African American Pts Research Articles

Real-world assessment of treatment-related symptoms and associated burden among African American and Caucasian patients receiving chemotherapy in the US.

11102 Background: In the treatment of breast cancer, research has identified racial differences in the ability to receive the full dose of prescribed chemotherapy which may be due in part to cancer-treatment symptom burden. In clinical trials, evaluation by race is challenging due to enrollment disparities, with African Americans (AA) accounting for 7% of trial participants, but comprising 12% of the US total population. The objective of this study is to evaluate treatment-related symptoms and treatment burden among patients treated with chemotherapy through an electronic remote symptom monitoring system, and explore whether there were any racial differences. Methods: Patients (pts) diagnosed with multiple myeloma, breast, ovarian, or lung cancer in academic cancer practices were enrolled in Carevive’s Patient Reported Outcomes Mobile Platform (Carevive PROmpt) between September 2020 and June 2023. A total of 1000 pts received chemotherapy alone or in combination. PRO-CTCAE-derived weekly surveys assessed severity, frequency, and interference for 16 symptoms: anxiety, constipation, cough, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth/throat sores, muscle pain, nausea, numbness and tingling, rash, sadness, shortness of breath, and vomiting. The GP5 assessed weekly overall burden from treatment. Results: The mean age of pts was 60.9 (SD=12.8) years, with 75% female, and 20% AA. At the time of enrollment, fatigue was reported by roughly 48% of AA and Caucasian (C) pts. Muscle pain was noted in 38% of AA pts, followed by general pain (33%), and anxiety (30%), with constipation, decreased appetite, insomnia, nausea, and numbness/tingling occurring in over 20% of pts. A different pattern was observed in C pts, with anxiety occurring in 38%, followed by cough, decreased appetite, general pain, insomnia, muscle pain, nausea, and numbness/tingling present in 20% of pts. The proportion of pts at least “somewhat” bothered by the side effects of treatment were similar (44% AA, 45% C). Conclusions: This study enabled evaluation of symptom burden in cancer in a population closer in racial representation to the real world than in clinical trials; with AA representation being three-fold that seen in clinical trials. Consistent with a qualitative study of AA breast cancer pts, fatigue was identified as the most frequent symptom among those treated with chemotherapy either alone or in combination in the real world. Racial differences in the proportions of pts reporting pain (muscle or general) and anxiety suggest that treating physicians should consider these symptoms to ensure they do not interfere with patients’ ability to receive full chemotherapy courses. Additionally, the levels of anxiety reported in patients highlights the importance of considering concomitant psycho-oncology treatments in cancer therapy.

Abstract PO3-12-10: Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet

Abstract Background: Taxane based chemotherapy (chemo) forms a critical part of breast cancer (BC) treatment in early and metastatic settings. Taxanes can cause peripheral neuropathy (CIPN)-sensory and motor, primarily of the hands and feet, resulting in quality of life decline and negaive impact on BC survival. Acral cryotherapy has shown benefit in reducing in in minimizing the incidence and severity ofcidence and severity of CIPN. However, these studies have included limited number of patients (pts) with inconclusive evidence to change US practice guidelines, have been primarily conducted in Asia, and did not include racially diverse patients. Methods: We conducted a single arm non randomized study at Mayo Clinic that included early BC pts who underwent standard of care paclitaxel or docetaxel based chemo. Pts had ECOG performance status 0-2, no sensory peripheral neuropathy at study entry and were able to give signed informed consent. Pts with metastatic BC, Raynaud's and peripheral vascular disease, cryoglobulinemia, cold intolerance, prior exposure to neurotoxic or taxane chemotherapy were excluded. Participating pts wore frozen gloves and socks (−20 to −10°C) on both hands and feet, 15 min before, during and until 15 min post taxane infusion. During chemo, grade (G) of CIPN (sensory) per CTCAE v5 was collected prior to each cycle of chemo, end of and 3 months after chemo. Schedule of events is listed in Table 1. Continuous variables were summarized using mean and standard deviation, and categorical variables were summarized with number and percentage of patients. Numeric variables were compared with t tests (paired and unpaired), and categorical variables were compared with Chi-Squared test for independent data and Mcnemar’s test for dependent data. All statistical tests were two-sided and were performed using R Statistical Software (version 4.1.2; R Foundation for Statistical Computing). Results: A total of 95 patients were included in this study. Median age is 54 years, 66.3% pts were White (W), 23.2% African American (AA), 4.2% Asian (A) and 4.2% Hispanic (H). Median BMI was 27.7. Most pts had stage I/II (75.8%), ER positive (64.9%) and HER2 negative (55.3%) BC and got adjuvant chemo (52.6%). Only 10.6% pts had diabetes, 55.3% used alcohol. Vitamin D3 use seen in 65.6%, B12 in 6.2% and folate, B12 and D3 in 6.2% pts. A total of 41 pts (44.1%) developed neuropathy at some point during chemo, of which 27 pts were W (43%), 10 pts AA (45%), 2 pts H, 1 Asian and 1 other. CIPN was G1 in 37 pts (90%). G2 CIPN was seen in 4 pts, at or after cycle 10 of weekly paclitaxel. Cold intolerance was seen in 24 pts (25%), G1 in 20 and G2 in 4 pts, all seen in cycle 1 with 1 pt withdrawal. Recovery to G0 was seen in 15 W pts at chemo end and 2 additional pts at 3 month after chemo. None of the AA pts, one H and one A pt had CIPN recovery to G0. In 4 AA pts who had G1 CIPN during chemo, G2 CIPN was noted at 3 month follow up. No Statistically significant differences in baseline characteristics and neuropathy results for W vs nonwhites (NW) were seen except Charleson score (p-value 0.023). Conclusion: Acral cryotherapy was found to be effective in reducing the incidence and severity of CIPN from taxane in our study. This is the only study with diverse racial/ethinic pt inclusion and incidence of CIPN was similar in W and NW. However, majority of G2 CIPN pts were AA and recovery to G0 CIPN was not seen in AA pts. Majority (63%) of W pts recovered to G0 at end of follow up. Analysis of objective testing of all pts is underway. Continued research into risk factors for AA pts to develop CIPN and its mitigation are warranted. XX XX Citation Format: Pooja Advani, Jinky Harvey, Ivy Vilches, Alex Hochwald, David Hodge, Amanda Arnold, Morgan Weidner, Dana Haley, Tanmayi Pai, Saranya Chumsri, Rohit Rao, Kostandinos Sideras, Cindy Tofthagen, Alvaro Moreno-Aspitia. Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet [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 PO3-12-10.

Impact of race on outcomes to 177Lu-PSMA-617 (LuPSMA) for metastatic castrate-resistant prostate cancer (mCRPC).

