bluuebunny/crossref_metadata_2025_split huggingface dataset:
The role of real-world evidence (RWE) registries using NGS testing to address cancer health disparities (CHD) in small community oncology practices.
Authors: Gor Asutosh S. , Patel Kashyap B. , Rabara Viral , Clinton Natasha 
Published: June 2022

e18519 Background: CHD may result from multiple factors, including access to care, screening, and clinical trials; limited uptake of biomarker and next-generation sequencing (NGS) testing; and unfavorable social determinants of health. CHD may contribute to almost 34% of deaths among adult cancer patients and additional spending of $230 billion. Addressing CHD could result in an indirect savings of as much as $1 trillion over 3 years (AACR, CDR, 2020). Biomarker testing enables the option of targeted treatment, providing better outcomes and reduced toxicity. The NGS testing rate is very low in some regions and among minority populations, and underuse worsens disparities. Carolina Blood and Cancer Care Associates (CBCCA) has created best practices to improve biomarker testing and provide standard-of-care treatment in advanced cancer. Methods: As a part of a pledge to decrease CHD, CBCCA partnered with 2 national NGS testing vendors to create a RWE registry to identify appropriate patients and provide access to NGS biomarker tests for somatic mutations, including whole exome sequencing (WES). Liquid biopsy was made available when tissue was unavailable. Results: CBCCA has 1 suburban and 1 rural location, with an ethnically diverse population. Regular care was provided for 1466 of the 1786 unique cancer patients seen in 2021, and 442 participated in a RWE registry. Nonparticipants were survivors having routine follow-up care (n = 512), patients with early-stage or noninvasive disease (510), or patients who refused testing because they were responding to ongoing treatment or had reservations. NGS testing was obtained for 354 patients, 31% of whom were members of ethnic minority groups. Liquid biopsy was used for 133 samples, and the remaining 221 were analyzed with somatic NGS panels or WES. Of the liquid biopsies, 24 patients had actionable mutations; an additional 52 had findings of germline implications. Actionable mutations that could be treated with an FDA-approved drug were identified using tissue-based NGS testing in 38 pt. In tissue-based testing, WES detected more results with germline implications, compared to somatic testing alone. Another 64 tests found mutations treatable with an approved drug in another tumor type. The NGS and biomarker testing rate (either tissue or liquid biopsy) was 84% of eligible pt. Of the patients tested with NGS, clinically actionable variants that could be treated with an approved agent were found in 23% (same tumor type) and 28% (another tumor type). Another 40% of patients had results with germline implications, of which P53 deletion was the most common finding. Conclusions: It is feasible to increase the NGS testing rate in appropriate situations. In this study, actionable mutations impacting treatment selection were found in up to 25% of patients where targeted therapy could be offered.
Non-small cell lung cancer disparities in stage at presentation and treatment status for Asian American, Native Hawaiian, and Pacific Islander females.
Authors: Hong Ji Hyun , Lam Miranda , Dee Edward Christopher , Swami Nishwant 
Published: June 2022

e18526 Background: Asian Americans, Native Hawaiians, and Pacific Islanders (AANHPI) represent the fastest-growing racial group in the United States. While often described in aggregate as one of the healthiest populations, large variations in the social determinants of health and subsequent health outcomes exist within the AANHPI community. We identified differences in stage at presentation and treatment status among AANHPI women with non-small cell lung cancer. Methods: Between 2004 and 2016, a retrospective cohort study was performed using the National Cancer Database (NCDB) with 522,361 female patients with newly diagnosed non-small cell lung cancer (NSCLC). Asian subgroups were distinguished as Chinese, Japanese, Filipino, Hawaiian, Korean, Vietnamese, Laotian, Hmong, Kampuchean, Thai, Asian Indian, Pakistani, and Pacific Islander. Multivariable logistic regression models were used to define adjusted odds ratios (aORs) with 95% CI of presenting at stage IV disease and not receiving treatment. Effect measure modification (EMM) by age was also analyzed in all models. Results: Among 522,361 women, AANHPI women were more likely to present with stage IV disease at