bluuebunny/crossref_metadata_2025_split huggingface dataset:
Bringing experimental therapeutics clinical trials network (ETCTN) to underrepresented population.
Authors: Baranda Joaquina Celebre , Doolittle Gary C. , Parikh Rahul Atul , Kasi Anup , Wulff-Burchfield Elizabeth Marie , Powers Benjamin , Pluenneke Robert E. , Hoffmann Marc Steven , Yacoub Abdulraheem , Saeed Anwaar , Corum Larry R. , Lin Tara L. , Sun Weijing , Mooney Margaret M. , Moscow Jeffrey , Doroshow James H. , Waters Brittany , Ivy S. Percy , Gore Steven , Jensen Roy A. 
Published: June 2022

6542 Background: Access to health care including clinical trials (CT) leading to paradigm-changing cancer treatments are critical for high quality cancer care and equity in society. In this report, we highlight methods in accruing to ETCTN wherein underrepresented rural, low-income, and racial minorities comprise >50% of enrollment. Methods: University of Kansas Cancer Center (KUCC) is one of eight National Cancer Institute (NCI) designated cancer centers awarded CATCH-UP.2020 (CATCH-UP), a congressionally mandated P30 supplement to enhance access for minority/underserved populations to ETCTN precision medicine CT. KUCC catchment area is 23% rural by Rural Urban Continuum Codes (RUCC); almost 90 % of counties are designated primary care HPSA’s (Health Professional Shortage Areas). KUCC Early Phase and Masonic Cancer Alliance (rural outreach network) partnered to operationalize CATCH-UP. We engaged disease-focused champion investigators in disease working groups and MCA physicians who selected scientifically sound CT that fit catchment area needs. Patient and Investigator Voices Organizing Together, a patient research advocacy group provided practical feedback. MCA navigator coordinated recruitment. Telehealth was used for rural patients that would have a significant distance to travel just to be screened. Results: CATCH-UP was initiated in September 2020. Twenty-eight CT were activated, many in community sites. Average activation time was 81 days. Delays were mainly from CT amendments. KUCC enrolled the first patient in the CATCH-UP program. In 6 months, we met accrual requirements (24/year, 50% minorities). During first year, we enrolled 47 (>50% minorities), an increase of 680% from our average accrual of 6/year (>50% minorities) in ETCTN through Early Drug Development Opportunity Program (2016-2020). To date, we have enrolled 61, 54% from rural, HPSA, race and other minorities. Although the proportion of minorities did not change but remained high, this funding allowed us to substantially increase the number of patients from a catchment area with high proportion of geographically and socioeconomically underserved minorities given access to early phase CT through ETCTN. Conclusions: Amid COVID-19 pandemic, the NCI CATCH-UP program and methods we used allowed access to novel therapies for rural, medically underserved, and other minority groups. Funded by NIH: 3P30CA168524-09S2.
Impact of depression among adolescents and young adults with cancer.
