NCI-designated Comprehensive Cancer Center Research Articles

Abstract PO5-10-06: A Pilot Study for Clinical Research Nurse Navigation at an Urban NCI-Designated Comprehensive Cancer Center

Abstract Background: Breast cancer is now the leading cause of cancer death for non-Hispanic Black women in Georgia with non-Hispanic Black women 40% more likely to die of breast cancer compared to White women. Inadequate representation of patients in clinical trials may contribute to health care inequity, though prior work has also shown disparate outcomes on similar clinical trials at Emory, suggesting differences in tumor biology may also be contributing to the disparity. Improving diversity in trial participation is imperative to better understand these differences, particularly with newer molecularly targeted therapies. We aimed to utilize Clinical Trials Nurse Navigation to increase clinical trial enrollment at an urban NCI-designated comprehensive care center in Atlanta, Georgia. Methods: A prospective pilot study was conducted investigating the role of a Clinical Research Nurse as a dedicated Clinical Trials Nurse Navigator to identify, pre-screen, and refer potential patients to both breast and next generation sequencing (NGS)-driven basket clinical trials at the Winship Cancer Institute at Emory University. The role also included centralizing all molecular data from patients with stage IV breast cancer into a database as a tool to refer patients to NGS-driven clinical trials. This role expands upon the Institute’s current research nursing scope to better meet the needs of our diverse patient population. Our catchment area is 35% non-Hispanic Black or African American. The nurse prescreened patients with stage IV breast cancer from breast oncology clinic templates and the breast NGS database to match them with clinical trials, with a particular emphasis on patients with stage IV triple negative breast cancer. The study began in January 2022 and is currently ongoing. Results: Since study initiation in January 2022, there has been a 27% increase in breast cancer clinical trial enrollment over a 12-month period. Over the last 6 months from January 2023, this has increased even further with 57 patients enrolled onto breast cancer clinical trials compared to a total enrollment of 70 patients onto breast cancer clinical trials in 2022 (Table 1). Of these patients, 11% enrolled in NGS-driven clinical trials in 2022 to present compared to 0% in 2021. Twenty-two (31.4%) non-Hispanic Black women enrolled onto breast cancer clinical trials in 2022 with another 21 (36.8%) non-Hispanic Black women enrolled thus far in 2023 (Table 1). Conclusion: Disparities in clinical trial enrollment may contribute to racial inequities in breast cancer outcomes. Implementation of clinical research nurse navigation has successfully improved clinical trial enrollment and diversity in clinical trial enrollment at our urban cancer center. Through increasing clinical trial prescreening, centralizing an NGS database, and dedicated nurse support to allow patients to navigate onto clinical trials, we achieved a 21% improvement in clinical trial enrollment from 2021 to 2022 and are on track to increase enrollment by 200% by the end of 2023. Clinical trials nurse navigators serve as an essential link between clinical trial patients and their providers, and should strongly be considered a key component of all clinical trials programs. Table 1 Breast Working Group Patient Enrollment by Race and Ethnicity, 2019-2023 Citation Format: Lizzie Huckaby, Maisey Ratcliffe, Madison Canning, Demetria Smith-Graziani, Kevin Kalinsky, Manali Bhave. A Pilot Study for Clinical Research Nurse Navigation at an Urban NCI-Designated Comprehensive Cancer Center [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-10-06.

Impact of Clinical Trial Design on Recruitment of Racial and Ethnic Minorities.

Knowledge related to how oncology treatment trial design influences enrollment of racial and ethnic minorities is limited. Rigorous identification of clinical trial design parameters that associate favorably with minority accrual provides educational opportunities for individuals interested in designing more representative treatment trials. We identified oncology trials with a minimum of 10 patients at an NCI-Designated Comprehensive Cancer Center from 2010 to 2021. We defined a study endpoint of racial and ethnic minority accrual greater than zero. Multivariable logistic regression was used to determine whether co-variables predicted our study endpoint. P-values of less than 0.05 were considered significant. A total of 352 cancer trials met eligibility criteria. These studies enrolled a total of 7981 patients with a total of 926 racial and ethnic minorities leading to a median enrollment of 10%. Trials open in community sites (yes versus no) were more likely to have a minority patient (OR, 2.21; 95% CI, 1.02-4.96) as well as pilot/phase I studies compared to phase II/III (OR, 3.19; 95% CI, 1.34-8.26). Trials incorporating immunotherapy (yes versus no) were less likely to have a minority patient (OR, 0.47; 95% CI, 0.23-0.94). Trials open in community sites as well as early phase treatment studies were more likely to accrue minority patients. However, studies including immunotherapy were less likely to accrue racial and ethnic minorities. Knowledge gained from our analysis may help individuals design oncology treatment trials that are representative of more diverse populations.

National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data.

National estimates of cancer clinical trial participation are nearly two decades old and have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other elements of clinical research. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from the Commission on Cancer (CoC). The data were obtained from accreditation information submitted by the 1,200 CoC programs, which represent more than 70% of all cancer cases diagnosed in the United States each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality-of-life (QOL), and registry studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (eg, National Cancer Institute [NCI]-designated cancer centers) and pooled. The overall estimated patient participation rate to cancer treatment trials was 7.1%. Patients with cancer participated in a wide variety of other studies, including biorepository (12.9%), registry (7.3%), genetic (3.6%), QOL (2.8%), diagnostic (2.5%), and economic (2.4%) studies. Treatment trial enrollment was 21.6% at NCI-designated comprehensive cancer centers, 5.4% at academic (non-NCI-designated) comprehensive cancer programs, 5.7% at integrated network cancer programs, and 4.1% at community programs. One in five patients (21.9%) participated in one or more cancer clinical research studies. In a first-time use of national accreditation information from the CoC, enrollment to cancer treatment trials was 7.1%, higher than historical estimates of <5%. Patients participated in a diverse set of other study types. Contributions of adult patients with cancer to clinical research is more common than previously understood.

Psychosocial consequences of head and neck cancer symptom burden after chemoradiation: a mixed-method study.