presentation when compared to White women (54.32% vs 40.28%, aOR = 1.54, 95%CI = 1.45-1.64, p < 0.001). All AANHPI subgroups also had greater odds of presenting with stage IV diseases when compared to White populations: Chinese (aOR = 1.49, 95%CI = 1.38-1.61, p < 0.001), Japanese (aOR = 1.22, 95%CI = 1.09-1.37, p < 0.001), Filipino (aOR = 1.63, 95%CI = 1.49-1.78, p < 0.001), Korean (aOR = 1.49, 95%CI = 1.30-1.70, p < 0.001), Vietnamese (aOR = 1.74, 95%CI = 1.54-1.97, p < 0.001), Laotian (aOR = 2.24, 95%CI = 1.49-3.37, p < 0.001), Kampuchean (aOR = 1.61, 95%CI = 1.06-2.46, p = 0.027), Thai (aOR = 1.64, 95%CI = 1.17-2.31, p = 0.004), Asian Indian (aOR = 1.50, 95%CI = 1.30-1.73, p < 0.001), and Pacific Islander (aOR = 1.50, 95%C = 1.20-1.88, p < 0.001). In EMM analysis, Asian women aged younger < 65 years were more likely to present with stage IV diseases (p = 0.030 for interaction). Asian women were also more likely not to receive treatment (7.01% vs. 8.80%, 95%CI = 0.84-1.09, p = 0.497). Vietnamese women (aOR = 1.30, 95%CI = 1.06-1.58, p = 0.010) showed significant differences compared to White women. Conclusions: Differences in stage at presentation and treatment status in women with NSCLC were observed among AANHPI subgroups when populations were disaggregated. Efforts are needed to elucidate the barriers these populations face that may explain the observed delays in diagnosis. Further disaggregated study of AANHPI subpopulations is needed to reduce inequities in lung cancer.
Positive impact of oncology nurse navigation based on health insurance in head and neck cancer patients.
Authors: Pallas Christopher R , Boselli Danielle , Kuch Madison , Neelands Brittany , Carrizosa Daniel R. 
Published: June 2022

e18545 Background: Health disparity in squamous cell carcinoma of the head and neck (SCCHN) is well-recognized. Privately insured SCCHN patients are observed to have better outcomes, but underlying factors are poorly understood. Oncology nurse navigators (ONN) are a well-established role focused on optimizing cancer care and patient experience. The effects of ONN on bridging health disparities have not been demonstrated. We sought to characterize health and outcome disparities in patients diagnosed with oropharyngeal cancers and to assess if the implementation of ONN bridges gaps in health disparities. Methods: Patients aged >18 diagnosed with node positive, non-metastatic oropharyngeal cancers at a large hybrid academic-community cancer center between June 2018 and September 2021 were analyzed retrospectively. Baseline demographic, socioeconomic and clinicopathologic factors including the frequency and percentage of patients receiving ONN were summarized. Clinical outcomes were assessed as a function of baseline factors and ONN. Overall survival (OS) and progression free survival (PFS) were evaluated with Kaplan Meier methods. Results: 184 patients were evaluated. Median age at diagnosis 62 (range 33-91). Median follow-up 24 months. The majority were HPV+ (73%). Navigation received in 64%. More males presented with cN1+ disease than females (57% v. 37%; p = 0.053). More Black patients presented with cN1+ disease than White patients (76% v. 50%; p = 0.017). More privately insured patients (92%) went to imaging after definitive treatment versus those with Medicaid (MD)/Self-pay (SP) (78%) or Medicare (MC)/Veteran’s affairs (VA) (78%) (p = 0.043), while more navigated patients went to imaging after definitive treatment than non-navigated patients (70% v. 40%; p = 0.003). Univariate modeling indicated clinical nodal stage, HPV status, race, and insurance status were associated with OS and PFS. In multivariable modeling adjusted for age, nodal stage, and HPV status, there was a disparity in OS associated with insurance type (MD/SP v. Private: HR 9.24, 95% CI = 2.34 to 36.41 and MC/VA; p = 0.004). There was a significant interaction of navigation and insurance type (p = 0.0157). In those not navigated, a difference in hazards exists between MD/SP or MC/VA compared with private insurance. This difference was not detected in those navigated. Similar interaction of navigation and insurance was noted in the analysis of PFS. Conclusions: We observed a disparity in patients with non-private insurance having an inferior PFS, OS and reduced rates of imaging after definitive treatment. An improved rate of post-treatment imaging was significantly associated with ONN. There was a trend towards benefit in outcomes for those receiving ONN but without private insurance suggesting that ONN may help mitigate disparities in the non-private insurance groups.
