United States Community Research Articles

Unmet Medical Needs Amongst Older Patients Aged ≥60 Years with Newly Diagnosed Acute Myeloid Leukemia Receiving Intensive Chemotherapy: Experience from a Predominately United States Community Setting

Background: Venetoclax (Ven) in combination with hypomethylating agents is approved for treatment in patients (pts) with newly diagnosed (ND) acute myeloid leukemia (AML) who are ≥75 years old or unfit for intensive chemotherapy (IC), based on the longer median overall survival (OS) with Ven+azacitidine (Aza) compared with Aza in combination with placebo in the Phase III VIALE-A study (NCT02993523). Several studies are now evaluating Ven-based regimens in pts eligible for IC, for example Ven+Aza compared with IC (NCT04801797). Additionally, Ven in combination with cladribine (CLAD) and low-dose cytarabine (LDAC) is currently under investigation in a Phase II single-arm study (NCT03586609) amongst older pts (aged ≥60 years) with ND AML. An interim analysis of this trial evaluated 60 pts where complete remission (CR) and CR with incomplete count recovery (CRi) was observed in 93% of pts, and the median OS, overall and by transplant status, was not reached; 1-year OS was 72.9% and 2-year OS was 63.5% (Kadia et al. J Clin Oncol 2022). The aim of this study is to better understand treatment outcomes amongst older pts (aged ≥60 years) with ND AML receiving IC in a routine clinical care setting in the United States (US). Methods: This was a retrospective cohort study using the Flatiron Health electronic health record-derived, US nationwide, de-identified database. Pts aged ≥60 years with ND AML who initiated IC within 60 days of AML diagnosis (Dx) between January 1, 2014, and November 30, 2022, with ≥2 visits recorded within 3 months of AML Dx, and ≥3 months of follow-up before study end date (February 28, 2023) were included. Clinical trial participants and pts with acute promyelocytic leukemia or core binding factor were excluded. Descriptive analysis on patient characteristics was conducted. The proportion of pts who achieved real-world response (defined as <5% bone marrow [BM] blasts), real-world CR/CRi (defined as <5% BM blast with either platelet count <100 x 10 9/L or absolute neutrophil count <1000 x 10 9/L) and received a stem cell transplant (SCT) post-remission were reported. Thirty-day mortality, 60-day mortality, 1-year real-world OS (rwOS), and 2-year rwOS were evaluated using Kaplan-Meier (KM) analyses. The starting points for KM analyses were IC treatment initiation (all pts), SCT (pts who underwent SCT post-remission), and remission (pts who did not undergo SCT post-remission). Pts were censored at the last activity date or SCT date (whichever occurred earliest) for the overall patient cohort, and the last activity date for pts with or without SCT post-remission. Results: A total of 1105 pts met the study criteria. The median (IQR) age was 67 (64-71) years, 57% were male, 27% had secondary AML, 48% had BM blast >50% at Dx, and 66% were treated in the community setting. Excluding 340 pts with unknown cytogenetic and molecular data, 19%, 32%, and 48% of pts had European LeukemiaNet 2017 favorable, intermediate, and adverse risk, respectively. At a median (IQR) follow-up of 13 (6-28) months from AML Dx, 74% (n=821) of pts achieved real-world response, including 66% (n=724) who achieved real-world CR/CRi. For all pts, the 30-day mortality was 3%, 60-day mortality was 6%, 1-year rwOS was 58%, 2-year OS was 34%, and the median rwOS was 14.3 months ( Figure A). A total of 37% (n=306/821) of pts underwent SCT post-remission; 98% (n=300/306) underwent allogeneic-SCT and 2% (n=6/306) underwent autologous-SCT. The median rwOS was 40.4 months for pts undergoing SCT post-remission, and 13.8 months for pts without SCT post-remission ( Figure B). Conclusions: In this large real-world data study, we observed older pts (aged ≥60 years) with ND AML receiving IC treatment had a median OS of <14 months and <35% of pts remained alive 2 years after IC initiation. Findings from this study suggest the need for other novel treatment options, including Ven based regimens, to improve OS in older pts (aged ≥60 years) with ND AML who are eligible for IC. Future studies are warranted to conduct randomized controlled trials to comparatively evaluate IC vs other novel treatment options in older pts (aged ≥60 years) with ND AML, or conduct the appropriate statistical adjustment to minimize confounding in indirect treatment comparisons from different studies.

