bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Man Van: Mobile targeted case finding for prostate cancer.
Authors: Moghul Masood , Croft Fionnuala , Kinsella Netty , Cahill Declan , James Nicholas D. 
Published: June 2023

6522 Background: Early intervention is potentially lifesaving in prostate cancer. The debate for screening continues with recent developments suggesting the arguments in favour are becoming stronger however, barriers to access remain. The Man Van project is designed to address these with a highly novel community-based targeting of high-risk groups on a mobile unit. Methods: A bespoke mobile health vehicle was moved to 8 community-based locations in areas of high deprivation indices in London, UK, inviting men for a health check consisting of: general health questionnaires, blood pressure, height/weight, HbA1c for diabetes and a PSA test. Telemedicine was used to inform patients of outcomes. Direct referrals to secondary care was performed. Community engagement was utilised to increase uptake using: primary healthcare centres, religious organisations and community centres. Results: Between December 2021 and December 2022, 618 men were seen at our Man Van clinics at a range of community settings (non-attendance rate 24%). The highest uptake was in locations where there was collaboration with primary care to recruit patients. The median age of attendees was 56 years, range 25-87. 43% of attendees were non-white (20% black). The median BMI was 27.7, range 16.2-50.5. 422 PSA tests were performed with 14 prostate cancers (3.3%) found till date. 9 (64%) of these cancers were grade group 2 (all > 5% pattern 4) or 3. Of patients diagnosed with prostate cancer the median age was 59 years, range 48-73, 10 were black (71%), median PSA 6.85 g/L, range 0.81-45, median IPSS score was 9.5, range 2-31, median IIEF-5 was 16, range 1-25. The IPSS score was significantly higher (P < 0.05) in men diagnosed with prostate cancer. 1 bladder (G3pT1) and 1 oesophageal cancer (T3N2M1) were also found. 3 patients had either HGPIN or ASAP, 3 patients had renal stones, 2 urethral strictures were found. 334 HbA1c tests were performed with 18 diabetics diagnosed (5.4%). 46 patients (7.4%) required input for benign urinary symptoms and 20 for erectile dysfunction (3.2%). Primary care referrals were as follows: 171 for hypertension (27.6%), 43 for an elevated BMI (7.0%), 37 for mental health issues (6.0%), 43 for excess alcohol intake (7.0%), 51 for smoking cessation assistance (8.3%). Significantly more patients 45 years were referred for primary care follow-up versus < 45 years (P < 0.01). Service evaluation questionnaires showed overwhelmingly positive support for the service. Conclusions: The Man Van initiative is a novel method of linking primary and secondary care for a range of health checks, including PSA. By improving community awareness and access in high-risk groups we demonstrate high uptakes for health checks including for prostate cancer and a willingness to engage with health improvement measures. As well as comparatively high levels of prostate cancers diagnosed at early stages, high levels of other health conditions were found; improving the economic value of the service.
Analysis and optimization of equitable US cancer clinical trial center access by travel time.
Authors: Lee Hassal , Bates Alexander , Marshall Andrea , Callier Shawneequa , Chambwe Nyasha , Janowitz Tobias 
Published: June 2023

6524 Background: Racially minoritized and socioeconomically disadvantaged populations are underrepresented in cancer clinical trials. Data-driven, quantitative approaches are required to address this inequity. Here, we systematically analyze the geographical distribution of self-identified racial and socioeconomic demographics within commuting distance to cancer clinical trial centers and all hospitals U.S.-wide. Methods: We calculate self-identified racial and socioeconomic demographics of populations living within 30-, 60-, and 120-minute one-way driving commute times from U.S. cancer clinical trial centers and all U.S. hospitals. Data sources include the U.S. 2020 census (for race and socioeconomic data), OpenStreetMaps (for calculation of commuting times), NCT trial registry (for cancer clinical trial quantification), NCI Designated Cancer Centers List, Nature Index of Cancer Research Health Institutions and National Homeland Infrastructure Foundation-Level Data (for U.S.-wide hospital and cancer clinical trial center identification). Data analysis was conducted in R, and Ggplot2 used for all data visualizations. Results: Analysis of clinical trial numbers between 2012–2022 identified 78 high-volume U.S. cancer trial centers. Compared to U.S. national averages, these centers are in areas with socioeconomically more affluent populations (+27.6K USD (95% CI +23.1 to 32.8K) median income unpaired mean difference; -0.073 (95% CI -0.063 to -0.084) deprivation index unpaired mean difference), with higher proportions of affluent self-identified White individuals (+10.1% unpaired mean difference (95% CI +6.8 to +13.7%)). The top 10th percentile of all U.S. hospitals (N=7,623) show a range of absolute sum difference from 2.4% to 35% from equal racial representation of White, Black/African American and Asian/Mixed/Other groups. For each U.S. city above 500,000 inhabitants, we compile map overlays that display all prospective hospitals within commutable distance to racially diverse and socioeconomically disadvantaged populations. These maps may inform the design of future clinical trials or investigations in enrollment and retention strategies for clinical trials. Conclusions: Our analysis identifies biases in the sociodemographics of populations living within commuting distance to U.S.-based cancer trial sites and enables the determination of more equitably commutable prospective satellite hospital sites that could be mobilized for enhanced racial and socioeconomic representation in clinical trials. Other recruitment barriers still need to be tackled to ensure racial and socioeconomic demographics within the geographical vicinity of a clinical site can translate to equitable trial participant representation.