27 Background: Prior work suggests that African American (AA) and other minority patients (pts) derive equal benefit from taxane chemotherapy and androgen receptor pathway inhibitors (ARPIs) for mCRPC as white pts. LuPSMA showed an overall survival (OS) benefit in mCRPC pts after prior taxane and ARPI. However, there are no data on racial differences in outcomes to LuPSMA. Methods: We queried an IRB-approved registry of all pts treated with at least 2 cycles of LuPSMA between June 2022 and August 2023 at two academic medical centers in Boston, MA. Clinical data, including self-reported race, was abstracted from the electronic medical record. Pts of AA, Hispanic/Latino and Asian race were categorized as minorities. Outcomes of interest were the proportion of patients with ≥50% decrease in PSA levels during LuPSMA therapy (PSA50) and OS, defined from the date of the first cycle of LuPSMA. PSA50 and OS between races were compared with the Chi-Square and log-rank tests, respectively. Results: A total of 156 pts were included. Median age at LuPSMA initiation was 73 years (range 53-92) and the median number of prior lines of therapy was 5 (range 2-12); all pts had received ≥1 taxane and ≥1 ARPI. 136 (87%), 10 (6%), 6 (4%) and 4 (3%) pts were White, AA, Hispanic/Latino and Asian, respectively. The median number of LuPSMA cycles received in the entire cohort was 4 (range 2-7), and median follow-up was 7.1 months. A numerically higher proportion of minority pts had visceral disease at baseline compared to White pts (50% vs. 31%, (X2 = 2.87, p=0.090). Overall, 86 pts (55%) had a PSA50, with PSA50 of 55% (n=75), 60% (n=6), 67% (n=4) and 25% (n=1) amongst White, AA, Hispanic/Latino and Asian pts, respectively. There was no significant difference in PSA50 between White and minority pts (X2 = 0.00, p=0.990). Median OS in the entire cohort was 12.9 months and was not significantly different between White and minority pts (12.9 months vs. 8.5 months, p=0.533). The Table summarizes outcomes by race. Conclusions: PSA50 and OS were comparable between minority and White pts receiving LuPSMA for mCRPC, despite minority pts tending to present with more visceral disease, a known adverse prognostic factor. Validation of these findings and efforts to widen access to LuPSMA amongst minorities are required, given that pts of all racial backgrounds appear to benefit equally from LuPSMA. [Table: see text]

Treatment Outcomes and Prognostic Factors with Lenalidomide, Bortezomib, and Dexamethasone (RVd) Alone Versus Rvd Plus Autologous Stem Cell Transplantation (ASCT) in African American (AA) Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) in the Determination Phase 3 Trial

Background AA pts with NDMM have equal or longer overall survival (OS) vs White pts when treatment access is equal (Fillmore, Blood 2019; Dong, Blood Cancer J 2022). DETERMINATION included one of the largest cohorts of AA pts in prospective NDMM trials (n=132/722, 18.3%). The overall progression-free survival (PFS) difference (RVd-alone vs RVd+ASCT; median 46.2 vs 67.5 months [mos]; hazard ratio [HR] 1.53) was not seen in AA pts (HR 1.07; Richardson, N Engl J Med 2022). Multivariable PFS analyses, overall and by arm, showed that prognostic factors may vary according to treatment received, potentially indicating differences in MM pathobiology; PFS in AA vs White pts was longer with RVd-alone (HR 0.58) but similar with RVd+ASCT (HR 0.95) (Hassoun, EBMT 2023). We build upon this prior work with new analyses to explore outcomes with RVd-alone vs RVd+ASCT in AA and White pts. Methods Pts aged 18-65 y received RVd (3 cycles), stem cell mobilization, then 5 more RVd cycles (RVd-alone: n=357; 66 AA, 268 White) or ASCT and 2 more RVd cycles (RVd+ASCT: n=365; 66 AA, 272 White), and then R maintenance. We analyzed PFS (primary endpoint) by race, with exploration of potentially confounding effects of body mass index (BMI) and sex. Treatment exposure, response, event-free survival (EFS; events: progressive disease [PD], death, non-protocol therapy [NPT]), OS, and safety by race were evaluated. Exploratory genomic analyses in a subset of pts assessed frequency of Duffy-null genotype, a common variant in AA pts associated with lower circulating neutrophil count without increased infection risk that may have a key role in cytokine homeostasis (Jinna, Cells 2022). Results AA pts were younger and more commonly female than White pts, as seen in the GRIFFIN study (Nooka, Blood Cancer J 2022), with higher rates of ECOG PS >0, BMI ≥30, LDH >ULN, and low hemoglobin (panel A). Of 153 samples tested to date, 13 (8.5%) were Duffy-null: 11/17 (64.7%) AA and 2/136 (1.5%) non-AA pts. Median treatment duration from randomization (cycle 2) in AA and White pts, respectively, was 27.5 and 28.7 mos (RVd-alone) vs 36.1 and 36.2 mos (RVd+ASCT); 16% of AA and 13% of White pts discontinued within the first 3 RVd cycles due to adverse events (AEs; 5%/3% of AA/White pts), pt/investigator decision (5%/6%), PD (3%/3%), death (2%/<1%), or other reasons (2%/1%). In the 79%/86% of AA/White pts (RVd+ASCT) who underwent ASCT on study, transplant parameters were similar. 77%/83% of AA/White pts on the RVd-alone arm and 74%/80% on RVd+ASCT started R maintenance; median duration was 43.3/35.8 mos and 45.2/40.4 mos, respectively. In AA/White pts, median % of cycles with mean R dose >10 mg was 78%/88% (RVd-alone) and 83%/58% (RVd+ASCT). At data cut-off, of pts who started maintenance, 35%/25% of AA/White pts on the RVd-alone arm and 35%/29% on the RVd+ASCT arm were ongoing, and 65%/75% and 65%/71% had discontinued (including 37%/57% and 33%/37% due to PD), respectively. AE data are shown in panel B. Odds of achieving ≥CR were greater with RVd-alone vs RVd+ASCT in AA pts and were lower for AA vs White pts on the RVd+ASCT arm (panel B). Median PFS (RVd-alone vs RVd+ASCT) was not reached (NR) vs 61.4 mos (HR 1.07) in AA pts and 44.3 vs 67.2 mos (HR 1.67) in White pts. PFS with RVd-alone vs RVd+ASCT was longer in AA pts with BMI ≥30 (median NR vs 58.6 mos, HR 0.74), but shorter in AA pts with BMI <30 (66.4 mos vs NR, HR 1.86) and White pts with BMI <30 (45.3 vs 82.3 mos, HR 1.78) or ≥30 (41.1 vs 64.4 mos, HR 1.58). The PFS with RVd-alone vs RVd+ASCT was similar in male (HR 1.28) and female (HR 0.90) AA pts but shorter in male (HR 1.47) and female (HR 1.85) White pts. With RVd-alone vs RVd+ASCT, median EFS was 47.7 vs 48.2 mos (HR 0.99) in AA pts and 31.7 vs 46.7 mos (HR 1.30) in White pts; 5-y OS was 83.2% vs 78.7% (HR 0.99) in AA pts and 77.1% vs 80.3% (HR 1.08) in White pts. Among AA/White pts off study treatment, 64%/77% had received NPT; 27%/28% (RVd-alone arm) had received ASCT as NPT. Conclusions Our analyses suggest that PFS, EFS, and OS were similar with RVd-alone and RVd+ASCT in AA pts on this study. Importantly, while outcomes with RVd+ASCT were similar in AA and White pts, exploratory analyses suggest AA pts with high BMI and female AA pts may derive more PFS benefit from RVd-alone. Rates of starting maintenance/NPT use were lower in AA vs White pts, but maintenance duration proved longer in AA pts, with similar rates of grade ≥3 hematologic AEs, including neutropenia; analyses of outcomes by Duffy status are ongoing and will be presented.