Patients with head and neck cancer (HNC) experience significant symptom burden from combination chemotherapy and radiation (chemoradiation) that affects acute and long-term health-related quality of life (HRQOL). However, psychosocial impacts of HNC symptom burden are not well understood. This study examined psychosocial consequences of treatment-related symptom burden from the perspectives of survivors of HNC and HNC healthcare providers. This was a cross-sectional, mixed-method study conducted at an NCI-designated comprehensive cancer center. Participants (N = 33) were survivors of HNC who completed a full course of chemoradiation (n = 20) and HNC healthcare providers (n = 13). Participants completed electronic surveys and semi-structured interviews. Survivors were M = 61years old (SD = 9) and predominantly male (75%), White (90%), non-Hispanic (100%), and diagnosed with oropharynx cancer (70%). Providers were mostly female (62%), White (46%) or Asian (31%), and non-Hispanic (85%) and included physicians, registered nurses, an advanced practice nurse practitioner, a registered dietician, and a speech-language pathologist. Three qualitative themes emerged: (1) shock, shame, and self-consciousness, (2) diminished relationship satisfaction, and (3) lack of confidence at work. A subset of survivors (20%) reported clinically low social wellbeing, and more than one-third of survivors (35%) reported clinically significant fatigue, depression, anxiety, and cognitive dysfunction. Survivors of HNC and HNC providers described how treatment-related symptom burden impacts psychosocial identity processes related to body image, patient-caregiver relationships, and professional work. Results can inform the development of supportive interventions to assist survivors and caregivers with navigating the psychosocial challenges of HNC treatment and survivorship.

Abstract 813: Primary cutaneous gamma-delta T-Cell lymphoma in the United States: A nationwide analysis of demographics and survival outcomes among the Hispanic population

Abstract BACKGROUND: Primary Cutaneous Gamma-Delta T-Cell Lymphoma (PCGDTCL) is a rare subtype of cutaneous T-cell lymphoma (CTCL) that, despite comprising &amp;lt;1% of cutaneous lymphomas, has gained recognition in recent years as an entity separate from other rare CTCLs. (LeukemiaPMID 35732829) A 5 year survival of 11% demonstrates a low response to current available therapies. (BloodPMID 30635287, Clin Hematol Int.PMID 35950208) Due to lack of consistency in behavior between CTCLs, there exists a need for studies of demographic, clinical, and survival disparities, including between Hispanics (HI) vs. non-Hispanics (NH). METHODS: Data were analyzed on PCGDTCL patients in the United States reported to the National Cancer Database (NCDB) between 2004-2019. Demographic and treatment characteristics were compared between ethnic groups. Kaplan-Meier and Cox regression analyses were used to compare OS between populations. Multivariate analysis and propensity score matching was performed with adjustment for age, stage, co-morbidity score, and insurance status, type of facility and great circle distance. RESULTS: Among 132 PCGDTCL patients studied (5% HI, 92% NH), the HI group was younger at diagnosis than NH (49.5y vs. 60y) (p=0.384); The majority of HI (50%) was diagnosed between 2010-2012 vs 2017-2019 for NH (45%) (p=0.673). Most of HI and NH were white (67% vs 79%). Private insurance was the most prevalent type in HI (67%) vs government sponsored for NH (49%). The most non-Insured group was NH (3%) vs HI (0%). The most prevalent bracket for Census Median Income (2008-2012) was $63,000+ for both HI (50%) and NH (31%). 17% HI vs 13%. NH had median income &amp;lt;$38,000. For Charlson-Deyo Score (comorbidities score), HI had 0% =/&amp;gt; 2 score, vs NH 6%. NCI-designated comprehensive cancer centers were the most prevalent type of facility providing care for HI (100%) and NH (56%) Survival probability (OS) at 2, 5 and 10y (HI vs NH) were (80% vs 48%), (80% vs 44%), and (80% vs 26%), respectively. Median survival time (MS) was not reached for HI vs 1.9 years for NH. Overall survival (OS) difference favored HI (p=0.13) On multivariate analysis, there was no independent variable associated with better or worse OS. Interestingly, the propensity matched analysis demonstrated significant MS difference between HI vs NH (median not reached vs. 1.35 years). CONCLUSION: There was no significant difference in OS between groups; however, the weighed MS favored the HI cohort, likely in part due to the difference in numbers between cohorts. The drastically low survival in all demographics is consistent with prior studies. These results demonstrate an unmet need for more comprehensive studies with the potential inclusion of correlatives looking at intrinsic biologic characteristics that may offer insight into druggable targets, aiming for improvement in survival outcomes for this rare lymphoma. Citation Format: Katherine Thiel, Rosa White, Qianqian Liu, Joel Michalek, Adolfo Enrique Diaz Duque. Primary cutaneous gamma-delta T-Cell lymphoma in the United States: A nationwide analysis of demographics and survival outcomes among the Hispanic population [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 813.

Optimizing presurgical education for patients with head and neck cancer receiving laryngectomy and free flap surgery: A qualitative study.

There has been limited study of oncology professionals' perspectives on optimizing delivery of presurgical education for individuals with head and neck cancer (HNC). Therefore, we assessed oncology professionals' perspectives about presurgical education for laryngectomy and free flap surgeries, which have a significant impact on patients' quality of life. Interviews were conducted with 27 oncology professionals from an NCI-designated Comprehensive Cancer Center and a community oncology setting. Participants identified six recommendations to improve presurgical education: (1) establishing preoperative consultations with allied health professionals; (2) educating patients and providers on the concept of team-based care; (3) optimizing education through multimodal strategies; (4) connecting patients with other HNC surgical patients; (5) preparing caregivers for their role; and (6) educating patients on insurance navigation. Study findings demonstrate gaps in the timing, content, and mode of delivery for presurgical education and suggest strategies for further evaluation in future studies.

Revisiting Feeding Tube Utilization in Oropharynx Cancer: 6-Year Prospective Registry Analysis.

