Assad, Hadeel

e13730 Background: Financial toxicity, the burden of treatment cost, affects up to half of people with cancer and can affect survival. Financial toxicity is a health equity issue, disproportionately affecting Black patients. This cross-sectional study used baseline data from the Discussions of Cost (DISCO) Trial, an RCT to improve patient-provider treatment cost discussions and, in turn, mitigate financial toxicity, to examine whether Black and White patients differed in patient-provider communication perceptions and financial toxicity correlates. Methods: Data were collected from 2021-2025 at an NCI-designated comprehensive cancer center. Participants were Black or White patients diagnosed with solid tumor cancers. At baseline, patients completed demographic measures; communication measures of self-efficacy in patient-provider interactions (e.g., “I am confident I know what questions to ask a provider”); self-efficacy in managing cancer treatment costs (e.g., “I am confident I can understand treatment costs”); and whether they have a provider- or patient-centered approach (e.g., “the provider should decide what gets talked about”); and financial measures including economic burden (e.g., “it’s difficult to live on my income”); treatment cost distress (e.g., “worries about paying for my cancer treatment keep me up at night”); and anticipated material hardship (e.g., “I worry about the financial problems I will have in the future as a result of my treatment”). Comparisons were conducted by patient race. Results: A total of 202 patients participated (116 Black patients, 86 White patients). White patients were more likely to have advanced degrees, a higher annual income, and less likely to have Medicaid compared to Black patients. Black patients reported higher self-efficacy for managing treatment costs ( p = .002) and a higher provider-focused orientation to the patient-provider relationship ( p = .001), than White patients. Black patients reported greater levels of financial burden ( p < .001), cost distress ( p = .005), and anticipated material hardship ( p = .003). There was no difference in self-efficacy for interacting with providers. Conclusions: These results suggest that a communication intervention for patients may help mitigate the experience of financial toxicity, especially for Black patients. Clinical trial information: NCT04766190 . Patient characteristics. Black Patients White Patients p -value Race 116 86 Education < High School High School/GED Some College 2 or 4-year College Degree Graduate/Professional College Trade/Technical/Vocational School 10352626712 0141631187 < .001 Annual Household Income 0 - $19,999 $20,000 - 39,999 $40,000 - 59,999 $60,000 - 79,999 $80,000 - 99,999 $100,000 - 149,999 $150,000 + 53201611431 51215991716 <.001 Insurance Type* Medicaid Medicare Medicare supplement Private None 604911330 113726393 <.001>.99<.001.20.15 *Patients could select more than one

e13729 Background: Financial toxicity, the burden of treatment cost, affects up to half of people with cancer and can affect survival. Financial toxicity is a health equity issue, disproportionately affecting Black patients. Patient education about cost and patient-provider cost discussions are recommended to mitigate financial toxicity but occur infrequently. The Discussions of Cost (DISCO) App, designed to mitigate financial toxicity through a tailorable education and communication intervention, was assessed for efficacy in an RCT with Black and White patients. Here we describe the DISCO App's feasibility and acceptability. Methods: Data were collected from 2021 to 2025 at an NCI-designated comprehensive cancer center. Participants were Black or White patients diagnosed with solid tumor cancers. While waiting to see their provider, patients randomized to the intervention arm used the DISCO App on a tablet. The DISCO App includes a video about treatment costs, ways to manage costs, and the importance of discussing costs with providers. Once patients enter their socio-demographic information (e.g., employment) and financial concerns, they receive a tailored list of cost questions to ask their provider. Patients responded to measures immediately after using the DISCO App. Feasibility was assessed by patient reports of how much time they needed to use the DISCO App and if they were able to use the DISCO App before the provider entered the exam room. Acceptability was measured by items assessing patient perceptions of the DISCO App (1 = strongly disagree; 5 = strongly agree). Descriptive statistics summarized results and mean comparisons were used to assess perceptions by patient self-identified race. Results: Of the 202 patients recruited, 124 were randomized to the intervention arm (67 Black patients; 57 White patients). All patients completed using the DISCO App prior to their provider entering the exam room and 80% of patients needed 15 minutes or less to use the DISCO App, with no difference by patient race. Black patients ( M = 4.4) reported finding the DISCO App more helpful than White patients ( M = 3.9; p = .02) and it brought up cost issues they had not considered (Black patients = 3.5; White patients = 3.0; p = .05). Patients reported the questions were easy to understand ( M = 4.4), helped them feel it was okay to talk with their provider about cost ( M = 4.0), that it prompted cost questions ( M = 3.3), that they learned what costs to consider (55%), and learned ways to manage cost (62%) with no differences by patient race. Conclusions: The DISCO App was feasible and acceptable to Black and White patients with cancer, with Black patients reporting more favorable perceptions than White patients. Next steps include assessing effectiveness in improving outcomes including prompting patient-provider treatment cost discussions and related financial toxicity outcomes (e.g., treatment adherence). Clinical trial information: NCT04766190 .

