tbuckley/cabot-search huggingface dataset:
5-year multicenter analysis of clinical trial participation and total cost of care for older adults with cancer.
Authors: Ishwaria M. Subbiah, Puneeth Indurlal, Naiyar Alam, Hope Ives, Stuart George Staggs, Lalan S. Wilfong
Journal: Journal of Clinical Oncology (2024)

11013 Background: Clinical trial access particularly for older adults aged 65 years and above with cancer is impacted by multilevel barriers, including cost concerns to payers in the usual models of cancer care delivery. Alternative models recently studied include the Centers for Medicare and Medicaid Innovation’s Oncology Care Model (OCM), a value-based care pilot to enhance quality &amp; reduce costs. Here, we investigated the association between clinical trial participation (CTP) and the total cost of care (TCOC) within this non-traditional model. Methods: We identified prospective longitudinal observational cohort of patients cared for in 11 states within 323 clinics in 14 multi-site community practices participating in OCM, in The US Oncology Network and extracted data (episode claims, medical records, episodes) from OCM performance periods (PP) 3-11 between 7/1/17 and 6/30/22. Propensity score matching by PP, age, gender, date of death, cancer type identified the analysis cohort of matched episodes, then stratified by trial participation (CTP vs usual care) to compare TCOC and drug expenditures. Results: Over 5 years, 121,717 unique patients (94% of whom were aged 65y+) received 282,604 episodes of cancer care in the community, most common cancers being breast, lung, multiple myeloma. Propensity score matching identified 13,260 matched episodes (6630 usual care, 6630 CTP). The actual expenditure differed by $2,341 per episode between CTP &amp; usual care (CTP $43,890 vs usual care $41,548; p &lt; 0.0001), while trial participation had significant savings against the OCM CTP benchmark ($4816 saved per CTP episode), compared to usual care vs its benchmark ($826 saved per usual care episode, p &lt; 0.0001). Drug costs per episode did not differ between the two groups (CTP $29,516 vs usual care $30,553; p 0.54). Further breakdown shows that drug spending on anticancer agents (CTP $28,008 vs usual care $29,139) and other drugs including supportive care meds (CTP $1,511 vs usual care $1,414) did not differ significantly. Conclusions: Clinical trial participation saw relative cost savings against the benchmark compared to usual care, owing largely to the higher benchmark prices for CTP episodes in OCM’s risk-adjusted price prediction model, rather than an absolute cost savings to payers. Drug expenditures remain the largest contributor to total cost of care in this alternative model. The contributors to both drug expenditures as well as the absence of absolute cost savings between the two cohorts represent key areas for further investigation. CMMI Disclaimer: The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of CMS. The authors assume responsibility for the accuracy and completeness of the information contained in this document.
Influence of family caregivers on clinical trial decisions: Results from a qualitative study.
Authors: Eric Blackstone, Sana Loue, Barbara J. Daly, Jennifer Anne Dorth, Patricia T. Brandt, Susan R. Mazanec
Journal: Journal of Clinical Oncology (2024)

e23023 Background: Family caregivers are key stakeholders in cancer clinical trial decisions who have been overlooked in previous research. Caregivers play a critical role in supporting patients during clinical trial participation, yet there is little consensus regarding how they should be included in informed consent. Clinical trial staff communicate regularly with patients and caregivers during consent and throughout trial participation, making their perspectives vital to understanding the role caregivers play in these decisions. Methods: This qualitative study identifies the roles caregivers play in cancer trial decision-making, influential factors from the caregiver perspective, and practices of clinical trial staff regarding caregiver inclusion in consent. Patients who were offered a clinical trial at a midwestern comprehensive cancer center were asked to identify a caregiver to participate. Clinical trial staff were recruited via email invitation. We conducted focus groups with caregivers and trial staff, followed by semi-structured interviews with caregivers. Caregivers were asked about attitudes towards research, experiences with trial consent, and their role in decision-making. Trial staff were asked how they included caregivers in consent and attitudes towards their involvement. Transcripts were coded, then analyzed with NVivo using content analysis. Results: Focus groups consisted of 9 caregivers and 10 clinical trial staff, then 15 caregivers completed interviews. Caregiver themes included promoting patient autonomy, influential factors, and burdens of trial participation. Trial staff themes were approaches to caregiver inclusion, navigating challenging situations, and the need for training. Caregivers viewed their role as supporting patient understanding and deferring to the patient as final decision-maker. Hope for therapeutic benefit, oncologist endorsement, and practical barriers (e.g. cost, distance) were influential. Trial staff viewed caregivers as highly influential and encouraged their involvement in consent despite occasional challenges such as family disagreement and undue influence. Conclusions: Early communication with caregivers when offering a trial is vital due to their influential role in decision-making. Clinical trial staff would benefit from training on best practices for inclusion of caregivers, including communication, managing emotions, mediating disagreement, and where to refer caregivers for support. Researchers should consider caregiver burden and potential sources of caregiver support during trial design to minimize barriers to participation.