Prototype Pathogens for Vaccine and Monoclonal Antibody Countermeasure Development: NIAID Workshop Process and Outcomes for Viral Families of Pandemic Potential.

Given the increased risk of pandemics driven by emerging and reemerging infectious diseases, it is imperative that the United States and global scientific community be better prepared for future threats by prioritizing and launching key research programs and strategies. In December 2021, the National Institute of Allergy and Infectious Diseases (NIAID) published its pandemic preparedness plan, which focuses on the prototype pathogen approach for medical countermeasure development. The plan was introduced before its release at a NIAID-hosted workshop in November 2021 that featured scientific experts from the extramural community, government, and the private sector and focused on selection of prototype pathogens from 10 viral families with pandemic risk and moderate resources. This article will serve as an introduction to this special issue and will briefly define the prototype pathogen approach, describe the workshop goals and process for outcomes, and provide an outline of the viral working group articles to follow and future directions for NIAID.

Association of Discharge Location Following Pediatric Tracheostomy with Social Determinants of Health: A National Analysis.

To evaluate the breakdown of discharge locations among pediatric tracheostomy patients and determine the impact of demographic variables and social determinants of health. Retrospective review of the 2016 and 2019 Healthcare Cost and Utilization Project Kids' Inpatient Database (HCUP KID). A total of 4000 United States community hospitals, defined as short-term, non-Federal, general, and specialty hospitals. ICD-10-PCS, ICD-10 CM codes, and HCUP data elements were selected for patients and variables of interest. Bivariate comparisons were performed using Rao-Scott Chi-square tests; significance levels in post hoc pairwise testing were adjusted using Bonferroni adjustment. Multinomial generalized logistic regression models were used to determine the average annual odds ratio (OR) of 3 dispositions at discharge relative to discharge home for self-care. Patients aged 11-17, patients from large metropolitan areas, and patients of "Other" race have an increased odds of discharge to a short- or long-term care facility (all P < .001). Weekend admissions, nonelective admissions, patients in Northeast hospitals, and patients at urban nonteaching hospitals are also more likely to be discharged to a short- or long-term care facility (all P < .001). Mean and median total costs of admission were $424,387 and $243,479, respectively, with a median total charge of $854,499. Among pediatric tracheostomy patients, demographic factors that affect discharge disposition include age, community type, and race, and significant hospital factors include day and type of admission, geographic region, and hospital type. Hospitalizations are associated with high overall costs and charges to the patient, which are increasing over time.

Treatment patterns, resource utilization and clinical outcomes in patients with higher risk myelodysplastic syndromes (MDS) in United States community practices

Management of higher-risk myelodysplastic syndromes (HR-MDS) is challenging in the real world. We studied 200 patients with HR-MDS within a large US community hospital network. We describe the clinical presentation, patient-related factors, prognostic characteristics, treatment patterns, clinical outcomes and resource utilization. Patients with HR-MDS, treated in our community setting, were elderly (median age 76 years) with a high comorbidity burden. First-line therapy was hypomethylating agent (HMA) monotherapy (20%), lenalidomide (2%), and venetoclax (2%), while the rest were treated with supportive care. Sixty-one percent of the 200, were subsequently hospitalized within 6 months of initial diagnosis. Overall survival was 11.8 months. Curative transplantation was infrequent, HMA-based therapy was underutilized, responses were not durable, most patients became transfusion-dependent or transformed to AML, and resource utilization was substantial and was highly correlated with total in-hospital days. There is a clear unmet need for tolerable treatments that can produce durable remissions in this population.

98P Real-world effectiveness and safety of neratinib in the extended adjuvant treatment of patients with HER2+ early breast cancer (eBC) in the United States community oncology setting

98P Real-world effectiveness and safety of neratinib in the extended adjuvant treatment of patients with HER2+ early breast cancer (eBC) in the United States community oncology setting

The Positive Effects of Manual Pronation in a United States Community Based Hospital Intensive Care Unit During the COVID-19 Surge Crisis