The Epidemiology of Cardiovascular Disease in African American Patients with Myeloid Neoplasms: A SEER Data Analysis

Introduction: Cardiovascular disease (CVD) mortality rates are higher in cancer survivors compared to the general population. Numerous studies have reported racial disparities in CVD mortality among cancer survivors. However, there is a lack of research exploring CVD mortality specifically in African American (AA) patients (pts) with myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPN). To address this gap, we conducted a comprehensive population-based study to analyze cardiovascular mortality in the AA population with MDS and MPN. Methods and Statistical analysis: In Surveillance, Epidemiology, and End Results (SEER) database using the 17 registries, we identified cases of essential thrombocythemia (ET), Polycythemia Vera (PV), Primary Myelofibrosis (PMF), and Myelodysplastic syndromes (MDS) in AA population diagnosed between 2001-2020, with the diagnosis age >=20. CVD deaths included deaths from heart diseases, hypertension without heart disease, cerebrovascular diseases, atherosclerosis, and diabetes mellitus, based on the SEER Causes of Death Register and International Classification of Diseases (10th Revision, ICD10). Death rates were calculated by dividing the number of deaths over person-years of follow-up. We also estimated the standardized mortality ratios (SMR by dividing the observed cardiovascular deaths rates in our sample over expected CVD death rates of general population with no cancer, matched to age, gender and ethnicity. All analyses were performed by SEER*Stat 8.4.1.2 and R 4.2.2. Results: The study included 8135 patients, with following diagnoses: ET (n= 2317), PV (n= 1231), PMF (n= 377) and MDS (n= 4210). Overall, 2640 of the total study population (32.45%) died, of which 39.5% were CVD deaths. The mean follow up for PV, ET, PMF and MDS cohorts was 6.44, 5.95, 3.67 and 3.82 years, respectively (Table 1). The CVD mortality rate per 1,000 person-years in PV, ET and PMF subgroups were 17.9, 14.95, and 29.6, respectively. Notably, the rate was highest in the MDS subgroup, 40.37 compared to other subgroups (P<0.01). Comparing the CVD mortality of each risk group to the general US AA population, we observed significantly increased CVD SMRs. These were highest in PMF and MDS (SMR, 3.07; 95% CI, 2.2-4.16 and 2.25; 95% CI, 2.08-2.43, respectively), followed by PV (SMR, 1.75; 95% CI, 1.47-2.06) and ET (SMR, 1.67; 95% CI, 1.45-1.92).When comparing CVD mortality to the general CVD mortality rate in the AA population, we found higher rates across all age groups, including SMR, 13.16; 95% CI, 4.27- 30.72 in 20-29 yrs, SMR, 5.4; 95% CI, 2.95- 9.06 in 30-39 yrs, (SMR, 2.20; 95% CI, 1.92- 2.52) in 60-69 yrs, (SMR, 1.87; 95% CI, 1.67- 2.1) in 70-79 yrs (Figure 1). Conclusion: Our analysis highlights the magnitude of CVD-related deaths in the AA population with MDS and MPN. Among studied subgroups, the impact was highest in patients with MDS. This could be explained by a shared mechanism of CVD pathogenesis with MDS and clonal hematopoiesis of indeterminate potential (CHIP). In addition, we report a higher risk of CVD mortality at younger ages in AA pts relative to older age group. Because CVD-related mortality is high in AA with MDS and MPN, introduction of preventative cardiology services after diagnosis might be warranted to improve survival.

Disparities in medical oncology visit adherence among African American (AA) men with prostate cancer (pCa).

e18671 Background: AA patients (pts) with pCa tend to have worse outcomes when compared to Caucasians. Disparities in access to healthcare among AA pts with pCa is a significant barrier to improvement in outcomes. Medical oncology visit attendance among this population has not been thoroughly investigated. Methods: Pts with a diagnosis (dx) of pCa scheduled to see a provider (MD or advanced practice provider) at a single academic institution medical oncology clinic between January 2022 and December 2022 were retrospectively identified. Pts were categorized by self-identified race. The total number of scheduled clinic visits was recorded, and each visit was categorized by visit status; completed, cancelled, no-show, or left clinic. The reason for visit cancellation was assessed and cancelled visits for non-pt driven reasons (ie. scheduling error) were removed. The data were summarized using descriptive statistics. Z-test and Chi-square analysis were utilized to compare proportions of visits between AA and Caucasian pts and the association of race with visit status. Results: A total of 992 pts were selected, 80% (n = 792) were Caucasian and 16% (n = 162) were AA, representing 4231 clinic visits during the study period. AA pts accounted 18% (n = 763) of the total scheduled visits. 94% of visits (n = 3962) were follow up and 6% (n = 269) were new pt visits. 86% of all scheduled visits were completed and 10 % (n = 436) were cancelled for pt driven reasons. Roughly 3% (n = 135) of visits were no-show. AA pts had fewer completed visits compared to Caucasian pts, 78% vs 88% (p < 0.001) and a higher no-show rate of 10% vs 1.5% (p < 0.001). The cancellation rate was similar between AA and Caucasian pts, 11% vs 10% (p = 0.33). The combined no-show and cancellation rate for AA pts was 22% vs 12% for Caucasian pts (p < 0.001). There was a significant association between AA race and no-show visit status (p < 0.001). Conclusions: AA men with pCa have much poorer visit adherence to scheduled medical oncology visits compared to their Caucasian counterparts. Identifying reasons for no-show and visit cancellations and targeted interventions to improve access to care are needed to improve outcomes. [Table: see text]

Examining experiences of African American patients with breast cancer in a multidisciplinary survivorship clinic.

e18621 Background: Breast cancer (BC) is the most commonly diagnosed cancer in women. More effective therapies have led to improved survival rates, yet, the survival benefit is not shared across all patient (pt) populations, with worse breast cancer outcomes among African American (AA) pts. The American College of Surgeons has mandated that accredited sites have a cancer survivorship program. At the Cardinal Bernardin Cancer Center (CBCC), there remain disparities in access and utilization of the survivorship clinic, especially by AA BC survivors. Of the 385 new BC analytic cases CBCC treated between March 1, 2020, and March 1, 2021, 72 of these were AA pts. Unfortunately, less than 10% of AA BC pts who received curative intent therapy attended the CBCC Survivorship Clinic. As part of the "Bringing Quality Care Training to Komen’s African American Health Equity Initiative" in collaboration with ASCO, CBCC remodeled its survivorship program into a multidisciplinary clinic staffed by medical oncology, oncologic psychology, genetic counselor, nutritionist and social worker in order to provide comprehensive care to pts following diagnosis and treatment. Methods: The CBCC team performed the following: construction of a process map outlining the current pathway for referring pts to the survivorship clinic; creation of a fishbone cause and effect diagram highlighting factors contributing to poor utilization of the clinic; implementation of faculty surveys to assess reasons for lack of referral to survivorship clinic; development of pt experience surveys; and identification of countermeasures. Tumor registry identified BC pts by stage, race, and ethnicity. Results: Review of the CBCC BC registry showed a low attrition rate among 72 AA pts, with only 1.4% (n = 1) of AA pts diagnosed at CBCC treated elsewhere. AA pts made up a disproportionate number of stage IV diagnoses comprising 40% (n = 8). Surveys demonstrated the following reasons for poor utilization of the survivorship clinic by faculty in order of descending importance: providers felt they were providing survivorship care to their pts; pts declined referral due to appointment fatigue; lack of understanding to make referral; no outcomes data to support survivorship clinics; pt misunderstanding the purpose; fear of losing the pt; pt financial burden. Pt surveys (n = 20) showed high pt satisfaction, with an average rating of 4.8 out of 5 for overall care. Conclusions: Lack of utilization of the cancer survivorship clinic among AA BC pts leads to inefficient application of resources, decreased survivorship care, reduced pt experience, and diminished opportunity for survivorship education and increased health literacy. Paths for the future include increased faculty and pt education, faculty engagement, designated scheduler for survivorship clinic, and increased promotional and marketing work.

