drugs), then the FDA (1 drug). The median (IQR) time between first and last regulator’s first approval was 2.4 y (1.3-3.5 y). Some drugs had >5 y between first and last regulator’s approval (Table 1). Conversely, only 16 drugs were approved by all regulators within 1 y, and only 1 drug (isatuximab) was approved by all within 6 months. Of the 16 drugs approved within 1 y by all regulators, 6 (37.5%) were first-in-class: asciminib, elotuzumab, idecabtagene vicleucel, inotuzumab ozogamicin, sotorasib, and trastuzumab emtansine. Conclusions: This study shows that patients with cancer in the US usually have access to new cancer drugs earlier than those in Europe, Japan, and Canada, at least in part due to AA pathways. Less than 8% of newly approved cancer therapies are approved by all 4 regulatory agencies within 1 y of first approval, with a lengthy median first-to-last delay that could exceed the life expectancy of many patients with advanced cancer. Greater global regulatory collaboration in the approval of new anticancer drugs is essential to ensure patients have aligned and coordinated access. (1) Lythgoe et al. JAMA Network Open 2022.[Table: see text]
Assessing out-of-pocket cost differences in treatment for Medicare-eligible patients with favorable prognosis early-stage Hodgkin lymphoma.
Authors: Wu Victoria , Khlopin Martha , McClelland Shearwood
Published: October 2023

15

Background: In the treatment of favorable Hodgkin Lymphoma (HL), Level 1 evidence comparing combined modality therapy (CMT) with chemotherapy alone has persistently demonstrated that obviating radiation therapy (RT) worsens recurrence rates despite no significant overall survival difference. As there remains limited evidence on the granularity of the impact of insurance on HL treatment, this project disaggregates costs by insurance plans to enhance the transparency of out-of-pocket (OOP) cost estimations in Medicaid and/or Medicare-eligible (age 65+) patients. Methods: National Comprehensive Cancer Network guidelines were queried to assess the appropriate therapy for HL. Following initial adriamycin/bleomycin/vinblastine/dacarbazine (ABVD) chemotherapy x 2 cycles with Deauville 1-2 response on PET scan, CMT was defined as involved site RT (20 Gy / 10 fractions), while chemotherapy alone was defined as an additional ABVD x 2. Current Procedural Terminology and Healthcare Common Procedure Coding System codes identified treatments. OOP expenditures, deductibles, and copay/coinsurance were computed for Medicaid, Original Medicare, and Medigap Plan G plans via medicare.gov, medicaid.oh.gov, and cms.gov. Price estimates (from actual prices per insurance plan rather than claims data predictions) assume an Ohio hospital location (zip code = 44106) for all treatments. Total costs were calculated based on all treatments plus a 5-year follow-up (not adjusted for inflation). Treatment charges for chemotherapy alone include initial medical oncology office visit, cost of ABVD x 4, and infusion costs for 4 cycles. Additional treatment charges for CMT include initial radiation oncology consultation, treatment planning, dosimetry calculations, treatment device, simulation and verification, RT delivery, on-treatment visits, medical physics consultation, and annual TSH labs. Results: With Original Medicare plans, patients are faced with an OOP cost of 20% for Medicare Part B claims with no cost cap for approved procedures after the deductible. As such, patients are faced with a total 6-year charge of $1,928.95 for chemotherapy alone, and $2,385.28 for CMT. Under Medigap Plan G, patients encounter an OOP charge of $1,151.14 for chemotherapy alone and $1,176.34 for CMT. Medicaid beneficiaries (assuming all treatments are approved by Medicaid) face no OOP expenses for both treatment plans, as all expenses are covered without limit. Conclusions: By comparing OOP costs between Medicare and Medicaid plans, this model improves cost transparency in the treatment of favorable early-stage HL. Our findings indicate that omitting RT in favor of chemotherapy alone yields a cost savings of 2-24% at a 5-year follow-up. Further studies are required to assess whether these savings compensate for the inferior outcomes achieved by omitting RT in this patient population.
The impact of neighborhood socioeconomic deprivation on pancreatic cancer stage and treatment in Florida: A statewide retrospective cohort study.
Authors: Pattnaik Aishwarya , Permuth Jennifer B , Anaya Daniel A. , Vadaparampil Susan Thomas , Fleming Jason B. , Powers Benjamin Daniel
Published: October 2023