Is essential thrombocytosis associated with worse outcomes in patients with stroke? Results from 2016-2020 National Inpatient Sample study.
Authors: Himal Kharel, Samikchhya Keshary Bhandari, Zeni Kharel, Aditya Sanjeevi, Aniket Rao, Purva Shah, Abdullah Ahmad Orakzai, Basant Eltaher, Nishan Babu Pokhrel, Saad Jamshed
Journal: Journal of Clinical Oncology (2024)

e23060 Background: Essential thrombocythemia (ET) is a myeloproliferative neoplasm. Thrombosis is a major cause of morbidity and mortality in ET. It is unknown whether the morbidity and mortality of ischemic stroke in ET is different from that in non-ET patients. Similarly, the quantitative data regarding the use of platelet pheresis in this population is also unknown. This National Inpatient Sample (NIS) database study aims to answer these questions. Methods: A retrospective analysis of the NIS database from 2016 to 2020 was conducted using ICD-10 codes to identify hospitalizations with ischemic stroke. STATA version SE18.0 was used for statistical analysis. We used multivariate regression analysis to calculate the effects of ET on mortality and length of stay along with various other variables including age, gender, primary payer, household income, Charlson Comorbidity index, hospital bed size, hospital region, diabetes mellitus, heart failure, hypertension, coronary artery disease, smoking, hyperlipidemia, carotid artery stenosis, and atrial fibrillation. Results: There were 2,635,595 hospitalizations with primary diagnosis of ischemic stroke. Among these, 9604 patients had secondary diagnosis of ET. The mean age of ET patients with stroke was 67 years. 60.5% of patients were females. 40 (0.41%), 335 (3.48%) and 720 (7.49%) patients underwent plateletpheresis, thrombectomy, and thrombolysis respectively. Multivariate logistic regression showed that ET was not associated with increased mortality, but was associated with significantly increased length of stay with odds ratio (OR) of 0.95 [95% confidence interval (CI) = 0.73 to 1.23, p-value = 0.7) and 2.58 (95% CI = 2.12 to 3.04, p-value = 0.00) respectively. The effect of other pertinent variables are summarized in Table 1. Conclusions: Our analysis shows that stoke in ET was not associated with increased mortality. ET was associated with increased length of stay in patients with stroke. 0.41% of ET patients with stroke received platelet pheresis. Limitations of this study include failure of the multivariate model to account for all the variables, coding errors, and increased risk of bias due to retrospective nature of the data. [Table: see text]
Budget impact analysis of participating in sponsored clinical trials in cancer within the Colombian healthcare system: A real-world evidence approach.