Training oncologists (Oncs) to conduct better informed discussions with African American (AA) cancer (CA) patients (pts) about tumor genomic profiling (TGP): Results of a randomized pilot trial of gene pilot pro (GPP).

10552 Background: Molecular characterization of tumors to guide therapy choices using next-generation sequencing-based TGP has become standard practice for pts w/multiple CA types. AAs are more likely to have negative attitudes towards genetics, rooted in concerns about privacy, cost and discrimination, and higher mistrust of medical institutions. Oncs are poorly prepared for informed discussions w/CA pts about secondary hereditary risks of TGP and often fail to have these conversations despite 2015 ASCO guidelines benchmarking this standard, and further are poorly informed of the potential challenges of discussing TGP and germline risk w/their AA CA pts. Methods: Formative work included 1-on-1 interviews (n = 10) to assess oncs’ perceptions of TGP use and discussions w/AA CA pts, and a national survey (n = 50) to assess TGP practice patterns, communication of hereditary risk, and challenges encountered in AAs. Interviews/survey data and advisory board input informed development of GPP, a 12 min online training video to improve Oncs’ awareness of ASCO guidelines, confidence and preparation to have TGP discussions w/pts, and improve awareness of barriers to TGP unique to AA CA pts. The control consisted of 10 slides with information about TGP drawn from industry/academic websites and the 2015 ASCO guidelines. Participants (n = 63) completed baseline (100%), post-intervention (100%), and 1-month (95%) follow-up surveys. The study was approved by the Fox Chase Cancer Center IRB 18-8006. Results: Oncs were recruited by email and randomized to view GPP or control material. The majority were age 40-49 (38%), 71% male, 44% White, w/mean 15 yrs in practice; 85% reported none or only informal training to communicate TGP risks/results to pts. GPP produced a durable increase in recognition of 4 core ASCO guideline elements (20% baseline, 67% post, 63% 1 month). At 1-month follow-up, GPP significantly improved recognition of barriers specific to AA CA pts related to TGP and hereditary risk (p = 0.001) and promoted greater preparedness to support TGP discussions w/AA pts including preparedness to identify (p < 0.01) and understand (p < 0.01) issues that matter most to their AA pts. 1-month confidence to conduct difficult discussions related to genetic mistrust (p = 0.004) and TGP cost (p = 0.003) was better preserved after viewing GPP compared to control. Among Oncs viewing GPP, 90% agreed/strongly agreed that GPP helped them “better understand how to address concerns my AA pts may have about TGP” and 97% definitely/probably would recommend GPP to other Oncs. Conclusions: GPP significantly improved Oncs’ awareness of barriers related to TGP communication in AA CA pts, improved preparedness to facilitate informed decision-making, and supported sustained confidence to lead difficult discussions.

Racial differences in outcomes of patients with relapsed/refractory multiple myeloma treated with selinexor.

e20016 Background: Multiple Myeloma (MM) is the 2nd most common hematologic malignancy in the US, though survival in patients with MM has improved over the past decade. Survival improvements in African Americans (AAs) have been smaller, which may be due to disparity in access to therapies. There are also key differences in MM biology between races, including higher rates of IgA disease and genetics. Given underrepresentation of minorities in clinical trials, we analyzed whether outcomes were similar between AAs and other races in the phase 2 STORM trial (NCT02336815) of selinexor. Selinexor, an oral, first-in-class selective inhibitor of nuclear export via exportin 1, has proven efficacy for refractory MM. To our knowledge, this is the first race subgroup analysis of selinexor in any clinical trial. Methods: Pts from STORM who received study drug (N = 202) were included. Pts with heavily pretreated MM, including triple-class and penta- refractory MM refractory to the last line of therapy were given selinexor (80mg) + dexamethasone (20mg) twice weekly. We conducted a retrospective racial subgroup analysis. Cox proportional modeling was used to determine the hazard ratio (HR) for MM relapse between races controlling for covariates. Results: AAs represented 17% of pts (35 AAs, 148 White, 2 Asian, 11 other and 6 missing). AAs were younger compared to other races (median age 60.7 vs 65.3) with more females (74.3% vs 40.7%). Cytogenetic abnormalities and R-ISS staging were similar between races. AAs had a median progression free survival (PFS) of 6.5 mos (95% CI 4.7, NR) compared with 3.7 mos (95% CI 2.8, 4.6; p = 0.035) for other races. Overall response rate (ORR) was 25.7% (95% CI 12.5, 43.3) in AA pts vs 23.4% [17.2, 30.5] in other races), clinical benefit rate (37.1% [21.5, 55.1] vs 35.9% [28.7, 43.7]), median duration of response (5.6 mos [2.1, NR] vs 5.3 [3.6, NR]), median duration of treatment (9 wks [IQR 3-22 wks] vs 8 wks [4-16 wks]), and mean dose intensity (117.9 mg/wks [STD 35.1] vs 117.1 [34.7]) were similar between grps. Rates of Adverse Events (AEs) ≥ grade 3 (94.3% vs 95.8%), and AE-related dose reductions (45.7% vs 54.5%), discontinuations (22.9% vs 30.5%), and deaths (5.7% vs 10.8%) were also similar. The adjusted HR for MM relapse in AAs was 0.45 (95% CI 0.22, 0.92; p = 0.028) after controlling for gender, age and prior therapy. Conclusions: This subgroup analysis showed that compared with other races, AAs pts were younger and included a greater percentage of women. Although ORRs were similar, AAs had a longer PFS compared with other races after adjusting for covariates. Despite small sample size, the differences were statistically significant. It is unclear if the better PFS reflects a different biology, pharmacology of selinexor or both. Dose adjustments and tolerability were relatively comparable. These results could assist in the placement of selinexor in the treatment sequence of relapsed refractory MM for AAs.

Presence of hyperdiploidy and history of tobacco use in African American patients with SMM.