Background&#x0D; Patients in acute respiratory distress syndrome suffer a high mortality rate; however, manual pronation has a survival advantage up to 17% (Gattinoni, 2013). March 2020 marked the initial COVID-19 surge in the US, characterized by government lock-downs, inundation of healthcare systems, and high patient fatality levels. Initially, COVID-19 patients who might benefit from manual pronation were transferred to other local facilities until our interdisciplinary team implemented a manual pronation policy within 27 days of receiving our first COVID-19 positive patient.&#x0D; Aim&#x0D; The aim of this study was to describe the impact of a community hospital partaking in manual pronation for the first time, quality care metrics—specifically Central Line-Associated Bloodstream Infections (CLABSIs), Catheter-Associated Urinary Tract Infections (CAUTIs), and Ventilator-Associated Pneumonia/Events (VAP/VAEs)—associated with the COVID-19 surge, and the barriers overcome during this process.&#x0D; Methods&#x0D; This retrospective data collection study included hypoxemia, intubation, discharge and quality safety data from March 13 to June 1, 2020 for patients who underwent manual pronation.&#x0D; Results/Findings &#x0D; Pronation occurred a total of twenty-seven times in 13 patients (seven (53.8%) survived and six (46.2%) died during hospital admission). Four (57.1%) of the patients who survived were discharged home, two (28.6%) went to a rehabilitation facility, and one (14.3%) was transferred to an outside hospital. Zero CAUTIs (458 catheter days), CLABSIs (371 central line days), and VAEs (384 ventilator days) occurred during the study.&#x0D; Conclusions&#x0D; With the newly acquired proning policy in place and creative COVID-19 care, data were consistent with an overall improvement in patient outcomes. Manual pronation was shown to improve P/F ratios. There were no upticks in hospital acquired infections, notably CAUTIs, CLABSIs, and VAP/VAEs at our facility.

The Perth Alexithymia Questionnaire-Short Form (PAQ-S): A 6-item measure of alexithymia

BackgroundAlexithymia is a trait characterized by difficulties identifying feelings, difficulties describing feelings, and externally orientated thinking. It is widely regarded as an important transdiagnostic risk factor for a range of psychopathologies, including depressive and anxiety disorders. Whilst several well-validated psychometric measures of alexithymia exist, these are relatively lengthy, thus limiting their utility in time-pressured settings. In this paper, we address this gap by introducing and validating a brief 6-item version of the Perth Alexithymia Questionnaire, called the Perth Alexithymia Questionnaire-Short Form (PAQ-S). MethodAcross two studies with adult samples (Study 1 N = 508 United States community; Study 2 = 378 Australian college students), we examined the psychometric properties of the PAQ-S in terms of its factor structure, reliability, and concurrent/criterion validity. ResultsIn exploratory and confirmatory factor analyses, all PAQ-S items loaded well on a single general alexithymia factor. The PAQ-S total score had high reliability, and correlated as expected with the long-form of the PAQ, as well as other established markers of alexithymia, emotion regulation, and affective disorder symptoms. LimitationsOur samples were general community or college student samples from two Western countries; future validation work in clinical samples and more diverse cultural groups is thus needed. ConclusionsThe PAQ-S retains the psychometric strengths of the PAQ. As such, the PAQ-S can be used as a quick, robust measure of overall alexithymia levels. The introduction of the PAQ-S hence enables valid assessments of alexithymia in a more diverse range of settings and research designs.

Zanubrutinib in patients with treatment-naïve or relapsed/refractory Waldenström macroglobulinemia: An expanded-access study of 50 patients in the United States.

Zanubrutinib in patients with treatment-naïve or relapsed/refractory Waldenström macroglobulinemia: An expanded-access study of 50 patients in the United States.

2046. Local validation of methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa prevalence in a community hospital: A cross-sectional retrospective cohort study