Are enrollment criteria for phase II and III clinical trials in acute myeloid leukemia arbitrarily restrictive?
Authors: Hantel Andrew , Walsh Thomas , Clancy Dillon , Luskin Marlise Rachael , DeAngelo Daniel J. , Lathan Christopher S. , Abel Gregory A. 
Published: June 2023

6525 Background: Ethical clinical research requires fair subject selection and a favorable risk-benefit ratio. Enrollment criteria can unfairly exclude patients if they are not based in safety. There are few data regarding variability within criteria, which can also represent unfair exclusion, or for acute myeloid leukemia (AML). Methods: We assessed enrollment criteria use and variability for frontline phase II and III therapeutic AML trials from 2010-2019 listed on Clinicaltrials.gov. Drug safety profiles were obtained from protocols, publications, and FDA labels. FDA publications guided a standardized abstraction and coding process. Associations between criteria and safety profiles were identified using X2 and t-tests. Regression modeling identified differences in infectious disease (ID) exclusion by sponsor adjusted for trial phase, year, size, and safety profiles. Results: 190 trials were eligible; 159 (84%) were phase II and 32 (17%) phase III. Trials were sponsored by the National Institutes of Health (NIH; 50; 26%), industry (109; 57%), and academic investigators (AI; 108; 57%). Exclusions and variability are shown in the table. ID exclusions were for HIV (96; 51%) and hepatitis B (60; 32%) and C (64; 34%). Older adults were considered as over 60 (42 trials; 39%), 65 (23; 21%), 70 (13; 12%), or 75 years (18; 17%). There was no association between QTc limits and the use of QTc prolonging drugs (criteria presence p=0.2; mean 450 vs 474 ms, p=0.3) or renal function limits and nephrotoxic drugs (presence p=0.2; mean 1.65 vs 1.67 ULN, p=0.8). Hepatitis B and C exclusions were associated with the use of drugs linked to viral reactivation (OR 2.1 [95% CI 1.1,3.9], 2.0 [95% CI 1.1,3.7]). This was not the case for HIV (OR 1.2 [95% CI 0.7,2.2]). Industry sponsorship was independently associated with hepatitis B and C exclusion (OR 3.0 [95% CI 1.2,7.3], 3.3 [95% CI 1.4,4.7]) and AI sponsorship with HIV exclusion (OR 2.5 [95% CI 1.4,5.5]). Conclusions: There is substantial variability in enrollment criteria for AML clinical trials. Many criteria are related to risks, but some exclusions and variability are not clearly based in safety. Avoiding arbitrary exclusions will likely enhance trial representativeness and enrollment rates. [Table: see text]
Evaluating social vulnerability impact on care and prognosis of head & neck-nervous system cancers in the US.