Authors: Qiao Edmund Men , Qian Alexander , Mariano David J , Lee Terrence C. , Youngblood Eventine , Chou Linda , Murphy James Don 
Published: June 2022

6549 Background: The incidence of adolescent and young adults (AYAs) with cancer continues to increase. The psychosocial burden of early cancer diagnosis within this unique AYA population remains poorly characterized. Without proper resources, these patients are likely to seek care in the acute care setting. For AYA patients, we evaluated the impact of malignancy on concurrent diagnosis with depression and on presenting to the emergency department (ED) with intentional self-injury. We further described the influence of concurrent depression diagnosis on hospital admission and extended length of stay (LOS) for AYA cancer patients. Methods: From the National Emergency Department Sample (NEDS), we identified patients between 15-39 years who presented to an ED in 2019. Diagnosis of cancer and depression were identified using International Classification of Diseases, 10th Revision coding. Separate multivariable logistic regressions evaluated the impact of cancer diagnosis on concurrent depression diagnosis and on presenting with intentional self-injury. For the subset of AYA cancer patients, multivariable logistic regressions evaluated the impact of depression on hospital admission and extended LOS ( > 14 days). Results: We identified 10,570,148 AYA patients, and 35,035 had cancer (0.33%). Among AYA cancer patients, average age was 31 and the cohort skewed White (48.7%), female (58.1%), and with Medicaid insurance (48.4%). The prevalence of depression among AYA cancer patients was 9.6% vs. 4.4% for patients without cancer. On multivariable regression, AYA cancer patients had a 46% increased odds of depression diagnosis (odds ratio (OR), 95% confidence interval (CI): 1.46. [1.43-1.49] P < 0.01) and 32% increased odds of intentional self-injury (OR, 95% CI: 1.32 [1.19-1.47] P < 0.01) when compared to patients without cancer. Additional significant factors associated with depression diagnosis among AYA cancer patients were White race, female gender, and Medicaid insurance. Within AYA cancer patients, a concurrent diagnosis with depression was associated with ̃3-fold increased odds of hospital admission (OR, 95% CI: 3.02 [2.90-3.14] P < 0.01) and a 31% increased odds of extended LOS (OR, 95% CI: 1.31 [1.23-1.39] P < 0.01). Conclusions: From this national sample, we found a significant association between cancer diagnosis and depression within AYA patients, with cancer diagnosis also increasing the risk of intentional self-injury. Furthermore, AYA cancer patients diagnosed with depression had increased risk of both hospital admission and extended LOS. Our results underscore the potential gap in psychological care for AYA cancer patients and highlight the need for stronger mental health resources for this at-risk population.
Racial disparities in diagnostic follow-up following BIRADS 0 mammogram.
Authors: Manik Ritika , Grady Connor B. , Ginzberg Sara , Edmonds Christine E. , Conant Emily F. , Hubbard Rebecca A. , Fayanju Oluwadamilola Motunrayo 
Published: June 2022

6559 Background: Delays in follow-up after abnormal mammograms can lead to worse outcomes and may contribute to health disparities. BIRADS 0 mammograms necessitate additional diagnostic imaging, and BIRADS 4 or 5 mammograms should be followed by biopsy. The goal of this study was to investigate racial disparities in rates and timeliness of (1) diagnostic follow-up after a BIRADS 0 screening mammogram and (2) biopsy following a subsequent BIRADS 4 or 5 diagnostic mammogram. Methods: We included women ≥18 years old who underwent a screening mammogram at the Hospital of the University of Pennsylvania with an assessment of BIRADS 0 between September 2010 and February 2018. The distributions of time from screening to diagnostic mammogram and from BIRADS 4 or 5 diagnostic mammogram to biopsy were estimated using the Kaplan Meier method. Follow-up was censored at 365 days. Case-mix adjusted Cox proportional hazards models were used to estimate the association between race/ethnicity and time to diagnostic mammogram and biopsy. Results: We identified 6299 women (Asian/PI=257, Black=3223, Hispanic=124, White=2420, Other/Unknown=275) with 6880 BIRADS 0 screening mammograms during the study period. Following these BIRADS 0 mammograms, the overall rate of diagnostic mammograms within 365 days was 87.3% (n=6006 mammograms), with a rate of 90.6% (2432) for White women and 85.3% (2971) for Black women. For the 1151 BIRADS 4-5 diagnostic mammograms in the cohort, the overall rate of follow-up biopsies within 365 days was 91.8% (n=1057 biopsies), with a rate of 93.8% (396) for White women and 91.1% (575) for Black women. Compared to mammograms obtained by White women, those obtained by Black women were less likely to be followed up with a diagnostic mammogram (HR 0.71, 95% CI 0.63-0.80, p<0.001) and biopsy (HR 0.74, 95% CI 0.55-0.98, p=0.037) when indicated (Table). Almost 1/4 (24.2%, 95% CI 23.1-25.9%) of BIRADS 0 screening mammograms among Black women were not followed by diagnostic imaging within 30 days as compared to 14.6% among White women (95% CI 13.3-16.0%, p<0.001). 23.6% (95% CI 20.5-27.2%) of BIRADS 4-5 diagnostic mammograms among Black women were not followed up with biopsy within 30 days vs 18.7% for White women (95% CI 15.4-22.8%, p=0.61) (Table). These disparities persisted at 90 days. Conclusions: Racial disparities exist in rates of follow-up after BIRADS 0 mammograms. The additive effects of delays at each diagnostic step put Black women at disproportionately greater risk for worse outcomes. [Table: see text]
Disparity of treatment-related adverse events and outcome in patients with early-onset metastatic colorectal cancer (mCRC).
