bluuebunny/crossref_metadata_2025_split huggingface dataset:
Racial and ethnic enrollment disparities in acute myeloid leukemia clinical trials.
Authors: Hantel Andrew , DeAngelo Daniel J. , Luskin Marlise Rachael , Garcia Jacqueline Suen , Abel Gregory A. 
Published: June 2021

6523 Background: Racial and ethnic disparities in clinical trial enrollment compound inequities in drug development and the delivery of patient-centered care. Despite significant survival disparities in acute myeloid leukemia (AML), enrollment disparities data are limited. Methods: We performed a structured search and abstraction of demographic data for all United States (US) AML clinical trials from 2002-2017 listed on clinicaltrials.gov and compared the results to the incidence and demographic distribution of AML using the Surveillance, Epidemiology, and End Results program and 2010 US Census. We calculated enrollment fractions (the number of enrollees divided by the number of incident cases) for the five mutually exclusive race/ethnicity groups of non-Hispanic White (NH-White), Black (NH-Black), Asian/Pacific Islander (NH-Asian/PI), American Indian/Native Alaskan (NH-AI/AN), and Hispanic patients. We compared these using X2 testing, with NH-White as the comparator, and reported odds ratios with 95% confidence intervals (CI). To assess trends over time, we adjusted enrollment from 2005-2008 for changes in AML incidence and NH-White enrollment for a later period (2011-2014), comparing this expected enrollment fraction to the actual enrollment fraction during that later period. Results: Of 223 eligible studies (patient N=17372) on clinicaltrials.gov, 99 (44.4%) reported racial demographics (N=8417; 48.5%) and 68 (30.5%) reported race and ethnicity (N=6554; 37.7%). Enrollment and incidence proportions by race are shown in the table. Among trials reporting race and ethnicity, all groups had lower odds of enrollment compared to NH-White patients (Table). For the 99 trials reporting race data, Black and AI/AN patient enrollment odds were lower (OR 0.60 [95% CI: 0.55, 0.65]; 0.50 [95% CI: 0.33, 0.76]), but Asian/PI enrollment was not (OR 0.91 [95% CI: 0.82, 1.01]). The relative enrollment of NH-Black, NH-Asian/PI, and Hispanic patients declined later in the study period (Table). Conclusions: In AML clinical trials performed in the US from 2002-2017, NH-White patients were enrolled at higher rates compared to other racial and ethnic groups; enrollment diversity declined over time. An important first step to reducing enrollment disparities will be to improve the reporting of demographic enrollment data.[Table: see text]
Access to cancer care for Medicaid patients at cancer hospitals in the United States.
Authors: Marks Victoria A. , Hsiang Walter R. , Nie James , Buck Matthew , Demkowicz Patrick C , Umer Waez , Haleem Afash , Galal Bayan , Pak Irene , Kim Dana , Kenney Patrick Aloysius , Leapman Michael S. 
Published: June 2021

6548 Background: As the result of expansions associated with the Affordable Care Act (ACA), one in five Americans are now insured through Medicaid. Despite overall increases, access to care for Medicaid-insured patients with cancer may be limited by facilities due to lower reimbursement and administrative burden. We aimed to directly assess facility-level acceptance of Medicaid patients with a new diagnosis of cancer. Methods: We performed a cross-sectional secret shopper study to evaluate access to cancer care for colorectal, breast, urologic, and skin cancer at Commission on Cancer (CoC) accredited hospitals. We studied the relationship between Medicaid access and facility-level characteristics assessed through American Hospital Association and Center for Medicare and Medicaid Service data using univariable statistics and multivariable logistic regression. Results: Among 334 CoC facilities contacted, the overall rate of Medicaid acceptance for at least one investigated cancer type was 99% (n = 331). However, we identified hospital-level variation in Medicaid acceptance across cancer types, where Medicaid acceptance for colorectal, breast, urologic, and skin cancer was 90%, 96%, 87%, and 80%, respectively. Of the hospitals that accepted Medicaid, 2% accepted Medicaid for one cancer type, 8% for two, 21% for three, and 68% for all four cancer types. In multivariable logistic regression, odds of Medicaid acceptance were lowest in comprehensive community cancer centers (p < 0.05 for colorectal and urologic cancer) and for-profit designated facilities (p < 0.05 for urologic and skin cancer) (Table). Hospitals in states with Medicaid expansion were also more likely to accept Medicaid for urologic (OR: 2.5, 95% CI: 1.2-5.2) and breast (OR: 12.8, 95% CI: 2.7-60.2) cancer care. Conclusions: Access disparities persist for patients with Medicaid, with acceptance rates differing substantially within and between facilities. Facility-level differences in Medicaid access among CoC facilities are notable given the use of hospital registry data to estimate ACA-related effects.[Table: see text]
Racial disparities in access to prostate cancer clinical trials: A county-level analysis.