Abstract Purpose: CD4 T-cell immunity is associated with improved survival in patients with breast cancer. We previously reported a phase I trial evaluating a folate receptor alpha (FRα) vaccine administered with cyclophosphamide (CP), demonstrating excellent safety and immunogenicity. To simplify the vaccine strategy for ease of use, we report here the results of a randomized phase II trial evaluating a lower vaccine dose alongside the original dose, administered with or without CP pretreatment. Patients and Methods: Patients with triple-negative breast cancer who completed all systemic and local therapies were assigned to receive either low-dose (825 μg) or high-dose (2.5 mg) vaccine peptides plus GM-CSF in six 4-week cycles, with or without CP prior to vaccination. Safety was monitored, and immunogenicity was evaluated before and after vaccination. Results: A total of 80 patients were dosed with vaccine, and 58 patients were evaluable for immunogenicity. Vaccination was well tolerated and elicited immunity in 83% of patients. Levels of FRα-specific T cells were high, persistent, and comparable with T-cell levels against tetanus toxoid. No differences in immunity were observed between the two doses. CP pretreatment also did not affect the immune responses. Recurrences occurred in eight evaluable patients and were unrelated to the treatment arm. No patients died during the study because of their disease. Conclusions: The reduced-dose FRα vaccine is as effective as the original dose and does not require CP to generate maximal immunity. These findings may inform the design of trials testing efficacy in triple-negative breast cancer or other cancers.

TPS1659 Background: Financial toxicity, the material and psychological burden of treatment cost, affects up to half of people with cancer and can affect adherence and survival. Financial toxicity is a health equity issue, disproportionately affecting Black patients. Patient education about cost and patient-provider cost discussions are recommended to mitigate financial toxicity but occur infrequently. Our goal is to mitigate financial toxicity through a tailorable education and communication intervention, the DISCO App. The DISCO App was shown to be feasible, acceptable, and preliminarily effective at prompting cost discussions and improving related outcomes in a pilot trial. The aim of the ongoing trial is to test the effectiveness of the DISCO App on short- and longer-term outcomes for Black and White patients with cancer. Methods: This study is a longitudinal RCT. Oncologists are eligible if they treat patients with solid tumors at the trial site. Patients of participating oncologists are eligible if they are ≥ 18 years of age; identify as Black or White; can read and write in English; have an email address; and were diagnosed with a solid tumor for which systemic therapy is a likely recommended treatment. Strata were created to balance arms by patient race, income, age, and sex. Upon consent, patients are randomized to one usual care arm (1) or one of two intervention arms (2 and 3). All patients are asked to allow one treatment discussion with their oncologist to be video recorded for analysis. Prior to the recording, intervention patients utilize the DISCO App on an iPad. The DISCO App includes a video about treatment costs, ways to manage costs, and the importance of discussing costs with oncologists. Once patients enter their socio-demographic information (e.g., employment, insurance) and any financial concerns, they receive a tailored list of questions to ask their oncologist. Arm 3 patients receive an intervention booster via email two months after the recording. Patients complete measures at baseline, right after the recording, and at 1, 3, 6 and 12 months after the recording. Measures assess outcomes including cost discussions, communication quality, cost knowledge, self-efficacy for cost management, referrals for support, short- and longer-term financial toxicity, and treatment adherence. The patient-oncologist interaction is the unit of analysis and we will use multi-linear models to compare outcomes by arm. We anticipate recruiting up to 15 oncologists and 240 patients. Data collection began in March 2021 and will continue until July 2025. Participants to date include 13 oncologists and 192 patients (116 Black, 76 White). Most patients completed the baseline assessment (n=164), the post-interaction assessment (n=137), and at least 1 follow-up assessment (n=132); 125 treatment discussions have been recorded. The IRB reviewed the trial in December 2024 and approved continuation. Clinical trial information: NCT04766190 .

Abstract Purpose: The prevalence of pathogenic variants in BRCA1 and BRCA2 in populations other than Ashkenazi Jewish (AJ) is not well defined. We describe the racial and ethnic-specific prevalence of BRCA1/2 pathogenic variants and variants of uncertain significance (VUS) among individuals referred for genetic testing in a large urban comprehensive cancer center over a 20-year period. Methods: The population included 3,537 unrelated individuals who underwent genetic testing from January 1999 to October 2019 at the Karmanos Cancer Institute. We estimated the prevalence of pathogenic variants and VUS and evaluated associations with race and ethnicity for African American (AA), Arab, AJ and Hispanic individuals compared to Non-Hispanic Whites (NHW). We used multivariable models to adjust for other predictors of pathogenic variants. We also reported the most common pathogenic variants by racial and ethnic group. Results: The racial and ethnic breakdown of our population was: NHW (68.9%), AA (20.3%), AJ (2.5%), Arab (2.2%), Hispanic (1.0%), Asian Pacific Islander, Native American/Alaskan Native (4.7%), and <1% unknown. The overall prevalence of pathogenic variants in BRCA1/2 was 8.9% and the prevalence of VUS was 5.6%. Compared to NHW, there were no racial or ethnic differences in the rate of pathogenic variants. However, AA individuals were more likely to have VUS in BRCA1 (adjusted OR 2.43, 95% CI 1.38-4.28) and AJ more likely to have VUS in BRCA2 (adjusted OR 3.50, 95% CI 1.61-6.58).Conclusion: These results suggest the continued need for genetic testing and variant reclassification for individuals of all race and ethnic groups.