Patients treated for oropharyngeal cancer (OPC) have historically demonstrated high feeding tube rates for decreased oral intake and malnutrition. We re-examined feeding tube practices in these patients. Retrospective analysis of prospective cohort from 2015 to 2021. Single-institution NCI-Designated Comprehensive Cancer Center. With IRB approval, patients with new oropharyngeal squamous cell cancer or (unknown primary with neck metastasis) were enrolled. Baseline swallowing was assessed via videofluoroscopy and Performance Status Scale for Head and Neck Cancer (PSSHN). G-tubes or nasogastric tubes (NGT) were placed for weight loss before, during, or after treatment. Prophylactic NGT were placed during transoral robotic surgery (TORS). Tube duration was censored at last disease-free follow-up. Multivariate regression was performed for G-tube placement (odds ratio [OR] [95% confidence interval [CI]) and removal (Cox hazard ratio, hazard ratio [HR] [95% CI]). Of 924 patients, most had stage I to II (81%), p16+ (89%), node-positive (88%) disease. Median follow-up was 2.6 years (interquartile range 1.5-3.9). Most (91%) received radiation/chemoradiation, and 16% received TORS. G-tube rate was 27% (5% after TORS). G-tube risk was increased with chemoradiation (OR 2.78 [1.87-4.22]) and decreased with TORS (OR 0.31 [0.15-0.57]) and PSSHN-Diet score ≥60 (OR 0.26 [0.15-0.45]). G-tube removal probability over time was lower for T3 to T4 tumors (HR 0.52 [0.38-0.71]) and higher for PSSHN-Diet score ≥60 (HR 1.65 [1.03-2.66]). In this modern cohort of patients treated for OPC, 27% received G-tubes-50% less than institutional rates 10 years ago. Patients with preserved baseline swallowing and/or those eligible for TORS may have lower G-tube risk and duration.

Cannabis Use among Cancer Survivors: Use Pattern, Product Type, and Timing of Use.

Despite growing interest in the use of cannabis for the treatment of cancer-related symptoms, there are limited studies that have assessed the use pattern, type, and mode of delivery of cannabis products used by cancer survivors. This study describes the current state of the use pattern, product type, and mode of delivery of cannabis used by cancer survivors. This was a cross-sectional study of cancer survivors from 41 U.S. states who received treatment at the largest NCI-designated comprehensive cancer center. The weighted prevalence of the use patterns, product types, and modes of delivery of cannabis used by cancer survivors was estimated. A total of 1886 cancer survivors were included in the study, with 915 (48% [95% CI: 45-51]) reporting ever using cannabis. Of survivors who had ever used cannabis, 36% (95% CI: 33-40) were current users. Among survivors who reported cannabis use after diagnosis, 40% used cannabis during and after cancer treatment, 35% used cannabis during treatment, and 25% used cannabis after completing their cancer treatment. Additionally, 48% of survivors reported an increase in cannabis use since cancer diagnosis. The commonest types of cannabis products used by cancer survivors were dry leaf cannabis (71%), cannabidiol (CBD) oil (46%), and cannabis candy (40%). Moreover, cancer survivors frequently used baked goods (32%), creams and gels (21%), and tinctures (18%). Furthermore, among ever users, the predominant mode of use was cannabis inhalation/smoking (69%) compared to eating/drinking (59%). More so, the common mode of inhalation/smoking of cannabis products were rolled cannabis cigarettes (79%), pipes (36%), water pipes (34%), vaporizers or vapes (14%), and e-cigarette devices (14%). A substantial number of cancer survivors use cannabis during cancer treatment, with increased use following cancer diagnosis. The forms and modes of delivery of cannabis varied among survivors, with most survivors inhaling or smoking cannabis. There is a need to educate healthcare providers (HCPs) and survivors on current evidence of cannabis use and strengthen cannabis regulatory frameworks to optimize benefits and minimize adverse events from cannabis use during cancer treatment.

Safety and Efficacy of Immune Checkpoint Inhibitors in the Treatment of Hodgkin Lymphoma in People Living with Human Immunodeficiency Virus: A Case Series

Introduction: Immune checkpoint inhibitors (ICI) have changed the landscape of cancer treatment. They work by disrupting the binding of immune checkpoint proteins, such as PD-1, PD-L1, and CTLA-4, which function to prevent over-activation of the immune system. By interrupting this binding, the body's natural immune response against cancer cells is enhanced. Nivolumab and pembrolizumab, two ICIs that target PD-1, are approved for use in relapsed/refractory Hodgkin lymphoma (HL). HIV is associated with higher rates of cancer, including HL. Several studies have demonstrated the safety of ICI in people with HIV (PWH) in many types of cancer. Unfortunately, many cancer clinical trials continue to exclude PWH without consideration of long-term adherence to highly active antiretroviral therapy (HAART), normal CD4+ counts, or undetectable viral loads because of fear regarding increased adverse events (AEs) and poor outcomes. In addition, studies have shown that PWH diagnosed with cancer are less likely to receive any cancer treatment. Here, we present three cases of PWH diagnosed with HL and treated with an ICI and examine their outcomes and ICI-related AEs. In addition, we discuss five matched cases of people without HIV infection diagnosed with HL and treated with an ICI. Methods: A retrospective study was performed for HL patients at an NCI-designated comprehensive cancer center from 2015 to 2022, diagnosed with HIV (confirmed with antibody testing) and treated with an ICI. Three patients met these criteria. HIV-negative matches for the above patients were identified based on diagnosis, treatment, stage, sex, and age. Five patients with HL without HIV infection were identified as appropriate matches based on these criteria. Demographic data and clinical outcomes data were collected from the electronic medical record. The common terminology criteria for adverse events (CTCAE) were used to classify and grade AEs. Due to a small sample size, statistical analyses and comparisons were not performed between PWH and PWOH Results: Demographic data (Table 1) and clinical response/outcome data (Table 2) are shown for all patients. Patients 1, 2, and 3 were HIV positive, while patients 4, 5, 6, 7, and 8 were HIV negative. ICI-related AEs were documented in three patients, one with and two without HIV. Patient 1, who was not compliant with HAART (CD4+ 70, viral load 1.39x10 6), experienced grade 4 myocarditis (confirmed on cardiac MRI) after cycle 2 with nivolumab, with pulseless electrical activity requiring pressor support and mechanical ventilation for four days, along with high-dose steroid taper, IV diuresis, and initiation of guideline-directed medical therapy (GDMT). Nivolumab was discontinued, and the patient was lost to follow-up with reported death three months later, attributed to HL. Patient 7 developed symptomatic grade 2 hypothyroidism on nivolumab after two cycles, requiring levothyroxine, to which the patient responded appropriately. Nivolumab was continued. Patient 8 experienced grade 3 myocarditis (confirmed on cardiac MRI) after cycle 7 of pembrolizumab, with hospitalization for IV diuretics and GDMT initiation. Pembrolizumab was discontinued. Discussion: In conclusion, ICIs are a therapeutic option for the treatment of HL in PWH. This limited case series suggests that PWH on long-term HAART tolerate ICIs well. The patient in our study who was not compliant with HAART experienced grade 4 myocarditis, with death attributed to lymphoma three months later. This may suggest an increased risk of ICI-related AEs and poorer outcomes in patients not on HAART and/or with poorly controlled HIV. However, further studies are required to investigate this risk, as our sample size was too small to draw statistically meaningful conclusions. Interestingly, one patient without HIV infection also experienced ICI-related myocarditis, but of less severe grade (grade 3 versus grade 4) than the patient with HIV. Most patients from both groups had an overall survival (OS) of more than two years, which may suggest that ICIs are not associated with decreased OS in patients with HIV infection. Unfortunately, our study was limited by the sample size, and statistical comparison of patients with and without HIV infection could not be performed. Further research is needed to investigate the tolerance and efficacy of ICIs as therapeutic options in PWH with Hodgkin lymphoma.

