Late-Breaking Abstracts

October 2024 Vol 15, No 10
 

Category I: Community Outreach/Prevention

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A1 Comadre a Comadre: Enhancing Cancer Screening Among Hispanic/Latinx Through Community-Based Patient Navigation

Elba L. Saavedra Ferrer, PhD1; Wendy L. Hine, PhD2; Patricia Corona de Ortega1; Carmengloria Hulsey, BS1; Andrew Sussman, PhD, MCRP1

1UNM Comprehensive Cancer Center; 2University of New Mexico Hospitals

Background: Hispanic/Latinx have lower mammogram screening rates for breast cancer compared with non-Hispanic Whites and are more likely to die of breast cancer, as it is the leading cause of cancer death. In particular, monolingual Spanish-speaking Hispanics/Latinx face tremendous challenges navigating the US healthcare system, often lack insurance, lack access to primary care services, and are challenged with needing medical interpretation. All this contributes to lower screening rates and lower rates of early detection. The implementation of oncology nurse navigation in oncology settings has become a standard of care. Less is known about the efficacy of patient navigation in community-based settings. Some reported studies show that community-based patient navigation can be applied with specific vulnerable, ethnically diverse populations for various health outcomes, such as increasing colorectal cancer screening and follow-up for an abnormal screening mammogram. Under-resourced individuals face additional barriers that are outside the domain of the medical clinic setting, such as emotional distress in seeking cancer screening (fear of cancer and fatalistic beliefs about cancer), practical and logistical barriers (ie, transportation), and language barriers (despite medical interpreters). Community- based patient navigation is a component of the Comadre a Comadre Program. The Comadre Program is a multilevel, community-based patient navigation intervention that applies culturally and linguistically competent strategies across the breast cancer continuum to improve the outcomes among Hispanic/Latinx in New Mexico.

Objective: To use descriptive analysis to show how community- based patient navigation enhanced cancer screening for breast and cervical cancer for 200 Hispanic/Latinx.

Methods: Participants self-referred for patient navigation services through attendance at Comadre-sponsored breast and cervical educational classes in the community, telephoned the program requesting assistance, signed up at a health fair, or were referred by a community health clinic. Once enrolled, a needs assessment was conducted, and social drivers (social determinants of health/barriers) were identified along with breast and cervical health needs ultimately resulting in being navigated for a medical appointment. A total of 200 uninsured, Hispanic/Latinx, and monolingual Spanish speakers were enrolled in patient navigation. All navigation efforts were tracked and entered into REDCap for analysis.

Results: Outcomes reported will include graphs showing the number who completed their cancer screening appointments, type of follow-up, process of partnering with community clinics and the role of memoranda of understanding, process of resolution of barriers, and data showing overall enhanced cancer screening resulting from navigation.

Conclusion: Less is known about the efficacy of patient navigation in community-based settings concerning cancer screening; results from this screening navigation study will present data that may be able to further our understanding of the key strengths of community-based patient navigation and perhaps apply it to other cancers, other health conditions, and other populations.

Sources

American Cancer Society. Cancer Facts & Figures for Hispanics and Latinos 2018-2020. 2018. www.cancer.org/research/cancer-facts-statistics/hispanics-latinos-facts-figures.html

Baik SH, Gallo LC, Wells KJ. Patient navigation in breast cancer treatment and survivorship: a systematic review. J Clin Oncol. 2016;34:3686-3696.

Berchick ER, Hood E, Barnett JC. Health Insurance Coverage in the United States: 2017. Washington, DC: United States Census Bureau; 2018. Accessed February 2, 2019. www.census.gov/library/publications/2018/demo/p60-264.html

Buki LP, Borrayo EA, Feigal BM, Carrillo IY. Are all Latinas the same? Perceived breast cancer screening barriers and facilitative conditions. Psychology of Women Quarterly. 2004;28(4):400-411.

Jerome-D’Emilia B. A systematic review of barriers and facilitators to mammography in Hispanic women. J Transcult Nurs. 2015;26:73-82.

Luque JS, Tarasenko YN, Bryant DC, et al. An examination of sociocultural factors associated with mammography screening among Latina immigrants. Hisp Health Care Int. 2017;15:113-120.

Maskarinec G, Sen C, Koga K, Conroy SM. Ethnic differences in breast cancer survival: status and determinants. Womens Health (Lond). 2011;7:677-687.

Ramachandran A, Freund KM, Bak SM, et al. Multiple barriers delay care among women with abnormal cancer screening despite patient navigation. J Womens Health (Larchmt). 2014;24:30-36.

Reeder-Hayes KE, Wheeler SB, Mayer DK. Health disparities across the breast cancer continuum. Semin Oncol Nurs. 2015;31:170-177.

Thompson B, Hohl SD, Molina Y, et al. Breast cancer disparities among women in underserved communities in the USA. Curr Breast Cancer Rep. 2018;10:131-141.

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Category II: Care Coordination/Care Transitions

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B1 Effectiveness of Clinical Trials Education for Native American Patients With Cancer: A Quality Improvement Project

Aminah Tayyab, MD1; Sheryl Buckner, PhD, RN, ANEF2; Justin D. Dvorak, PhD3; Ryan Nipp, MD4; Mark P. Doescher, MD, MSPH4; Amanda E. Janitz, PhD3; Amber A. Anderson-Buettner, PhD3; Dorothy A. Rhoades, MD, MPH4

1University of Oklahoma College of Medicine, University of Oklahoma Health Sciences, Oklahoma City, OK; 2OU Fran and Earl Ziegler College of Nursing, University of Oklahoma Health Sciences, Oklahoma City, OK; 3Hudson College of Public Health, University of Oklahoma Health Sciences, Oklahoma City, OK; 4OU Health Stephenson Cancer Center and University of Oklahoma Health Sciences, Oklahoma City, OK

Background: Native American (NA) populations are underrepresented in cancer clinical trials.1,2 We sought to address this disparity through clinical trials education (CTE) for NA patients with cancer.

Objective: To evaluate the effectiveness of in-person CTE to enhance NA patients’ understanding of clinical trials and the importance of trial participation.

Methods: The American Indian Navigation Program at the Stephenson Cancer Center in Oklahoma developed an enhanced navigation model incorporating CTE at the initial navigation visit based on input from an indigenous community advisory board. From September 2023 to July 2024, NA patients completed a 6-item survey assessing attitudes and perceptions toward clinical trials, including importance of minority participation, likelihood of seeking information, searching for clinical trials, discussing trials with clinicians, talking with family and friends, and joining a trial. Patients responded using a 5-point scale; high score (5) indicated strong agreement and low score (1) strong disagreement. The navigator presented an 11-slide CTE presentation on clinical trial types, ethical treatment, informed consent, participation risks/benefits, and clinical research. A postpresentation survey identical to the first was administered to evaluate changes. We assessed change in agreement scores, performed group comparisons, and tested associations between age and agreement scores using nonparametric tests.

