Background and Aims:Colorectal cancer (CRC) incidence in those under age 50 is increasing and minority populations are known to have worse CRC survival outcomes. Therefore, we evaluated 5-year CRC-specific survival by race and ethnicity among medically insured patients with early-onset CRC. Methods:This retrospective cohort study included Kaiser Permanente Northern California patients aged 18-49 years diagnosed with CRC between 2006 and 2019. Five-year CRC-specific survival by race and ethnicity was assessed using Kaplan-Meier survival analyses and unadjusted and adjusted Cox proportional hazards models. Results:Among 1620 patients, 50.3% were White, 21.6% Hispanic, 20.1% Asian or Pacific Islander, and 8.0% Black. Stage IV disease was found in 23.4% of White, 28.7% of Black, 30.1% of Asian or Pacific Islander, and 31.1% of Hispanic patients. Five-year CRC-specific survival probability estimates ranged from 74.4% in Hispanic patients to 79.9% in White patients with no statistically significant differences in unadjusted risk estimates. However, after adjusting for age, sex, comorbidities, and socioeconomic status measures, risk of death was higher in Hispanic vs White patients (hazard ratio: 1.46; 95% confidence interval: 1.08-1.97) but was attenuated (hazard ratio: 1.13; 95% confidence interval: 0.83-1.53) after further adjustment for stage at diagnosis. Conclusion:Among medically insured patients in a large integrated healthcare setting, Hispanic patients were more likely to be diagnosed with stage IV CRC and had the lowest 5-year CRC-specific survival probability compared to other race groups. Additional research is needed to identify factors contributing to the higher rate of late-stage disease diagnosis in Hispanic patients.

447 Background: A+B is the standard first-line (1L) treatment for uHCC based on the IMbrave150 trial, which demonstrated superior efficacy over sorafenib with longer median overall survival (19.2 vs 13.4 months) and progression-free survival (6.8 vs 4.3 months) among patients with Child Pugh (CP) A cirrhosis. Evidence about A+B use and outcomes in routine clinical practice, including in patients with impaired liver function, remains limited. Methods: This retrospective observational study included adult patients who initiated 1L A+B for uHCC within The US Oncology Network between 1/1/2019 and 8/31/2022 (followed through 11/30/2022) using structured and unstructured electronic health records (EHR) based data. CP classes were reported by physicians or derived from risk factors. Kaplan-Meier methods were used to assess real-world overall survival (rwOS) and progression-free survival (rwPFS) from initiation of A+B. Exploratory subgroup analyses were conducted by CP class, albumin-bilirubin (ALBI) grade, liver disease etiology, and race/ethnicity. Results: We identified 374 patients with uHCC who initiated 1L A+B during the study period. Compared with patients enrolled in IMbrave150 (n=336), those treated with A+B in clinical practice were older (median age: 69 vs 64 years), had worse liver function (CP A: 61% vs 100%; ALBI Grade >1: 66% vs 43%), and had poorer performance status (ECOG PS>1: 18% vs 0%). At a median follow-up of 5.6 months, 78% (n=293) had discontinued treatment. Among them, 57% discontinued was progression and 4% discontinued due to toxicity alone. Median rwOS was 13.2 months (95%CI: 9.5–15.9) and median rwPFS was 6.4 months (95%CI: 5.1–7.7). Subgroup results are shown (Table). Conclusions: In community oncology settings, 1L A+B demonstrates effectiveness in diverse patient cohorts, including those with impaired liver function, non-viral liver disease, and racial/ethnic minorities. Predictive biomarkers can help identify subgroups who may most benefit from 1L A+B. [Table: see text]

Many patients with hepatocellular carcinoma (HCC) experience recurrence after curative-intent resection or ablation, with a poor prognosis. Real-world patterns of recurrence and the prognostic significance of early recurrence in U.S. clinical practice have not been well characterized. This retrospective observational study was designed to evaluate the impact of recurrence on overall survival (OS) among patients with HCC following initial curative-intent resection or ablation. We used the Surveillance, Epidemiology, and End Results cancer registry linked with Medicare claims (January 1, 2010–December 31, 2019). Eligible patients (≥66 years) diagnosed with HCC (2010–2017) had liver resection or ablation within 180 days of diagnosis. Patients were stratified by recurrence status using diagnosis- and treatment-based definitions of recurrence. Early or late recurrence was defined as within 1 year or after 1 year, respectively. Adjusted OS analyses used multivariable Cox regression models. A total of 1,146 patients were included. During a median overall follow-up of 35.2 months, 736 (64