Authors: Bansal Aasthaa , Wang Wei-Jhih , Bennette Caroline Savage , Ramsey Scott David 
Published: June 2021

6553 Background: African American men (AAs) have a higher burden of prostate cancer compared to other populations. We sought to determine if they experience disparities in access to prostate cancer clinical trials. Methods: We created a county-level database of all U.S. counties by linking together prostate cancer clinical trial data from the Aggregate Analysis of ClincalTrials.gov (AACT) database with county-level socioeconomic, demographic and healthcare facility data derived from several external data sources. Using this data linkage, we examined two specific potential access barriers. First, we investigated the relationship between %AAs in the county and access to NCI designated cancer facilities, adjusting for county population size and other characteristics. Then, among counties with cancer facilities, we investigated the relationship between the %AAs in the county and number of available prostate cancer treatment trials per capita per year. We used logistic and negative binomial regression models, respectively, to address these questions. Results: Between 2008 and 2015, 613 prostate cancer trial sites were found among 3,145 U.S. counties. Counties with higher %AAs were less likely to have cancer facilities (adjusted odds ratio = 0.85, 95% CI (0.78, 0.92)). Among counties with cancer facilities, those with higher %AAs had significantly fewer prostate cancer trials per capita per year (rate ratio per 10% increase in %AAs: 0.90, 95% CI (0.83,0.96)), after adjusting for county-level sociodemographic and healthcare system factors. Conclusions: Counties with higher proportions of AAs appear to be less likely to have access to NCI designated cancer facilities. Among counties with cancer facilities, those with higher proportions of AAs appear to have fewer available prostate cancer treatment trials per capita per year. Clinical trials in prostate cancer therapy should ensure adequate availability of enrollment sites in regions with high concentrations of AAs.
The impact of HIV infection on overall survival among women with stage IV breast cancer in South Africa.
Authors: Pumpalova Yoanna S , Ayeni Oluwatosin , Chen Wenlong Carl , O'Neil Daniel , Nietz Sarah , Phakathi Boitumelo , Buccimazza Ines , Cacala Sharon , Stopforth Laura , Farrow Hayley , Joffe Maureen , Mapanga Witness , Jacobson Judith , Crew Katherine D. , Cubasch Herbert , Ruff Paul , Neugut Alfred I. 
Published: June 2021

6559 Background: Advanced stage at breast cancer (BC) diagnosis is common in sub-Saharan Africa. In public hospitals across South Africa (SA), 10-15% of women present with metastatic BC, compared to <5% in the U.S., and 20% of new BCs are diagnosed in women living with HIV (WLWH). We evaluated the impact of HIV on overall survival (OS) among women with stage IV BC, which is associated with a poor prognosis in SA. Methods: We conducted a prospective cohort study of women diagnosed with stage IV BC between February 2, 2015 and September 18, 2019 at six public hospitals in SA. Baseline characteristics were compared by HIV status and multivariate Cox regression models were used to estimate the effect of HIV on OS. Results: Among 550 eligible women, 147 (26.7%) were WLWH. Compared to HIV-negative BC patients, WLWH were younger (median age 45 vs. 60 years, p<0.001), predominantly black (95.9% vs. 77.9%, p<0.001), and more likely to have hormone receptor-negative BC (32.7% vs. 22.6%, p=0.016). HER2 tumor status did not differ by HIV status (25.3% HER2 positive overall), and Ki67 index was not increased among WLWH (57.1% Ki67 > 20 overall). Receipt of systemic anti-cancer therapy did not differ by HIV status (80.9% treated overall) and most women were treated with anthracycline (55.5%). HIV status was not associated with OS (Hazard Ratio (HR)=1.13, 95% confidence interval (CI)=0.89-1.44) (Table). In an exploratory subgroup analysis, WLWH and hormone receptor-negative BC had shorter OS compared to HIV-negative women (1-year OS: 27.1% vs. 48.8%, p=0.003; HR=1.94, 95% CI=1.27-2.94), which was not observed for hormone receptor-positive BC. Results were unchanged when analysis was restricted to black women only. Conclusions: HIV status was not associated with worse OS in women with stage IV BC in SA and cannot account for the poor survival in our cohort. Subgroup analysis revealed that WLWH with hormone receptor-negative BC had worse OS; this differential effect of HIV on BC survival by hormone receptor status is a novel finding that warrants further investigation.[Table: see text]
Impact of disruptions in breast cancer control due to the COVID-19 pandemic on breast cancer mortality in the United States: Estimates from collaborative simulation modeling.