Results: Ninety-six patients completed pre/post-CTE surveys. Over 25 different cancers were reported, with prostate cancer the most common (11%). Average age was 58 years (±13), and 57% were female. An increase in pre/ post-CTE scores occurred for importance of minority participation (3.85 to 4.14; p43; P=.55) or of joining a trial (3.60 to 3.66; P=.46). Age was not associated with changes in scores. Pre-CTE scores were higher for female versus male patients for importance of minority participation (4.04 vs 3.58; P=.01), but no significant differences in changes in scores by gender occurred. About 13% of patients had prior clinical trial experience, but no statistical differences were noted for this group.

Conclusion: In-person CTE increased understanding and attitudes toward clinical trials among NA patients with cancer, particularly regarding the importance of diversity and engaging in discussions with clinicians and family. However, no significant shifts in proactively searching for trials or willingness to join a trial occurred. Additional efforts are needed to assess whether improved awareness translates into increased participation in clinical trials.

This project is supported by a patient navigation capacity- building grant from the American Cancer Society.

References

  1. Aldrighetti CM, Niemierko A, Van Allen E, et al. Racial and ethnic disparities among participants in precision oncology clinical studies. JAMA Netw Open. 2021;4:e2133205.
  2. Mainous AG, Kelliher A, Warne D. Recruiting indigenous patients into clinical trials: a circle of trust. Ann Fam Med. 2023;21:54-56.
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B2 Equipping Navigators With Clinical Trial Knowledge: Development of a Clinical Trial Educational Series

Jordan Henderson, BSN, RN, OCN, ONN-CG

Director of Program Development, AONN+

Background: As navigation evolves, clinical trial navigators are emerging to address the needs and challenges of recruitment and retainment. Patient navigation is a strategy to improve participation in addressing diversity gaps by raising awareness of available trials, promoting patient recruitment with education on clinical trial availability, and supporting logistics of retainment.1

Objectives: Acknowledging navigation’s role in clinical trials, Bayer Pharmaceuticals collaborated with the Academy of Oncology Nurse & Patient Navigators (AONN+) and developed 5 education modules to equip navigators with the knowledge and tools to better educate their patients and address clinical trial knowledge gaps.

Methods: A 5-part webinar series was developed with clinical trial key opinion leaders and offered to all AONN+ members. The 5 module topics included:

  • Clinical Trial Education for the Navigator
  • Health Equity: Mobilizing the Role of the Navigator Within Clinical Trials
  • Role Delineation Within the Clinical Trial Team
  • Increasing Patient Engagement Within Clinical Trials
  • Clinical Trial Navigation Practice – Case Study Exchange

These topics were selected based on key findings from a 2022 AONN+ clinical trials focus group that highlighted the lack of communication between clinical trial teams and navigation, which creates missed opportunities for patient engagement and retention and the need for more education on the navigation role within clinical trials.2

This series evaluated navigator current knowledge gaps and gains through pre- and posttest surveys on 4 of 5 modules, as the case study module lacked a survey.

Results: Within a 3-month period, there were 140 viewers of the series. Total views included 1931, with the highest engagement videos being Increasing Patient Engagement (244 views) and Clinical Trial Education (244 views). Health Equity, Role Delineation, and Case Study had 205, 229, and 87 views, respectively. Survey metrics include 236 course attempts, 111 course passes, and 66 fails.

The educational course with the highest pass rate was Clinical Trial Education (32); the highest fail rate was with Role Delineation (31). Of the total course attempts, 59 were incompletes in which the participant for an unknown reason did not complete the evaluation.

Conclusion: Navigators need education and awareness of the clinical trials process to contribute to patient recruitment and retainment. The posttest evaluation validates the need to increase educational offerings on role delineation and patient engagement to increase navigator confidence in guiding patients through clinical trials. The clinical trial modules are foundational to arm navigators with the knowledge and tools to better educate their patients and address clinical trial knowledge gaps.

Dr Kreb’s statement, “to provide information about clinical trials for their patients, navigators must first start with their own education,”3 supports this initiative. AONN+ will continue to advance clinical trial educational initiatives.

References

  1. Gentry S, Burhansstipanov L. Navigation and Clinical Trials. In: Shockney L (ed). Team-Based Oncology Care: The Pivotal Role of Oncology Navigation. Springer; 2018:251-274.
  2. Academy of Oncology Nurse & Patient Navigators. Proposal for Navigation Professional Enhancement. https://indd.adobe.com/view/6c13d683-1db4-4ccf-80b6-10aaac337e3d?utm_source=aonnonline&utm_medium=tool&utm_campaign=navigationtools
  3. Krebs LU. The role of navigators, patients, and community members in accruing for clinical trials. Journal of Oncology Navigation & Survivorship. 2021;12(5):152-153.
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B3 Lung Cancer: Care Transitions and Coordination to Improve Timeliness to Care

Carol Kirton, MBA, BSN, RN, OCN, ONN-CG1; Valerie Patterson, MSN, BSN, RN1; Susie Sonnier, MS, RN2; Apryl Stewart, BSN, RN, OCN1; Janet Pollard, MSW, LCSW, OSW-C3

1HCA Healthcare Sarah Cannon Cancer Network; 2Parallon Patient Navigation Services; 3HCA Houston Healthcare

Background: Lung cancer is the leading cause of cancer death in the United States with approximately 234,580 new cases and 125,070 deaths expected in 2024. Resolution of suspicious incidental findings should occur within 2 months of the initial study; similarly, definitive therapy for proven malignancy should occur within 6 weeks of diagnosis.

Objective: To identify barriers preventing patients from obtaining care within the recommended 6 weeks from diagnosis to treatment and identify processes that can help improvement.

Methods: Cancer registry, electronic medical record, and navigation data were analyzed for 76 lung cancer patients in 2022. Reasons for treatment delay were reviewed and included timeliness of referrals from physicians, patients lost to follow-up, patient choice, and additional workup needs. A process improvement plan was implemented in 2023 with a goal to initiate treatment within 45 days and improve timeliness of treatment by 15%. The plan included a process to manually track all 85 hospital-diagnosed lung cancer patients in 2023. Data were collected to show improvement.