Aim: Evaluate the association of race/ethnicity and socioeconomic position (SEP) on emergency department (ED) visits for patients with hepatocellular carcinoma (HCC), which may reflect access to and quality of cancer care. Materials & methods: Patients with HCC identified from a commercial multi-payer claims database between 2015 and 2018 were matched to near-neighborhood social determinants of health (SDOH) and stratified by race/ethnicity and SEP (proxied by annual household income). Analyses evaluated the effect of race/ethnicity and SEP on ED utilization, adjusting for SDOH, demographic and clinical characteristics using multivariable regression methods. Results: A total of 22,247 patients were included. Black and Hispanic patients had 43 and 18% higher ED utilization than White patients at higher-income levels (p < 0.01); these differences were nonsignificant at lower-income. Regardless of income level, Asian patients had lower ED utilization. Conclusion: Further research on the intersectionality between race/ethnicity, SEP and other SDOH may guide structural-level interventions to address health inequities. Health disparities among racial/ethnic minorities have been observed in patients with hepatocellular carcinoma (HCC). We conducted a real-world retrospective insurance claims study of more than 22,200 adult patients with HCC between 2015 and 2018. We evaluated the association of race/ethnicity and socioeconomic position (measured by income level) with emergency department (ED) utilization. Our study consisted of 69% White, 14% Black, 7% Hispanic, 6% Asian and 4% other patient populations. Black and Hispanic patients had the highest number of ED visits, followed by White and Asian patients. Compared with White patients, ED visits were 27% higher for Black, 17% higher for Hispanic and 36% lower for Asian patients. Compared with low income, middle income was associated with 4% more and high income with 6% less ED use, regardless of race/ethnicity. At higher income levels, Black and Hispanic but not Asian patients demonstrated higher ED use than White patients. These findings suggest that improved socioeconomic position of Black and Hispanic patients may not provide as protective an effect on health outcomes, potentially due to structural health inequities.

Asian Americans and Pacific Islanders have an increased risk of developing liver cancer and higher risk of death compared to non-Hispanic White individuals. The role of individual-level risk factors, social determinants of health, and barriers navigating health systems present unique challenges in obtaining liver cancer care for these patients. Additionally, the Asian American and Pacific Islander population is a heterogenous group originating from several different countries and speaking various languages, and they are often underrepresented in cancer clinical trial populations. This article describes the challenges faced by Asian American and Pacific Islander patients with liver cancer from the clinician, research, and patient advocacy perspectives and proposes targeted solutions to reduce healthcare disparities in this group.

Background/Objectives: This study evaluated comparative overall survival (OS) of United States veterans with unresectable hepatocellular carcinoma (uHCC) receiving first-line (1L) atezolizumab plus bevacizumab vs. sorafenib or lenvatinib, overall and across racial and ethnic groups. Methods: In this retrospective study, patients with uHCC who initiated atezolizumab plus bevacizumab (post-2020) or sorafenib or lenvatinib (post-2018) were identified from the Veterans Health Administration National Corporate Data Warehouse (1 January 2017-31 December 2022). Patient characteristics were evaluated in the year prior to 1L treatment initiation. Kaplan-Meier and multivariable Cox regression methods were used to compare OS starting from treatment between cohorts, both overall and by race and ethnicity. Results: Among the 1874 patients included, 405 (21.6%) received 1L atezolizumab plus bevacizumab, 1016 (54.2%) received sorafenib, and 453 (24.2%) received lenvatinib, with a median follow-up time of 8.5, 7.6, and 8.2 months, respectively. Overall, patients receiving atezolizumab plus bevacizumab had longer unadjusted median OS (12.8 [95% CI: 10.6, 17.1] months) than patients receiving sorafenib (8.0 [7.1, 8.6] months) or lenvatinib (9.5 [7.8, 11.4] months; both log-rank p < 0.001). After adjustment, atezolizumab plus bevacizumab was associated with a reduced risk of death by 30% vs. sorafenib (adjusted HR: 0.70 [95% CI: 0.60, 0.82]) and by 26% vs. lenvatinib (0.74 [0.62, 0.88]; both p < 0.001). OS trends in the White, Black, and Hispanic patient cohorts were consistent with that of the overall population. Conclusions: Atezolizumab plus bevacizumab was associated with improved survival outcomes compared with sorafenib and lenvatinib in patients with uHCC, both overall and across racial and ethnic subgroups.