Assessing baseline cancer demographics versus those that participate in cancer clinical trials over one year in Louisiana.
Authors: Pierre Aliyah , Castellano Tara , Jernigan Amelia , Chapple Andrew G , Li Tingting , Yi Yong 
Published: June 2022

e18546 Background: To determine which barriers exist for cancer clinical trial participation in Louisiana and define areas for improvement, we report cancer demographics of all new cancer diagnoses in Louisiana in 2019 and compare those to the baseline demographics of cancer patients that enrolled on a cancer treatment trial. Methods: A retrospective study evaluating baseline cancer demographics over 2019 was performed. Our baseline population included all new cancer diagnoses in patients 18+ registered with the Louisiana Tumor Registry (LTR) between January-December 2019. Baseline demographics were compared between all patients enrolled in a cancer treatment clinical trial in 2019 through the Gulf South Clinical Trials Network (GSCTN) versus those who were not. Summary statistics were performed with regards to basic cancer and patient demographics. Results: Although patients of the highest socioeconomic group made up, n = 5,444, (21.9%) of total cancers, a larger proportion, n = 35 (32.4%), p = 0.01 ultimately enrolled in a trial. Similarly, of those living in an urban area, n = 22,258 (84.5%), a larger proportion, n = 103 (92.8%), enrolled in a trial when compared to those that were not, p = 0.02. There was a significant positive correlation (p = 0.01) between clinical trial enrollment and residency in geographic areas with higher rate of high-school graduation. Our data also demonstrated that a smaller proportion, n = 7 (6.3%), of clinical trial participants died compared to those who did not participate, n = 5176 (19.6%), p < 0.01. Urologic cancer, including both prostate and bladder cancer, was the second most-diagnosed cancer primary site in Louisiana in 2019 with, n = 5481, patients diagnosed. Although black men made up, n = 1767 (32.2%) of diagnosed urologic cancer, only, n = 9 (14.1%), were accrued to participate in a urologic cancer clinical trial, p < 0.01. White men, who made up, n = 3661 (66.8%), of diagnosed urologic cancer, had a larger proportion, n = 55 (85%), of trial participation, p < 0.01. Conclusions: Overall, lack of geographic access proves to be a barrier for recruitment in clinical cancer trials. Patients of higher SES that live in urban areas make up a larger proportion of clinical trial participants and have better survival rates than those who do not participate. For specific cancers such as urologic cancer, further investigation on the cancer-specific inclusion and exclusion criteria must be investigated to determine the effect on equitable trial entry for populations in need. In conclusion, Louisiana offers a diverse cancer population, however, further efforts must be made to improve clinical trial access to our diverse and underserved populations.
Financial distress, health literacy, numeracy, and treatment receipt by race/ethnicity amongst breast cancer survivors.
Authors: Odai-Afotey Ashley , Lederman Ruth , Ko Naomi Y , Gagnon Haley , Hershman Dawn L. , Crew Katherine D. , Keating Nancy Lynn , Gundersen Daniel A. , Revette Anna C. , Freedman Rachel A. 