Results: Data analyzed in 2022 showed a total of 76 patients were diagnosed at the facility. Forty-four patients met the study’s eligibility criteria, and 32 patients were excluded. In 2022, 13 of the 44 (30%) patients encountered delays resulting in initiation of therapy in greater than 45 days. Seventy percent of the group met the 45-day goal for timely care. A total of 85 patients were diagnosed at the facility in 2023. Twenty-three of the 85 patients did not meet eligibility. Six of 62 patients (10%) had a greater than 45-day treatment initiation, with 56 patients (90%) receiving treatment within the 45-day goal.

Conclusion: This multidisciplinary team project resulted in enhanced communication, collaboration, and coordination among the key stakeholders. Due to these findings, a follow-up study with the inclusion of a low-dose computed tomography screening navigator will be included. A positive correlation was seen with the process/communication improvement plan by a reduction of treatment delay by 20%.

Sources

American Cancer Society. Cancer Facts & Figures 2024. www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf

Asch S, Kerr E, Hamilton EG, et al. Quality of Care for Oncologic Conditions and HIV: A Review of the Literature and Quality Indicators. RAND Corporation. 2000. www.rand.org/pubs/monograph_reports/MR1281.html

Chan RJ, Milch VE, Crawford-Williams F, et al. Patient navigation across the cancer care continuum: an overview of systematic reviews and emerging literature. CA Cancer J Clin. 2023;73:565-589.

Oh J, Ahn S. Effects of nurse navigators during the transition from cancer screening to the first treatment phase: a systematic review and meta-analysis. Asian Nurs Res. 2021;15:291-302.

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B4 Oncology Equity Alliance at Boston Medical Center: A Collaborative Approach to Standardizing a Sustainable Oncology Patient Navigation Protocol

Katrina A. Steiling, MD; Erika Christenson, MPH; Debi Amburgey, BS; Julia Vance, BA

Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine

Background: The Oncology Equity Alliance (OEA) program at Boston Medical Center (BMC) is dedicated to advancing equitable, high-quality cancer care across the continuum of care. The multimodal intervention strategy aims to improve and resolve barriers to timely care, enhanced collaboration among care team providers, and system-wide policies supporting continuous improvement for navigation.

Objectives: To identify gaps and opportunities to standardize formal evidence-based oncology navigation policy and improve equity in cancer care at BMC, OEA conducted workflow assessment interviews1 to evaluate and document the patients’ journey while receiving cancer care navigation services.

Methods: Semistructured interviews were conducted with care team members across the care continuum in 4 cancer areas (breast, lung, gastrointestinal, head/neck). Interviewees included patient navigators, clinicians, nurse practitioners, social workers, and operational managers. The interview guide questions aimed to explore the overview of navigation services in the following areas: processes for identifying patients for navigation services, workflows for longitudinal tracking and follow-up, protocols for identifying barriers to care/distress level, and systems for addressing the barriers. OEA staff compiled and reviewed existing navigation policies, procedures, and job descriptions. Interview descriptions of navigation workflows, existing policies, and procedures were compiled into disease-specific reports detailing the status of patient navigation in each area. These reports were reviewed with key stakeholders to collect and integrate additional feedback and formulate recommendations for standardizing evidence-based navigation policy at a health system level.

Results: Forty-one care team members were interviewed to capture the landscape of patient navigation cancer care at BMC. Four key system-wide recommendations for enhancing navigation processes were identified and implemented.2,3 First, the need to standardize navigation protocols across disease areas resulted in the development of a standardized universal process for screening patients with a new cancer diagnosis for unmet social needs. Second, the need to monitor fidelity to navigation protocols resulted in updated protocols to document social needs assessments (SNAs) in the electronic health record and implement systems to track referrals for unmet social needs identified by screening. Third, the need to link prediagnosis navigation with in-treatment navigation resulted in an updated protocol to facilitate transitions between prediagnosis (eg, screening) and disease-specific in-treatment navigators. Fourth, the need for additional personnel to conduct SNAs to reduce barriers to cancer care resulted in the addition of 2 operationally funded intake navigators.

Conclusion: Comprehensive workflow assessment of current navigation protocols and policies in the BMC Cancer Center successfully identified gaps and opportunities to improve evidence-based navigation. Collaboration with key stakeholders, including patient navigation teams and cancer center leadership, resulted in updated protocols to standardize and document screening for unmet social needs and standardize protocols across disease areas. Importantly, our results supported hiring 2 additional operationally funded patient navigators to conduct SNAs for newly diagnosed cancer patients. Our results suggest a pathway for successful advocacy for improving the implementation of evidence-based navigation protocols with a focus on sustainability.

References

  1. Casanova NL, LeClair AM, Xiao V, et al. Development of a workflow process mapping protocol to inform the implementation of regional patient navigation programs in breast oncology. Cancer. 2022;128(suppl 13):2649-2658.
  2. Buitron de la Vega P, Losi S, Sprague Martinez L, et al. Implementing an EHR-based screening and referral system to address social determinants of health in primary care. Med Care. 2019;57(suppl 6):S133-S139.
  3. Lemon SC, LeClair AM, Christenson E, et al. Implementation of social needs screening for minoritized patients newly diagnosed with breast cancer: a mixed methods evaluation in a pragmatic patient navigation trial. BMC Health Serv Res. 2024;24:783.
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Category III: Patient Advocacy/Patient Empowerment

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C1 Impact of a Proactive Patient Assistance Program for Diverse Ambulatory Oncology Patients: A Retrospective Cohort Study

Lisa Philipp, MSN, RN, OCN; Alexandra Elyse Velozo, BSN, RN, CCM; Aja M. Scott, MS, PMP, CRCR; Patricia Falconer, MBA; Joseph Pizzolato, MD, MBA

University of Miami, FL

Background: Differences persist in cancer morbidity and mortality. Individuals of lower socioeconomic status (SES) suffer disproportionately from cancer compared with individuals with higher SES.1 Cancer survivors report psychosocial distress and delaying or forgoing care because of cost. Financial distress is linked to patient outcomes, quality of life, compliance, and survival.2

Objective: In July 2022, an NCI-designated comprehensive cancer center (CCC) partnered with a third-party vendor to launch a patient financial assistance program, which included screening of all patients receiving systemic therapy administered at infusion centers to reduce their financial hardship related to cancer treatment.

Methods: The technology company deployed a platform with an artificial intelligence–matching engine that integrated with the electronic medical record (EMR) data to automatically match patients with program opportunities. The type of patient assistance programs included were premium/co-pay assistance for patients treated in 18 distinct EMR departments corresponding to hospital-based infusion centers. The technology company hired, trained, and deployed remote patient advocates who interacted with patients receiving treatments and evaluated each for potential qualification for financial assistance. The patient advocates were fluent in English and Spanish to assist with communication barriers. Patient advocates identified eligible patients and, after obtaining consent, enrolled patients in philanthropic foundations and pharmaceutical assistance programs. Patient advocates submit claims, track the status of enrollment and re-enrollment, facilitate payments, and log awards. Robust reporting facilitates efficient management and transparency.