Authors: Andres Felipe Cardona Zorrilla, Luis Leonardo Rojas Puentes, Antonio Robles, Carlos Badillo, Jorge Ceballos, Natalia Sanchez, Virginia Abello, Carlos Eduardo E. Bonilla Gonzalez, William Armando Mantilla, Jairo Andrés Zuluaga
Journal: Journal of Clinical Oncology (2024)

e23031 Background: Clinical trials (CTs) are a key element in researching and developing new technologies for cancer. Assessing the economic impact of CTs and the potential savings for healthcare systems in Low- and Middle-Income Countries (LMICs) is vital to guide healthcare decision-making. This research aims to quantify the budget impact for the Colombian Health System of including hematology and oncology patients in sponsored clinical trials. Methods: This study uses real-world data (RWD) from CTIC, a high-complexity cancer center from Bogotá, Colombia. We followed the Budget Impact Analysis methodology defined by the local HTA agency using data for five tumors retrieved from an institutional data lake resource using clinical information and related costs. Tumors were selected based on their prevalence and economic burden. CTIC’s clinical experts validated the cost-generating events for each disease. The eligible population for phase 3 clinical trials was estimated from the literature and CTIC oncology units’ leaders’ opinions. Prevalent and incident population data were obtained from the Colombian High-Cost Account (CAC). Results: There are 7,703 potential patients to be included in CTs, representing a total cost of 217,544,023 for 2023 USD (1 USD = 4,325 COP). If at least 25% of patients with these tumors were included in CTs in 2023, the approximate cost would be 54,386,006 USD. Advanced prostate cancer represented the highest cost, given its prevalence and CT inclusion opportunity. Conclusions: With approximately USD 24 billion spent on healthcare (USD 5 billion in drugs), Colombia could save around 4% of its drug expenditure if all potential candidates were to be included in cancer CTs. Furthermore, assuming similar average costs per patient, inclusion rates, and population growth for 5-years, this could represent savings of around USD 1.1 billion. These savings would ease the reimbursement and access to innovation for Colombian patients, improving health outcomes and enhancing long-term financial sustainability. [Table: see text]
Outcomes of liver transplant recipients with pretransplant malignancies: Insights from a single institution’s experience.
Authors: Nikitha Vobugari, Kirk Heyne, Ashton Connor, Zainub Ajmal, Shubham Adroja, Yuan Gao, Sunil Mathur, Sudha Kodali, Ashish Saharia, Constance M Mobley, Ahmed M Elaileh, Khush Patel, Rafik Mark Ghobrial
Journal: Journal of Clinical Oncology (2024)

11173 Background: Increasing liver transplantation (LT) utilization has resulted in more and more patients with a history of a non-hepatobiliary malignancy. Rather than deny such patients a lifesaving therapy the benefits must be weighed against risk of tumor recurrence and de novo malignancies (DNM) post-LT, especially with the immunosuppression required. While data has been presented on outcomes of pre transplant malignancies (PTM) in kidney and heart transplants, LT data is lacking. Our aim is to characterize rates of recurrence, DNM, and overall survival (OS) post-LT at a single, high volume American center. Methods: This retrospective study at Houston Methodist Hospital included patients who underwent LT with known history of PTM. Data was extracted from electronic health records, and descriptive statistics performed. Institutional IRB approval is obtained. Results: Between 01/1999- 12/2022, 1617 LTs were performed at our institute. We identified 261 LT recipients with 297 PTM, including 91 non- and 206 hepatobiliary cancers (See Table). Follow-up period ranged from 1 to 23 years. Post-LT malignancies were observed in 66 patients, 25% of the study population. Tumor recurrences accounted for 44 (17%) cases, and DNM were seen in 22 (8%). The DNMs included skin non-melanoma (n=8 cases), head &amp; neck (3), PTLD (2), prostate (2), renal (1), lung (1), CRC (1), pancreatic (1), gynecologic (2), and poorly differentiated (1). The OS rate at 1-, 5-years (excluding those less than 5 years follow-up and unknown), and at time of last follow-up were 86.6%, 60-65% and 70%, respectively. Patients with post-LT malignancies had lower OS compared to those without (46% vs. 77.7%). Conclusions: To our knowledge, this study is the first to assess post-LT outcomes in patients with PTM. This study of LT recipients with PTM demonstrates post-LT malignancy rates of 25%, including 17% with recurrences and 8% with DNM. The latter is within the previously reported range of 3-14% DNM in the general post-LT population and dominated by skin cancers. Post-LT OS is excellent in these recipients and comparable to all LT patients. However, OS is lower in those with post-LT malignancies, implying a possible role for increased cancer surveillance. Limitations include retrospective design and potential chart bias. Future work in this cohort will focus on immunosuppression effects for this high-risk population. [Table: see text]
Supplemental Nutrition Assistance Program (SNAP) policy changes and mammography use in the United States.