Disparities in Clinical Outcomes of B-Lymphoblastic Lymphoma: A National Cancer Database Study with Focus on Hispanic Populations in the United States

BACKGROUND Lymphoblastic lymphoma, a rare non-Hodgkin's lymphoma subtype, exhibits striking cytological and histological parallels with acute lymphoblastic leukemia (ALL). Such similarities have led to its classification as precursor B and T lymphoblastic lymphoma/leukemia by the World Health Organization. Exhibiting a modest global incidence of 1 to 5 cases per 100,000 population, it is notable that two-thirds of cases of ALL cases are of B-cell phenotype (PMID 15698386). To deepen our comprehension of this rare disease, it becomes essential to understand its behavior across various demographics, particularly among Hispanic (HI) and Non-Hispanic (NH) populations in the United States (US). To bridge this knowledge gap, this pioneering nationwide study endeavors to unravel how demographic, clinical, and survival outcomes vary between HI and NH patients with this disease. METHODS: Data were analyzed on B-Lymphoblastic lymphoma patients in the US reported to the National Cancer Database (NCDB) between 2004 and 2019. Demographic and treatment characteristics were compared between ethnic groups. Kaplan-Meier and Cox regression analyses were used to compare OS between Hispanic and Non-Hispanic populations. Multivariate analysis and propensity score matching was performed with adjustment for age, stage, co-morbidity score, and insurance status, type of facility and great circle distance. RESULTS Of 989 B-Lymphoblastic Lymphoma patients, 16 were HI, and 81% NH. 53% of HI were male, compared to 57% of NH. At diagnosis, HI patients were younger (40 years vs. 56 years) (p=&amp;lt;0.001); the majority of HI 84% and NH 68% were diagnosed in the age bracket of &amp;lt; 65 (p=&amp;lt;0.001). With respect to race, most of both HI and NH were whites (87% vs 85%), followed by blacks (1% vs 10%). Examining the stage, most of both HI 45% and NH 47% were stage IV (p= 0.260). When looking at insurance type; private insurance was the most prevalent type in HI vs NH (42% vs 51%), followed by government-sponsored (40% vs 44%). The most uninsured group was HI 16% vs NH 3%. Considering Census Median Income (2008-2012), the most prevalent bracket for HI was Less than $38,000 (29%) and NH was $63,000+ (34%). When it comes to median income of less than $38,000, HI were 29% vs NH 16%. As for Charlson-Deyo Score (comorbidities score), HI had 10% =/&amp;gt; 2 scores, vs NH 8%. In terms of Academic/Research Programs, including NCI-designated comprehensive cancer centers, it was the most prevalent type of facility providing care for both HI 55% and NH 50%. Regarding the median distance in miles between the patient's residence and the hospital that reported the case (Great Circle Distance), HI lived at a median of 9.3 miles, vs NH at a median of 12.4 miles. On survival analysis; the survival probability at 2, 5, and 10 years of HI vs NH were (0.624 vs 0.552), (0.516 vs 0.435), and (0.458 vs 0.362), respectively. The median survival time (MS) was 10.0 years for HI, vs 3.1 years for NH; and there was an overall survival (OS) difference favoring HI with (p=0.017). On multivariate analysis, there were no independent variables associated with better or worse OS; however, the propensity matched analysis showed a striking MS difference between HI vs NH (3.02 y vs. 1.43 y). CONCLUSION This groundbreaking study provides crucial insights into the distinct demographic and clinical characteristics of HI and NH patients with B-Lymphoblastic Lymphoma in the US. Importantly, we found that HI patients were significantly younger at diagnosis, and despite having a higher percentage of uninsured individuals and lower median income, showed better survival outcomes compared to NH. These findings highlight the critical role ethnicity plays in disease presentation and prognosis, thus emphasizing the importance of culturally sensitive, tailored healthcare approaches. This study underscores the urgent need for further research to understand intrinsic biologic factors contributing to these disparities and enhance health equity in lymphoma care.

