Real-world and clinical trial outcomes in large B-cell lymphoma with axicabtagene ciloleucel across race and ethnicity.

ABSTRACT: Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Despite extensive data supporting its use, outcomes stratified by race and ethnicity groups are limited. Here, we report clinical outcomes with axi-cel in patients with R/R LBCL by race and ethnicity in both real-world and clinical trial settings. In the real-world setting, 1290 patients who received axi-cel between 2017 and 2020 were identified from the Center for International Blood and Marrow Transplant Research database; 106 and 169 patients were included from the ZUMA-1 and ZUMA-7 trials, respectively. Overall survival was consistent across race/ethnicity groups. However, non-Hispanic (NH) Black patients had lower overall response rate (OR, 0.37; 95% CI, 0.22-0.63) and lower complete response rate (OR, 0.57; 95% CI, 0.33-0.97) than NH White patients. NH Black patients also had a shorter progression-free survival vs NH White (HR, 1.41; 95% CI, 1.04-1.90) and NH Asian patients (HR, 1.67; 95% CI, 1.08-2.59). NH Asian patients had a longer duration of response than NH White (HR, 0.56; 95% CI, 0.33-0.94) and Hispanic patients (HR, 0.54; 95% CI, 0.30-0.97). There was no difference in cytokine release syndrome by race/ethnicity; however, higher rates of any-grade immune effector cell-associated neurotoxicity syndrome were observed in NH White patients than in other patients. These results provide important context when treating patients with R/R LBCL with CAR T-cell therapy across different racial and ethnic groups. ZUMA-1 and ZUMA-7 (ClinicalTrials.gov identifiers: #NCT02348216 and #NCT03391466, respectively) are registered on ClinicalTrials.gov.

Preventative Cancer Screening Rates Among Uninsured Patients in Free Clinics: A Retrospective Cohort Study of Cancer Survivors and Non-cancer Survivors.

BACKGROUND: There is limited research on screening rates among uninsured cancer survivors. Uninsured cancer survivors are at higher risk of poorer health outcomes than the insured due to limited access to preventative screening for secondary cancers. This study examines the rates of surveillance and screening of uninsured cancer survivors and compares to uninsured patients without a cancer history seen in free clinics. METHODS: Data were collected retrospectively from electronic medical records and paper charts of patients from 10 free clinics between January 2016 and December 2018 in the Tampa Bay area. The prevalence of socioeconomic characteristics, cancer diagnoses, and screening practices were compared for cancer survivors and free clinic patients without a history of cancer. Study participants were determined to be eligible for cancer screenings based on the United States Preventive Services Task Force guidelines. RESULTS: Out of 13 982 uninsured patients frequenting free clinics between 2016 and 2018, 402 (2.9%) had a documented history of cancer. Out of the 285 eligible cancer survivors, 44 (15.4%) had completed age-appropriate colon cancer screening. Among the 170 female cancer survivors, 75 (44.1%) had completed breast cancer screenings, and only 5.9% (59/246) had completed cervical cancer screenings. After adjusting for age, gender, race, salary, employment status, and household size, cancer survivors were more likely to undergo colorectal cancer screening (OR: 3.59, 95% CI: 2.10-6.15) and breast cancer screening (OR: 2.13, 95% CI: 1.30-3.84) than patients without a cancer history. This difference was not seen for cervical cancer screening (OR: 0.99, 95% CI: .62-1.58). CONCLUSIONS: Uninsured cancer survivors frequenting free clinics represent a unique population that is underrepresented in the medical literature. Our results suggest that uninsured survivors use screening services at higher rates when compared to uninsured patients without a reported cancer diagnosis. However, these rates are suboptimal when compared to national screening rates of insured cancer survivors.

Colorectal Cancer Risk Factors and Screening Among the Uninsured of Tampa Bay: A Free Clinic Study.