8062 Background: Smoldering multiple myeloma (SMM) has a clinically variable course in progression to active myeloma (MM). Accurate risk stratification is essential in identifying which patients may benefit from early therapeutic intervention. Current models do not account for the potential impact of race on risk of progression to SMM. Here, we seek to identify independent risk factors for progression in African American (AA) versus white patients in a real-world single institutional database of SMM patients. Methods: We retrospectively identified 224 patients (pts) with untreated SMM from 2007 to 2021 treated at our institution. Patient demographics and disease characteristics were obtained from our IRB-approved myeloma database. TTP was defined as the time from diagnosis of SMM to diagnosis of active MM, estimated by Kaplan-Meier and compared by log-rank test. Univariate analyses were performed using Cox proportional hazard models for TTP. Results: A total of 224 pts (AA 35%, white 47%, other/unknown 17%) were identified with median age 62y (range 32-82). Median follow-up was 4.3y in Whites and 5y in AA pts. Notable characteristics include M/F 45%/54%, IgG/IgA/FLC 76%/17%/6%, 30% current/past smoker (median 15 pack-years), 12% alcohol use (≥10 drinks/wk), 45% with BMI > 30. Multiple cytogenetic abnormalities were defined as presence of ≥2 of the following: t(4;14), t(14;16), gain(1q21), del(1p), del(13), or del(17p). The median TTP (mTTP) was 6.8 [95% CI (3.7, 8.2)] years in whites and 5.6 [95% CI (4.6, 11.8)] years in AA. On univariate analysis, M-spike > 1.5, involved K/L ratio > 12, and bone marrow PC > 20% were associated with increased risk of progression for both AA and whites (all p < 0.05). As expected, gain of 1q21 was associated with increased risk of progression for both groups, though more pronounced in AA (HR 2.94, p = 0.025) versus whites (HR 2.33, p = 0.013). Hyperdiploidy was associated with shorter mTTP in AA (HR 3.03, p = 0.004) compared to whites (HR 1.39, p = 0.3). Multiple cytogenetic abnormalities was associated with shorter mTTP in whites (HR 2.63, p = 0.004) but was not statistically significant in AA (HR 2.63, p = 0.104). Interestingly, tobacco use was associated with shorter mTTP in Blacks (HR 2.94, p = 0.005) but not in whites (HR 0.96, p = 0.85). Conclusions: Understanding the potential impact of racial background on progression from SMM to MM is critical in the appropriate management of all patients with SMM. In this database, with a large proportion of AA patients, hyperdiploidy and +1q portend high risk of progression in AA patients. Further study is needed to better classify these potential differences to ensure risk stratification models are applicable to all patients.

African American Race Is a Potential Favorable Biologic Factor That Impacts Clinical Outcome for Patients with Multiple Myeloma

Multiple myeloma (MM) remains an incurable malignancy characterized by plasma cells that are nurtured and proliferate within the permissive bone marrow milieu. It has a greater incidence in African Americans (AA) compared to whites (13.8 vs. 6.5/100,000). The five-year age adjusted mortality rate, according to SEER database, is greater in AA compared to white Pts (5.8 vs. 2.9/100,000), which is likely explained by a greater incidence in the AA population. However, recent reports have also shown that AAs with equal access to care have an even better survival than their white counterparts [Fiala et al. Cancer. 2017]. Conversely, results from the CoMMpass registry database showed that OS was shorter for AA compared with Whites (age-adjusted hazard ratio (HR) 1.7, 95% confidence interval 1.2-2.4, P = 0.003) [Derman et al. Blood Cancer J. 2020]. Here, we report the interplay of race and other dimensions of MM care using the National Cancer Database (NCDB). Methods: NCDB is the largest cancer database in the US including >70% of all newly diagnosed cancer patients. The International Classification of Diseases for Oncology (ICD-O) code of 9732 was used. OS was calculated from the date of MM diagnosis. Given that Smoldering MM (SMM) does not have specific ICD code, we defined patients who did not receive any treatment within 3 months after the diagnosis as SMM, similar to other authors (Ravindran et al. Blood Cancer J. 2016). Initiation of systemic treatment was considered as a surrogate of progression to symptomatic MM. Overall survival (OS) of SMM patients was calculated from initiation of systemic treatment after they progressed to MM, estimated by the Kaplan-Meier method, and compared with the log-rank test. Cumulative incidence of progression from SM to MM was calculated with death as a competing risk and compared with the Gray's test. Multivariable Cox and logistic regression analysis were performed to identify independent predictors of OS and progression to MM, respectively. Results: We identified 56,021 patients with MM and 11,485 with SMM between 2010 to 2014 in this database. Among MM patients, 42,836 (76%) were white and 11,255 (20%) self-identified as AA. For AA patients, there was a lower proportion of Medicare (46 vs. 56%), and private insurance (35 vs. 36%) and a higher percentage of Medicaid (11 vs. 5%) and uninsured Pts (6 vs. 3%) compared to Pts that self-identified as white. A larger proportion of AAs had a Charlson score ≥1 (30 vs. 24%, p<0.001). The percentage of Pts who underwent radiation was higher among whites compared to AA (23 vs 8%). However, unadjusted OS was greater for AA compared to white Pts, 55 vs. 48 months, respectively (P < 0.0001). Among SMM patients, 8,324 (72%) were white and 2,756 (24%) were AA. SMM was diagnosed in AA patients at a median of 3.7 years younger than in white patients. Similar socioeconomic disparities were observed in SMM as in MM cohort. The time from diagnosis of SMM to first therapy which is indicative of progression from SMM to MM is the same among AA and white (median time in days 136 vs 135 days, p=0.672) with comparable OS. Multivariable Cox and logistic regression analysis showed that lower age, AA race, Female gender, ASCT, living in a higher income area and having Medicare or Private insurance compared to no insurance were independent predictors for better OS in MM. Although other predictive factors persisted for patients with SMM, race did not reach statistical significance. Conclusion: Taken together, our results utilizing one of the largest available datasets in the US, reflect a similar outcome for AA and white patients with MM despite a clear disparity in healthcare access and SES. This finding might suggest a more favorable biology of the disease among AA Pts. The lower rate of radiation among AA is also an indirect measure of bone complications. AA enjoy less bone loss and fractures under physiologic and pathologic conditions. Further studies to elucidate the role of bony compartment of the MM microenvironment at the cellular and molecular levels might be able to explain this disparity and help advance a more personalized treatment options to improve outcomes. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Abstract 11606: The Association Between Sarcoidosis and In-Hospital Outcomes Among African Americans With Acute Myocardial Infarction

Introduction: Sarcoidosis (SD) has a higher prevalence among African Americans (AA). It is also associated with an increased risk of ischemic heart disease (IHD); however little is known of its effect on in-hospital outcomes after an acute myocardial infarction (AMI). Therefore, we sought to evaluate the association between SD and in-hospital outcomes among AA patients (pts). Methods: Using the National Inpatient Sample between 2005-2014, we evaluated admissions of AA presenting with AMI and a concurrent diagnosis of SD. We used propensity score matching in 1:3 fashion to create a comparison group of patients without SD based on age and comorbidities. Our primary outcome of interest was in-hospital mortality. Secondary outcomes were length of hospital stay and total cost of hospitalization. Results: We evaluated 416, 209 representative admissions of AA with AMI. Of these, we compared 2,647 had a concurrent diagnosis of SD to 7,942 pts without SD. The pt group with SD had mean age 58.1 years and were 61.5% female. When compared with the pts without SD, the pts with sarcoid were more likely to smoke (21.5% vs 19.5%, p=0.028), have liver failure (4.5% vs. 3.4%, p=0.007) and have a cancer diagnosis (2.8% vs. 2.1%, p=0.37), but less likely to have renal failure (25.0% vs 29.1%, p&lt;0.001). When compared with the pts without SD, pts with SD had a significantly lower in-hospital mortality and cost of hospitalization ($46,593±69,981 vs $51,941±80,624, p=0.023). Conclusion: Although sarcoidosis is associated with increased risk of IHD, SD is associated with lower in-hospital mortality and lower cost of care in AA pts presenting with AMI. Further investigations are warranted to understand these outcomes. Table 1: Baseline characteristics of AA patients with AMI and sarcoidosis compared with a propensity-score matched cohort without sarcoidosis.