Published: June 2022

e18554 Background: Low-income and minority women are less likely to receive breast cancer treatments and have higher mortality rates compared with other women.We examined economic hardship, health literacy, and numeracy by race/ethnicity and whether these factors were associated with differences in receipt of recommended treatment. Methods: We conducted a telephone survey in 2018-2020 of adult women diagnosed with stage I-III breast cancer between 2013-2016 at three centers in Boston and New York. We asked women about treatment receipt and factors contributing to decision-making. We used X2 and Fischer exact tests to examine associations between economic distress, health literacy/numeracy, and treatment receipt by race/ethnicity. Results: Among 326 respondents (AAPOR cooperation rate 63-80% across sites), 55% were Non-Hispanic (NH) White, 23% were NH Black, and 14% Hispanic; 15% were Medicaid-insured. Due to item non-response, sample sizes ranged from 294-315 per question. A substantial proportion of women, and particularly Black and Hispanic women, reported economic distress, worse finances over time, and low literacy/numeracy (Table). Overall, 7% (n = 22) did not initiate at least one recommended treatment. Although we observed no differences in treatment by race/ethnicity (p = 0.70), those not initiating recommended treatment(s) reported more worry about paying large medical bills (52% vs. 27%) and covering visit costs (27 vs. 10%); p < .05 for both. Conclusions: In a diverse sample of breast cancer survivors, financial distress was common, particularly for non-White participants; non-White women also had lower literacy/numeracy. Although we observed some associations of these factors (but not race/ethnicity) with less receipt of recommended treatments, because few women declined treatments, understanding the scope of impact is limited. However, our results highlight the importance of up-front and longer-term assessments of resource needs and allocation of support for breast cancer survivors. Novelty of this work includes the granular measures on financial distress and the focus on health literacy/numeracy among a diverse population.[Table: see text]
Project facilitate: Innovation and advancement in FDA’s oncology expanded access program.
Authors: Chan Mitchell , Antony Ramya , Boehmer Jessica , Kim Tamy , Pazdur Richard 
Published: June 2022

e18556 Background: FDA Oncology Center of Excellence’s (OCE) Project Facilitate (PF) was launched in June 2019 in response to perceived barriers providers face when accessing Expanded Access (EA). Since launch, PF continues to evolve and innovate to provide a comprehensive service to assist oncology healthcare providers requesting EA. An analysis of single-patient investigational new drugs (IND) was performed over 1 year to assess the growth and impact of the program. Methods: Data was extracted from Project Facilitate’s central database that yielded 640 single-patient INDs between June 1, 2020 and June 1, 2021. Data collected included IND receipt date, granting date, status, application type, indication, drug name, address of requestor, and patient demographics. Results: Of the 640 single-patient INDs extracted, there were 183 emergency INDs (eIND) and 457 non-emergency INDs (SPI). EA requests originated primarily from academic centers (81%) and community hospitals (18%) whereas Veterans Affairs and Military Treatment Facilities (0.5%) and Other (0.5%) were the least common. The 5 most common states requests originated from include New York (14%), California (13%), Texas (11%), Pennsylvania (7%), and North Carolina (4%). Although the current FDA Form 3926 does not request race and ethnicity information, this data was reported in 17 requests: White (8), Asian (3), Black/African American (3), American Indian or Alaskan Native (0), Native Hawaiian or Other Pacific Islander (0), Hispanic or Latino (3) and non-Hispanic or Latino (0). Age distribution was analyzed for pediatric (24%) and adult (76%) patients. Age distribution was further analyzed in geriatrics >75 (10%), in pediatrics < 2 (7%) and patients 2-17 years old (17%). The processing and review times for 630 applications were <1 day (96%) and > 1 day (4%). PF granted 100% of EA requests received in this time period. PF’s call center received 525 phone calls of which 499 (95%) were answered on the first call. PF also received 7843 emails during this period. Conclusions: Since 6/1/2020, PF started performing the reviews, processing and granting of CDER oncology EA requests that generally were performed by the FDA Review Divisions. By consolidating this process to PF, review times have drastically reduced to <1 day. PF has evolved since launch to promote effective and equal access to oncology expanded access.[Table: see text]
Prognostic testing and treatment patterns in Black patients (pts) with chronic lymphocytic leukemia (CLL) from the informCLL prospective, observational registry.