Authors: Meng Lingbin , Thapa Ram , Kim Richard D. , Laber Damian A. , Xie Hao 
Published: June 2022

6560 Background: While the incidence of newly diagnosed early-onset mCRC has been increasing, disparity of treatment-related adverse events (AE) and outcomes of this patient population has been inadequately studied with inconclusive findings. We aimed to evaluate such age-related disparity and explore potential underlying causes. Methods: We used individual patient data from 3 clinical trials in Project Data Sphere where 756 and 467 patients with mCRC received first-line FOLFOX in study 1 (NCT 00305188, NCT00272051) and study 2 (NCT00364013), respectively. Clinical NGS data of 763 patients with mCRC from prospectively maintained Moffitt Clinical Genomics Database were used to assess genomic alterations. Patients were categorized into 3 age groups: <50, 50-65, and >65 years. Continuous and categorical variables were compared with t test and χ2 test, respectively. Kaplan-Meier method and log-rank test were used for survival analysis. Benjamini-Hochberg procedure was used to adjust for multiple comparisons. Results: Among 1986 patients included, 341 (17.2%) in the <50 group, 912 (45.9%) in the 50-65 group, 733 (36.9%) in the >65 group had similar baseline characteristics. Outcomes: Patients in the <50 group had shorter median OS compared to the 50-65 (15.5 vs 20.5 month, p=0.003) and >65 groups (15.5 vs 20.8 months, p=0.004) and shorter median PFS compared to the 50-65 (8.1 vs 9.4 month, p=0.039) and >65 groups (8.1 vs 8.6 months, p=0.07) in study 1. Findings were confirmed in study 2. Toxicity: Compared to other age groups, the <50 group had a higher incidence of severe (grade≥3) abdominal pain (8.4% vs 3.4%, p=0.01), severe anemia (6.1% vs 1.2%, p=0.001), nausea/vomiting (69.3% vs 58.8%, p=0.02), but lower incidence of severe diarrhea (6.1% vs 10.8%, p=0.02), severe neutropenia (25.7% vs 44.2%, p<0.001), and severe fatigue (4.5% vs 7.3%, p=0.02). The <50 group had earlier onset of nausea/vomiting (1.0 vs 2.3 weeks, p=0.01), mucositis (3.6 vs 5.4 weeks, p=0.05), and neutropenia (8.0 vs 9.0 weeks, p=0.04), and shorter duration of mucositis (0.6 vs 0.9 weeks, p=0.006). Outcomes + toxicity: In the <50 group, abdominal pain was associated with worse OS (HR 1.6, p=0.01). In contrast, fatigue (HR 0.66, p=0.03) and mucositis (HR 0.67, p=0.046) were associated with better OS. Neuropathy was associated with better PFS (HR 0.61, p=0.009). Genomics: Our NGS data showed that the <50 group had more ERBB2 amplification (10.5% vs 4.0%, p=0.04) and a trend of more TP53 mutations (80.2% vs 72.0%, p=0.07). These findings were confirmed in an independent mCRC cohort (n=471, MSK, Gastroenterology 2020). Conclusions: Patients with early-onset mCRC had worse outcome and unique treatment-related AE patterns. Distinct genomic profiles could explain some of the disparities. Our findings might improve a personalized management approach in patient selection for chemotherapy, counseling and AE monitoring.