Abstract 12544: Sex Differences in Cardiac Catheterization Outcomes Among Black Patients in an Urban Center

Introduction: Sex disparities persist in the management of CAD. Although between-racial and ethnic group disparities continue to exist, there are limited data regarding intra-race sex differences within African American (AA) populations. Thus, we describe the sex differences in outcomes among Black patients receiving left heart catheterization (LHC) in a large urban medical center (UMC). Methods: Using electronic health data, we extracted data of AA patients (pts) undergoing LHC between January 2014 to December 2019 from an UMC. Baseline demographics and management were compared between men and women. The primary outcome of interest was percutaneous coronary intervention (PCI), with secondary outcomes of coronary artery bypass graft (CABG) and Intra-aortic balloon pump (IABP). Outcomes were analyzed with chi-square testing and multivariable regression. Results: There were 3,379 LHC performed (42% in women). Men were relatively younger compared to women (63±11 vs 65±12, p&lt;0.001), had lower BMI (29±8 vs 33±9, p&lt;0.001), EF (45±15 vs 50±15, p&lt;0.001), and rates of health insurance (59% vs 66%, p&lt;0.001). Women had higher rates of dyslipidemia (42% vs 33%, p&lt;0.001), hypertension (87% vs 83%, p=0.001), and Type II DM (43.6% vs 33.6%, p&lt;0.001), but lower rates of smoking (30.5% vs 45%, p&lt;0.001). Men also had higher rates of STEMI 12.8% vs 5.2% and NSTEMI 29.6% vs 28.7% (P&lt;0.001). Men were more likely to receive PCI (40.5% vs 34.5%, p&lt;0.001), CABG (4.6% vs 2.3%, p=0.001), and IABP (2.1% vs 0.5%, p=0.001). After multivariable regression, men had higher odds of PCI (OR=1.15, p=0.15), CABG (OR=2.4, p=0.001), and IABP (OR=5.5, p=0.002). Conclusions: In this cohort of AA pts receiving LHC at an urban center, men were more likely to undergo interventions including PCI, CABG, and IABP as compared to women. Even among AA populations, significant sex differences occur. More work is needed to understand underlying factors and address healthcare disparities in this high-risk population.

Risk of Radiation Dermatitis in Patients with Skin of Color Who Undergo Radiation to the Breast or Chest Wall Irradiation and Regional Nodes

<h3>Purpose/Objective(s)</h3> Radiation dermatitis (RD) is common after RT for breast cancer with data indicating potentially worse RD in African American (AA) patients (pts). Current measures of RD, such as the CTCAE, do not include hyperpigmentation, which may disproportionately affect how RD is classified and treated in pts with skin of color (SOC). We aim to characterize RD in SOC and identify factors, including baseline skin pigmentation (BSP) that predict RD. <h3>Materials/Methods</h3> Pts treated with whole breast (WB) or chest wall (CW) with regional nodal RT or high tangents with 50 Gy in 25 fractions from 2015-2018 were identified. Three dermatologists independently classified BSP using photographs from CT simulation based on the Fitzpatrick scale ([FS], range=I-VI; I=light/pale white to VI=black/ very dark brown). SOC was defined as FS IV-VI. Pt characteristics were investigated for association with interventions to treat RD, clinician-graded acute RD, and late skin toxicity (NCI CTCAE scale) with Chi-squared and logistic regression analyses. <h3>Results</h3> 325 pts met eligibility criteria (58 African American [AA], 42 Asian, 151 Caucasian, 77 other). 40% (n=129) had SOC, 60% underwent CW RT, 40% WB RT and 82% had systemic therapy. Pts with SOC were more likely to be Hispanic (14% vs 8% p=0.007), AA (43% vs 1%, p<0.001) and have greater mean BMI (28.0 vs 26.5, p=0.02). Acute grade 2/3 RD was lower in SOC (FS I 60%, FS II 63%, FS III 52%, FS IV 64%, FS V 40%, FS VI 41%; p=0.049). Increased BSP (OR 0.83; p=0.01) and AA pts (OR: 0.22; p<0.001) had lower odds of acute grade 2/3 RD, whereas bolus and dosimetric parameters such as increased PTV volume had increased odds. On multivariable analysis (MVA), AA pts and bolus remained significant (OR: 0.14, p=0.01; OR: 6.63 p<0.001, respectively). Topical steroid use to treat RD was less frequent and oral analgesic use was more frequent in SOC (43% vs 63%, p<0.001; 50% vs 38%, p=0.05, respectively). Pts with increased BSP (OR 0.73, p<0.001), AA race (OR 0.19, p<0.001) and greater BMI had lower use of topical interventions whereas any boost phase, bolus, IMN RT and increased PTV volume had greater use. On MVA, AA pts (OR 0.27, p=0.04), boost (OR 2.04, p=0.033), IMN RT (OR 2.73, p=0.003) and PTV V105% (OR=1.002, p=0.03) retained significance. Late grade 2/3 hyperpigmentation was greater in SOC (16% vs 3%, p=0.01). Increased BSP (OR 2.14, p=0.001), AA pts (OR 8.18, p=0.02), bolus and CW boost had greater odds of grade 2/3 hyperpigmentation. On MVA, increased BSP (OR: 3.76, p=0.03) and bolus (OR: 14.1, p=0.01) retained significance. <h3>Conclusion</h3> We found less clinician-graded acute RD in SOC and AA pts, less frequent use of topical interventions but more oral analgesic use. We also found higher rates of late pigmentation change with increased BSP independent of race. These findings suggest that RD may be under-diagnosed in SOC. This study confirms the necessity for objective measures of RD that account for variability in BSP to accurately classify the severity of radiation skin toxicity in SOC and treat accordingly.

Clinical outcomes and immune markers by race in a phase I/II clinical trial of durvalumab concomitant with neoadjuvant chemotherapy in early-stage TNBC.

516 Background: The incidence of triple negative breast cancer (TNBC) is higher among Black or African American (AA) women, yet AA patients (pts) are underrepresented in clinical trials, exemplifying racial disparity in oncology. We conducted a phase I/II trial to assess the safety and efficacy of durvalumab concurrent with weekly nab-paclitaxel and dose dense doxorubicin/cyclophosphamide (ddAC) neoadjuvant therapy for stage I-III TNBC. The primary efficacy endpoint was pathologic complete response (pCR; ypT0/is,N0) rate. Given the unclear efficacy and safety of immunotherapy in AA pts with breast cancer, we extended our accrual to recruit AA pts, with the goal of evaluating the association between racial groups and PD-L1 expression, stromal tumor infiltrating lymphocytes (sTILs), toxicities, treatment response and survival. Methods: Our study population included 67 pts. PD-L1 immunohistochemistry results and sTIL counts were available on 59 and 60 pts, respectively. Chi-Squared test was used to evaluate associations between race and baseline characteristics. Cox proportional hazards model was used to assess association between AA race and overall survival (OS) and event free survival (EFS), adjusting for age, comorbidities and pCR status. Multivariate logistic regression analyses were used to evaluate the association between race and pCR, development of immune-related adverse events (irAEs) and breast cancer recurrence. Results: Twenty-one pts (31%) self-identified as AA. No significant associations between AA race and baseline body mass index (BMI; p=0.075), Charlson comorbidity index (p=0.32), tumor stage (p=0.40), grade (p=0.54), PD-L1 status (0.92) and sTIL count (p=0.57) were observed. pCR rates did not significantly differ between AA and non-AA pts: 9/21 (43%) AA vs. 22/48 (48%) non-AA (p=0.71). 3-yr OS was 87% in the non-AA versus 81% in the AA cohort (HR 1.72, 95% CI 0.481-6.136; p=0.405); 3 yr EFS were 78.3% and 71.4% in non-AA and AA pts respectively. (HR 1.451, 95% CI 0.524-4.017; p=0.474). Pts with pCR were more likely to remain event-free at 3 yrs, irrespective of race (HR 0.234, 95% CI 0.066-0.829; p=0.024). In multivariate logistic regression analyses, lack of pathologic response (OR for pCR 0.17, 95% CI 0.03-0.7; p=0.02) and node positive status (OR 4.13, 95% CI 1.05-19.88; p=0.05) were associated with recurrence. The incidence of irAEs was similar between AA and non-AA pts and no significant associations were found between irAEs and pathologic response. Conclusions: pCR rates after neoadjuvant immunotherapy and chemotherapy were similar in AA and non-AA pts. Stromal TILs, PD-L1 status, 3yr OS and EFS, and the frequency of irAEs were also similar. These results suggest that when patients receive identical treatment and are monitored closely, disparities in outcomes can be mitigated or abolished. Clinical trial information: NCT02489448.