Racial and Ethnic Disparities for Primary CNS Lymphoma: A National Cancer Database Analysis with Emphasis on Hispanics

BACKGROUND Primary central nervous system lymphoma (PCNSL) is an aggressive, extra nodal non-Hodgkin lymphoma (NHL), that accounts for ~4% of newly diagnosed central nervous system (CNS) tumors and 1-2% of all NHL. ( Blood PMID 26980727). The majority of PCNSL tumors are of the highly aggressive diffuse large cell subtypes, usually of B-cell phenotypic origin ( J Clin OncolPMID 28640701). Treatment survival remains heterogenous due to biologic differences and racial disparities. Multiple epidemiological studies have evaluated racial differences, with heterogenous results. There are published reports of culturally and ethnically diverse populations from high-income countries, showing statistically significant differences in PCNSL incidence and survival rates among different ethnicities ( Neuro OncolPMID 19273630), but there are no studies comparing Hispanics (HI) and Non-Hispanics (NH). This National Cancer Database (NCDB) analysis aims to provide information on how demographic, clinical, and survival outcomes differ in HI versus NH patients with PCNSL. METHODS Data were analyzed on PCNSL patients in the US reported to the NCDB between 2004 and 2019. Demographic and treatment characteristics were compared between ethnic groups. Kaplan-Meier and Cox regression analyses were used to compare OS between HI and NH populations. Multivariate analysis and propensity score matching was performed with adjustment for age, stage, co-morbidity score, and insurance status, type of facility and great circle distance. RESULTS Of 15908 PCNSL patients, 8% were HI, and 87% NH. 58% of HI were male, compared to 50% in NH. As compared to NH at diagnosis, HI pts were younger (mean 60 years vs. 67 years) (p&amp;lt;0.001); the majority of HI (59%) were diagnosed in the age of &amp;lt;65 vs majority of NH (45%) who were diagnosed in the age bracket of 65-70 (p&amp;lt;0.001). Regarding race, most of HI and NH were whites (92% vs 85%), followed by blacks (0.9% vs 7.3%). When examining insurance type; Government Sponsored was the most prevalent type in HI vs NH (56% vs 61%), followed by private insurance (29% vs 33%). The most non-Insured group was HI (12%) vs NH (2%). Regarding Census Median Income (2008-2012), the most prevalent bracket (29%) for HI was $48,000 - $62,999, and for NH (36%) $63,000 +. When looking at median income of less than $38,000, HI were 25% vs NH 14%. Regarding Charlson-Deyo Score (comorbidities score), HI had 20% =/&amp;gt; 2 score, vs NH 16%. (p&amp;lt;0.001). Academic/Research Programs, including NCI-designated comprehensive cancer centers, was the most prevalent type of facility providing care for both HI (49%) and NH (50%). Regarding the median distance in miles between the patient's residence and the hospital that reported the case (Great Circle Distance), HI lived at a median of 9.7 miles, vs NH at median of 14.7 miles. On survival analysis, the survival probability at 2, 5 and 10 years of HI vs NH were (54% vs 47%), (43% vs 34%), and (32% vs 22%), respectively. The median survival time (MS) was 3 years for HI, vs 1.6 years for NH; and there was an overall survival (OS) difference favoring HI with (p&amp;lt;0.0001). Independently, on multivariate analysis, not insured status was associated with worse OS (HR 1.22, CI 1.02-1.47, p&amp;lt;0.01) and private insurance type was associated with better OS (HR 0.82, CI 0.73-0.93, p&amp;lt;0.01). Interestingly, the propensity matched analysis demonstrated significant MS difference between HI vs NH (median 1.64 years vs. 1.43 years; p&amp;lt;0.01). CONCLUSION In this data analysis from the NCDB between 2004-2019, HI with PCNSL have dissimilar outcomes when compared to NH. There were statistically significant differences between HI and NH in age at diagnosis, median income, and higher Charlson-Deyo Score. There were statistically significant differences in MS, survival at 2, 5, and 10 years and OS favoring the HI cohort. Unique and heterogeneous characteristics from HI may explain why there is an increase in OS after PCNSL diagnosis in this cohort of patients, with differences mainly arising from HI being diagnosed at a younger age and living closer to the treatment facilities as compared to NH. As personalized therapies for PCNSL are being developed, equitable access including clinical trials should be advocated for resource-limited settings as well as aiming at studying biologically characteristics of HI with PCNSL to better understand and improved outcomes in all cohorts.

Evaluation of delays to multidisciplinary treatment of soft tissue sarcomas at a tertiary cancer center.

62 Background: Management of soft tissue sarcomas often requires coordinated multidisciplinary care including radiation, medical, and surgical oncology. Delays in the multidisciplinary evaluation and treatment may lead to poorer outcomes. Coordination of care through a multidisciplinary clinic (MDC) offering access to all three specialties during the same clinic visit may reduce time from initial evaluation to treatment. Methods: Adult patients treated for soft tissue sarcoma at an NCI-designated comprehensive cancer center following the opening of a sarcoma MDC in November 2021 to May 2023 were included. Patients were either seen in the sarcoma MDC or separately by oncologic providers (usual care). The primary outcome was delay in treatment initiation, defined as greater than 21 days from initial consultation to first treatment. Reasons for delay were abstracted. Descriptive statistics and bivariate analyses were performed. Results: Among 147 patients, 20 were (13.6%) seen in MDC and 127 (86.4%) by usual care. Initial treatments were surgery (46.9%), radiation (30.6%), or systemic therapy (22.4%). Median time to treatment was 34 days (IQR 14-57 days), which differed by treatment modality (surgery 34 days, radiation 37 days, systemic 18 days). There were no significant differences in time to treatment for MDC patients (33 days, IQR 25-44) versus usual care (34 days, IQR 13-57) (p=0.93). However, a significantly higher proportion of MDC patients received multiple modalities of treatment (75.0% vs 48.8% usual care, p=0.011), with a longer average time to treatment in the multi- versus single-modality groups (41 vs 22 days, p&lt;0.001). Among patients requiring multimodal therapy, median time to treatment was 33 days for MDC patients versus 44 days for usual care (p=0.07). MDC patients were also much more likely to receive radiation (90.0% MDC vs 45.6% usual care, p=0.001). Delays in care (n=76, 51.7% of cohort) were seen in 66.7% (12/18) of MDC patients versus 58.3% (63/108) of usual care patients. The most common reasons for delay were need for additional imaging (29.7%) or preoperative testing (18.8%). Conclusions: In this single-center study, no improvement in time to treatment was seen following the opening of a sarcoma multidisciplinary clinic, likely explained by higher proportion of MDC patients receiving multiple treatment modalities. Primary reasons for delay could be anticipated prior to initial evaluation and represent an opportunity for more active case review prior to in-person evaluation to reduce delays in sarcoma treatment.