Treatments for unresectable hepatocellular carcinoma (HCC) have varying benefit-risk profiles. We elicited 200 US patients' preferences for attributes associated with various first-line systemic treatments for unresectable HCC in a discrete-choice experiment (DCE) survey. Respondents answered nine DCE questions, each offering a choice between two hypothetical treatment profiles defined by six attributes with varying levels: overall survival (OS), months of maintained daily function, severity of palmar-plantar syndrome, severity of hypertension, risk of digestive-tract bleeding, and mode and frequency of administration. A random-parameters logit model was used to analyze the preference data. Patients regarded an additional 10 months of maintaining daily function without decline to be as important or more important than 10 additional months of OS, on average. Respondents valued avoiding moderate-to-severe palmar-plantar syndrome and hypertension more than extended OS. A respondent would require >10 additional months of OS (the greatest increase presented in the study) on average to offset the increased burden of adverse events. Patients with unresectable HCC prioritize avoiding adverse events that would severely impact their quality of life over mode and frequency of administration or digestive-tract bleeding risk. For some patients with unresectable HCC, maintaining daily functioning is as important or more important than the survival benefit of a treatment.

Objective Real-world data characterizing differences between African American (AA) and White women with metastatic triple-negative breast cancer (mTNBC) are limited. Using 9 years of data collected from community practices throughout the United States, we assessed racial differences in the proportion of patients with mTNBC, and their characteristics, treatment, and overall survival (OS). Methods This retrospective study analyzed de-identified data from 2,116 patients with mTNBC in the Flatiron Health database (January 2011 to March 2020). Characteristics and treatment patterns between AA and White patients with mTNBC were compared using descriptive statistics. OS was examined using Kaplan-Meier analysis and a multivariate Cox proportional hazards regression model. Results Among patients with metastatic breast cancer, more AA patients (23%) had mTNBC than White patients (12%). This difference was particularly pronounced in patients who lived in the Northeast, were aged 45–65, had commercial insurance, and had initial diagnosis at stage II. AA patients were younger and more likely to have Medicaid. Clinical characteristics and first-line treatments were similar between AA and White patients. Unadjusted median OS (months) was shorter in AA (10.3; 95% confidence interval [CI]: 9.1, 11.7) vs. White patients (11.9; 95% CI: 10.9, 12.8) but not significantly different. After adjusting for potential confounders, the hazard ratio for OS was 1.09 (95% CI: 0.95, 1.25) for AA vs. White patients. Conclusions The proportion of patients with mTNBC was higher in AA than White mBC patients treated in community practices. Race did not show an association with OS. Both AA and White patients with mTNBC received similar treatments. OS was similarly poor in both groups, particularly in patients who had not received any documented anti-cancer treatment. Effective treatment remains a substantial unmet need for all patients with mTNBC.

Abstract Background Amid continued uncertainty about the management of cancer patients during the pandemic, this study sought to obtain real-world data on the use of immune checkpoint inhibitors (ICIs) before COVID-19 diagnosis and its association with severity and survival outcomes in cancer patients who contracted COVID-19. Methods Cancer patients diagnosed with COVID-19 were identified from a large electronic health record database; those treated with ICIs before COVID-19+ diagnosis were matched in a 1:2 ratio to those not treated with ICIs, using a 2-step matching procedure. A descriptive analysis examined the difference in COVID-19 mortality (30-day and overall) and severity outcomes between the 2 cohorts, and overall survival was compared. Results Among 17 545 adults ≥18 years with cancer who tested positive for COVID-19 between February 20, 2020, and January 28, 2021, in the US, 228 ICI-treated patients were matched to 456 non-ICI-treated patients, comprising the 2 study cohorts. Clinical characteristics differed significantly between the 2 cohorts before matching, with metastatic disease, lung cancer, a history of smoking, and the presence of pulmonary comorbidities being more common in the ICI-treated cohort; after matching, the 2 cohorts were similar. There were no significant differences between the ICI-treated and non-ICI-treated cohorts for 30-day mortality (12.7% vs. 14.9%, P = .235), overall mortality (22.4% vs. 22.4%, P = 1.000), hospitalization (38.6% vs. 39.0%, P = .912), or emergency department visits (16.7% vs. 14.7%, P = .500). Overall survival was similar between the 2 cohorts. Conclusion This analysis adds to the clinical evidence base that use of ICIs before SARS-CoV-2 infection does not affect COVID-19 severity or survival outcomes, supporting the continued use of ICIs in cancer patients during the pandemic.