Authors: Alagoz Oguzhan , Lowry Kathryn P. , Kurian Allison W. , Mandelblatt Jeanne S. , Ergun Mehmet Ali , Huang Hui , Lee Sandra J. , Schecter Clyde , Tosteson Anna N.A. , Miglioretti Diana L. , Trentham-Dietz Amy , Nyante Sarah , Kerlikowske Karla , Sprague Brian L. , Stout Natasha K. 
Published: June 2021

6562 Background: The COVID-19 pandemic has disrupted breast cancer control through short-term declines in screening, delays in diagnosis and reduced/delayed treatments. We projected the impact of COVID-19 on future breast cancer mortality.Methods: Three established Cancer Intervention and Surveillance Modeling Network (CISNET) models projected the impact of pandemic-related care disruptions on breast cancer mortality between 2020 and 2030 vs. pre-pandemic care patterns. Based on Breast Cancer Surveillance Consortium data, we modeled reductions in mammography screening utilization, delays in symptomatic cancer diagnosis, and reduced use of chemotherapy for women with early-stage disease for the first six months of the pandemic with return to pre-pandemic patterns after that time. Sensitivity analyses were performed to determine the effect of key model parameters, including the duration of the pandemic impact. Results: By 2030, the models project 1,297 (model range: 1,054-1,900) cumulative excess deaths related to reduced screening; 1,325 (range: 266-2,628) deaths from delayed diagnosis of symptomatic women, and 207 (range: 146-301) deaths from reduced chemotherapy use for early-stage cancer. Overall, the models predict 2,487 (range 1,713-4,875) excess deaths, representing a 0.56% (range: 0.36%-0.99%) cumulative increase over deaths that would be expected by 2030 in the absence of the pandemic’s disruptions. Sensitivity analyses indicated that the impact on mortality would approximately double if the disruptions lasted for a 12-month period. Conclusions: The impact of the initial pandemic-related disruptions in breast cancer care will have a small long-term cumulative impact on breast cancer mortality. The impact of the initial pandemic-related disruptions on breast cancer mortality will largely be mitigated by the rapid return to usual care. As the pandemic continues it will be important to monitor trends in care and reassess the mortality impact.[Table: see text]
Initial reporting from the prospective National Cancer Institute (NCI) COVID-19 in Cancer Patients Study (NCCAPS).