Molecular profiling of African American patients with pancreatic cancer.

e16242 Background: Pancreatic cancer (PC) is a highly fatal disease, and multiple studies have shown that African Americans (AA) have a higher incidence of PC compared with Whites and have a higher risk of PC-related mortality. Differences in known risk factors for PC including cigarette smoking, obesity, diabetes and family history have been demonstrated to not fully account for the racial disparity in incidence. Furthermore, differing mortality rates by race are not entirely attributable to variables such as access to care and disparate management. Whether there are molecular and biologic differences in PC that could explain these disparities is a question that has important scientific and clinical consequences. Unfortunately, most large studies of genomic alterations in PC include very few AA patients (pts). This study tries to characterize molecular alterations seen in AA pts with PC. Methods: The electronic medical record was queried for all self-identified Black or AA pts who were diagnosed with PC and had molecular profiling from November 2015 to November 2021. Patient demographics, clinical characteristics and molecular genomics were analyzed. The primary outcome was percent of patients with specific KRAS mutations. The secondary outcome was differences in KRAS mutations by gender. Results: We identified 50 AA pts with PC who underwent molecular profiling, 19 of whom (38%) were female. As expected, most (66%) were advanced stage at diagnosis. 32 pts (64%) had tissue-based molecular profiling with 18 (36%) having blood-based testing. A KRAS mutation was identified in 38 pts (76%). 15 (30%), 12 (24%), and 11 (22%) had G12V, G12D, and G12R mutations in KRAS, respectively. Men were more likely to have a G12D mutation (35.5% vs 5.3%, P = 0.018), and women were more likely to have a G12V mutation (47.4% vs 19.4%, P = 0.036). There was no significant difference in overall survival between men and women. 30 pts (60%) had additional mutations other than KRAS. 6 pts (12%) did not have a KRAS mutation detected despite the presence of other alterations. 4 pts had no mutations detected on molecular next generation sequencing, 3 of which had blood-based testing. Conclusions: In our review of genomic mutations of AA pts with PC, KRAS G12V mutations were most common. Only 24% of our studied population had KRAS G12D mutations. The frequency of specific KRAS mutations differs from what has been described in the literature among predominantly White pts with PC, where almost half of pts have a G12D mutation and 28% and 17% harbor G12V and G12R mutations, respectively. Two major limitations of this study are the small sample size which limits definitive comparisons between races, and the imperfect sensitivity of molecular profiling. KRAS is thought to be present in &gt; 90% of PC, but the mutation was only identified in 76% of our pts. Further studies should be conducted to determine whether different molecular characteristics could account for racial disparities in PC mortality.

Institutional review of African American (AA) patients with metastatic triple-negative breast cancer.

e13059 Background: Atezolizumab+ Abraxane (Ate+Abx) was approved as 1st line treatment in metastatic TNBC based on IMPASSION (IM) 130 trial and was subsequently withdrawn per IM131 trial. Treatment of mTNBC remains challenging. Pembrolizumab with chemotherapy received accelerated approval based on Keynote-355. Poor outcomes among AA patients (pts) are linked to biological differences, BRCA1/2 mutations, obesity, and socioeconomic barriers. In TNBC clinical trials, AA pts continue to be underrepresented, e.g., 5.8% (26) in IM130 and 4.9% (21) in IM131. Our cancer center sees over 300 new BC pts a year, and at least 50% identify as AA. Here we examine our institutional experience. Methods: IRB-approved retrospective database search was conducted between 01/01/2019- 04/16/2021 to identify 11 pts treated with Ate+Abx for mTNBC at Medstar Washington Hospital Center, DC. Demographic variables manually extracted were age, BMI, insurance type and outcomes. Results: 10/11 (91%) pts were AA with lines of therapy ranging 1-6. 20% (2/10) showed partial response (PR) on 3-month (M) interval imaging per the RECIST 1.1 scoring. PD occurred in 6/10 (60%) of pts, although PD-L1 was positive in 90% (9/10) pts. Time to progression (TTP) was 1-7 M (median 3M) compared to TTP of 5.59 to 7.46M (median 7.16M) for all races in the IM130 study. Autoimmune colitis, peripheral neuropathy, and fatigue were notable adverse effects (AEs). 2/10 (20%) pts discontinued treatment due to AEs. Colitis and neuropathy in IM130 were &lt;1%. Mean age at drug initiation was 52.2 vs. 55 years in IM130, indicating earlier onset of mTNBC in the AA population. Conclusions: Trends of higher PD and earlier TTP were noted in our AA pts. Young age at metastasis, high number of previous lines of therapy, high number of metastatic sites, and obesity were noted amongst our AA mTNBC pts. Positive PD-L1, BRCA mutations, metastatic sites, BMI, or insurance type did not correlate with outcomes. Pts with PR vs. PD were not different in terms of insurance, metastasis sites, and BMI. Differences in AEs are noted; however, the small pt population size and lack of a control group are limitations. While the FDA has withdrawn Ate from trials for mTNBC, this study suggests a need for more AA pts to be included in clinical trials for TNBC. Lack of health care access, insufficient education, inadequate recruitment, and distrust of the medical system are contributing factors that require continued efforts.[Table: see text]

The impact of obesity on triple negative breast cancer (TNBC) outcomes at a diverse academic cancer center.