Background: Reducing barriers to patient participation in clinical trials is vitally important to the cancer care community. Using data from a real-world cohort of metastatic breast cancer (mBC) patients (pts), we evaluated how race/ethnicity and other socioeconomic, institutional, and clinical barriers play a role in trial participation. Methods: Adult females with mBC were selected from Flatiron Health EHR-derived de-identified database (2011- 2020). Clinical trial participation was determined by having “clinical study drug” in any line of therapy. Multivariate logistic regressions were used to assess how various barriers impact trial participation. Results: In this cohort of 22,220 mBC pts, 1,131 (5.1%) were enrolled in clinical trials and participation rates vary by line of therapy, race/ethnicity, age, insurance, location, and care setting (Table 1). Comparing pts characteristics between enrolled vs. not enrolled, pts ever enrolled were significantly younger (mean age: 59 vs 63), had better performance status (ECOG PS ≥ 2: 3% vs 8%), and less Brain/CNS metastasis (3% vs 6%), more likely to be white (75% vs 61%), lived in the south (55% vs 38%), and had commercial insurance (34% vs 29%), with all p Conclusions: Preliminary results of this study reveal significant demographic and socioeconomic disparities in trial participation among mBC patients. In particular, AA and Hispanic patients were less likely to participate in clinical trials after controlling for other individual- or system-level factors that may impact enrollment. Future efforts to understand the relationship between racial disparity and other well-known barriers are needed. Citation Format: Ruoding Tan, Rongrong Wang, Ibrahim Abbass, Lourenia Cassoli, Edith P. Mitchell. Clinical trial participation in real-world patients with metastatic breast cancer: disparities and barriers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 2624.

Monday, April 27April 14, 2020Free AccessPatient and Physician Perspectives on the Care and Assistance Needs in Huntington’s Disease (HD) (946)Karina Raimundo, Ruoding Tan, Tu My To, Jonathan de Courcy, Umang Ondhia, Hugh Rickards, and Martha NanceAuthors Info & AffiliationsApril 14, 2020 issue94 (15_supplement)https://doi.org/10.1212/WNL.94.15_supplement.946 Letters to the Editor

Monday, April 27April 14, 2020Free AccessImpact of Caring for Patients with Huntington’s Disease (HD) on Work Status (956)Karina Raimundo, Ruoding Tan, Tu My To, Jonathan de Courcy, Umang Ondhia, Hugh Rickards, and Martha NanceAuthors Info & AffiliationsApril 14, 2020 issue94 (15_supplement)https://doi.org/10.1212/WNL.94.15_supplement.956 Letters to the Editor

Purpose Common causes of hospitalizations in the United States are acute bacterial skin and skin-structure infections (ABSSSIs). The objectives of this retrospective study were to characterize hospitalized ABSSSI patients including comorbidities and identify the microorganisms associated with the infection. Methods Adults (>18 years) hospitalized with 1 or more primary ABSSSI diagnosis were selected from the Cerner Health Facts electronic medical records database between 2009 and 2013. Causative microorganisms for ABSSSI and Gram-stain type were identified from microbiology culture, including patients with methicillin-resistant Staphylococcus aureus (MRSA). Results Of the 11,705 patients identified, 51.8% were male, with a mean age of 55 years at admission; 49.7% were obese; and 30.9% had diabetes. More than half (56.6%) of patients had no microbiology culture results. Of the patients with an identified ABSSSI-causing pathogen, 63.9% were gram-positive, including 18.4% infected with MRSA; 11.9% were gram-negative; and 24.2% had mixed infections (gram-positive and gram-negative), including 3.6% with MRSA. After adjusting for confounding variables, a significant association was noted between obesity and 30-day ABSSSI-related readmission among males, patients younger than 65 years, and patients without MRSA. Implications Hospitalized ABSSI patients had comorbidities, including obesity, diabetes, hypertension, and depression, which can complicate antibiotic selection. Patient characteristics and pathogen coverage must be considered in antibiotic selection in ABSSSI.