INTRODUCTION: Uninsured patients with low socioeconomic status are at high risk for developing colorectal cancer (CRC), and data on risk factors and prevalence of CRC in this population are limited. The purpose of this study was to assess the risk factors for CRC in uninsured patients from free clinics in the Tampa Bay area of Florida. METHODS: We conducted a retrospective cohort study among patients 50 years or older who were provided service at 9 free clinics in the Tampa Bay area between 2016 and 2018. Demographics, chronic disease characteristics, and screening data were collected via a query of paper and electronic medical records. RESULTS: Of the 13,982 patients seen, 5,139 (36.8%) were aged 50 years or older. Most were female (56.8%), non-Hispanic White (41.1%), and unemployed (54.9%). Patients with CRC screening were more likely to be employed compared with patients without CRC screening (54.4% vs 44.4%, P = .01). Within the cohort, 725 (22.7%) patients were active smokers, 771 (29.2%) patients currently consumed alcohol, and 23 patients (0.4%) had a history of inflammatory bowel disease. Patients had a median body mass index of 29.4 (interquartile range, 25.4-34.2) kg/m2, and 1,455 (28.3%) had diabetes. Documented CRC screening was found among 341 (6.6%) patients. CONCLUSION: Uninsured patients had a high prevalence of CRC risk factors but a low reported screening rate for CRC. Free clinics are uniquely positioned to provide patients at high risk for CRC with strategies to decrease their risk and to be screened for CRC.

Dermatologic care of uninsured patients managed at free clinics.

BACKGROUND: Uninsured patients are not well tracked within the health care system and therefore not commonly recorded in databases. Epidemiologic data regarding patients-specifically, those with dermatologic concerns visiting free clinics-are limited. OBJECTIVE: The purpose of this study was to explore the prevalence of dermatologic complaints among uninsured patients who visit free clinics. METHODS: A cross-sectional chart review of 5553 uninsured patients seen across 8 free clinics in Tampa, Florida, during 2016 was carried out to determine the prevalence of dermatologic chief complaints and patient demographics. RESULTS: Across 8 free clinics, a total of 5553 patients were seen in 2016. Of these patients, 444 (8%) presented with dermatologic complaints. The most common complaints pertained to rash, followed by lesions: localized rash (n = 83 [18.7%]), genital rash (n = 51 [11.5%]), generalized rash (n = 50 [11.3%]), questionable lesions (n = 35 [7.9%]), and genital lesions (n = 18 [4.1%]). LIMITATIONS: There are notable variations in medical documentation practices among free clinics, thereby limiting data collection. CONCLUSIONS: Free clinics have the potential to relieve a great dermatologic burden throughout the uninsured population. The findings from this study can inform other free clinics of the dermatologic conditions that are most likely to be seen among their patient population so that they can better provide their patients with higher-quality care.

Validation of the Khorana score in acute myeloid leukemia patients: a single-institution experience.

BACKGROUND: Although patients with acute myeloid leukemia (AML) were shown to have an increased risk of thrombosis, no thrombosis risk assessment scoring system has been developed for AML patients. The Khorana Risk Score (KRS), which has been widely used for thrombosis risk assessment in the clinical setting, was developed on the basis of solid tumor data and has not been validated among AML patients. This study aims to validate the use of the KRS as a thrombosis risk-scoring system among patients with AML. METHODS: Using data from H. Lee Moffitt Cancer Center and Research Institution's Total Cancer Care Research Study, we retrospectively identified patients who were histologically confirmed with AML from 2000 to 2018. Clinical and laboratory variables at the time of AML diagnosis were characterized and analyzed. The thrombotic event rate was estimated with the Kaplan-Meier method and compared using the log-rank test. RESULTS: A total of 867 AML patients were included in the analysis. The median age at AML diagnosis was 75 years (range, 51-96), and the majority were male (65%, n = 565). A total of 22% (n = 191), 51% (n = 445), 24% (n = 207), and 3% (n = 24) of patients had a KRS of 0, 1, 2, and 3, respectively. A total of 42 thrombotic events (3% [n = 6/191] with a KRS of 1; 5% [n = 23/445] with a KRS of 2; 6.3% [n = 13/207] with a KRS of 3) were observed, with a median follow-up of 3 months (range, 0.1-307). There was no statistical difference in the risk of thrombosis between these groups (P = .1949). CONCLUSIONS: Although there was an increased risk of thrombosis associated with a higher KRS among AML patients with a KRS of 1 to 3, the difference was not statistically significant. Furthermore, only a few patients were found to have a KRS > 3, and this was largely due to pancytopenia, which is commonly associated with AML. These results indicate the need for a better thrombotic risk-scoring system for AML patients.