Authors: Lutfallah Salim , Fei-Zhang David , Chelius Daniel , D'Souza Jill , Paludo Jonas , Ruff Michael W. , Rastatter Jeffrey , Sheyn Anthony 
Published: June 2023

6526 Background: In the current literature, the association between social determinants of health (SDH) and head & neck-nervous system cancer (HNNsC) is limited by the narrow scope of SDH assessed and the broad classifications of HNNsC. Our study utilizes the CDC-Social Vulnerability Index (SVI) to assess both the individual and collective impact of four social determinant themes on various HNNsC in US adults. Methods: This study utilized the SEER database to evaluate 116,373 adult patients from 1975-2017 who presented with HNNsC. Patients were assigned SVI scores based on county-of-residence at the time of diagnosis, encompassing total-SVI score and 4 sub-scores of socioeconomic status, minority-language status, household composition, and housing-transportation. Using these scores, univariate linear regressions were used to assess patient care (months of follow-up) and prognosis (months of survival). Results: As total-SVI score increased, decreases in months of follow-up (MOF) and months of survival (MOS) were observed for many HNNsC tumors (p less than 0.001) when comparing the lowest to highest vulnerability cohorts. There was a decrease ranging from 3.55-36.6% in the MOF, with the largest decreases occurring in embryonal, anaplastic oligodendroglioma, and anaplastic ependymoma tumor types, with the largest sub-score contribution coming from socioeconomic status for these three disease classes. Similarly, there was a decrease ranging from 6.90-45.81% in the MOS, with the largest decreases occurring in anaplastic ependymoma, anaplastic astrocytoma, and pilocytic astrocytoma tumor types with the largest sub-score contribution coming from socioeconomic status for these three disease classes. Increases in vulnerability within SDH themes contributed significantly to these total-SVI trends in MOF and MOS, with each social determinant impacting different disease classes to varying extents. Socioeconomic status was the most impactful sub-score for MOF in nine of fourteen disease classes, followed by housing-transportation and household composition, each leading the impact of two of fourteen disease classes, and minority-language status leading the impact of one of fourteen disease classes. Similarly, socioeconomic status was the most impactful sub-score for MOS in eight of fourteen disease classes, followed by housing-transportation leading the impact of three of fourteen disease classes, household composition leading the impact of two of fourteen disease classes, and minority-language status leading the impact of one of fourteen disease classes. Conclusions: The results of this study show that with increasing social vulnerability, there is a significant decrease in both the care (follow-up) and the prognosis (survival) of US adults with HNNsC and highlight which SDH contributes more to disparities.
Racial disparities in utilization of first line targeted therapies for metastatic breast cancer.
Authors: Martei Yehoda M. , Chen Kan , Mamtani Ronac , Shulman Lawrence N. , Hubbard Rebecca A. , Clark Amy Sanders 
Published: June 2023

6528 Background: This study evaluated whether there were racial disparities in utilization (decomposed as change in proportion of eligible patients initiating therapy over time and time to treatment initiation (TTI)) to CDK4/6 inhibitors and pertuzumab since FDA approval as first line (1L) treatment for ER+/HER2- and HER2+ metastatic breast cancer (MBC), respectively. Methods: This cohort study used the nationwide Flatiron Health electronic health record-derived de-identified database. Included women were ≥18 years old, diagnosed with de novo or recurrent MBC, who received 1L therapy, and documented as non-Hispanic White (NHW) or non-Hispanic Black/African American (NHB). Two cohorts were generated for patients with ER+/HER2- MBC diagnosed 3/2015-10/2021 and HER2+ MBC diagnosed 7/2012-9/2021. We estimated temporal trends in the proportion of NHW and NHB patients receiving respective therapy using logistic regression with natural cubic splines for time trends and tested for changes in uptake over time within each group as well as differences in trends between groups. A similar model was used for TTI among treatment initiators, using linear regression models. In addition to time and race, regression models included age, ECOG performance status, insurance, Medicaid expansion status, practice type, and proportion of black patients per practice among patients who met both cohort criteria. Results: 8318 patients (NHW=7006; NHB=1312) met ER+/HER2- cohort criteria and 2321 (NHW=1915; NHB=406) met HER2+ cohort criteria. There was a significant change over time in the proportion of NHW (p<0.0001) and NHB (p<0.0001) initiating 1L CDK4/6 inhibitors (Table). Temporal trends were also significantly different between NHW and NHB (p<0.0001). Higher ECOG performance status (OR=0.85 per unit increase, 95%CI 0.80-0.90; p<0.001) and an increasing proportion of black patients seen at practice (OR=0.45, 95%CI 0.29-0.71; p<0.001) were independent predictors of lower odds of initiating CDK4/6 inhibitors. Overall, 43% NHW vs 41% NHB received pertuzumab respectively. There was no significant difference in uptake trends for pertuzumab between NHW and NHB (p=0.41). There was no significant difference in the temporal trends of TTI for either CDK4/6 inhibitors (p=0.74) or pertuzumab (p=0.84). Conclusions: Utilization of CDK4/6 inhibitors steadily increased over time, however > 25% of eligible patients did not receive the drug, and less than half of individuals who met indication for pertuzumab were prescribed it. Racial disparities were significant for oral CDK4/6 inhibitors but not for intravenous pertuzumab. [Table: see text]
Outcomes of Black (B) versus White (W) patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation therapy (ADT) with or without orteronel (Ort): Analysis of pt-level data from SWOG-1216 phase 3 trial.