Abstract Background Current 2019 management guidelines for community-acquired pneumonia (CAP) recommend against using the category healthcare-associated pneumonia (HCAP) as a basis for selecting extended-spectrum therapy and recommend using site-specific prevalence data. This study aimed to identify the most common pathogens in patients admitted with the diagnosis of HCAP in our community hospital. Methods This cross-sectional retrospective cohort study included 560 adult patients admitted to our community hospital located in Evanston, Illinois, between January 1, 2017, and December 31, 2021, with the diagnosis of HCAP (ICD-10-CM code J18.9). We performed regression analyses to compare the prevalence and determine odds ratios (OR) with 95% CIs to compare percentages between our local data and previously reported US HCAP and CAP populations. Results Among 560 patients with an admitting diagnosis of HCAP in 5 years, 117 (20.9%) patients had a respiratory pathogen isolate. Of those, 58 (49.6%) were bacterial isolates, 51 (43.6%) were viral, 5 (4.3%) were viral and bacterial coinfections, and 3 (2.6%) were bacterial and fungal coinfections (Figure 1). Methicillin-resistant Staphylococcus aureus (MRSA) was identified in 12 (2.1%) patients, and Pseudomonas aeruginosa was identified in 9 (1.6%) patients, corresponding to 10.3% and 7.7% of patients with an identified respiratory pathogen, respectively. Other common pathogens were influenza virus, Enterobacterales (3 extended-spectrum beta-lactamase and one carbapenem-resistant), Streptococcus pneumoniae, and respiratory syncytial virus (Table 1). Compared to a large US public database of culture-positive HCAP (Kollef et al.), patients from our community hospital had a decreased risk for MRSA (vs. 262/988 [26.5%]: OR 0.23 (95% CI, 0.12 – 0.46; p &amp;lt; .001) and P. aeruginosa (vs. 250/998 [25.3%]: OR 0.25 (95% CI, 0.12 – 0.49; p &amp;lt; .001) among the culture-positive patients. These rates were also significantly lower than overall US CAP populations (Table 2).Figure 1.Isolated organisms in patients with healthcare-associated pneumonia in a community hospital in Evanston, Illinois.Table 1.Other common isolates among patients admitted with the diagnosis of HCAP in our community hospital.Abbreviations: HCAP, healthcare-associated pneumonia, MSSA, methicillin-susceptible Staphylococcus aureus; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.Table 2.Prevalence of positive testing for methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa in our community hospital vs. the overall United States community. 1. Aliberti S, Reyes LF, Faverio P, et al. Global initiative for meticillin-resistant Staphylococcus aureus pneumonia (GLIMP): an international, observational cohort study. Lancet Infect Dis. 2016 Dec;16(12):1364-1376. doi: 10.1016/S1473-3099(16)30267-5. 2. Restrepo MI, Babu BL, Reyes LF, et al. Burden and risk factors for Pseudomonas aeruginosa community-acquired pneumonia: a multinational point prevalence study of hospitalised patients. Eur Respir J. 2018 Aug 9;52(2):1701190. doi: 10.1183/13993003.01190-2017. Abbreviations: CI, confidence intervals; MRSA, methicillin-resistant Staphylococcus aureus; OR, odds ratios. Conclusion The prevalence of MRSA and P. aeruginosa pneumonia in patients categorized as HCAP was low in our community hospital, and the rates were significantly lower than previously reported US rates. Extended-spectrum therapy in our institution should be individualized and not generalized. Disclosures All Authors: No reported disclosures.

The association between trauma and interpersonal problems in a United States community mental health setting.

Previous research has documented associations between trauma and interpersonal problems. We examined the impact of trauma on interpersonal problems among depressed patients seeking treatment in a community mental health setting. A total of 453 patients seeking treatment and screened for a comparative effectiveness study of therapies for depression were included. We conducted analyses relating the 32-item inventory of interpersonal problems (IIP-32) to trauma measures. 99.1% of the sample experienced a traumatic event. There were significant associations between the total number of traumas, the number of sexually and physically assaultive traumas, and both gender and race. The number of sexually assaultive traumas was significantly related to the IIP-32 "too caring" subscale (simple r = 0.167, p < 0.001). Controlling for demographics and other IIP-32 subscales, the total number of traumas remained significantly related to the IIP-32 "too caring" domain (partial r = 0.163, p < 0.001). Traumatic events are prevalent among community populations and these experiences are associated with certain interpersonal problems. Trauma and interpersonal problems are key issues for the treatment of patients in the community mental health setting.

Comparative Effectiveness of Lenalidomide/Dexamethasone-Based Triplet Regimens for Treatment of Relapsed and/or Refractory Multiple Myeloma in Subgroups Defined By Cytogenetic Risk