Results: A retrospective analysis of the period (May 2022-December 2023) was performed for patients receiving philanthropic medical financial aid consisting of co-pay assistance and grants sponsored by drug manufacturers and not-forprofit foundations (Award Cohort). A comparison was performed of the cohort of patients receiving treatment in the CCC infusion centers (Total Active Infusion Patient Cohort) with the Award Cohort. Of the 90,719 unique patients who received systemic therapy in the CCC infusion centers, 1080 were matched for eligibility to patient assistance programs, resulting in $2,865,314.40 in total awards. Of the total matched awards, 88% ($2,511,403.35) were from pharmaceutical co-pay programs and 12% ($353,911.05) were from not-for-profit foundations. The average matched award value was $2438.57 per patient. Patients eligible for patient assistance were predominately commercially insured, 27 to 64 years old. This represents the disproportionate availability of assistance for patients who are not covered by federally funded programs.

Conclusion: A proactive patient financial assistance program can reduce financial distress for patients with cancer, especially those residing in high and medium-high Social Vulnerabilities Index (SVI) counties. Leveraging the expertise of a third party helps mitigate financial toxicity in the short term and can help drive more equitable cancer outcomes. The study is unique as it represents a diverse patient population that includes 10% Black/African American and 39% Hispanic/Latino, and a population at high risk for financial toxicity, given that 96% of Award Cohort patients reside in high or medium-high SVI counties.

References

  1. Dee EC, Nipp RD, Muralidhar V, et al. Financial worry and psychological distress among cancer survivors in the United States, 2013-2018. Support Care Cancer. 2021;29:5523-5535.
  2. American Cancer Society Cancer Action Network. The Costs of Cancer Survivorship – 2022. www.fightcancer.org/policy-resources/costs-cancer-survivorship-2022
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C2 GBM Patients Across the United States Face Barriers and Information Gaps in GBM Care That May Impact Longevity and Quality of Life

Jacob Ellen, MSc1,5; Quinn T. Ostrom, PhD, MPH2; Fabio M. Iwamoto, MD3; Lakshmi Nayak, MD4; Kelli Duprey, RPh, MBA5; Ed Pilkington5; David Robles, MA5

1Harvard Medical School, Boston MA; 2Duke University School of Medicine, Durham, NC; 3Columbia University Irving Medical Center, New York; 4Dana-Farber Cancer Institute, Boston, MA; 5OurBrainBank, Brooklyn, NY

Background: In 2020, OurBrainBank developed the Glioblastoma (GBM) Bill of Rights to ask that every GBM patient has access to the same quality of care regardless of location or financial situation.1 From 2022 through 2023, OurBrainBank surveyed their community about these rights, revealing alarming results, and prompting a follow-up survey with more participants.2

Objective: In collaboration with OurBrainBank, Drs Quinn Ostrum, Fabio Iwamoto, and Lakshmi Nayak launched a nationwide survey to evaluate the quality and accessibility of healthcare for glioblastoma (GBM) patients across the United States.

Methods: OurBrainBank designed and distributed a survey on the GBM experience to the OurBrainBank community/partners, at events, and on social media. Survey Healthcare Global hosted the survey online. The survey was designed to take approximately 10 minutes and contains 36 items, with sections focused on aspects of the patient experience, quality-of-life (QoL), and demographic data.

It was designed to be taken by both current GBM patients as well as caregivers for current and recently deceased GBM patients. Community recruitment efforts involved sending newsletters and reaching out to members of the OurBrainBank Facebook group. Partners were recruited at brain cancer leadership meetings, where collaborating organizations agreed to share our recruitment materials on their platforms. Social media efforts included weekly recruitment posts, Facebook ads targeting rural areas, and Google ads targeting GBM-related search terms.

Results: A total of 297 participants completed the survey (85% caregivers; 15% GBM patients with a median age at diagnosis of 57 years), including 78% who had some college education, and 69% reporting having commercial insurance coverage.

Preliminary results revealed that 69% of respondents were informed about tumor testing, yet 64% had no molecular testing beyond initial diagnostics. The majority of respondents (65%) were not informed about storing tissue for future testing, and 79% reported that their tissue was not stored for potential treatments or clinical trials. Furthermore, most patients (52%) reported no discussion of seeking a second opinion, and 64% were not offered clinical trial enrollment.

Approximately 80% of respondents reported that their doctor recommended the GBM standard-of-care consisting of tumor resection, 3 to 6 weeks of chemotherapy/radiation therapy, 6 months of chemotherapy, and sometimes tumor treating fields (TTF).3 However, 40% reported no discussion of TTF as an option and 29% of those who were informed reported financial difficulties in accessing TTF.

Conclusion: These findings illuminate significant barriers to achieving comprehensive and personalized care and raise concerns about the dissemination of information on treatment options and access to care. Additionally, missed opportunities for tumor testing and storage limit future access to emerging therapies that could improve individual outcomes.

More than half of the patients who responded did not discuss seeking a second opinion and were not offered clinical trial enrollment, hindering access to life-extending or QoL-improving treatments. The lack of TTF offering, combined with insurance-related challenges to accessing treatments, underscores critical obstacles to engaging in informed and shared decision-making, directly impacting survival and QoL for patients with GBM.

References

  1. OurBrainBank. Glioblastoma Bill of Rights. www.ourbrainbank.org/create-change/gbm-bill-of-rights/. Accessed August 21, 2024.
  2. Stebbins A, Duprey K, Pilkington E, Wilkie M. DISP-08. Unmet needs: What people living with glioblastoma lack today, including access to critical genomic tumor testing. Neuro Oncol. 2023;25(Suppl 5).
  3. National Comprehensive Cancer Network (NCCN). NCCN guidelines for patients: Glioblastoma. www.nccn.org/patientresources/patient-resources/guidelines-for-patients/guidelines-for-patients-details?patientGuidelineId=5. Accessed August 21, 2024.
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Category IV: Psychosocial Support, Assessment

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D1 Impact of Psychosocial Distress Screening Partnership With Cancer Support Community in the San Francisco Bay Area in an Ambulatory Community-Based Cancer Center: A Retrospective Cohort Study

Wendy Keck Ennis, BSN, RN, PHN; Patricia Falconer, MBA; Rob Tufel, MSW, MPH; Margaret Stauffer, LMFT; Jesse Kaestner, BS, RT(T); Yahna Williamson (MPHc)

Kaiser Permanente

Background: Emotional, social, and financial support services for cancer patients, families, and caregivers are available free of charge by a not-for-profit communitybased organization (CBO) but underutilized. A large, multispecialty medical group operates an outpatient cancer center that is part of a multihospital system and integrated delivery network (IDN). Cancer center patients’ psychosocial distress screening was done ad hoc, identified unmet health-related social needs were not visible to other IDN providers, and referrals were performed outside of the electronic medical record (EMR) workflows. This study aims to describe the implementation, feasibility, and acceptability of a cancer center psychosocial distress screening process in partnership with a CBO using an EMR integrated, evidence-based survey tool and referral matrix.