Physician awareness of immune-related adverse events from checkpoint inhibitors.
Authors: Khalid Ahmed Bilal , Jalal Shadia Ibrahim , Durm Greg Andrew 
Published: June 2022

6571 Background: Immune checkpoint inhibitors (ICIs) have been one of the most significant developments in Oncology over the last decade. Despite being very effective for certain patient subsets, they have a unique side effect profile different from conventional chemotherapy that can manifest as immune-related adverse events (IRAEs). With increasing ICI use, clinicians will increasingly encounter these adverse events and thus, adequate knowledge on recognition and management of IRAEs is very important. Methods: To assess physician knowledge on IRAEs of ICIs, an online survey was administered to resident physicians in internal medicine (IM), emergency medicine (EM) and family medicine (FM) as well as to faculty physicians in IM, and FM at 3 tertiary care hospitals in Indiana. Results: We sent the survey to 413 physicians out of which 155 responded with a response rate of 38%. Out of 155 physicians, 110 were residents and 45 were faculty (27 hospitalists and 17 primary care physicians). Pembrolizumab was identified as a checkpoint inhibitor correctly by 79% of physicians, nivolumab by 64% and ipilimumab by 55%. Twenty-five percent of physicians incorrectly believed infliximab and adalimumab were ICIs. Most physicians (93%) were able to identify the gastrointestinal tract as an IRAE site whereas only 57% and 67% were able to identify cardiovascular and renal systems as an IRAE site, respectively. Fifty-nine percent of physicians believed steroids negatively affect efficacy of ICIs and should be used with caution to treat IRAEs. Sixty-five percent of physicians incorrectly thought endocrinopathies due to IRAEs are usually reversible. Most physicians (79%) believed IRAEs most commonly manifest in the first 6 months of treatment. Forty-five percent of FM residents considered antibiotics as the mainstay of treatment in ICI associated immune mediated colitis; this was significantly different from EM (15%) and IM (8%) residents(p = 0.0004). When comparing between residency programs, on a scale of 0-100, IM residents felt significantly more comfortable identifying IRAEs secondary to ICIs (27.1±24.2) when compared to EM (12.2±12.7) and FM residents (9.4±13.8; p = 0.0009). There was no significant difference among IM (19.8±20.1), EM (11.9±13.6), and FM residents (11.6±18.9; p = 0.11) when comparing how comfortable they were in treating IRAEs. When asked what the best way would be to learn about IRAEs, 36% chose printed material and algorithms, 30% picked online teaching module and 30% chose one time in-person lecture from an Oncologist. Conclusions: Resident and faculty physicians in multiple specialties are not comfortable in the management and treatment of IRAEs due to ICIs. Given that most of these physicians are usually the first point of contact with patients, physician education on identification and treatment of IRAEs is needed. Early detection of these toxicities is critical for their resolution.
What is driving declines in oncology-prescribed opioids?