Introduction: Patients with relapsed/refractory multiple myeloma (RRMM) and high cytogenetic risk have poor prognosis. Despite the proven efficacy of lenalidomide and dexamethasone (Rd)-based triplet regimens in the RRMM population, further investigation of these triplet regimens in RRMM patients with standard and high cytogenetic risk is needed to inform the optimal treatment approach for such patients, especially given the lack of head-to-head clinical trials for these regimens. This real-world study compared the effectiveness of Rd in combination with proteasome inhibitors, ixazomib (I), carfilzomib (K), and bortezomib (V), or monoclonal antibodies, elotuzumab (E) and daratumumab (D) with respect to treatment outcomes among RRMM patients in the United States (US) within subgroups defined by cytogenetic risk. Methods: The Flatiron Health Database (01/01/2014-09/30/2020) was used for this retrospective longitudinal study. Adult RRMM patients who initiated IRd, KRd, VRd, ERd, or DRd in line of therapy 2 or later (LOT2+) on or after 01/01/2014 were included. High cytogenetic risk was defined as the presence of del[17p], t[4;14], or t[14;16] by fluorescence in situ hybridization or karyotype tests. Patients with evidence of the tests but without the presence of these abnormalities were defined as standard risk. Index was the date of initiation for each LOT (multiple LOTs per patient were included); baseline was the 6-month period pre-index. Multivariable Cox proportional hazards models were used to compare duration of therapy (DOT), progression free survival (PFS), time to next therapy (TTNT), and overall survival (OS) between regimens. Patients who did not experience the event were censored at end of observation. Analyses were conducted separately in patients with high cytogenetic risk and in those with standard cytogenetic risk. Comparisons with ERd are not presented due to limited sample size. Results: A total of 1,185 patients contributed to 1,332 LOTs, of which 180 (13.5%) had high cytogenetic risk (IRd: n=36; KRd: n=41; VRd: n=58; ERd: n=13; DRd: n=32), 985 (73.9%) had standard cytogenetic risk (IRd: n=184; KRd: n=155; VRd: n=420; ERd: n=63; DRd: n=163), and 167 (12.5%) had unknown risk. In patients with standard cytogenetic risk, median age was 71 years and the majority (89.9%) of patients were treated in community settings; most regimens were in LOT2 (64.0%). Among these patients, DRd was associated with longer DOT compared to IRd (adjusted hazard ratio [95% confidence interval]: 1.85 [1.37, 2.50]), KRd (2.08 [1.53, 2.83]), and VRd (1.71 [1.26, 2.33]). Similarly, DRd was associated with prolonged PFS in comparison to all triplets (IRd: 1.78 [1.28, 2.46]; KRd: 1.86 [1.33, 2.61]; VRd: 2.31 [1.61, 3.34]), as well as longer TTNT (IRd: 1.79 [1.32, 2.44]; KRd: 1.91 [1.40, 2.61]; VRd: 1.54 [1.12, 2.11]). KRd was associated with shorter OS compared with DRd (1.59 [1.01, 2.49]). No other statistically significant differences were observed. In patients with high cytogenetic risk, del[17p] (55.6%) and t[4;14] (38.9%) were the most frequent cytogenetic abnormalities, while a smaller proportion of patients had t[14;16] (14.4%). Median age was 69 years and almost all patients (90.0%) were treated in community settings; most (63.9%) regimens were in LOT2. High risk patients appeared to have comparable outcomes across triplet regimens as no statistical significance was detected in any pair-wise comparisons. Comparative results are shown in Table 1.Conclusions: This real-world study assessed RRMM patients treated primarily within US community settings. In patients with standard cytogenetic risk, DRd was associated with statistically significantly better PFS, DOT, and TTNT than PI-containing Rd-based triplets and better OS compared to KRd. In patients with high cytogenetic risk, results suggest comparable effectiveness of Rd-based triplet regimens, although the interpretation of these results is limited by the small sample size. These findings highlight the importance of cytogenetic risk when making treatment recommendations for RRMM patients, while further elucidating the effectiveness of triplet therapies in routine clinical care. Among high risk patients, larger studies are needed to clarify the effectiveness of various Rd-triplets currently FDA-approved for the broader RRMM population. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Pembrolizumab-combination therapy for previously untreated metastatic nonsquamous NSCLC: Real-world outcomes at US oncology practices.