Chronic Disease Burden of the Homeless: A Descriptive Study of Student-Run Free Clinics in Tampa, Florida.

Variation between homeless populations due to socioeconomic and environmental factors necessitates tailoring medical, health policy, and public health interventions to the unique needs of the homeless population served. Despite the relatively large size of the homeless population in Florida, there is a paucity of research that characterizes the homeless population who frequent homeless clinics within the state. This project describes the demographics, disease prevalence, and other risk factors among homeless individuals in Tampa, Florida. We conducted a retrospective chart review on adult homeless patients seen in 2015 and 2016 at two free clinic sites operated by Tampa Bay Street Medicine, a medical student-run organization from the University of South Florida in Tampa, Florida. Rates of diseases and substance use were recorded and Charlson Comorbidity Index (CCI) was calculated to assess mortality risk. Of the 183 homeless patients in this study, 34.4% reported hypertension, 13.7% reported diabetes, 27.1% reported a respiratory disease, 5.6% reported hyperlipidemia, and 32.8% reported a psychiatric disorder. Tobacco use was reported by 65.6% of patients, 32.2% reported alcohol use, and 17.5% reported illicit drug use. CCI was positively associated with age. Females reported higher rates of anemia, anxiety, chronic obstructive pulmonary disease, and psychiatric disorders. Hypertension, diabetes, certain respiratory diseases, and mental health disorders were more prevalent in the homeless population than in the general population in Tampa, Florida. Homeless women appeared to have higher morbidity than homeless men. Rates of tobacco and illicit drug use were significantly higher whereas alcohol use was lower in the study population than the general population. This study underscores the critical need for mental health initiatives, substance abuse treatment programs, and women's health programs that are accessible to the homeless in Tampa.

Evaluating kinase ATP uptake and tyrosine phosphorylation using multiplexed quantification of chemically labeled and post-translationally modified peptides.

Cancer biologists and other healthcare researchers face an increasing challenge in addressing the molecular complexity of disease. Biomarker measurement tools and techniques now contribute to both basic science and translational research. In particular, liquid chromatography-multiple reaction monitoring mass spectrometry (LC-MRM) for multiplexed measurements of protein biomarkers has emerged as a versatile tool for systems biology. Assays can be developed for specific peptides that report on protein expression, mutation, or post-translational modification; discovery proteomics data rapidly translated into multiplexed quantitative approaches. Complementary advances in affinity purification enrich classes of enzymes or peptides representing post-translationally modified or chemically labeled substrates. Here, we illustrate the process for the relative quantification of hundreds of peptides in a single LC-MRM experiment. Desthiobiotinylated peptides produced by activity-based protein profiling (ABPP) using ATP probes and tyrosine-phosphorylated peptides are used as examples. These targeted quantification panels can be applied to further understand the biology of human disease.

SYK and ZAP70 kinases in autoimmunity and lymphoid malignancies.

SYK and ZAP70 nonreceptor tyrosine kinases serve essential roles in initiating B-cell receptor (BCR) and T-cell receptor (TCR) signaling in B- and T-lymphocytes, respectively. Despite their structural and functional similarity, expression of SYK and ZAP70 is strictly separated during B- and T-lymphocyte development, the reason for which was not known. Aberrant co-expression of ZAP70 with SYK was first identified in B-cell chronic lymphocytic leukemia (CLL) and is considered a biomarker of aggressive disease and poor clinical outcomes. We recently found that aberrant ZAP70 co-expression not only functions as an oncogenic driver in CLL but also in various other B-cell malignancies, including acute lymphoblastic leukemia (B-ALL) and mantle cell lymphoma. Thereby, aberrantly expressed ZAP70 redirects SYK and BCR-downstream signaling from NFAT towards activation of the PI3K-pathway. In the sole presence of SYK, pathological BCR-signaling in autoreactive or premalignant cells induces NFAT-activation and NFAT-dependent anergy and negative selection. In contrast, negative selection of pathological B-cells is subverted when ZAP70 diverts SYK from activation of NFAT towards tonic PI3K-signaling, which promotes survival instead of cell death. We discuss here how both B-cell malignancies and autoimmune diseases frequently evolve to harness this mechanism, highlighting the importance of developmental separation of the two kinases as an essential safeguard.