Authors: Sayegh Nicolas , Swami Umang , Jo Yeonjung , Gebrael Georges , Haaland Benjamin , Gupta Shilpa , Plets Melissa , Hussain Maha H. A. , Quinn David I. , Lara Primo N , Thompson Ian M , Agarwal Neeraj 
Published: June 2023

6532 Background: Despite more aggressive prostate cancer (PCa) at presentation and higher mortality in real world, B pts with metastatic hormone resistant PCa did not have inferior outcomes than W pts when both were enrolled in clinical trials (PMID: 33951180). In the phase 3 S1216 trial, treatment with Ort, a novel CYP17 axis inhibitor, significantly improved progression-free survival (PFS) but not overall survival (OS) compared to bicalutamide (Bic) in pts with mHSPC receiving ADT. This trial enrolled the greatest number of B pts in a phase 3 trial in this setting to-date. We hypothesized that given comparable access to care as experienced in a clinical trial, outcomes in B pts would be similar to those of W pts in the mHSPC setting. Methods: Eligibility: Pts with mHSPC were enrolled. Only pts self-identifying as B or W were included in this analysis. PFS and OS for each group were estimated using Kaplan-Meier method. A multivariate analysis (MVA) adjusting for disease characteristics was conducted using a Cox proportional hazards model. Results: Among 1279 participants, 135 (10.6%) were B; 1077 (84.2%) were W. B and W were equally distributed between treatment arms, and had respectively similar proportion of pts with Gleason score ≥8 (61.3 vs 62.1%), Zubrod score ≥2 (5.1 vs 3.4%) and extensive disease (48.1 vs 48.7%). However, B pts, as compared to W, were younger (65.8 vs 68.4 yrs, p=0.001) and had a higher median baseline PSA (54.7 vs 26.7 ng/mL; p<0.001). PSA responses (≤ 0.2 ng/mL) at month 7 were similar in both groups (p=0.296). Overall, B vs W had similar median PFS (2.3 vs 2.9 yrs, p=0.71) and OS (5.5 vs 6.3 yrs, p=0.65). MVA confirmed similar PFS and OS after adjusting for known prognostic factors (Table). No interaction between race and treatment was observed (P-value interaction PFS= 0.77 and OS= 0.91). Conclusions: We demonstrate that even though B pts present with more aggressive disease in mHSPC setting, they did not have statistically significant worse OS and PFS than W pts and treatment effect was also similar for both racial groups. Equitable access to care may negate historical differences in outcomes among B vs W pts with advanced PCa. Funding: NIH/NCI/NCTN grant U10CA180888, U10CA180819; and Millennium Pharmaceuticals (Takeda Oncology). Univariate and MVA of PFS and OS. [Table: see text]
County-level jail incarceration and cancer mortality in the US.