Authors: Ali Kazmi, S. M. Qasim Hussaini, Fumiko Chino, Robin Yabroff, Justin Michael Barnes
Journal: Journal of Clinical Oncology (2024)

11033 Background: The Supplemental Nutrition Assistance Program (SNAP) alleviates food insecurity among low-income households, which has been linked to healthcare access. Several states increased SNAP eligibility by implementing policies that eliminate asset tests and/or broaden income eligibility criteria. This study investigates the associations of SNAP policy changes on mammography use within the past year among low-income females eligible for breast cancer screening. Methods: Income-eligible females ages 40-79 years were identified from the 2006-2019 Behavioral Risk Factors Surveillance System. 28 and 22 states adopted SNAP asset test elimination and income increase policies, respectively. Difference-in-differences analyses compared changes in the percentage of mammography within one year from pre- to post-SNAP policy adoption (asset test elimination or income eligibility increase) between states that did and did not adopt policies expanding SNAP eligibility. The samples were limited to females with household income &lt; 130% and &lt;200% federal poverty level for analyses of asset test elimination and income eligibility increase policies, respectively, to correspond to typical eligibility criteria. Results: A total of 171,684 and 294,647 income-eligible females were included for the asset test elimination and income eligibility increase policy analyses, respectively. Overall, 58.4% reported mammography within 1 year. Adoption of asset test elimination policies was associated with a 2.11 percentage point (95% CI = 0.07 to 4.15, P=0.043) increase in mammography, particularly for non-metropolitan residents (4.14 percentage points, 95% CI = 1.07 to 7.21, P=0.008), those with household income &lt;$25,000 (2.82 percentage points, 95% CI = 0.68 to 4.97, P=0.01), and those residing in states in the South (3.08 percentage points, 95% CI = 0.17 to 5.99, P=0.038) or in states that did not expand Medicaid under the Affordable Care Act (3.35 percentage points, 95% CI = 0.36 to 6.34, P=0.028). There was no significant association between state-level policies broadening SNAP income eligibility and mammography use (-1.07 percentage points, 95% CI = -2.64 to 0.49, P=0.18). Conclusions: This nationwide study suggests that policies eliminating the asset test for SNAP eligibility were associated with increased mammography use within one year, with the most pronounced positive impact observed in Southern states, non-expansion states, non-metropolitan areas, and households with the lowest incomes. Findings highlight the role that states policies have to both meet essential needs and promote health among vulnerable populations.
Impact of protein energy malnutrition on hospitalized patients with lung cancer: A United States population-based cohort study.