Objective: To increase access to psychosocial distress screening and curated emotional, social, and financial support services for cancer patients, families, and caregivers.

Methods: Aligning with National Comprehensive Cancer Network (NCCN) standards, the cancer center established procedures for patient distress management. The cancer center and CBO co-developed a psychosocial distress screening process and referral matrix for each patientreported health-related need using the NCCN Distress Screening Tool Version 2.2023. Demographic data were compared from the total visit, total distress screen, and negative/positive distress screen patient cohorts. Demographic data included age, sex assigned at birth, health insurance, marital status, employment status, race, ethnicity, and preferred language. Patients’ reported top unmet physical, emotional, social, practical, and spiritual needs were compared for each cohort. Patients who participated in CBO programs were identified.

Results: During January-July 2023, 124 distress screens, 11% of total visits, were performed for patient visits meeting the distress screen criteria. Sixty-eight percent (81) of the patients’ distress screens were negative; 52% (36) identified unmet needs, and 5 patients participated in CBO programs. In 39 patients with positive distress screens, 100% identified unmet needs, and 6 patients participated in CBO programs. For the positive distress screen cohort, patients’ demographic characteristics with the largest percentage were women, commercial insurance, employed, married/partnered, and non-Hispanic White. Notably, the demographic characteristics of the 81 negative distress screen patients included a higher percentage of retired individuals and Medicare insurance. Eighteen patients, 9.2% of the patients with completed distress screens, and 7 patients without completed distress screening participated in CBO programs. Prior to the study, a negligible number of cancer center patients participated in CBO programs. Patients’ top reported unmet needs for both distress screen cohorts included sleep, pain, fatigue, worry/anxiety, sadness/ depression, feeling of worthlessness/being a burden to spouse/partner, relationship with friends/coworkers, work, taking care of others, treatments decisions, sense of purpose/meaning, and death/dying/afterlife.

Conclusion: This study validates the feasibility and acceptability of a manual psychosocial distress screening process to identify cancer patients’ unmet health-related needs and referrals to organizations to fulfill those needs in a community- based cancer center through collaboration with a CBO. This retrospective study demonstrates how collaboration with a CBO can provide psychosocial distress screening at scale and increase patients’ access to free-ofcharge social, emotional, and financial support services. Patients and CBOs can’t rely on providers to refer patients needing psychosocial support when the process is timeconsuming and requires workflows outside of the EMR. Further exploration is needed to optimize EMR tools to improve care coordination and reduce provider burden.

Sources

  1. National Comprehensive Cancer Network Distress Management Guideline Version 2.2023. www.nccn.org/professionals/physician_gls/pdf/distress.pdf
  2. Miller M, Zaleta A, Melyssa L, et al. Impact of distress screening and referral on health care utilization and cost among breast cancer patients: a retrospective cohort study. 2022. dx.doi.org/10.1097/OR9.0000000000000070
  3. Centers for Medicare & Medicaid Services. CMS Framework for Health Equity 2022-2032. www.cms.gov/files/document/cms-framework-health-equity.pdf
  4. Oncology Nursing News. Jessica MacIntyre on Improving LLS Referrals for Patients with Hematologic Malignancies. 2023. www.oncnursingnews.com/view/jessica-macintyre-on-improving-lls-referrals-for-patients-with-hematologic-malignancies
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Category VI: Research, Quality, Performance Improvement

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E1 Improving the Patient Care Experience During Breast Biopsy With the Use of a Weighted Blanket

Meaghan McGuire, APRN, RN; Sue Connors, RN, CBCN; Kathleen Halasz, BSN, RN, CRC

Doylestown Hospital, Doylestown, PA

Background: A specific type of breast biopsy called stereotactic breast biopsy (SBB) can cause anxiety due to the way the biopsy is conducted. A review of nonpharmacologic options revealed weighted blankets (WBs) as a nonpharmacologic method that may provide a similar calming effect. The use of a WB is a form of deep pressure stimulation1 that evidence suggests may result in an increase in parasympathetic arousal that is thought to have a calming effect.2 WBs were discussed as a nonpharmacologic method to provide a similar calming effect. They have been shown to decrease anxiety related to sensory integration disorders,3 chronic pain,4 dental procedures,2 and in those undergoing chemotherapy infusions.5,6

Objective: This evidence-based project was developed to evaluate the effect on anxiety using a medical grade WB versus no blanket for patients undergoing SBB, with a secondary objective of looking at feasibility of the project.

Methods: A randomized controlled trial with a convenience sample will be conducted to evaluate anxiety levels pre- and postbiopsy. Patients undergoing SBB will be randomized onto 2 arms (one that will undergo WB use during biopsy and the other without WB use during the biopsy). Patients will be asked to complete an anxiety inventory scale utilizing a modified version of the VAS-A – State Trait Anxiety Inventory for adults form Y-1 and a Visual Analog Scale both pre- and postbiopsy.

Results: We hypothesize that the use of WBs will decrease anxiety versus no WBs. Our results will include levels of anxiety pre- and postbiopsy and show if any statistical differences exist.

Conclusion: Prebiopsy anxiety is something patients routinely experience, and utilizing a WB could offer an accessible, nonpharmacologic, inexpensive option for patients to assist with comfort during the procedure, thereby decreasing anxiety level.