Authors: Townsend Tarlise , Cerda Magdalena , Chino Fumiko 
Published: June 2022

6583 Background: Patients with cancer have experienced sharp declines in opioid prescribing during the past decade, raising concerns about insufficient pain management in a population with high rates of undertreated pain. It is unclear whether these declines are driven by certain oncology subspecialties, payors, or clinical guidelines regarding opioid prescribing released in/after March 2016. Methods: We conducted time series analyses using 2006-2019 IQVIA Longitudinal Prescription Data, which represents up to 92% of all U.S. prescription fills. Using log-linear regression stratified by group, we estimated annual percent change in opioid receipt by: subspecialty (medical oncology MO, radiation oncology RO, and surgical oncology SO); payor (third-party; Medicare, including Medicare Part D; Medicaid; cash/out-of-pocket); and pre- versus post-March 2016. Opioid receipt outcomes included: monthly fills of any opioid; monthly fills of extended-release/long-acting (ER/LA) opioids; and monthly number of patients receiving long-term opioid therapy (LTOT). Outcomes were per 1,000 survivors to account for temporal changes in cancer prevalence. Results: Between 2006 and 2019, 14,301,900 opioid fills were prescribed by oncologists to 3,476,354 distinct patients. Across all outcomes, MO had the highest levels of dispensing, followed by RO, then SO; for example, in 2006 MO dispensed 6.2 fills per 1,000 survivors (compared to 1.9 fills among RO, and 0.5 among SO). We observed substantial declines in all opioid outcomes. Per 1,000 survivors, there was an annual decline of: 5.7% (95CI: 5.1-6.3; total unadjusted decline 2006-2019=70.2%) in the rate of all opioid fills; 4.9% (95CI: 4.1-5.6; total unadjusted decline=66.8%) in ER/LA fills; 3.2% (95CI: 1.5-5.0; total unadjusted decline=56.2%) in LTOT fills, and 1.9% in average daily dose (95CI: 1.9-2.0; total unadjusted decline=29.8%). The annual decline in opioid fills prescribed by MO (7.1%, 95CI: 6.6-7.7) was sharper than for RO (5.9%, 95CI: 5.4-6.4) and SO (5.2%, 95CI: 4.7-5.7). Annual declines were steepest among fills paid out-of-pocket (14.5%, 95CI: 13.9-15.0), followed by those paid by Medicaid (13.1%, 95CI: 12.5-13.6), third-party payors (9.3%, 95CI: 8.7-9.9), and Medicare (2.4%, 95CI: 1.8-3.1). Declines in every outcome accelerated following clinical guidelines released in/after 2016. Conclusions: Opioids prescribed by oncologists declined dramatically across groups and outcomes. Medical oncologists were responsible for a disproportionate share of opioid fills in 2006, and for the sharpest declines. Out-of-pocket fills declined more sharply than fills covered by insurance and clinical guidelines may have contributed to accelerating declines. While de-escalation of opioid therapy may reduce risk of opioid-related harms to cancer survivors, care is needed to ensure cancer-related pain is appropriately treated.
Do publicly available OncoGenomic databases represent the population? A comparative analysis.
Authors: Brazel Danielle , Kumar Priyanka , Benjamin David Joseph , Moyers Justin Tyler 
Published: June 2022

6588 Background: Large publicly available databases are important repositories for analyses of clinicogenomic research used for identifying clinically relevant biomarkers. Diversity among individuals in these repositories is key for ensuring applicability of findings to patient populations. Methods: We compared two publicly available pancancer databases from academic institutions: The Cancer Genome Atlas (TCGA) and United States (US) institutions from the American Association for Cancer Research (AACR) Project GENIE version 11.0 (APG) with cancer incidence statistics from The US Cancer Statistics (USCS) in 2018, the most recently available data. We compared demographic data from key individual cancer types (Lung, Colorectal, Prostate, Breast, Gliomas, and Leukemias) for gender, race, and ethnicity. Frequencies are displayed as percentages and compared by Chi-Squared method. Results: The USCS includes 1,708,921 new cases in 2018 while the TCGA includes 12,958 cases and APG includes 109,041 cases. Women account for 49.5% of all cancer diagnosis and similarly 50.4% of all cases in AACR and 51.2% of TCGA cases. Table summarizes key demographic differences. Amongst all cancer types, 78% of all US cancers occur in White patients however 84% and 83% of patients were White in AACR and TCGA respectively. 16% of prostate cancer cases occur in Black patients, but only 9% (n = 328/3993) of AACR and 11% (n = 51/484) of TCGA cases were Black (p < 0.01). However, while Black patients are only 2% of all breast cancer diagnoses, they accounted for 9% (n = 841/9871) of AACR and 16% (n = 203/1343) of TCGA cases p < 0.01). Patients of Hispanic ethnicity were underrepresented amongst the population and all single tumor types with Hispanics accounting for 8% of cases in USCS but only 5% in the AACR and TCGA (p < 0.01). Pancreatic and lung cancers, which have historically short survivals, both had lower median ages at sequencing compared to the median age of diagnosis. Median age of sequencing for pancreatic cancers was 65 in both TCGA and AACR, while median age at diagnosis in US is 70. Median age at diagnosis of lung cancers is 71 years in US, however median age was 67 in both AACR and TCGA. Conclusions: Patients with advanced age and minority races are underrepresented in publicly available American databases. To make informed analyses from genomic databases, the diversity of the population must be reflected in these databases and efforts must be made to increase representation of underrepresented groups. [Table: see text]
Trends in low-value oncology care during the COVID-19 pandemic.