Authors: Korde Larissa A. , Best Ana F. , Gnjatic Sacha , Denicoff Andrea M. , Mishkin Grace E. , Bowman Melissa , Harris Lyndsay , Geiger Ann M. , McCaskill-Stevens Worta J. , Chanock Stephen J. , Spears Patricia , Rubinstein Lawrence , Mark Nicholas M. , Warner Jeremy Lyle , Allegra Carmen Joseph , Esbenshade Adam J. , Knopp Michael V. , Doroshow James H. , Rini Brian I. ,   NCCAPS Study Team
Published: June 2021

6565 Background: Patients (pts) with cancer are at increased risk of SARS-CoV-2 infection and severe COVID-19 disease. Longitudinal follow-up is needed to characterize the severity, sequelae and outcomes in pts with cancer who develop COVID-19. Methods: NCCAPS is a prospective, longitudinal study (NCT04387656) aiming to accrue 2,000 pts with cancer undergoing active treatment or prior stem cell transplant for hematologic or solid tumor malignancy. Adult patients are eligible to enroll within 14 days of their first positive SARS-CoV-2 test; pediatric patients may also enroll retrospectively. Clinical data, patient-reported outcomes, blood specimens, and imaging are collected for up to 2 years. This abstract provides initial baseline and 2-month follow-up data. Results: As of Jan 22, 2021, 585 pts (552 adults and 33 pediatric pts) had complete baseline data and of these pts, 215 adults had 2 months of complete follow-up data. 23.4% of adults and 42.4% of pediatric pts were of non-White race and/or Hispanic/Latinx ethnicity. The most common cancer diagnoses were breast (19.6%), lung (9.9%) and multiple myeloma (8.9%) in adults and acute leukemia (AML/ALL; 63.6%) in children. The most recent treatment was chemotherapy in 38.2%, immunotherapy in 9.6%, and radiation in 5.4%. Median time from positive SARS-CoV-2 test to study enrollment was 10.5 days in adults and 18 days in pediatric pts. Preliminary analysis of plasma cytokines will be presented. At enrollment, 84.6% of adults had COVID-19 symptoms. 55.9% reported symptoms 2 weeks after their positive SARS-CoV-2 test; this fell to 39.0% at 1 month and 28.8% at 2 months (see Table). Of the 215 adults with complete data at 2 months, sequelae included pulmonary (n=22, 10%), cardiovascular (n=12, 6%) thromboembolic (n=9, 4%), bleeding (n=9, 4%) and gastrointestinal (n=11, 5%). 144 (67%) reported at least one cancer treatment disruption in the first 2 months, most commonly delayed therapy (n=98; 46%).Of the 348 adults with baseline data and SARS-CoV-2 test date prior to Nov 23, 2020, 6.3% had died (median time from SARS-CoV-2 test to death: 27 days), and 22.1% reported at least one hospitalization for COVID-19. No deaths were reported in the pediatric population. Conclusion: Cancer pts with COVID-19 report ongoing symptoms after acute infection and a substantial number develop sequelae. Cancer treatment disruptions are common in the initial months following SARS-CoV-2 infection. Longer follow-up will inform whether these treatment disruptions are associated with adverse outcomes. Clinical trial information: NCT04387656. [Table: see text]
Initial report on hospitalized cancer patients with COVID-19 from the National Cancer Institute (NCI) COVID-19 in Cancer Patients Study (NCCAPS).
Authors: Mark Nicholas M. , Best Ana F. , Khorana Alok A. , Pergam Steven , Mishkin Grace E. , Bowman Melissa , Denicoff Andrea M. , Rubinstein Lawrence , Shankar Lalitha Krishna , Doroshow James H. , Rini Brian I. , Korde Larissa A. ,   NCCAPS Study Team
Published: June 2021

6566 Background: Hospitalized cancer patients (pts) with COVID-19 have a severe disease course and high mortality. Pts with lung cancer, hematologic malignancies and metastatic disease may be at higher risk. Detailed prospective inpatient data may help to identify those at greatest risk for poor outcomes. Methods: NCCAPS is a longitudinal study aiming to accrue 2,000 cancer pts undergoing treatment for hematologic malignancy or solid tumor with COVID-19. For pts’ first COVID-19 hospitalization, clinical data, research blood specimens and imaging are collected, and additional clinical data are collected during subsequent hospitalizations. Results: As of Jan. 22, 2021, among 757 enrolled adult patients from 204 sites, 124 (16.3%) reported at least one hospitalization for COVID-19, and discharge data was available for 98 hospitalizations in 88 patients. The median age was 67 (range 21-93, 1Q:56, 3Q:72), 35/88 (40%) were female. The most common malignancies in hospitalized adult pts were lymphoma (18.2%), lung cancer (15.9%) and multiple myeloma (10.2%). The most common presenting symptoms were shortness of breath (65%), fatigue/malaise (64%), and fever (49%). 