References

  1. Mullen B, Champagne T, Krishnamurty S, et al. Exploring the safety and therapeutic effects of deep pressure stimulation using a weighted blanket. Occupational Therapy in Mental Health. 2008;24(1):65-89.
  2. Chen HY, Yang H, Meng LF, et al. Effect of deep pressure input on parasympathetic system in patients with wisdom tooth surgery. J Formos Med Assoc. 2016;115:853-859.
  3. Eron K, Kohnert L, Watters A, et al. Weighted blanket use: a systematic review. Am J Occup Therapy. 2020;74:7402205010p1-7402205010p14.
  4. Baumgartner JN, Quintana D, Leija L, et al. Widespread pressure delivered by a weighted blanket reduces chronic pain: a randomized controlled trial. J Pain. 2022;23:156-174.
  5. Hermann C, Corbett M, Chicko L, et al. Weighted blanket: an anxiety reduction tool in the outpatient oncology infusion setting. Clin J Oncol Nurs. 2024;28:281-286.
  6. Abend R, Dan O, Maoz K, et al. Reliability, validity and sensitivity of a computerized visual analog scale measuring state anxiety. J Behav Ther Exp Psychiatry. 2014;45:447-453.
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E2 Lymphedema Prevention in Breast Cancer Using Proactive Multidisciplinary Interventions

Nichole Berry, LVN1; Melissa Eades, BSN, RN, ONN-CG2; Christina Jorski, PT3; Kelsie M. Phelps, PT, DPT, CLT3; Alexis Thomas, BSN, RN3

1Texas Breast Specialists; 2Sarah Cannon Cancer Institute of HCA Healthcare; 3HCA Houston Healthcare

Background:Breast cancer–related lymphedema affects 1 in 5 patients after breast cancer treatment.1 Using a prospective surveillance approach promotes early detection and may prevent lymphedema progression.2 Preoperative intervention, including baseline objective measurements and patient education on lymphedema risk factors, has the potential to reduce the risk of chronic breast cancer–related lymphedema.2

Objective: This abstract analyzed the positive impact of using the multispecialty approach to patient care in the lymphedema setting. The project goal was to increase presurgical evaluation referrals for patients with an increased risk of lymphedema and remove scheduling barriers to ensure that all patients are evaluated, educated, and managed for lymphedema following breast surgery for cancer treatment.

Methods: Evaluate the baseline number of surgical breast cancer patients for 2023 receiving preoperative intervention (baseline measurements and lymphedema prevention education). Identify a task force to improve program processes, and implementation to increase referrals for appropriate patients not currently undergoing preoperative evaluation. • The task force team: Breast surgical oncologist, clinic nurse, certified lymphedema therapist, facility oncology coordinator, breast oncology nurse navigator. • Educated all key stakeholders on baseline data and intervention goals. • Lymph edema physical therapy evaluation was added as a topic of focus to multidisciplinary breast care conference discussion for each patient presented. • Nurse navigator prioritized educating all patients on the importance of evaluation and reinforcing at presurgical touch points. • An education packet was created and provided to patients at the time of surgery scheduling. • A uniform post-op activity education document was developed with the surgical oncologist, the plastic surgeon, and the lymphedema physical therapy team. • Collaborated with other departments regarding patient scheduling to bundle appointments for patients with presurgical evaluation. • Coordinated monthly meetings to assess project data and intervention efficacy.

Results: The indicated methods resulted in a 60% difference or a 257% increase in preoperative lymphedema evaluation. Initially, in Quarter 1 of 2023, there was a total of 12 referrals for preoperative interventions out of 51 eligible patients, a 24% referral rate; in Quarter 1 of 2024, there was a total of 26 referrals for preoperative interventions out of 31 eligible patients, an 84% referral rate.

Conclusion: It is well documented that using a prospective surveillance approach can help in early detection and prevent the progression of lymphedema.3 When a multidisciplinary approach is used in the setting of lymphedema, patient management and outcomes are improved to potentially reduce the risk of chronic breast cancer–related lymphedema. The patients who were not receiving presurgical evaluation and prevention education are now being educated and offered this service to ensure the best possible patient outcome regarding lymphedema prevention and management.

Disclaimer: This research was supported (in whole or in part) by HCA Healthcare and/or an HCA Healthcare–affiliated entity. The views expressed in this publication represent those of the author(s) and do not necessarily represent the official views of HCA Healthcare or any of its affiliated entities.

References

  1. Gillespie TC, Sayegh HE, Brunelle CL, et al. Breast cancer–related lymphedema: risk factors, precautionary measures, and treatments. Gland Surg. 2018;7:379-403.
  2. Rockson SG. Lymphedema FAQs. Lymphedema Education & Research Network. https://lymphaticnetwork.org/images/uploads/LERN_Lymphedema_FAQs.pdf
  3. Rafn BS, Christensen J, Larsen A, Bloomquist K. Prospective surveillance for breast cancer-related arm lymphedema: a systematic review and meta-analysis. J Clin Oncol. 2022;40:1009-1026.
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Category IX: Clinical Research

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F1 EMERALD-Y90: A Phase 2 Study to Evaluate Transarterial Radioembolization Followed by Durvalumab and Bevacizumab for the Treatment of Unresectable Hepatocellular Carcinoma Eligible for Embolization

Riad Salem, MD1; Anne M. Noonan, MBBCh2; Ben Spieler, MD3; Sarah B. White, MD, MS, FSIR4; Laura Kulik, MD5; Dex Underwood, PharmD6; Eric Heilbron, MPH6; Binh Nguyen, MSc6; Graham Wetherill, MSc7; Renuka Iyer, MD8

1Northwestern University, Chicago, IL, USA; 2The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA; 3University of Miami, Miami, FL, USA; 4Medical College of Wisconsin, Milwaukee, WI, USA; 5Northwestern Memorial Hospital, Chicago, IL, USA; 6AstraZeneca, Gaithersburg, MD, USA; 7AstraZeneca, Cambridge, UK; 8Roswell Park Cancer Institute, Buffalo, NY, USA

Background: Liver cancer is the third most frequent cause of cancer-related deaths globally, with ~90% of primary liver cancer cases being hepatocellular carcinomas. Locoregional therapy (LRT), such as transarterial chemoembolization (TACE) or transarterial radioembolization (TARE), is commonly used for treatment of unresectable hepatocellular carcinoma (uHCC) eligible for embolization.

Objective: Median progression-free survival (PFS) following TACE or TARE in EMERALD-Y90 will evaluate efficacy and safety of TARE with an immunotherapy-based regimen consisting of durvalumab monotherapy (1 cycle), followed by durvalumab + bevacizumab (every 3 weeks) in uHCC eligible for embolization.