The availability of immunotherapies has expanded the options for treating metastatic NSCLC, but information is needed regarding outcomes of immunotherapy for patients treated outside of clinical trials. The aim of this retrospective study was to evaluate the outcomes of therapy with first-line pembrolizumab plus pemetrexed and carboplatin (pembrolizumab-combination) for patients with metastatic nonsquamous NSCLC in the real-world setting of oncology clinics in the United States (US). Using deidentified, longitudinal patient records from a nationwide, electronic health record-derived US database, we identified patients with metastatic nonsquamous NSCLC, without EGFR/ALK/ROS1 genomic alterations, who had received no previous systemic anticancer therapy. Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and initiated first-line pembrolizumab-combination therapy from 11-May-2017 to 31-January-2019; data cutoff was 31-August-2020. Patients treated in a clinical trial were excluded. Manual chart review supplemented technology-enabled abstraction to identify disease progression and tumor response. Time-to-event endpoints from initiation of pembrolizumab-combination therapy were determined using Kaplan-Meier. Of 377 patients with metastatic nonsquamous NSCLC, 105 (28%), 104 (28%), and 103 (27%) had programmed death-ligand 1 (PD-L1) expression ≥50%, 1-49%, and <1%, respectively; PD-L1 expression was not documented for 65 patients (17%). Median age was 66 years, and 227 patients (60%) were men. Median follow-up time from first-line therapy initiation to data cutoff was 31.2 months (range, 19.0-39.6 months). Median pembrolizumab real-world time on treatment (rwToT) was 5.8 months (95% CI, 5.0-6.7); 12- and 24-month on-treatment rates for pembrolizumab were 28.0% and 14.9%, respectively. Median overall survival (OS) was 17.2 months (95% CI, 13.6-19.9). For patients in PD-L1 expression ≥50%, 1-49%, <1%, and unknown cohorts, the 12-month survival rates were 66.0%, 58.5%, 54.5%, and 58.3%, respectively, and 24-month survival rates were 43.1%, 37.2%, 35.6%, and 42.0%, respectively. Median real-world progression-free survival was 6.2 months (95% CI, 5.5-7.1); and the real-world response rate was 39.3%, with median duration of response of 13.1 months (95% CI, 10.5-16.8). These findings demonstrate the benefits of first-line pembrolizumab-combination therapy for patients with EGFR/ALK-wild-type, metastatic nonsquamous NSCLC and good performance status who are treated at US community oncology clinics.

ABCL-051 realMIND: A Prospective, Multicenter, Observational Study of Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Starting Second/Third-Line Therapy and Not Receiving a Stem Cell Transplant

Up to 40% of patients with diffuse large B-cell lymphoma (DLBCL) will have relapsed/refractory (R/R) disease after first-line (1L) treatment with R-CHOP. Treatment options for autologous stem cell transplant (ASCT)-ineligible patients with R/R DLBCL include the chemo-free immunotherapy tafasitamab + lenalidomide, polatuzumab + bendamustine + rituximab, loncastuximab tesirine, selinexor, and CD19 chimeric antigen receptor (CAR) T-cell therapies. Treatment sequencing and identifying the optimal choice for individual patients can be challenging for oncologists. realMIND (NCT04981795) will assess real-world treatment patterns, effectiveness measures, and patient-reported outcomes among patients in the United States (US) with R/R DLBCL not receiving ASCT. A Phase IV, prospective, multicenter, observational study enrolling a diverse patient population with R/R DLBCL regarding age, ethnicity, and race. Expected enrollment is ~1000 patients with completion expected ~79 months after the first patient is enrolled. Actively recruiting in ~75 US community and academic centers. Eligible and aged ≥18 years with histologically confirmed R/R DLBCL after ≥1 systemic therapy, including ASCT. Patients may enroll (a) after completing 1L therapy and before starting second-line (2L) therapy, (b) within 30 days after starting 2L therapy, or (c) after completing 2L and before receiving third-line therapy. Patient history data on therapies received before study enrollment will be collected from patient records; data generated from the time of enrollment onwards will be collected prospectively. Real-world effectiveness measures include complete and objective response rate, duration of response, event-free survival, and overall survival; safety endpoints include serious adverse events and adverse events leading to treatment discontinuation, interruption, or dose modification. Patient-reported outcomes include general and lymphoma-specific measures of health-related quality of life assessed by the EORTC Quality of Life Questionnaire-Core 30 and Functional Assessment of Cancer Therapy - Lymphoma, and work productivity by the Work Productivity and Activity Impairment Questionnaire. Not yet available. realMIND will characterize the R/R DLBCL patient journey with respect to treatment patterns, clinical and patient-reported outcomes. The study population will reflect a representative patient distribution within the US, facilitating the investigation of outcomes reflecting real-world clinical practice and producing data to support healthcare decision-making. MorphoSys AG.