Authors: Zhao Jingxuan , Kajeepeta Sandhya , Han Xuesong , Nogueira Leticia M , Zheng Zhiyuan , Fan Qinjin , Shi Kewei Sylvia , Yabroff Robin 
Published: June 2023

6535 Background: Incarceration has been linked to poor community health outcomes, such as worse preterm births and mortality in the US, although little research has examined cancer outcomes. This study examined associations of county-level jail incarceration and cancer mortality. Methods: Annual county-level local jail incarceration rates (1990-2018) were obtained from the Vera Institute of Justice. We calculated annual county-level mortality rates (2000 -2019) with invasive cancer as the underlying cause of death (ICD-10 codes: C00-C97) using National Vital Statistics System. Associations of county-level jail incarceration and cancer mortality overall, and by sex, race, and common cancer sites were examined with generalized estimating equations with Poisson distribution and standard errors clustered at county level. To assess the short-, medium-, and long-term associations, we used lagged county-level incarceration rates by 1, 5, and 10 years prior to mortality rates in separate analyses. Results: Over the 20-year study period, each 1 per 1000 increase in county jail incarceration rate was associated with a 1.2% increase in cancer mortality rate in the short-term (model with 1-year lags, rate ratio (RR): 1.012, 95% CI: 1.009–1.015) and 1.1% increase in medium-term (5-year lags (RR: 1.011, 95% CI: 1.008–1.014) and 0.8% increase long-term (10-year lags (RR: 1.008, 95% CI: 1.004–1.012). After adjusting for county-level sociodemographic characteristics, the RRs were attenuated but remained statistically significant. Jail incarceration was associated with higher cancer mortality for all common cancers included in the study (Table) and for White people, but not for Black people. The magnitude of associations was similar for medium- and long-term effects (5- and 10-year lags, respectively). Conclusions: Higher county-level jail incarceration rates were associated with higher county-level cancer mortality rates, underscoring the collateral health consequences of mass incarceration. Efforts to identify interventions to decrease the cancer mortality burden in these communities are warranted. [Table: see text]
An intersectional approach to cervical cancer screening disparities by race/ethnicity and immigrant status.
Authors: Chen Jane J. , Sarkar Indra N. , Hsu Emily , Dizon Don S. 
Published: June 2023

6536 Background: Racial/ethnic minority and immigrant groups individually experience lower rates of cervical cancer (CC) screening. Although immigrants represent large proportions of racial/ethnic minorities, few studies have explored the interacting health consequences of these social categories. Intersectionality is a theoretical framework which recognizes that studying social categories independently cannot capture their cumulative effects on health. In the context of CC screening, only one study took this approach but did not analyze several important barriers to care. This study aims to analyze the joint influence of race/ethnicity and immigrant status on screening and identify barriers unique to each intersectional group. Methods: Data from the National Health Interview Survey years 2005, 2010 and 2015 were drawn from IPUMS. Analyses were restricted to those eligible for CC screening (n=17,941). Multivariable logistic regression was used to model the interactional effect of race/ethnicity and immigrant status on screening up to date (UTD) status adjusting for confounders. Variables reflecting socioeconomic status (SES), access to care, acculturation and language were separately included to see whether they explained identified disparities. Finally, amongst women not UTD on screening, reasons for this were analyzed. All analyses were adjusted for complex survey design. Results: US born Non-Hispanic Black women had higher odds of being UTD on screening (OR 1.63, 95% CI [1.23, 2.18]) while immigrant Non-Hispanic White (OR 0.45 [0.29, 0.7]), immigrant Asian (OR 0.29 [0.2, 0.42]) and immigrant Hispanic/Latinx women (OR 0.51 [0.39, 0.67]) had lower odds compared to US born Non-Hispanic White women. Adjusting for SES (OR 0.87 [0.65, 1.16]) and access (OR 1 [0.74, 1.36]) attenuated the ORs for immigrant Hispanic/Latinx women but not immigrant Asian and White women. Adjusting for acculturation attenuated the ORs for immigrant Hispanic/Latinx (OR 0.84 [0.58, 1.22]) and White women (OR 0.68 [0.42, 1.12]) only. Adjusting for language increased but did not attenuate the ORs for all immigrant groups. Analyses of reasons for not screening showed immigrant Non-Hispanic White, Black and Asian women had greater proportions selecting “Didn’t need or know needed this test” versus other groups (10-12% vs. 5.4-8.4%). Conclusions: Immigrant status continues to explain much of the CC screening disparities previously attributed to race/ethnicity. SES and access to care remain important barriers for immigrant Hispanic/Latinx women but less so for other immigrant groups. This study reveals that acculturation is an important barrier for immigrant Non-Hispanic White and Hispanic/Latinx women, possibly representing disparities in knowledge. Language barriers may also contribute in all immigrant women. Further intersectional studies are needed to identify remaining barriers.