e12529 Background: Multiple studies have linked obesity (BMI ≥30 kg/m2) to poor outcomes from triple negative breast cancer (TNBC). To further explore the association between obesity and TNBC, we conducted a retrospective chart review at our institution to examine the association of race and obesity with disease free survival (DFS) and pathologic complete response (pCR) rates. Our institution is a unique setting in which to study this because of its large African-American (AA) pt population relative to other academic medical centers in the United States. Methods: A chart review of 247 early-stage TNBC pts treated from 2004- 2017 was conducted. All cases were retrieved from pathology archival reports. Of these 247 pts, 116 were treated with adjuvant chemotherapy and 131 were treated with neoadjuvant chemotherapy (NAT). Pts were categorized as obese (BMI = / &gt; 30) and non-obese (BMI &lt; 30), AA [n = 151], Caucasian [n = 84], other [n = 11], and missing [n = 1]. The association of race and BMI with pCR following NAT (for the NAT group), and the association of race and BMI with DFS (for all pts) was evaluated. Results: 50.3% of AA pts and 32% of Caucasians were obese. 43% of obese pts had node-positive disease at diagnosis, compared with 31% of non-obese pts. Among the node-positive TNBC pts, non-obese pts had a trend towards a longer DFS than obese pts with a HR 0.80 (95% CI 0.37 – 1.71) and a non-statistically significant p-value of 0.562. We evaluated pCR rates based on race and BMI. Among AA pts, 56.9% did not achieve pCR after NAT, and of these pts 44.4% were obese; 43.1% achieved pCR and of these 58.8% were obese (p = 0.206). Among Caucasian pts, 65% did not achieve pCR, and of these 43.3% were obese; of the 35% of Caucasian pts who achieved pCR, 31.25% were obese (p = 0.424). Among pts who eventually developed distant metastases, there was a strong trend towards shorter DFS in the obese group, with a HR 1.92 (95% CI 0.94-3.95) and a non-statistically significant p-value of 0.075. Conclusions: In this sizable population of TNBC pts at a racially diverse academic medical center, obesity was associated with a higher incidence of nodal involvement at diagnosis, and shorter interval of time to development of distant metastatic disease. Race was not found to impact pCR or DFS in a statistically significant way. This could have been related to small sample size (particularly in the NAT group), or because some socioeconomic variables often tied to poor outcomes among minority pts may have been minimized in this study. The association of obesity with node positivity at diagnosis and with shorter interval times for development of metastases highlights the importance of adopting initiatives to minimize obesity in oncology practices and in the primary care setting. Improving access to healthy food and to safe spaces for exercise will help to prevent obesity, and thus may reduce the risk of developing TNBC and improve breast cancer outcomes among all pts, regardless of race.

Real-world outcomes of axicabtagene ciloleucel (Axi-cel) for the treatment of large B-cell lymphoma (LBCL) by race and ethnicity.

7571 Background: In clinical trials of CAR T-cell therapies and real-world studies published to date, there is a paucity of data on outcomes by race and ethnicity. Here, we examined outcomes by race and ethnicity among LBCL pts who received axi-cel in the real-world setting. Methods: A total of 1389 pts with LBCL were identified from a non-interventional post-authorization safety study with pts receiving commercial axi-cel between 10/2017 and 08/2020. Race (African American or Asian vs White) and ethnicity (Hispanic vs non-Hispanic) were self-reported by pts. Pts with rescinded consent, enrolled in trials, having prior non-HCT cellular therapy, primary CNS lymphoma, unknown comorbidity or data in query were excluded. Median follow-up was 12.7 mo. Outcomes included ORR, CR rate, DOR, PFS and OS, grade ≥ 3 CRS (Lee 2014 criteria) and ICANS (ASTCT consensus grade). ORR and CR were evaluated in pts with ≥ 180 days of follow-up. Kaplan-Meier estimates were calculated for PFS and OS. Multivariable analyses comparing race and ethnicity were conducted via logistic and Cox regression. Results: Among all, 1127 (81%) were White, 70 (5%) African American and 81 (6%) Asian; 152 (11%) were Hispanic including 104 White, 2 Black, and 1 Asian Hispanic. African Americans, compared to White, were younger (median age 55.5 vs 62.8 years), more likely to have pulmonary impairment (41% vs 28%) and tended to have longer time from diagnosis (≥ 12 mo 71% vs 59%). Hispanic pts were younger (median age 58.5 vs 62.6 years) than non-Hispanic pts. ORR was 74% (CR 57%, 12-mo PFS and OS 48% and 63%) for White, 57% (CR 45%, 12-mo PFS and OS 36% and 62%) for African American, 67% (CR 53%, 12-mo PFS and OS 55% and 65%) for Asian and 73% (CR 55%, 12-mo PFS and OS 50% and 65%) for Hispanic pts. Grade ≥ 3 CRS and ICANS occurred in 7% and 18% of African American, 10% and 19% of Asian, and 8% and 27% of White pts, respectively. Hispanic pts had lower rates of grade ≥ 3 CRS and ICANS (4% and 15%) vs non-Hispanic (9% and 27%). African American race was associated with inferior ORR (OR 0.40; 95% CI, 0.24-0.69) and CR rate (OR 0.55; 95% CI 0.32-0.93) vs White. Asian pts had favorable DOR compared to both White (HR 0.46; 95% CI 0.24-0.87) and African American (HR 0.39; 95% CI 0.17-0.88). No statistical differences were found in OS and PFS across races, nor in any efficacy outcome between Hispanic and non-Hispanic pts. Asian (OR 0.52; 95% CI 0.29-0.96 vs White) and Hispanic pts (OR 0.51; 95% CI 0.31-0.85 vs non-Hispanic) had lower risk of grade ≥ 3 ICANS. Conclusions: Overall, axi-cel showed favorable OS, PFS and safety profile regardless of race and ethnicity in the real-world setting. No notable differences in outcomes were observed for Hispanic or Asian pts. Lower response rates in African American pts noted here warrant further investigation including any underrepresentation not explained by a lower incidence rate for DLBCL (SEER), access to care, and disease burden.

National and local racial disparities in triple-negative breast cancer (TNBC) survival: Local outcomes counter the myth of national averages.

e18588 Background: Real-world studies comparing racial differences in overall survival (OS) outcomes between African American (AA) and White (W) patients (pts) with TNBC have yielded mixed findings. This exploratory study assessed differences between national and county-level OS estimates-comparing AA vs. W pts, and identifying counties with greater racial disparities for future research. Methods: This retrospective cohort study used the Surveillance Epidemiology and End Result (SEER) cancer registry to assess county-level OS among non-hispanic AA and W pts ≥18 years of age who were diagnosed with TNBC 2011-2016. Counties with low levels of racial diversity (&lt; 30 AA or W TNBC pts) were excluded. Five-year OS was evaluated using Kaplan-Meier and multilevel parametric OS models with a Weibull distribution. By county, OS differences between AA and W pts were tested using linear hypothesis tests after model estimation. OS models were adjusted for age at diagnosis, year of diagnosis, marital status, insurance type, surgery type, stage, grade and metastasis at brain, bone, liver and lung. Results: Among 46,125 TNBC pts in SEER, 15,723 pts (33.4% AA, 66.6% W) residing in 8 States and 47 Counties met inclusion criteria. W pts were older (mean 60; ∓14 vs 57∓13 for AA) and more likely to be married (57% vs 33%), insured (49% vs 45%) and diagnosed at an earlier stage (stage I 37% vs 29%). Controlling for potential confounders, AA pts were more likely to experience 5-year mortality compared to W pts (Hazard Ratio [HR] = 1.16; 95%CI = 1.07, 1.26). Among 47 included counties, only 4 counties demonstrated a statistically significant 5-year OS racial disparities after adjusting for confounders. The difference in HRs between AA and W pts in these 4 counties ranged from 1.49 to 2.26 as depicted in the result table (p value &lt; 0.05). Removing these 4 counties (n = 2,929) from the final analytic cohort yielded statistically non-significant estimates (HR = 1.06; 0.97,1.16). Conclusions: There is clinically meaningful OS variation between AA and W pts with TNBC across U.S. counties included in SEER. Measuring disparities at the national or state level may mask important OS disparities at the county level. Using a county-level analytic approach, we were able to identify localities that disproportionately contribute to OS disparities at the national level. Our findings will facilitate better targeting of local interventions to address TNBC racial disparities. Future analyses should also assess counties excluded (n = 13,032) for small population sizes and/or low levels of racial diversity, as well as states not represented in SEER.[Table: see text]