Outcomes Following Intolerance to Tacrolimus/Sirolimus Graft-versus-Host Disease Prophylaxis for Allogeneic Hematopoietic Cell Transplantation.

Although tacrolimus and sirolimus (TAC/SIR) is an accepted graft-versus-host disease (GVHD) prophylaxis regimen following allogeneic hematopoietic cell transplantation (HCT), toxicity from this regimen can lead to premature discontinuation of immunosuppression. There are limited studies reporting outcomes and subsequent treatment of patients with TAC/SIR intolerance. This study was conducted to assess the outcomes of patients with TAC/SIR intolerance and guide their subsequent management. We retrospectively analyzed transplantation outcomes of consecutive adult patients at Moffitt Cancer Center who underwent allogeneic HCT with TAC/SIR as GVHD prophylaxis between 2009 and 2018. TAC/SIR intolerance was defined as discontinuation of either TAC or SIR due to toxicity before post-transplantation day +100. A total of 777 patients met the inclusion criteria. The median duration of follow-up was 22 months (range, 0.2 to 125 months). Intolerance occurred in 13% (n = 104) of the patients at a median of 30 days (range, 5 to 90 days). The most common causes of intolerance were acute kidney injury (n = 53; 51%), thrombotic microangiopathy (n = 31; 28%), and veno-occlusive disease (n = 23; 22%). The cumulative incidence of grade II-IV acute GVHD at 100 days was 50% (95% CI, 39% to 64%) in the TAC/SIR-intolerant patients and 25% (95% CI, 22% to 29%) in patients tolerant to this regimen (P < .0001). In multivariate analyses, the incidence of grade II-IV 4 acute GVHD was significantly higher in the TAC/SIR-intolerant patients (hazard ratio [HR], 2.40; 95% CI, 1.59 to 3.61; P < .0001). Similarly, in multivariate analyses, the TAC/SIR-intolerant patients had a higher incidence of chronic GVHD (HR, 1.48; 95% CI, 1.03 to 2.12; P = .03). The nonrelapse mortality (NRM) at 1 year was 47% (95% CI, 38% to 59%) in the TAC/SIR-intolerant patients and 12% (95% CI, 10% to 15%) in those tolerant to the regimen (P < .0001). The 2-year relapse-free survival was 35% (95% CI, 25% to 44%) in the TAC/SIR-intolerant patients and 60% (95% CI, 57% to 65%) in the TAC/SIR-tolerant patients (HR, 2.30; 95% CI, 1.61 to 3.28; P < .0001). Intolerance stratified by early (≤30 days) versus late (31 to 100 days) significantly affected the cumulative incidence of acute GVHD at 75% (early; 95% CI, 59% to 94%) versus 33% (late; 95% CI, 21% to 50%) (P = .001), as well as the cumulative incidence of NRM at 61% (early; 95% CI, 48% to 77%) versus 35% (late; 95% CI, 24% to 51%) (P = .006). Most patients who developed TAC/SIR intolerance were switched to an alternative 2-drug regimen (71 of 104; 68%), most commonly mycophenolate mofetil in addition to continuing TAC or SIR (68 of 71; 96%). Overall, TAC/SIR intolerance was associated with poorer outcomes. Early intolerance contributed to a higher risk of acute GVHD, increased NRM, and inferior survival. Patients with early intolerance were often switched to an alternative agent, and patients with late intolerance tended to be continued on single-drug therapy without substitution. The use of single-drug versus 2-drug regimens after intolerance did not appear to affect outcomes. Management strategies to mitigate the risks of intolerance are warranted.

Chronic disease and socioeconomic factors among uninsured patients: A retrospective study.