Authors: Barrientos Jacqueline Claudia , Mato Anthony , Sharman Jeff Porter , Brander Danielle M. , Gutierrez Meghan E. , Wu Linda , Panjabi Sumeet , Young Alex , Upasani Sandhya , Naganuma Maoko , Ghosh Nilanjan 
Published: June 2022

e18559 Background: Real-world data on practice patterns in Black pts with CLL are limited. We evaluated treatment (tx) patterns and prognostic biomarker testing in Black pts enrolled in the informCLL registry. Methods: Pts who initiated FDA-approved tx for CLL/SLL (index tx) were enrolled from October 2015 to June 2019. Baseline (BL) characteristics, FISH testing rates, BL factors associated with FISH testing, and patterns of index tx are summarized by line of therapy (LOT; previously untreated [1L] and relapsed/refractory [R/R]). Results: Of 1462 enrolled pts (overall registry population), 106 (7%) were Black (Table). Community-based practices enrolled 87% of Black pts, similar to the overall population (93%). Black pts were predominantly enrolled in the South (69%). Among Black pts, median age was 66 y, 65% had ECOG status ≥1, 64% had Rai stage III-IV, and median time from diagnosis to tx on registry was 40 mo (7 mo for 1L). In the overall population, median age was 71 y, 53% had ECOG status ≥1, 51% had Rai stage III-IV, and median time from diagnosis to tx was 41 mo (19 mo for 1L). FISH testing was performed in 25% of Black pts, similar to the testing rate in the overall population (28%). In a multivariate analysis, BL factors significantly associated with FISH testing were shorter time from initial diagnosis to tx, better ECOG status, earlier LOT (1L), community practice setting, and prior malignancy (p<0.05 for all); race was not a predictive factor. As in the overall population, ibrutinib was the most frequent tx among Black pts in 1L (50%) and R/R (67%), followed by chemoimmunotherapy (CIT; 1L, 43%; R/R, 15%). In 1L pts, tx with ibrutinib generally increased over time (2016, 31%; 2017, 57%; 2018, 63%; 2019, 55%) while CIT use persisted (56%; 36%; 38%; 36%, respectively). In R/R pts, use of ibrutinib decreased over time while CIT remained consistent and tx with other novel agents increased. Conclusions: Black pts with CLL tended to be younger, with worse ECOG status, more advanced disease, and shorter time to 1L therapy than the overall informCLL registry population. While ibrutinib was the most common tx in Black pts, CIT use in 1L remained persistent. Similar to the overall registry population, prognostic testing rates were suboptimal in Black pts. These results highlight the importance of prognostic testing and the need to more closely monitor disease status in Black pts as they will tend to require initial CLL therapy more rapidly than other pts. Clinical trial information: NCT02582879. [Table: see text]
Tackling healthcare inequities through a social media-based platform to connect solid tumor patients with COVID-19 to clinical trials.
Authors: Leyfman Yan , Sandeep Samarth , McGregor Kirk , Rizk Peter , Khoury Carlo , Park Chandler H. 
Published: June 2022

e18560 Background: COVID-19 has contributed to healthcare inequity amongst minorities and lower socioeconomic populations, while complicating present anti-cancer treatment regimens. Due to their immunocompromised status, cancer patients are at an increased risk of severe SARS-CoV-2 infection. While sentiment analysis via SM has seen vast growth among healthcare professional, deeper connection and management has been lacking. Given the higher usage of SM impressions and the increase in healthcare disparities especially at the intersection of oncology and COVID-19, the aim of this study was to develop a platform that can: (1) show that the relationships highlighted within these tweets can be realized in biomolecular interactions—specifically within the interaction between solid tumors and COVID-19; (2) use SM data to connect patients with clinical trials. Methods: To determine this relationship, ontologies, which are groupings of terms and related identifiers, such as genes, were created for general search terms, utilizing the Human Phenotype Ontology. They were then combined with “COVID-19” and used as search terms in Twitter’s Standard Search tool. The keywords with the most matches were then queried through clinicaltrials.gov and European Bioinformatics Institute’s (EBI) Protein Search Tool to find relevant clinical trials and proteins. Finally, the proteins found by the EBI protein search were run through the SwissModel Tool to find relevant protein structures before being used in binding using Polar+’s Binding Platform from Iff Technologies, which provides K values related to 50% inhibition for each medication or immunotherapy. This produced a set of disease-specific keywords that are related to top tweets, clinical trials, protein structures, and binding concentration values in relevant biomolecular pathways for the keyword set “Tumor COVID-19”. Results: The example shown in Table is produced via our platform, with keywords with tweet numbers greater than 95% of all tweets with connected keywords used. Conclusions: By utilizing SM with highly relevant keywords, this platform can combat healthcare inequity by connecting patients and their tweets to clinical trials and enhance literacy about their medical conditions, while providing a greater understanding of the biomolecular pathways involved.[Table: see text]