150

Background: Increasing socioeconomic deprivation (SED) is associated with higher cancer stage at diagnosis and less treatment. However, most studies have used large geographic areas and lacked detailed staging or treatment variables. To overcome this, SED at the neighborhood (census-block group) level was used to assess pancreatic cancer stage and treatment in Florida. Methods: Using the incidence-based Florida Cancer Database, 16,319 patients diagnosed with pancreatic adenocarcinoma from 2008-2015 were identified. The Area Deprivation Index, a validated dataset that ranks census block groups (neighborhoods) from 1-100 (higher scores=higher deprivation) at the national level based on SED, was used to assess stage at diagnosis and treatment by quintile. Descriptive statistics and tests of association were used. Results: The median SED for pancreatic cancer in Florida was 57. SED was associated with stage at diagnosis (Table 1). The lowest SED patients had the lowest rate of stage IV disease (46.8%). Surgery and chemotherapy were delivered to 18% and 60% of all patients. Of stage I patients without risk factors contraindicating surgery, 29.1% received curative-intent surgery. For these patients, high SED compared to the lowest SED was associated with a lower surgery rate (25.8% vs 30.9%, respectively; p=0.006). For stage IV patients, 60.6% received chemotherapy and higher SED was associated with a lower rate of chemotherapy receipt compared to the lowest SED patients (55.8% vs. 66.7%, respectively; p=0.001). Conclusions: Neighborhood SED was associated with stage at diagnosis and receipt of pancreatic cancer treatment. Most eligible stage I pancreatic cancer patients in Florida do not receive curative-intent surgery and nearly half of stage IV patients do not receive chemotherapy. Higher SED is associated with lower rates of treatment. Research is urgently needed to characterize and overcome the failure to treat pancreatic cancer in Florida.[Table: see text]
Comprehensive cancer-related resources for adolescents and young adults (AYAs) treated in the community setting: 2022 Landscape survey results.
Authors: Beauchemin Melissa P , Ji Lingyun , Williams AnnaLynn , Nightingale Chandylen L , Wolfson Julie Anna , Salsman John M , Levine Jennifer , Freyer David R. , Grimes Allison , Sugalski Aaron Jon , Prasad Pinki Kumari , Pollock Brad H. , Santacroce Sheila Judge , Sheth Bhutada Jessica , Roth Michael , Parsons Susan K.
Published: October 2023

151

Background: Availability of guideline-endorsed, cancer-related resources for adolescents and young adults (AYAs: aged 15–39) with cancer is unknown. AYAs often receive treatment in community settings. We describe the current landscape of comprehensive cancer care resources for AYAs treated in community settings. Methods: NCI Community Oncology Research Program (NCORP) practice groups completed the Landscape Assessment in 2022 to describe available infrastructure, resources, and research capacity. Practice groups were included in this analysis if ≥10% of their annual cancer cases were within the AYA age range, or at least 50 AYA cancer cases are treated annually. We described the proportion of practices serving AYA patients with access to fertility preservation, mental health services, genetic testing and counseling, nutritional counseling, distress monitoring (psychosocial and financial), palliative care, and survivorship programs. Results: Of 271 responding practice groups, 77 (28%) met criteria for treating AYAs, whereas 102 (38%) did not meet criteria. The remaining 92 (34%) could not be classified due to missing data. Among the 77 practices treating AYAs, fertility preservation was available at 51% (oocyte cryopreservation) and 58% (sperm banking) of practices. While nutritional support and genetic testing were widely available (99% and 100% respectively), only 49% of practices treating AYAs offered survivorship programs (Table 1). Conclusions: Many AYAs receiving treatment in community settings lack access to key resources for cancer care, including fertility preservation and survivorship services. Future research should seek to identify barriers and facilitators to offering comprehensive resources in NCORP practices that serve AYAs and to advance understanding of AYA uptake of available resources.[Table: see text]
Disparities in time to initiation of treatment among patients with metastatic solid tumors in Washington state.
Authors: Fedorenko Catherine R. , Sun Qin , Kreizenbeck Karma L. , Shankaran Veena , Ramsey Scott David
Published: October 2023