8/88 (9%) pts were neutropenic (ANC < 1000) at presentation; 17/88 (19%) were thrombocytopenic. Median length of stay was 6.5 days (range 1-41, 1Q:4, 3Q:12). Among those hospitalized, 20/88 (22.7%) received care in the ICU or high dependency unit, with a median ICU stay of 7 days (range 1-22, 1Q:2.5, 3Q:9.5); of those admitted to the ICU, 25% (5/20) received invasive mechanical ventilation. Of those in whom inpatient medications were recorded (n = 63), 63% received corticosteroids, 46% received remdesivir, and 14% received convalescent plasma. One pt received bamlanivimab and 2 patients received tocilizumab. Most (46/63; 73%) received anticoagulation, primarily prophylactic low molecular weight heparin; 11/63 (17%) received therapeutic dose anticoagulation. Inpatient D-dimer values were recorded in 43 inpatients, 26 of whom had multiple measurements. 16/98 hospitalizations ended with death (16%). Conclusions: Preliminary analysis of NCCAPS data reveals that inpatient hospital admission is common among oncology patients with COVID-19 and mortality rates appear high within this cohort. Hematologic malignancies and lung cancer are the most common underlying diagnoses in patients requiring hospitalization. Corticosteroids and anti-coagulation were the most commonly used therapies. Despite high rates of ICU admission, invasive mechanical ventilation may be instituted less often in an oncology cohort. These observations may inform decisions about vaccine policy and decisions to limit life sustaining treatment. Clinical trial information: NCT04387656.
Knowledge about risks, benefits, and curative potential of immunotherapy among patients with advanced lung cancer or melanoma.
Authors: Petrillo Laura A , Zhou Ashley , Sullivan Ryan J. , Volandes Angelo E. , Greer Joseph A. , Temel Jennifer S. , El-Jawahri Areej 
Published: June 2021

6579 Background: Immunotherapy is a novel treatment paradigm that has improved survival for patients with advanced melanoma and lung cancer and poses new risks of immune-related adverse events, which are important for patients to recognize promptly. We aimed to describe patients’ knowledge about the risks and benefits of immunotherapy, and their understanding of the goal of treatment with immunotherapy. Methods: We conducted a cross-sectional study of patients at a single institution who had initiated therapy with an immune checkpoint inhibitor for advanced melanoma, small cell lung cancer, or non-small cell lung cancer in the past 12 weeks. We assessed patients’ knowledge about immunotherapy with a 9-item knowledge questionnaire (score range 0-100; higher score represents greater knowledge). We used the Perception of Treatment and Prognosis Questionnaire to assess patients’ understanding of the goal of their treatment. We used the two-sample t-test to compare knowledge scores and chi-square test to compare goals of therapy between patients with melanoma and lung cancer. Results: A total of 105 patients (57 with melanoma, 48 with lung cancer) completed the study questionnaire. Participants had a median age of 69 years (range 36-89), and 33% (35/105) were female. Participants’ mean knowledge score was 69.0 (SD = 23.3). Overall, 91% (96/105) of patients endorsed that immunotherapy works by turning on the body’s immune system to recognize and attack cancer cells and 33% (35/105) correctly identified that immunotherapy does not kill all rapidly dividing cells. With respect to immunotherapy side effects, 68% (71/105) of patients reported that immunotherapy side effects can affect any organ in the body and 65% (68/105) endorsed that side effects from immunotherapy can occur at any time, even after the treatment ends. Overall, 34% (36/105) of participants reported that the primary goal of their treatment is to cure their cancer. Participants with melanoma had higher mean knowledge scores compared to those with lung cancer (74.7 vs. 62.3, P = 0.003). Participants with melanoma were also more likely to report that the goal of their immunotherapy was to cure compared to those with lung cancer (58% [33/57] vs. 6% [3/48], P < 0.001) and that their oncologist had said that immunotherapy would cure their cancer (19% [11/57] vs. 0% [0/48], p = 0.005). Conclusions: We observed substantial knowledge deficits about immunotherapy and perceptions that immunotherapy is a cure for advanced cancer, particularly among patients with melanoma. These findings underscore the need for interventions to enhance patients’ knowledge about immunotherapy and to help them understand the goal of immunotherapy for patients with advanced cancer.