Development and initial evaluation of a visualization tool for multidisciplinary treatment discussion of patients with pancreatic cancer.

585 Background: Pancreatic cancer is the third leading cause of cancer death in the United States; it is a complex disease requiring coordinated patient care. Multidisciplinary tumor boards (MTB) are today's gold standard in pancreatic cancer but are frequently criticized for being time-intensive and inefficient. To address this issue, Cancer Collective and Hive Networks have developed a novel patient-information visualization tool designed to improve the communication and efficiency of multidisciplinary tumor board meetings. This pilot study investigated the patient-information visualization tool's usability, efficiency, and feasibility in pancreatic cancer tumor board meetings. Methods: A prospective multi-center pilot study was conducted at Northwell Health (a comprehensive community cancer program [NCCCP] in the Northeastern United States) and the University of California San Diego (an NCI-designated comprehensive cancer center in [NCCC] in the Southwestern United States. The feasibility of the tool was assessed by measuring the percentage of MTB cases discussed that used the patient-information visualization tool. The usability and efficiency of the tool were assessed via Likert scale questions. Acceptable usability and effectiveness were defined as a 70% score or higher. Additionally, MTB participants were queried for input on design improvements for future iterations and expected future directions of tool use. Results: The patient-information visualization tool was rolled out on 07/22/2022 at the NCCP and NCCC. From 07/22/2022-05/31/2023, 170 (92%) MTB cases were reviewed at the NCCP. From 07/22/2022-05/31/2023, 74 cases (100%) of MTB cases were reviewed using the patient-information visualization tool at the NCCP. The NCCP (n=9) mean scores for usability and efficiency were 4.31 (86%) and 4.17 (83%) respectively. The NCCC (n=6) mean scores for usability and efficiency were 4.04 (81%) and 3.96 (79%) respectively. Qualitative feedback, reported on survey open-ended questions, included suggested enhancements to improve the tool’s usability, such as leveraging data automation to reduce data entry burden, improving the user interface for ease of data visualization, and adding additional data elements (e.g., specific procedure and appointment details) to improve decision-making utility. Conclusions: Implementing the novel digital dashboard to visualize pancreatic cancer patient data was highly feasible, usable, and efficient. Future directions of tool use include refining based on qualitative feedback from end users and planning for data automation and interoperability with the EMR.

Recruiting Black and White patients to a behavioral oncology clinical trial: Lessons from the DISCO trial.

102 Background: Data show that 55% of trials are terminated due to insufficient accrual, which is especially low for patients identifying as Black. In 2021, we initiated recruitment to a clinic-based behavioral oncology trial testing the effectiveness of a health equity communication intervention designed to address patient cost concerns. This study involves patients and clinicians completing surveys before and after a video-recorded clinical interaction. We are implementing this study at an NCI-designated comprehensive cancer center in Detroit, Michigan, a city comprised of a majority of Black residents (80%). Based on the aims and literature showing that most patients agree to participate in trials if they are eligible and invited, we set a sample goal of 50% Black and 50% White patients. We use strategies based on literature and our own experience, including having a diverse staff and building trusting relationships with participants. As we begin the third and final year of recruitment with about 2/3 of our required patient sample (N=180) recruited, we consider what suggestions we can offer teams seeking to efficiently recruit a diverse patient sample to clinical trials. Methods: We based our strategies on evidence that racially concordant (same racial group) clinical dyads have greater communication quality than racially discordant (different racial group) dyads, and that medical mistrust is greater among Black than among White patients. First, we hired and trained a team that includes both Black and White members, and encouraged them to take leadership roles in the team. Second, we built trust with clinic staff, clinicians and patients. Procedures involve discussing the study with clinicians and their staff, recruiting clinicians as participants, and screening their patients for eligibility. We then recruit patients in-person in the clinic or by phone. Patients who provide oral consent are later met in person to collect written consent. Results: We have achieved a consent rate of 52% across 4 clinics; our sample includes 74 (62%) Black patients and 45 (38%) White patients. We attribute this to critical aspects of our protocol. First, recruitment of clinicians as participants helps capture the attention of and build trust with patients. Second, we have a flexible recruitment approach. Once potential participants are screened, we decide whether to approach them in person or by phone. Third, our team is comprised of Black and White individuals to reflect the patient population we hope to recruit. Last, we have the support of a diverse group of medical student team members who assist in times of increased recruitment. Conclusions: Our strategies, based on social science literature, helped achieve our goal of recruiting a sample that reflects racial diversity in our patient population. These and similar strategies can be adapted for other trials with the goal of achieving clinical trial recruitment equity. Clinical trial information: NCT04766190 .

Access to Care and Healthcare Quality Metrics for Patients with Advanced Genitourinary Cancers in Urban versus Rural Areas.

Compared to the urban population, patients in rural areas face healthcare disparities and experience inferior healthcare-related outcomes. To compare the healthcare quality metrics and outcomes between patients with advanced genitourinary cancers from rural versus urban areas treated at a tertiary cancer hospital, in this retrospective study, eligible patients with advanced genitourinary cancers were treated at Huntsman Cancer Institute, an NCI-Designated Comprehensive Cancer Center in Utah. Rural-urban commuting area codes were used to classify the patients' residences as being in urban (1-3) or rural (4-10) areas. The straight line distances of the patients' residences from the cancer center were also calculated and included in the analysis. The median household income data were obtained and calculated from "The Michigan Population Studies Center", based on individual zip codes. In this study, 2312 patients were screened, and 1025 eligible patients were included for further analysis (metastatic prostate cancer (n = 679), metastatic bladder cancer (n = 184), and metastatic renal cell carcinoma (n = 162). Most patients (83.9%) came from urban areas, while the remainder were from rural areas. Both groups had comparable demographic profiles and tumor characteristics at baseline. The annual median household income of urban patients was $8604 higher than that of rural patients (p < 0.001). There were fewer urban patients with Medicare (44.9% vs. 50.9%) and more urban patients with private insurance (40.4% vs. 35.1%). There was no difference between the urban and rural patients regarding receiving systemic therapies, enrollment in clinical trials, or tumor genomic profiling. The overall survival rate was not significantly different between the two populations in metastatic prostate, bladder, and kidney cancer, respectively. As available in a tertiary cancer hospital, access to care can mitigate the difference in the quality of healthcare and clinical outcomes in urban versus rural patients.