153

Background: Timely initiation of cancer treatment can improve quality of life and survival. As part of a large, statewide effort aimed at improving cancer care quality, we estimated time from diagnosis to initial treatment among patients with newly diagnosed metastatic cancers. Methods: Using an established linkage of Washington state cancer registry records with claims data from commercial insurers, Medicare, and Medicaid, we identified patients diagnosed with metastatic solid tumors diagnosed between 2017 and 2019. Time to first treatment with chemotherapy (CT), radiation therapy (RT) or hormone therapy (HT) was measured as the number of days from first visit at an oncology clinic to the date of first treatment. Patients seen at multiple oncology clinics were assigned to the clinic with the greatest number of physician visits. We used linear regression to evaluate factors associated with timeliness of care (tumor type, age, sex, race/ethnicity, insurance type, resident neighborhood deprivation, comorbidity). Results: 3,237 patients met inclusion criteria with median time to initial treatment of 34 days (CT 35 days; RT 28 days; HT 37 days). Mean time to treatment was 45.2 days (CT 47.6 days; RT 39.4 days; HT 49.0 days). Factors that were significantly associated with time to initiation of treatment are shown in the Table. Conclusions: Black and Medicaid-enrolled patients with metastatic cancers experience significantly longer times to first treatment. Future research will focus on identifying factors underlying the observed differences so that interventions can be designed to reduce these disparities.[Table: see text]
The impact of dosing approaches for lenalidomide on total cost of care in episodic value-based care models at a community oncology network.
Authors: Indurlal Puneeth , Garey Jody S. , Mendenhall Molly , Waterhouse David Michael , Thomas Hope Ives , Wilfong Lalan S.
Published: October 2023

16

Background: The Oncology Care Model (OCM) was a 6-year long Medicare value-based care (VBC) program that rewarded practices for maintaining high-quality cancer care, while decreasing the total cost of care (TCOC) compared to a benchmark price. Lenalidomide, an oral medication used to treat multiple myeloma and other hematologic cancers, had the highest total Part D spending in the OCM. Lenalidomide is available as capsules of multiple strengths (2.5mg, 5mg, 10mg, 15mg, 20mg and 25mg), having the same cost per pill (mean cost of $735 per pill (over the 6 years)) for each of the strengths. Standard lenalidomide dosing includes one of the dose strengths taken once daily for 21 days on a 28-day cycle, 14 days on a 21-day cycle, or 28 days on a 28-day cycle. Doses and schedules may be adjusted to account for patient toxicities, different indications, or individual preferences. We studied the impact of different dosing approaches for Lenalidomide on TCOC. Methods: We used Medicare prescription dispense data for Lenalidomide for 15 practices in The US Oncology Network (The Network), participating in the OCM. We grouped dispenses based on pills per day (calculated using count of pills dispensed & days' supply), and evaluated the prevalence of different dosing approaches, cost of Lenalidomide, and the impact on TCOC throughout the OCM time periods (July 2016 to June 2022). Results: 85.5% of 52,793 total dispenses were for one pill daily doses, 10% (5,281) for fewer than one pill daily doses, and 4.5% (2,377) for alternative dosing approaches using more than one pill per day, such as multiple pills taken once daily, one pill taken more frequently than once daily, or the total strength being dispensed as a combination of multiple smaller strengths. Alternative dosing approaches led to a mean total cost of $28,300 per dispense, versus $15,600 per dispense for one pill daily doses. 95% of the episodes with alternative dosing approaches had TCOC more than the benchmark, whereas only 52% of the episodes with one pill daily dosing had TCOC more than the benchmark. Total strengths of Lenalidomide dispensed as a combination of multiple smaller strengths had the highest mean total cost of all alternative dosing approaches. Conclusions: Dosing approaches utilizing more than one pill per day for oral medications like Lenalidomide can lead to significantly higher total cost and unfavorable VBC outcomes. Similar impacts may be found with other oral medications where per pill costs are high. Appropriate dosing strategies for optimizing pill counts of oral medications can lead to cost savings for patients, and the health system at large.
Assessing the impact of the COVID-19 pandemic on newly diagnosed metastatic lung cancer healthcare resource utilization and costs in the United States.
Authors: Zyczynski Teresa Maria , Weech-Maldonado Robert , Hearld Larry , Sen Bisakha , Velcheti Vamsidhar , Zhang Ying , You Min
Published: October 2023