Authors: Yajur Arya, Arshi Syal, Phuuwadith Wattanachayakul, Elvis Obomanu, Joao Manoel da Silveira Lara, Bruce Adrian Casipit, John Charles Leighton, Claudia M. Dourado
Journal: Journal of Clinical Oncology (2024)

11160 Background: Lung cancer is the leading cause of cancer related deaths in the United States. Patients with advanced lung cancer tend to have varying degrees of protein energy malnutrition (PEM), due to multiple reasons including cancer related cachexia, sarcopenia, and adverse effect of chemotherapy. However, the impact of PEM on clinical outcomes in this subgroup needs further exploration. Methods: We utilized the 2020 National Inpatient Sample (NIS) Database in conducting this retrospective cohort study. We identified patients with lung cancer and PEM using appropriate ICD-10 diagnostic codes. We stratified patients with lung cancer based on the presence or absence of PEM. A survey multivariable logistic and linear regression analysis was used to calculate adjusted odds ratios (ORs) for the primary and secondary outcomes. A p value of &lt;0.05 was considered statistically significant. The aim of this study was to investigate the impact of PEM on in-hospital mortality, hospital length of stay (LOS), and total hospitalization charge among hospitalized patients with lung cancer. Results: We identified a total of 92425 hospitalized patients with lung cancer, of which 10.53% (9739/92425) had comorbid PEM. The overall in-hospital mortality among patients with lung cancer was 5.79% (5360/92425). Among those with concomitant PEM, the mortality rate was significantly higher at 13.13% (1279/9739, p&lt;0.001). Utilizing a stepwise survey multivariable logistic regression model that adjusted for patient and hospital level confounders, PEM was found to be an independent predictor of increased in-hospital mortality (adjusted OR 2.11; 95% (confidence interval [CI] 1.77-2.51; p&lt;0.001), longer LOS (coefficient 3.02; CI 2.62-3.42; p&lt;0.001), and higher total hospitalization charge (coefficient $22105; CI $13423- $30786; p&lt;0.001). Conclusions: Our analysis demonstrated that PEM was widely prevalent in hospitalized patients with lung cancer and associated with worse outcomes. Efforts should be made to promote nutritional assessment and screening mechanisms with the aim to initiate early nutritional support as indicated. Further prospective studies are warranted to better understand these associations and guide management.
Second neoplasms in patients with hereditary retinoblastoma.
Authors: Dolores Corral, Adela Escudero, Nuria Rodriguez Salas, Sonsoles San Roman, Jesus Peralta, Elisa Izquierdo, Jaime Feliú, Antonio Perez Martinez
Journal: Journal of Clinical Oncology (2024)

10620 Background: Patients with hereditary retinoblastoma have an increased risk of developing second tumors during adolescence and adulthood. The incidence of second malignant neoplasms (SMNs) is a concern, since SMNs are the leading cause of death in these patients. This risk is increased in patients who have received external radiation therapy as part of treatment but is also increased in non-radiated patients. Increased sarcoma and melanoma risks after hereditary retinoblastoma are well established. Methods: We present a cohort of patients with hereditary retinoblastoma assessed in our multidisciplinary pediatric and adult genetic predisposition cancer unit (UPGeCI) from September 2018 to December 2023. During this period, 62 patients with retinoblastoma were attended, all with RB1 gene mutation. Of these, 84% of patients had bilateral retinoblastoma, and 16% had unilateral retinoblastoma. They ranged in age from 6 months to 55 years (median 13 years). 18 patients (29%) were treated with external beam radiation therapy. Clinical follow-up and orbital magnetic resonance imaging were performed every two years. Results: Six cases of SMNs were detected in 5 patients (9.3%), all soft tissue sarcomas. The mortality rate was 60% (3/5 patients). Four patients (80%) had received external radiotherapy as part of the treatment of retinoblastoma. Three patients presented 3 sarcomas in the facial region within the irradiated area, of which one was an osteosarcoma and the other two leiomyosarcomas. Two of them presented in adulthood, and one at 9 years old. One of the patients died, the other two are living disease-free. The fourth patient who had received external radiotherapy presented with osteosarcoma of the femur at 15 years of age. She died of septic shock. The patient who had not received external radiotherapy presented with osteosarcoma of the tibia at 6 years of age and later with osteosarcoma of the contralateral femur at 10 years of age. She died of progression. Conclusions: There is an increased risk of SMNs in patients with hereditary retinoblastoma, mainly soft tissue sarcomas, with high mortality. This risk increases if they have received external radiation therapy. Therefore, screening for SMNs is essential for of follow-up in patients with heritable retinoblastoma.