Methods: EMERALD-Y90 (NCT06040099) is a phase 2, single-arm study that will enroll ~100 participants aged ≥18 years with uHCC (Child-Pugh Class A, ECOG performance status 0-1) amenable to embolization, who are ineligible for, or who have declined treatment with, resection and/or ablation, or liver transplant. Participants may have received a single previous TACE/TARE ≥6 months prior to study, administered for a different primary intrahepatic lesion unrelated to the current tumor lesion. Exclusion criteria include having prior anticancer systemic therapy for uHCC or evidence of extrahepatic spread or major portal vein invasion (Vp3/Vp4). Eligible participants will receive partition-based dosing of TARE using Y-90 glass microspheres. Following TARE, participants will receive a single dose of durvalumab 1500 mg followed by durvalumab 1120 mg + bevacizumab 15 mg/kg every 3 weeks until study completion, disease progression, unacceptable toxicity, or another discontinuation criterion is met.

Results: The primary end point is PFS, defined as the time from TARE until the date of disease progression assessed by the investigator per modified Response Evaluation Criteria in Solid Tumors (mRECIST), or death due to any cause. Key secondary end points include safety and tolerability; 6-, 12-, and 24-month PFS, objective response rate (proportion of participants with a confirmed complete response or partial response assessed by the investigator per mRECIST), overall survival (time from TARE until death due to any cause), and duration of response (time from the date of first documented response until date of progression determined by the investigator per mRECIST, or death due to any cause). An early safety review is planned when ~15 participants complete 1 cycle of durvalumab + bevacizumab. Study enrollment is currently ongoing at ~20 sites across the United States.

Conclusion: US practice guidelines recommend LRT such as TACE or TARE for treatment of uHCC eligible for embolization. LRT controls tumor burden locally; however, many people do not achieve an optimal response and experience disease progression within 1 year. Immunotherapy-based regimens can be complementary to LRT by combining tumor response with systemic disease control. Despite recent advances in combining TACE with immunotherapy-based regimens, an unmet need still exists for evidence to support additional treatment options in settings where TARE is the preferred locoregional treatment modality. Results from the EMERALD- Y90 study will address this unmet need for uHCC eligible for embolization.

This abstract was originally presented at the 2024 Society of Interventional Oncology Annual Scientific Meeting.

Sponsored by AstraZeneca.

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F2 Nonpharmacological Interventions for Managing Abemaciclib-Associated Adverse Events in Patients With Early/Advanced HR+/HER2– Breast Cancer – A US-Based Healthcare Provider Survey

Pamela K. Ginex, EdD, MPH, RN, OCN1; Kelli Thoele, PhD, RN, OCN2; Qinli Ma, PhD2; Alexandra S. Vitko, PhD2; Astra M. Liepa, PharmD2; Wambui Gathirua-Mwangi, PhD2; Elyse H. Panjic, PharmD2; Engels Chou, MS2; Jodi L. Taraba, PharmD, MS, BCOP3; Hilary Ellis4; Charlotte Clewes, MS4; Joanna DeCourcy4; Hope S. Rugo, MD5

1State University of New York at Stony Brook, Stony Brook, NY, USA; 2Eli Lilly and Company, Indianapolis, IN, USA; 3Mayo Clinic, Rochester, MN, USA; 4Adelphi Real World, Bollington, UK; 5University of California San Francisco Comprehensive Cancer Center, San Francisco, CA, USA

Background: Diarrhea, nausea, fatigue, and abdominal pain are the most common patient-felt abemaciclib-associated adverse events (AEs), and AEs are a common reason for treatment discontinuation. In addition to pharmacological interventions such as dose modification or co-medication, nonpharmacological interventions (NPIs) aid in the management of abemaciclib-associated AEs to support adherence.

Objective: To describe utilized NPIs and their perceived effectiveness by healthcare providers (HCPs) to manage abemaciclib-associated AEs in patients with early or advanced HR+/HER2– breast cancer (BC).

Methods: A cross-sectional survey was conducted between July and October 2023 among US-based HCPs, including advanced practice providers (APPs), oncologists, and pharmacists, with at least 12 months of experience in caring for patients with BC in community settings and in treating or supporting patients taking abemaciclib. HCPs were recruited through a third-party agency and screened for eligibility using screening questions. Eligible HCPs then completed a one-time online survey, selecting and ranking (based on perceived effectiveness) recommendations for NPIs. The survey questions were designed based on literature and insights from exploratory qualitative work, which included interviews of 9 HCPs (3 from each specialty of HCPs). The resulting questionnaire was then pilot-tested and reviewed by clinical experts. Data were collected via online structured questionnaires featuring closed-ended questions and were analyzed descriptively.

Results: Overall, 46% (282 of 608 eligible) of HCPs (APPs 91, oncologists 91, pharmacists 100) completed the survey; 85% of HCPs had ≥5 years of experience treating BC; >90% recommended NPIs for managing abemaciclib-associated AEs. HCPs utilized various NPIs to manage specific symptoms. Diarrhea: “assessment of fluid-intake/hydration status” was most recommended (65.6% of HCPs) and perceived effective (49.6% of HCPs), followed by “emphasis on importance of hydration” (63.5%; 47.9%). Nausea: “taking medication with food” topped recommendations (63.5%) and perceived most effective (55.3%). Fatigue: “moderate exercise (walking/biking/swimming)” was most recommended (57.8%) and effective (51.4%); “creating rest-time in the day” (57.4%; 49.3%) closely following. Abdominal pain: “keeping side-effect (SE) diary to track SE’s frequency and severity for follow-ups” (44.3%) was most recommended and effective (32.6%), alongside “taking medication with food” (40.4%; 33.3%) and “recommend patient monitor diet to assess SE’s cause” (40.8%; 32.6%). Compared with oncologists, a greater portion of APPs and pharmacists considered NPIs to be effective.

Conclusion: NPIs are commonly utilized by APPs, oncologists, and pharmacists for management of abemaciclibassociated diarrhea, nausea, fatigue, and abdominal pain. HCPs recommend NPIs that they perceive as effective and that are unique for each patient-felt symptom. These data describe common approaches that can be used in addition to pharmacological interventions to manage AEs effectively and to optimize therapy.

Sponsor: Eli Lilly and Company, Indianapolis, IN, USA. This study was conducted with HCPs using online surveys.