164

Background: The COVID-19 pandemic has derailed normal operations in the healthcare delivery systems in the US and globally, providing prioritized care to patients seeking acute management of the novel coronavirus and its complications. Simultaneously, cancer screening tests have decreased, resulting in decreased rates of cancer diagnoses and referrals to oncologists. The purpose of this study was to assess metastatic lung cancer-related and total healthcare resource utilization (HCRU) and costs during the pandemic/post-pandemic period compared with the pre-pandemic period. Methods: A retrospective claims study using de-identified medical and pharmacy insurance adjudicated claims from national and sub-national health plans and self-insured employer groups was initiated in patients greater than 18 years of age with commercial, commercial self-pay, and Medicare Advantage insurance. Analyses were conducted from January 1, 2019 to February 29, 2020, the pre-pandemic period, and compared to March 1, 2020 to April 30, 2021, the pandemic/post-pandemic period. Multivariable logistic regression models were used to assess the probability of having a hospital, ER or hospice/palliative visit. Multivariable linear regression models were used to see differences in the utilization of outpatient visits. Multivariable Generalized Linear Models with a log transformation and gamma distribution were used to see if there were differences in healthcare costs. Results: 3,230 (pre-pandemic period) and 2,922 (pandemic/post-pandemic period) patients with newly diagnosed metastatic lung cancer were included in the study. The mean age of the patients in the pre-pandemic period was 61.1 years and 61.3 years in the pandemic/post-pandemic period. The odds of receiving outpatient and inpatient hospice/palliative care, inpatient and ER care were lower in the pandemic/post-pandemic period. After controlling for all variables, (OR=0.813; 95% CI: 0.729, 0.906), p=0.0002. Per patient per month (PPPM) metastatic lung cancer-related and total costs were higher in the pandemic/post-pandemic time period. After controlling for all variables, (Cost ratio=1.059; 95% CI: 1.023, 1.096), p=0.0011. Conclusions: This is the first study assessing the impact of the COVID-19 pandemic on HCRU and costs in patients with newly diagnosed metastatic lung cancer.
Socioeconomic influence of insurance coverage and ethnicities on efficacy outcomes and side effects related to immune checkpoint inhibitors in non-small cell lung cancer.
Authors: Mahadevia Himil , Eidenschink Benjamin , Sharma Parth , Khan Abat , Harry Stephanie Sarita , Kujtan Lara Ann
Published: October 2023