Authors: Parikh Ravi Bharat , Civelek Yasin , Ozluk Pelin , Debono David Joseph , Fisch Michael Jordan , Sylwestrzak Gosia , Bekelman Justin E. , Schwartz Aaron L 
Published: June 2022

6594 Background: Low-value services, which provide minimal patient benefit while entailing costs and risks, are prevalent in cancer care. Shifts in cancer care delivery during the COVID-19 pandemic to minimize exposure provided opportunities for health systems and clinicians to prioritize higher-value over low-value oncology services. Methods: In this retrospective cohort study, we investigated the association between the COVID-19 pandemic period and low-value cancer care practices using administrative claims from the HealthCore Integrated Research Environment, consisting of ̃65 million members managed by 14 health plans across the US. We identified commercial or Medicare Advantage members diagnosed with breast, colorectal, or lung cancer between January 2015 and March 2021. Low-value cancer care practices were identified from peer-reviewed medical literature, including ASCO and ASTRO Choosing Wisely campaigns and evidence-based pathways. Five low-value practices were studied: (1) conventional fractionation instead of hypofractionation for early-stage breast cancer; (2) off-pathway systemic therapy; (3) non-guideline-based antiemetic use for minimal-, low-, or moderate-to-high-risk chemotherapies; (4) Positron Emission Tomography/Computed Tomography (PET/CT) instead of conventional CT for staging; and (5) aggressive end-of-life care (chemotherapy ≤14 days, multiple emergency department visits ≤30 days, ICU utilization ≤30 days, hospice initiation ≤3 days, and/or no hospice before death). We used linear probability models to evaluate the association between the COVID-19 period (March to December 2020) and the 5 outcomes, adjusting for patient, facility, geographic and temporal characteristics. Results: Among 204,581 members (mean age 63.1, 139,488 [68.1%] female), 83,593 (40.8%) had breast cancer, 56,373 (27.5%) had colon cancer, and 64,615 (31.5%) had lung cancer. Rates of low-value care were similar in pre-COVID vs. COVID periods: conventional radiotherapy: 22.1% vs. 9.4%; off-pathway systemic therapy: 36.7% vs. 43.2%; non-guideline-based antiemetics: 61.2% vs. 58.1%; PET/CT imaging: 39.9% vs. 41.3%; aggressive end-of-life care: 75.8% vs. 73.3%. In adjusted analyses, the COVID-19 period was associated with no changes in off-pathway therapy (adjusted percentage point difference [aPPD] 0.82, SD 0.08, p = 0.33), PET/CT imaging (aPPD 0.10, SD 0.005, p = 0.83), and aggressive end-of-life care (aPPD 2.71, SD 0.02, p = 0.16). Small changes in conventional radiotherapy (aPPD 3.93, SD 0.01, p < 0.01) and non-guideline-based antiemetics (aPPD -3.62, SD 0.006, p < 0.01), were noted. Conclusions: The shock of the COVID-19 pandemic did not meaningfully change several metrics of low-value cancer care. Broader changes to payment and incentive design should be considered to turn the tide toward higher-value cancer care.