Sociodemographic Determinants of PFAS Contamination in United States Community Water Supplies: An Analysis of Sampling Data from 11 States

Background and Aim Many studies show marginalized communities are disproportionately exposed to air pollution. However, relatively few studies have considered water quality disparities, including exposures to per- and polyfluoroalkyl substances (PFAS). We evaluated whether Community Water Systems (CWS) serving greater proportions of minority and low-income individuals had higher likelihoods of detecting PFAS and exceeding Maximum Contaminant Levels (MCL) using recent statewide drinking water monitoring data. Methods We compiled drinking water PFAS concentration data from 11 states with statewide monitoring data and ancillary data on sociodemographics, CWS characteristics, active PFAS treatment, and PFAS sources. We examined associations between PFAS concentrations in drinking water and sociodemographics at various spatial units for 4,698 CWS (serving 62.2 million people) using multivariate logistic regressions. Results CWS serving 20.8 million people (33%) had detectable concentrations (&amp;#x3e;5 ng/L) of at least one of five PFAS and those serving 16 million people (26%) exceeded the lowest state-level MCL for several PFAS. CWS with detectable PFAS levels and MCL exceedances served greater proportions of Hispanic and Black residents than those with PFAS levels below detection and without exceedances. At the county-level, a percentage point increase in the proportion of Hispanic residents served by a CWS was associated with a 4-6% increase in the odds of detecting PFAS. Results for state-level relationships were more mixed, although CWS in five of the 11 states had increased odds of detecting several PFAS for CWS serving counties with greater proportions of Hispanic residents. Conclusions Our findings suggest that CWS serving some communities with greater proportions of Hispanic and non-Hispanic Black residents have increased likelihood of detecting PFAS, including detection at levels above regulatory thresholds. These disparities are concerning and warrant consideration when planning remediation strategies and treatment for sites contaminated with PFAS. Keywords Community water systems, Environmental justice, Drinking water, Anthropogenic compounds, Disparities

1465P Real-world (RW) outcomes in metastatic renal cell carcinoma (mRCC) patients treated with first-line (1L) nivolumab plus ipilimumab (NIVO+IPI) in the United States

NIVO+IPI is a first-in-class combination immunotherapy for the treatment of IMDC intermediate- or poor-risk (I/P-risk) advanced renal cell carcinoma. In this RW study, treatment patterns, clinical outcomes, safety, sequences, and healthcare resource utilization in a United States community oncology setting were evaluated for this regimen.

CO99 Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Utilization Patterns for Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Among United States (US) Community Hematologists/Oncologists (CH/OS)

Patients with R/R DLBCL are initially treated by cH/Os and require referral for CAR-T. Aspects of the patient’s complex journey are not well understood. This study assessed CAR-T recipient care from the cH/O perspective.

Perceptions of the SARS-CoV2 pandemic: a small comparative survey analysis between language preference populations in a United States community health center

ABSTRACT In 2019, a new variant of coronavirus, SARS-CoV-2 (COVID-19) created a global pandemic that has highlighted and exacerbated health disparities. Educating the general public about COVID-19 is one of the primary mitigation strategies amongst health professionals. English is not the preferred language for an estimated 22% of the United States population making effective mass communication efforts difficult to achieve. This study seeks to understand and compare several topics surrounding COVID-19 health communication and healthcare disparities between individuals with English language preference (ELP) and non-English language preference (NELP) within the United States. A survey available in seven languages asking about knowledge and opinions on COVID-19, vaccines, preferred sources of health information, and other questions, was administered February-April 2021 to patients at an urban federally qualified health center that also serves global refugees and immigrants. Descriptive statistics and comparative analysis were performed to identify differences between ELP and NELP individuals. Analysis of 144 surveys, 33 of which were NELP, showed 90.97% of all patients agreed that COVID-19 was a serious disease and 66.67% would receive the COVID-19 vaccine. There were numerous differences between ELP and NELP individuals, including trust in government, symptom identification, preferred source of health information, and feelings that cultural needs had been met. This study has identified several significant differences in patient perceptions relating to the COVID-19 pandemic when comparing NELP to ELP and highlighted areas where improvement can occur. Applying this information, easily utilized targeted resources can be created to quickly intervene and address health disparities among patients seeking care at an urban community health center.