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F3 Analysis by Treatment Period and Liver Function in EMERALD-1: Phase 3 Study of Durvalumab (D) With/Without Bevacizumab (B) With Transarterial Chemoembolization (TACE) in Unresectable Hepatocellular Carcinoma (uHCC) Eligible for Embolization

Stephen L. Chan, MD1; Masatoshi Kudo, MD, PhD2; Thomas Decaens, MD3; Joseph P. Erinjeri, MD, PhD4; Shukui Qin, MD, BA5; Zhenggang Ren, MD6; Yasuaki Arai, MD, PhD7; Mohamed Bouattour, MD8; Valeriy V. Breder, MD, PhD9; Shi-Ming Lin, MD10; Jeong Heo, MD, PhD11; Jean-Marie Peron, MD12; Vincenzo Mazzaferro, MD, PhD13,14; Quang T. Nguyen, MD, PhD15; Joong-Won Park, MD, PhD16; Lunan Yan, MD17; Alejandro Molina Alavez, MD18; Chang-Fang Chiu, MD, PhD19; Kwong-Ming Kee, MD20; Florinda A. Santos, MD, MSc21; Aibing Xu, MD22; Anil Veluvolu, MD23; Yoshitaka Inaba, MD24; Satheesh Chiradoni Thungappa, MD25; Farshid Dayyani, MD, PhD26; Arlene Ortega, MSN, NP-C, AOCNP27; Vimal Dave, MSc28; Claire Morgan, MD, MPH29; Kerry Parsons, PharmD30; Mallory Makowsky, PharmD30; Riccardo Lencioni, MD31; Bruno Sangro, MD32

1Department of Clinical Oncology, Prince of Wales Hospital, Sir Yue-Kong Pao Center for Cancer, The Chinese University of Hong Kong, Hong Kong SAR, China; 2Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan; 3Univ. Grenoble Alpes, Department of Hepato-Gastroenterology and Digestive Oncology, CHU Grenoble Alpes, Institute for Advanced Biosciences INSERM U1209, Grenoble, France; 4Interventional Radiology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA; 5Cancer Center of Nanjing, Jinling Hospital, Nanjing, China; 6Department of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China; 7Department of Diagnostic Radiology, National Cancer Center, Chuo-ku, Tokyo, Japan; 8AP-HP Hôpital Beaujon, Liver Cancer and Innovative Therapy, Paris, France; 9Department of Chemotherapy, N. N. Blokhin National Medical Research Center of Oncology, Moscow, Russian Federation; 10Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan; 11Department of Internal Medicine, College of Medicine, Pusan National University and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea; 12Hepatology Unit, Rangueil University Hospital, Toulouse, France; 13Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; 14HPB Surgery and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy; 15Friendship Hospital, Hanoi, Vietnam; 16Department of Gastroenterology and Hepatology, Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang, Republic of Korea; 17Liver Transplantation Center, Department of Liver Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan, China; 18Medical Oncology Department, SCP Oncology Clinical Research and Care Center, Merida, Yucatan, Mexico; 19Cancer Center and Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan; 20Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan; 21Department of Oncology, Barretos Cancer Hospital, Barretos, Brazil; 22Department of Medical Oncology, Nantong Tumor Hospital, Nantong, China; 23Willis- Knighton Hematology/Oncology, A Department of Willis-Knighton Medical Center, Shreveport, LA, USA; 24Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan; 25Department of Medical Oncology, HCG Oncology, Bangalore, India; 26Division of Hematology/Oncology, Department of Medicine, University of California Irvine, Orange, CA, USA; 27University of California San Diego (UCSD), San Diego, CA, USA; 28Oncology Biometrics, Late Oncology Statistics, AstraZeneca, Macclesfield, UK; 29Global Patient Safety Oncology, AstraZeneca, Gaithersburg, MD, USA; 30Oncology R&D, Late-Stage Development, AstraZeneca, Gaithersburg, MD, USA; 31Department of Diagnostic and Interventional Radiology, University of Pisa School of Medicine, Pisa, Italy; 32Liver Unit and HPB Oncology Area, Clínica Universidad de Navarra and CIBEREHD, Pamplona – Madrid, Spain

Background: TACE has been a standard of care for embolization- eligible uHCC; however, most people with uHCC treated with TACE progress within 1 year. In uHCC, liver function is often impaired and may be worsened by TACE. EMERALD-1 (NCT03778957) evaluated D+B+TACE versus placebos+TACE, administered in 2 periods (D-TACE, D-B) in embolization-eligible uHCC.

Objective: The EMERALD-1 study primary end point was met: D+B+TACE significantly improved progression-free survival (PFS) versus placebos+TACE in participants with embolization-eligible uHCC with a manageable safety profile. This post hoc analysis assessed safety in the 2 study treatment periods (D-TACE, D-B) and efficacy by baseline liver function.

Methods: Participants were randomized 1:1:1 to receive D+TACE, D+B+TACE, or placebos+TACE in 2 treatment periods: D-TACE period and D-B period. In the D-TACE period, participants received 1–4 TACE (cTACE or DEBTACE [number/modality per investigator choice]) plus D (1500 mg) or placebo for D (Q4W) within 16 weeks. Upon completion of the D-TACE period, participants received D (1120 mg) plus placebo for B, D (1120 mg) plus B (15 mg/ kg), or placebo for D and B (Q3W). Safety of D+B+TACE and placebos+TACE in both study treatment periods was assessed in participants who received any study treatment in the arm to which they were randomized, until end of follow-up. PFS and time to progression (TTP) were assessed by blinded independent central review per RECIST v1.1 in randomized participants with albumin-bilirubin (ALBI) grade 1 or 2 at baseline (no participants had ALBI grade 3 in the D+B+TACE or placebos+TACE arm).

Results: In participants who received D+B+TACE versus placebos+TACE, adverse events were reported by 139 (72.0%) versus 148 (74.0%) in the D-TACE period and 147 (76.2%) versus 132 (66.0%) in the D-B period, and adverse events were possibly related to D or B in 56 (29.0%) versus 41 (20.5%) in the D-TACE period and 114 (59.1%) versus 69 (34.5%) in the D-B period, respectively. Baseline characteristics were generally consistent across treatment arms, regardless of ALBI grade. For D+B+TACE versus placebos+ TACE in participants with ALBI grade 1, median PFS was 17.4 versus 9.2 months (hazard ratio [HR], 0.76; 95% CI, 0.56-1.05), and median TTP was 22.1 versus 9.5 months (HR, 0.65; 95% CI, 0.47-0.92); and in participants with ALBI grade 2, median PFS was 11.1 versus 7.2 months (HR, 0.76; 95% CI, 0.52-1.09), and median TTP was 19.4 versus 10.0 months (HR, 0.57; 95% CI, 0.36-0.88).

Conclusion: D+B+TACE had a manageable safety profile across the D-TACE and D-B treatment periods, consistent with the individual agents and underlying disease. Furthermore, numerical improvements in efficacy outcomes were observed with D+B+TACE versus placebos+TACE, regardless of baseline ALBI grade. This further supports D+B+ TACE as a new potential standard of care in embolization- eligible uHCC.

This abstract was previously submitted to the International Liver Cancer Association Annual Conference 2024 and the Society for Immunotherapy of Cancer Annual Meeting 2024.

Sponsored by AstraZeneca.

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