168

Background: Immune checkpoint inhibitors (ICI) are approved for treatment of various malignancies. However, ethnic minorities and underprivileged patient populations are often not adequately represented in clinical studies. We hereby delineate updated data on efficacy outcomes and immune-related adverse effects (IRAEs) among patients with advanced non-small cell lung cancer (aNSCLC) belonging to diverse ethnicities, and government sponsored (Medicare/Medicaid-MM) vs commercial insurance (COI) vs uninsured (UNI). Methods: A retrospective study of adult patients who received ICI or ICI plus chemotherapy was conducted at an urban safety net hospital. The timeline was expanded from January 2015 to June 2022. Data was collected from the electronic medical record with IRB approval. All grade (CTCAE v5.0) IRAEs were identified. Progression at 1 year (1y-PFS) in addition to survival at 1-year (1y-OS) from ICI initiation was calculated for aNSCLC patients using RECIST 1.1. Chi-square analysis and ANOVA testing were utilized to determine statistical significance. Results: 291 patients were identified with ICI use. 104 patients had aNSCLC and had follow up for at least 1 year. This aNSCLC population had 42 African American (AA) and 62 Caucasian patients (CC). 79 patients had MM, 24 possessed COI and 7 were UNI. AA patients with aNSCLC had poorer 1y-OS at 44% (p=0.12) and 1y-PFS at 15% (p=0.0005) compared to CC patients which had 1y-OS of 61% and 1y-PFS of 51%. CC patients had more all grade IRAEs (42.4%) in comparison to AA patients (36.2%) (p=0.58). 1y-PFS and 1y-OS were 39% and 67% respectively in COI patients compared to MM patients who had 38% and 50% (p=0.51 and p=0.46 respectively). Self-pay had the worst 1y-PFS (19%) and 1-yr OS (36%). All grade IRAEs were 41% in MM patients, 40% in UNI and 35% in COI patients (p=0.68). Conclusions: This expanded study with updated data further upholds the influence of ethnicities and insurance coverage on the incidence of IRAEs and efficacy with ICI. There was a significant difference with worse outcome in AA population compared to CC with ICI use in aNSCLC. COI patients showed better outcome trend (non-significant) than patients with government sponsored insurance and uninsured patients had worst outcomes. This implies that impoverished patients and ethnic minorities may have inferior outcomes with ICI therapy. Larger population studies may provide further validation of these findings.[Table: see text]
Economic burden and healthcare resource utilization (HRU) associated with cystectomy (CYS) in US patients with muscle invasive bladder cancer (MIBC).
Authors: Shi Qian , Emond Bruno , Morrison Laura , Tardif-Samson Anabelle , Pilon Dominic , Lefebvre Patrick , Ellis Lorie , Ireland Andrea
Published: October 2023

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Background: CYS is strongly recommended for surgically eligible patients with MIBC following cisplatin-based neoadjuvant chemotherapy and is associated with significant surgery-related complications as well as meaningful health-related quality of life impacts. This study described real-world HRU and costs for patients with MIBC, overall and among those who had a CYS. Methods: Adults with MIBC were selected from de-identified IBM MarketScan Commercial and Medicare Supplemental Databases (1/1/2010-2/28/2021) and Multi-State Medicaid Database (1/1/2010-12/31/2019). The index date was defined as the date of initiation of treatment with systemic therapy, radiotherapy, or CYS (used as proxies to identify MIBC) following the first observed bladder cancer (BC) diagnosis. HRU and costs (in 2021 US dollars) were reported per-patient-per-year (PPPY) from the index date to the earliest of metastatic BC, end of continuous insurance eligibility, or end of data. Results: Among 2,249 patients with MIBC (71% male, mean age 65 years, mean [median] follow up = 21 [13] months), 20.3% (N=456) had a CYS (75% male, mean age 63 years, mean [median] follow up = 24 [17] months). In the overall MIBC population, median all-cause total healthcare costs PPPY were $10,524 in the 12-month pre-index period, and $40,980 in the post-index period (Table) with 32% of total healthcare costs PPPY attributable to BC ($13,284). Post-index median all-cause total healthcare costs PPPY were 2.4 times higher among those with CYS ($97,824) relative to the overall MIBC population, with 67% of costs attributable to BC. Patients with CYS had higher all-cause and BC-related HRU PPPY in both inpatient and outpatient settings than the overall MIBC population (TABLE). In addition to the removal of the bladder, CYS surgeries frequently required alteration of other organ systems including prostate and seminal vesical for male; uterus, ovaries, fallopian tubes, and anterior vaginal wall for female patients. Conclusions: This study demonstrates the significant cost and healthcare resource burden associated with CYS in patients with MIBC and further illustrates the need for effective therapies that leave the bladder intact and avoid surgical removal or alteration of otherwise functional organ systems. [Table: see text]