OBJECTIVES: Uninsured patients represent an understudied population. The current study aimed to estimate the burden of 10 common chronic conditions and to investigate the associated factors among patients who use free clinics for their health care needs. METHODS: Patient charts from four free clinics were reviewed from January to December of 2015. Proportion of prevalence, adjusted odds ratios (AOR), and 95% confidence intervals (CI) for associations between participant characteristics and chronic conditions are reported. RESULTS: Prevalence of hypertension and hyperlipidemia significantly differed by clinic, age, gender, race, and marital status. Compared to age 15-44 years, older patients (45-64 years, and ≥65) were 5-10 times more likely to suffer from hypertension. Compared to women, men; compared to White, African-Americans; and compared to single, married patients had higher prevalences of hypertension. Older patients were 5-8 times more likely to suffer from hyperlipidemia. Asians, and married patients were also more likely to experience hyperlipidemia. Prevalence of diabetes, depression and arthritis significantly differed by age and race. Prevalence of coronary artery disease and chronic obstructive pulmonary disease increased 6-13 folds among older patients. DISCUSSION: Patients of free clinics suffer from high burden of chronic conditions. Patients who frequent free clinics are primarily older, unemployed, women, minorities, and are of low income.

Treatment of Pharyngitis in Uninsured Patients: A Multicenter Study of Free Clinics.

Introduction Appropriate antibiotic prescription practices for pharyngitis slow anti-microbial resistance. Unnecessary antibiotic prescribing and non-adherence to practice guidelines remain a clinical problem. The objective of this study was to examine the relationship between group A Streptococcus (GAS) throat culture testing and antibiotic prescriptions at 10 free clinics in the Tampa Bay Area serving the uninsured population. Methods A retrospective cohort study was conducted using data from patient charts from January 2018 to December 2019. We obtained data regarding a chief complaint related to strep pharyngitis: sore throat, enlarged tonsils, pharyngeal erythema, and/or cervical lymphadenopathy. The frequency and relative proportions of throat swab administration and antibiotic prescription were also analyzed. Results Of the 12,005 patients serviced during the study period, 245 (2.0%) reported one or more of the chief complaints related to strep pharyngitis. Of the patients reporting pharyngitis, the mean age was 40.2 years, with 66% being female. Of the patients receiving antibiotics for pharyngitis symptoms, 93 (91.2%) did not receive a throat swab. Patients receiving a throat swab showed a significantly increased odds of antibiotic prescription (OR=3.4, 95% CI: 1.1-12.7). Patients reporting symptoms of pharyngitis commonly had other comorbidities, including smoking (14.7%) and diabetes (13.5%). Conclusion The large proportion of patients receiving antibiotics for pharyngitis symptoms reveals the need for provider counseling on current recommendations of antibiotic prescription practices, which state that a throat swab with a rapid antigen detection test and/or culture should be performed for all patients where bacterial symptoms of rhinorrhea, cough, and/or oral ulcers are present. Another potential area of improvement indicated by this study may be providing additional supplies of throat swabs for these underserved clinics. Further research is needed to understand the root causes of providers' non-compliant prescribing patterns in the free clinics and to assess the role of the uninsured population in reducing anti-microbial resistance.

Diagnosing Cardiac Amyloidosis: From Heart Failure to Electrical Storm.

Cardiac amyloidosis is a condition when amyloid fibers are deposited in the extracellular space of the heart causing tachyarrhythmias, heart failure, or sudden cardiac death. We present a 71-year-old woman presenting with dyspnea on admission. Echocardiogram revealed diastolic heart failure and left ventricular hypertrophy with strain pattern concerning for an infiltrative process. She was discharged with diuretic therapy and scheduled for a cardiac magnetic resonance imaging. One week after discharge, she was readmitted with progressive shortness of breath and syncope. She was found to be in shock and had multiple episodes of cardiac arrest with both ventricular tachycardia and pulseless electrical activity. She developed electrical storm and eventually passed within 24 hours. Autopsy revealed gross cardiomegaly and left ventricular hypertrophy with Congo red staining revealing amyloid fibrils with apple-green birefringence. This case demonstrates the rapid progression of cardiac amyloidosis from acute-onset diastolic heart failure to uncontrollable ventricular tachycardia, and eventually death. We review the literature regarding multiple diagnostic modalities that facilitate the confirmation of cardiac amyloidosis.

Hypomethylating Agents and FLT3 Inhibitors As Maintenance Treatment for Acute Myeloid Leukemia and Myelodysplastic Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation-A Systematic Review and Meta-Analysis.