Surveillance With Serial Imaging and CA 19-9 Tumor Marker Testing After Resection of Pancreatic Cancer: A Single-Center Retrospective Study.

Most patients receiving curative-intent surgery for pancreatic cancer will experience cancer recurrence. However, evidence that postoperative surveillance testing improves survival or quality of life is lacking. We evaluated the use and characteristics of surveillance with serial imaging and CA 19-9 tumor marker testing at an NCI-designated comprehensive cancer center. We conducted a retrospective cohort study of patients who entered surveillance after curative-intent resection of pancreatic adenocarcinoma. We abstracted information from the electronic medical record about oncology office visits, surveillance testing (cross-sectional imaging and CA 19-9 tumor marker testing), and pancreatic cancer recurrence, with follow-up through 2 years after pancreatectomy. We conducted analyses to describe the use of surveillance testing and to characterize the sensitivity and specificity of CA 19-9 tumor marker testing for the identification of cancer recurrence. We identified 90 patients entering surveillance after pancreatectomy. CA 19-9 was the most frequently used surveillance test, followed by CT imaging. Forty-seven patients (52.2%) experienced recurrence within two years of pancreatectomy. Recurrence risk was 58.8% versus 31.8% in patients with elevated versus normal CA 19-9 at diagnosis ( P =0.03). Elevated CA 19-9 at any point during surveillance was significantly associated with 2-year recurrence risk ( P <0.001). Elevated CA 19-9 had a sensitivity of 83% (95% CI 0.72-0.95) and specificity of 87% (0.76-0.98) for identification of recurrence within 2 years of pancreatectomy. CA 19-9 demonstrates clinical validity for identifying recurrence of pancreatic cancer during surveillance. Surveillance approaches with reduced reliance on imaging should be prospectively evaluated.

Community-engaged basic science in an NCI-designated comprehensive cancer center: antioxidants and chemotherapeutic efficacy.

While community engagement has been a longstanding aspect of cancer-relevant research in social and behavioral sciences, it is far less common in basic/translational/clinical research. With the National Cancer Institute's incorporation of Community Outreach and Engagement into the Cancer Center Support Grant guidelines, successful models are desirable. We report on a pilot study supported by the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC), that used a community-engaged, data-driven process to inform a pre-clinical study of the impact of antioxidants on the efficacy of platinum-based chemotherapeutics. We conducted a survey of UMGCCC catchment area residents (n = 120) to identify commonly used antioxidants. We then evaluated the effect of individually combining commonly used antioxidants from the survey (vitamin C, green tea, and melatonin) with platinum agents in models of non-small cell lung cancer (A549), colon adenocarcinoma (SW620) and head and neck squamous cell carcinoma (FaDu). In vitro, the anti-neoplastic activity of each chemotherapy was not potentiated by any of the antioxidants. Instead, when combined at fixed ratios, most antioxidant-chemotherapy combinations were antagonistic. In vivo, addition of antioxidants did not improve chemotherapeutic efficacy and in a FaDu-tumor bearing model, cisplatin-mediated tumor growth inhibition was significantly impeded by the addition of epigallocatechin gallate, the main antioxidant in green tea. These initial findings do not support addition of antioxidant supplementation to improve platinum-based chemotherapeutic efficacy. This study's approach can serve as a model of how to bring together the two seemingly discordant areas of basic research and community engagement.

Real-World Toxicity of Conventional Versus Hypofractionated Definitive Prostate Radiotherapy across a Large, Diverse, Academic and Community-Based Enterprise.

Over the past 10-15 years there has been increasing adoption of moderate hypofractionation (HF) for definitive prostate radiotherapy as compared to conventional fractionation (CF). Based on several randomized trials hypofractionation results in equivalent treatment efficacy with similar rates of long-term toxicity. However, some studies suggest higher acute GI toxicity with moderate hypofractionation. We sought to compare the rates of toxicity between these two groups across our enterprise including 16 community-based practices and one academic NCI-designated comprehensive cancer center. We retrospectively extracted radiation treatment intent from our network-wide clinical pathways for patients diagnosed with prostate cancer between 3/2019 and 10/2022. Patients treated after prostatectomy and those treated with brachytherapy or SBRT were excluded. For the remaining 1529 patients treated with either conventional fractionation or moderate hypofractionation, we identified and merged physician-graded toxicity data using CTCAE version 5.0 recorded in their electronic medical record at each weekly on-treatment visit and follow-up. A total of 1051 patients had toxicity data available. Rates of toxicities were then compared between the cohort of patients who received CF and those who HF using the Chi-square test. Of the 1051 patients, 450 (43%) received CF and 601 (57%) received HF. These patients were treated by 40 different radiation oncologists (median patients per physician = 18, interquartile range = 7-35). Median age in the CF and HF cohorts was 71 (IQR: 66-76) and 71 (IQR: 66-77; p = 0.51), respectively. The CF cohort had more patients with Gleason 8+ disease (39% vs 19%; p<0.01), PSA >20 (26% vs 11%; p<0.01), or T3a+ (18% vs 8%; p<0.01). Rates of any grade 2+ toxicity were significantly higher in patients who received HF at 45.8% vs 39.6% for those treated with CF (p = 0.04). However, the respective rates of any grade 3+ toxicity were no different at 2.0% vs. 1.8% (p = 0.80). The difference in grade 2 toxicities appeared to be primarily driven by the rates of urinary frequency at 27.1% vs. 17.8% (p<0.01) and prostatic obstruction 14.8% vs. 10.2%, p = 0.03). Rates of grade 2 diarrhea were worse with MF at 5.3% vs. 2.8% for CF (p = 0.04). There were no significant differences between HF and CF in the rates of grade 2 dysuria (6% vs 5.2%), urinary urgency (6.5% vs. 4.2%), proctitis (3.0% vs. 3.6%), urinary incontinence (0.5% vs. 1.3%), rectal bleeding (0.3% vs. 0%), hematuria (0% vs. 0.4%), and fatigue (14.1% vs. 15.1%). In this large network-wide analysis, toxicity was slightly increased among patients with prostate cancer treated with HF compared to CF, consistent with published randomized data. However, the increased toxicity appeared to be primarily GU rather than GI. This study demonstrates the feasibility of analyzing impacts of treatment decisions on a large scale using real-world data through an integrated network of practices.