AbstractBackgroundThere is sparse clinical information on the racial and ethnic distribution of results of multigene panel testing among individuals at high risk for hereditary cancer.MethodsWe evaluated the results of multigene panel testing across eight clinical sites across the state of Michigan for individuals seen for genetic counseling from May 13, 2013 to October 31, 2019 at the Karmanos Cancer Institute's cancer genetics clinic. We estimated the prevalence of pathogenic variants and variants of uncertain significance (VUS) from genes other than BRCA1/2 among individuals of non‐Hispanic White (NHW), Black or African American (AA), Ashkenazi Jewish (AJ), Arab, Hispanic, and other ancestry.ResultsThe racial and ethnic distribution of 2419 individuals who had panel testing included 68.8% NHW, 22.1% AA, 2.3% Arab, 2.2% AJ, 1.0% Hispanic, and 3.6% other. Of these, 11.2% had pathogenic variants and 17.5% had VUS. After multivariable analyses, compared to NHW, AA were less likely to have pathogenic variants (OR 95% CI, 0.38, 0.24–0.59, p < 0.001). Both AA and Arabs were more likely to have VUS (OR 95% CI, 1.53, 1.18–1.98, p = 0.001 and OR 95% CI, 2.28, 1.17–4.43, p = 0.015, respectively). There were no significant differences for other groups. The most common pathogenic variants were CHEK2 (n = 65), MUTYH (n = 45), ATM (n = 28), and MSH2 (n = 22); the most common pathogenic variants by race and ethnicity were CHEK2 (NHW), MSH2 and MUTYH (AA), MSH2 (Arab), MSH6 and CHEK2 (AJ), and MLH1 (Hispanic); the most common pathogenic variants by primary cancer site were CHEK2 (breast), MSH2 (colon), BRIP1 and MUTYH (ovarian), and MSH2 and MSH6 (endometrial).ConclusionsUnderstanding the racial and ethnic distribution of pathogenic variants in multi‐gene panels has the potential to lead to better identification of individuals at risk for hereditary cancer.

e13540 Background: The identification of pathogenic variants and variants of unknown significance (VUS) in multi-gene cancer predisposition testing raises new questions regarding cancer risk and management. We evaluated the personal and family cancer patterns and variation by race and ethnicity, among individuals positive for pathogenic variants in non-BRCA1/ 2 cancer predisposing genes. Methods: The Karmanos Cancer Institute (KCI) Cancer Genetics database was queried from May 13, 2013 through December 31, 2018. There were 3,544 unrelated individuals evaluated for hereditary cancer predisposition of whom 1,868 had 18-gene panel testing at 6 sites across Michigan. Data was collected on personal and family cancer history including ages at diagnosis utilizing a 3-generation pedigree, self-identified race and ethnicity and results of genetic testing. We describe the prevalence of pathogenic variants by proband cancer diagnosis, family history, race, and ethnicity. Results: The race/ethnic distribution of the tested cohort included 67.5% non-Hispanic White (NHW), 24.4% African American (AA), 2.1% Arab, 1.8% Ashkenazi Jewish (AJ), 1.0% Hispanic, and 3.4% other. The distribution of cancer diagnoses included 40.6% breast, 5.5% ovarian, 4.1% colon, 3.5% endometrial, 2.0% pancreas and 39.7% unaffected. Pathogenic variants were seen in 151 (8.1%) individuals and VUS in 309 (16.5%). The five most common pathogenic variants were CHEK2 (40), MUTYH (22), ATM (20), and PALB2 (18). The most common pathogenic variants by race and ethnicity were CHEK2 (NHW), RAD51C (AA), PALB2 (Arab), CHEK2, MSH6 (AJ), and none in Hispanics. Variants associated with the four most common cancer types were breast ( CHEK2 ), ovarian ( CHEK2, MUTYH, BRIP1), colon ( ATM), and endometrial ( MSH6, PALB2). Of 40 individuals with CHEK2 variants, 92.5% were NHW, and 34 (85%), 31 (78%), 10 (25%), 1 (2.5%) had family history of breast cancer, breast cancer before age 50, ovarian, and colon cancer, respectively. Of 20 with ATM variants, 95% were NHW, 13 had family history data and 10 (76.9%), 8 (61.5%), 2 (15.4%), 1 (7.7%) had family history of breast, breast cancer before age 50, ovarian, and colon cancer, respectively. Conclusions: Pathogenic variants seen using multigene panel testing differ by race, ethnicity and personal/family history of cancer. This data will inform genetic counseling strategies in regards to cancer risk and management. Data on additional genes updated through 2019 will be presented.