BACKGROUND: Disease relapse remains the major cause of death among patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) who receive an allogeneic hematopoietic cell transplant (allo-HCT). Maintenance treatment with FLT3 inhibitors and hypomethylating agents (HMA) has been studied in various clinical trials with mixed results. OBJECTIVE: To synthesize the current evidence on the efficacy and safety of FLT3 inhibitors and HMA for maintenance therapy after allo-HCT in AML and MDS. METHODS: For this systematic review and meta-analysis Cochrane Library, Google Scholar, Ovid Medline, Ovid Embase, PubMed, Scopus, and Web of Science Core Collection were searched from inception to March 2021 for studies on maintenance therapies after allo-HCT in AML and MDS. Studies were excluded if they were reviews, commentaries, case series with <5 patients, or basic research articles, not published in English, not on post-allo-HCT maintenance with FLT3 inhibitors or HMA in AML or MDS, or if they were clinical trials without published results or duplicate publications from the same patient cohort. Studies with insufficient reporting of the primary endpoint (2-year overall survival [OS]) and studies using FLT3 inhibitors or HMA for pre-emptive treatment of imminent relapse based on positive measurable residual disease testing were excluded. Random-effects models were used to pool response rates for the primary outcome of 2-year OS. Hazard ratios (HR) for death and relapse were calculated for studies that included a control group. Rates of relapse-free survival (RFS), non-relapse mortality, and acute and chronic graft-versus-host-disease (GVHD) were studied as secondary endpoints. Downs and Black checklist and risk of bias assessments were used to gauge the quality of individual studies. The study protocol has been registered on PROSPERO (CRD42020187298). RESULTS: Our search strategy identified 5559 studies. Twenty-one studies with a total of 809 patients were included in the meta-analysis. The 2-year OS rates were 81.7% (95% confidence interval [CI], 73.8%-87.7%) and 65.7% (95% CI, 55.1%-74.9%) among patients treated with FLT3 inhibitors and HMA, respectively. In sensitivity analyses restricted to studies that included a control group, maintenance therapy with FLT3 inhibitors (HR for death = 0.41; 95% CI, 0.26-0.62) or HMA (HR = 0.45; 95% CI, 0.31-0.66) appeared superior to no maintenance therapy. The 2-year RFS rates were 79.8% (95% CI, 75.0%-83.9%) and 62.4% (95% CI, 50.6%-72.9%) among patients treated with FLT3 inhibitors and HMA, respectively. Rates of any grade acute and chronic GVHD were 33.1% (95% CI, 25.4%-41.8%; grade 3/4: 16.5%) and 42.5% (95% CI, 26.3%-60.4%) among FLT3 inhibitor and 42.7% (95% CI, 33.5%-52.4%; grade 3/4: 8.1%) and 41.5% (95% CI, 32.0%-51.6%) among HMA-treated patients, respectively. CONCLUSION: Maintenance therapy with either FLT3 inhibitors or HMA after allo-HCT can lead to prolonged and improved OS and RFS with a favorable safety profile. Additional studies are needed to define the optimal duration of treatment, the role of measurable residual disease status, and transplant characteristics in patient selection.

Nutritional Literacy Among Uninsured Patients With Diabetes Mellitus: A Free Clinic Study.

Objective Evaluate nutrition literacy in uninsured subjects with diabetes mellitus (DM) who presented to free diabetes management classes.  Design  This single-site, cross-sectional observational study recruited thirty subjects from a free clinic for uninsured patients to attend diabetes mellitus, self-management classes. Before starting the classes, DM care-related data were collected, and subjects were administered the Nutrition Literacy Assessment Instrument (NLit). The assessment covers six subscales in nutrition and categorizes results into three possible categories: the likelihood of poor nutrition literacy (NLit Score ≤ 44), the possibility of poor nutrition literacy (NLit Score- 45-57), and the likelihood of good nutrition literacy (NLit score ≥ 58).  Results  Median glycated haemoglobin (HbA1c) was 7.45% for study participants. The mean NLit score was 38.1 (SD ± 9.4), correlating with a likelihood of poor nutrition literacy. All participants had either likelihood or the possibility of poor nutrition literacy based on the NLit Assessment. There were no participants who scored in the range of likelihood of good nutrition literacy. Subjects who scored in the range of likelihood of poor nutrition literacy had a significantly higher mean HbA1c (8.6 %) than those who scored in the possibility of poor nutrition literacy (6.9 %, p=0.005). Conclusions Poor nutrition literacy is associated with worse glycemic control among uninsured subjects with diabetes mellitus.