Improving Sexual Orientation and Gender Identity Documentation at an NCI-Designated Comprehensive Cancer Center

To increase the rate of sexual orientation and gender identity (SOGI) patient data collection in healthcare software for new patients at a NCI-Designated Comprehensive Cancer Center, via targeted identification of Advanced Practice Providers (APP), development of novel SOGI collection workflows, creation of a real-time SOGI data dashboard, and tailored training utilizing existing High Reliability Organization (HRO) huddles in order to measure, analyze, and improve the quality of care, safety, and patient experiences for Sexual and Gender Minority (SGM) patients. Prior to interventions, project leadership (PL) and data analytics staff obtained SOGI baseline data, while cancer center clinical leadership, registration, and administrative staff identified APPs as the most appropriate staff to collect patient SOGI data. Intervention 1: PL met with Disease Management Groups (DMG)/HRO leads of thoracic medical oncology to identify a practice-level APP champion. PL and the APP champion scripted language for multiple scenarios when asking SOGI questions, and served as a resource for additional practice APPs. PL provided SGM-focused training during HRO huddles, which included how to ask and document SOGI, and significance of asking SOGI information. SOGI data completion rate was tracked on a HRO scorecard. This intervention was replicated across additional DMG/HROs during the study period. Intervention 2: Breast surgical oncology completed Intervention 1 and added SOGI questions to their new patient-facing intake form, allowing patients to self-identify. PL and data analytics team provided continuous feedback to DMG/HRO leads on provider-level completion rates and additional education as needed. At the end of the Interventions, there were 9 LGBTQ+ Knowledge and Awareness HRO training sessions completed resulting in over 300 unique individuals receiving advanced SOGI documentation education. For intervention 1, there were 12,322 new patients asked their SOGI information, which was a greater than 300% increase in SOGI documentation (baseline completion rate for sexual orientation and gender identity was 17% and 21%, respectively, which improved to 77% and 84%). For intervention 2, there were 3,217 new patients asked their SOGI information, which was a greater than 400% increase (baseline completion rate for sexual orientation and gender identity was 13% and 16%, respectively, which improved to 81% and 81%). Together, patient self-reporting quickly increased data completion rates from baseline, comparable to clinical sites from Intervention 1, and may decrease the burden of APPs collecting SOGI history; however, clinical review of questions is important and may further increase SOGI data completion. Leadership buy-in, site champions, and active data monitoring are essential to measurable change. Together, improved SOGI data completion will allow for improved equitable cancer care and increased assessment of SGM cancer disparities.

Stereotactic Radiosurgery as an Effective and Safe Treatment Modality in Central Nervous System Lymphoma, a Single Institution Experience

CNS lymphoma (CNSL) is an aggressive liquid cancer with the potential for rapid progression. Standard treatment regimens for CNSL have included chemotherapy and whole brain radiotherapy (WBRT). WBRT carries a high risk of leukoencephalopathy (LE) manifesting as cognitive decline and is identifiable on brain MRI as fluid attenuation inversion recovery (FLAIR) changes. Stereotactic radiosurgery (SRS) can precisely deliver higher biologically effective doses of radiation, while minimizing damage to surrounding healthy brain tissue. SRS offers enhanced local control in CNSL with minimal risk of LE. Patients undergoing SRS at an NCI-designated comprehensive cancer center from 2000 to 2022 were prospectively enrolled into a database. Twenty-nine consecutive patients diagnosed with relapsed primary CNSL (59%) or secondary CNSL (41%) were included in this study. Median age at diagnosis was 70 (range 23-91) years and 14 were female. Follow up MRI imaging was obtained at 1-, 3-, 6- and 12-months post-procedure. Measurement of tumor volumes was performed at treatment and each subsequent follow-up by image co-registration and tumor segmentation. Pre and post SRS brain MRIs were independently reviewed by a neuro-radiologist to score the grade of LE for each patient. Progression-free survival (PFS) and overall survival (OS) were calculated using Kaplan-Meier analyses and Log-rank tests using statistical software. Twenty-nine patients treated for 50 tumors were studied. Twenty-four patients were treated for a single tumor, and 5 for multiple tumors. Six patients underwent repeat SRS treatment for 10 out-of-field recurrences and 1 patient for an in-field recurrence. Of the 35 SRS procedures performed, 32 (88%) were single session delivery and 3 were hypofractionated. Stereotactic immobilization was achieved with frame (57%) or thermoplastic mask (43%). Median prescribed dose was 14 Gy (range 10-21) to the 50% isodose line (range 40-100). Median coverage, selectivity and gradient index were 0.97, 0.69, and 2.9 respectively. Median follow-up time was 4.5 months (range 0.5-64). Twenty-six (52%) tumors completely responded to treatment with no residual enhancement, while the rest decreased in volume. No tumor failed to respond to treatment. Median time to best volumetric response was achieved in 2.9 months (range 1-6.1) and median volume of best response was zero cc (range 0-1.19). The median OS of the cohort was 7.0 months (95% CI 5.1-8.9), while the median PFS was 5.0 months (95% CI 1.2-8.8). Median score of LE was zero, and only one patient experienced grade 3 MRI FLAIR changes. With a median time to response of 2.9 months, a 100% initial response rate and a single in-field failure, our analysis demonstrates a rapid and effective response of CNSL to SRS. Distant failures were controlled with repeat SRS. The absence of LE in the treated patients provides further evidence for safety and tolerability of SRS in CNSL.