The study aims to examine real‐world weight change and the role of medication adherence among patients with type 2 diabetes who initiated one of three drug classes: glucagon‐like peptide‐1 receptor agonist (GLP‐1RA), dipeptidyl peptidase‐4 inhibitor (DPP4) and sulfonylureas (SUs).

Systemic lupus erythematosus (SLE) is a multisystem, progressive disease characterized by highly variable clinical manifestation. For patients with SLE, disease activity has been a consistent focus of studies analyzing health outcomes; however, patients with high disease activity (HDA), a key subpopulation with high unmet need, have not been studied extensively in the literature. A targeted literature review was conducted to describe the criteria for defining HDA and the burden of HDA. Articles were identified via PubMed search through 2016, complemented by additional hand searches. Both abstract and full-text were reviewed for relevance. Data on the clinical definition of HDA, clinical and humanistic burden of HDA under different definitions, and economic burden associated with patients with high levels of disease severity/activity were extracted. The literature search yielded 670 articles; 52 were included for data extraction. Fourteen studies evaluated the measurement of disease activity, 35 assessed the disease burden of HDA, and of 17 studies reporting economic outcomes, only one assessed the economic burden of HDA. The literature lacks a widely-accepted approach for measuring disease activity in this heterogeneous disease—a number of different instruments and clinical criteria have been developed for defining HDA, and the threshold used to define HDA varies across studies. Across definitions, elevated disease activity exacts heavy burden that manifests as elevated mortality risk, long-term organ damage, an array of burdensome comorbidities (e.g., psychosis, seizures, artery calcifications), heavy corticosteroid use, increased risk of work disability, and high resource utilization. This literature review revealed that HDA status is currently defined by varying assessment tools. Uniformly, HDA is found to exact significantly high disease burden, confirming the importance of this patient population, but comparability across measures is not well established. Further, gaps exist in quantifying economic burden of HDA which require additional study.

OBJECTIVE The objective of this study was to estimate and explain the gap between clinical efficacy and real-world (RW) effectiveness of type 2 diabetes medications. RESEARCH DESIGN AND METHODS This mixed-methods quasi-experimental study used retrospective claims (Optum/Humedica) to compare the change in HbA(1c) of RW patients with type 2 diabetes 12 months after starting a glucagon-like peptide 1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase 4 (DPP-4) inhibitor with published findings from randomized controlled trials (RCTs) evaluating these drugs. Selected RW patients were similar to RCT patients, and regression analysis was used in the RW data to adjust for differences between poorly adherent and adherent patients to explain why RCT and RW findings may differ. RESULTS RW patients initiating a GLP-1 RA (n = 221) or a DPP-4 (n = 652) experienced smaller reductions in HbA(1c) (GLP-1 RA: -0.52% [-6 mmol/mol], DPP-4: -0.51% [-6 mmol/mol])than reported in RCTs (-1.30% [-14 mmol/mol] from seven GLP-1 RA RCTs, n = 2,600; -0.68% [-8 mmol/mol] from four DPP-4 RCTs, n = 1,889). Baseline HbA(1c), additional medications, and adherence were significant explanatory factors in the RW HbA(1c) change. Modeled estimates of RCT efficacy (-1.04% GLP-1 RA [-12 mmol/mol], -0.69% DPP-4 [-8 mmol/mol]) were within the RCTs' reported range (GLP-1 RA: -0.84% to -1.60% [-9 to -18 mmol/mol], DPP-4: -0.47% to -0.90% [-5 to -10 mmol/mol]). Poor medication adherence accounted for approximately three-fourths of the gap between RW and expected RCT results (gap = 0.51% [6 mmol/mol] GLP-1 RA; 0.18% [3 mmol/mol] DPP-4). CONCLUSIONS Poor medication adherence is primarily why RW effectiveness is significantly less than RCT efficacy, suggesting an urgent need to effectively address adherence among patients with type 2 diabetes.