Mental health provider perspectives of the COVID-19 pandemic impact on service delivery: a focus on challenges in remote engagement, suicide risk assessment, and treatment of psychosis

BackgroundThe COVID-19 pandemic has been impacting the need, utilization, and delivery of mental health services with greater challenges being faced by clients and providers. With many clients facing reduced access to services and social isolation, a focus on suicide risk assessment and prevention is critical. Concern is particularly increased for clients with schizophrenia spectrum disorders given data show suicide rates are disproportionately high for those with psychosis in comparison to the general population. Provider perspectives of challenges in service delivery are needed to inform efforts to improve access, feasibility, and quality of mental health care throughout the evolving pandemic. This study explored mental health provider perspectives of client challenges in service utilization and provider challenges in service delivery, including remote engagement, suicide risk assessment, and treatment of psychosis.MethodsData were collected from social work mental health providers (n = 12) in United States community mental health setting. Providers consented to participate and responded to questions about service delivery experiences in late 2020 and in relation to COVID-19. Demographic and practice-related provider data were explored descriptively using SPSS and qualitative data using open coding and grounded theory methods in Dedoose.ResultsAmong the 9 providers who engaged in remote service delivery, 7 (77.8%) experienced challenges in remote engagement with clients and 8 (88.9%) experienced challenges in treatment of psychosis. Among the 7 providers who engaged in remote suicide assessment, 4(57%) experienced challenges. Qualitative themes emerged including logistic (e.g., technology access and use), engagement (e.g., virtual rapport-building and limited remote services), and clinical (e.g., difficulty assessing suicide risk, internal stimuli, abnormal involuntary movement, and affect) challenges in service delivery.ConclusionsProvider perspectives are essential to inform efforts to build resources and problem-solve challenges and barriers that both providers and clients face throughout various shifts in mental health service delivery. Findings emphasize the need to troubleshoot client access to technology, bolster support for providers to prevent burnout, and greater provider training to improve skills in remote engagement, assessment, and treatment, particularly in relation to psychosis and suicide prevention. Study implications are not only critical for the evolving COVID-19 pandemic, but also in preparation for ongoing shifts in service delivery as technology evolves.

Real world incidence and management of adverse events in patients with HR+, HER2− metastatic breast cancer receiving CDK4 and 6 inhibitors in a United States community setting

Objective To examine the real-world incidence and management of select adverse events (AEs) among female patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (MBC), receiving a cyclin-dependent kinase 4 and 6 (CDK4 and 6) inhibitor (palbociclib, abemaciclib, or ribociclib). Methods This retrospective study analyzed data from the US Oncology Network iKnowMed electronic health record database for 396 patients with an initial MBC diagnosis on/after 1 January 2014 and receipt of first CDK4 and 6 regimen between 1 January 2017 and 31 December 2018. In this descriptive study, the proportion of patients who experienced select AEs and associated dose modifications or discontinuations were reported. The occurrence of select healthcare resource utilization categories was also reported. Results Median follow-up time was 451, 262, and 355 days for patients in the palbociclib, abemaciclib, and ribociclib cohorts, respectively. The most common AEs were neutropenia (palbociclib, 44.8%; abemaciclib, 10.6%; ribociclib, 36.3%), diarrhea (palbociclib, 8.0%; abemaciclib, 43.0%; ribociclib, 8.8%), and fatigue (palbociclib, 12.9%; abemaciclib, 17.6%; ribociclib, 16.5%). AEs resulted in a treatment hold among 91 (23.0%), a dose reduction among 86 (21.7%), and permanent discontinuation among 48 (12.1%) patients overall. Conclusions This real-world study provides insight into the occurrence of AEs which varied by CDK4 and 6 inhibitor. Compared to clinical trials, frequencies of AEs were numerically lower but dose reductions due to AEs were numerically higher. It is possible these differences reflect proactive management of AEs on the part of clinicians to help patients remain on therapy.

Beyond Primary Care: Renewing the Community Health Center Vision for Today's Health Crisis.

United States community health centers address socioeconomic and environmental conditions and provide comprehensive primary care despite market forces that reinforce a medical model. Collaborating with 14 health center organizations, the RCHN Community Health Foundation promoted the original and broader health center vision of health, launching its population health management initiative in 2015. Although participating organizations were recognized as patient-centered medical homes and achieved rewards for quality, most identified gaps in their capacity for population health management. These challenges, addressed through peer learning and local initiatives, included engaging target populations, care coordination, socioeconomic and clinical data collection, and working with nontraditional local organizations. With relatively small funding, the zeal and enthusiasm for population health was revitalized among health center staff. The current pandemic and growing national concern for health disparities represents an opportunity to expand this broader vision of population health and to sustain it as the COVID-19 pandemic eventually subsides.