Prevalence and management of diabetes among the uninsured: A multicenter study in Tampa Bay, FL.

AIMS: This study describes the prevalence and management of uninsured patients with diabetes in free clinics around the Tampa Bay area. METHODS: A retrospective chart review collected data from uninsured patients who visited nine free clinics from January 2016 to December 2017. The data included sociodemographics, chronic disease diagnoses and treatments, and social history. Statistical analysis including chi-square tests and logistic regression were used to describe patients with diabetes. RESULTS: With a prevalence of 19.41% among 6815 uninsured patients and a mean HbA1c of 7.9% (63 mmol/mol), patients with diabetes were more likely to be White, women, obese, unemployed, and have hypertension and depression compared to patients without diabetes. There were no significant differences in sociodemographic variables between those with controlled and uncontrolled diabetes. Among the variables studied by logistic regression, unemployment was found to be a significant predictor of poor glycemic control among men. CONCLUSIONS: Diabetes is a challenging chronic disease among the uninsured of Tampa Bay due to its prevalence and suboptimal glycemic control. Obesity and unemployment represent significant challenges that increase the burden of diabetes among the uninsured. Free clinics may benefit from additional resources and intervention programs, with future research assessing their effects on care outcomes.

Incidence and Management of Effusions Before and After CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy in Large B Cell Lymphoma.

In patients with lymphoma, third-space fluid accumulations may develop or worsen during cytokine release syndrome (CRS) associated with chimeric antigen receptor (CAR) T cell therapy. Pre-existing symptomatic pleural effusions were excluded by the ZUMA-1 trial of axicabtagene ciloleucel for large B cell lymphoma (LBCL) and variants. The incidence and management of effusions during CAR T cell therapy for LBCL are unknown. We performed a single-center retrospective study evaluating 148 patients receiving CD19-directed CAR T cell therapy for LBCL between May 2015 and September 2019. We retrospectively identified patients who had radiographic pleural, pericardial, or peritoneal effusions that were present prior to the time of CAR T infusion (pre-CAR T) or that newly developed during the first 30 days after CAR T-cell infusion (post-CAR T). Of 148 patients, 19 patients had a pre-CAR T effusion, 17 patients without pre-existing effusion developed a new infusion after CAR T, and 112 patients had no effusions. Comparing pre-CAR T effusions to new effusions post-CAR T, pre-CAR T effusions were more often malignant (84% versus 12%), persistent beyond 30 days (95% versus 18%), and required interventional drainage after CAR T infusion (79% versus 0%). Compared to patients with no effusion, patients with pre-CAR T therapy effusions had a higher frequency of high-risk baseline characteristics, such as bulky disease and high International Prognostic Index. Similarly, patients with pre-CAR T therapy effusions had a higher rate of toxicity with grade 3 or higher CRS occurring in 32% of patients. On multivariate analysis adjusting for age, Eastern Cooperative Oncology Group status, bulky disease, albumin, and lactate dehydrogenase, a pre-CAR T therapy effusion was associated with reduced overall survival (hazard ratio, 2.34; 95% confidence interval, 1.09 to 5.03; P = .03). Moreover, there was higher non-relapse mortality (11% versus 1%; P = .005). Post-CAR T effusions were not associated with significant difference in survival. Effusions commonly complicate CAR T cell therapy for lymphoma. Malignant effusions that occur prior to CAR T therapy are frequently persistent and require therapeutic intervention, and patients have a higher rate of toxicity and death. Effusions that newly occur after CAR T therapy can generally be managed medically and tend not to persist.

Secondary prevention among uninsured stroke patients: A free clinic study.

OBJECTIVES: Free clinics manage a diversity of diseases among the uninsured. We sought to assess the medical management of stroke in a population of uninsured patients. METHODS: A retrospective chart review was conducted to collect chronic disease statistics from 6558 electronic medical records and paper charts at nine free clinics in Tampa, Florida, from January 2016 to December 2017. Demographics and risk factors were compared between stroke patients and non-stroke patients. Medication rates for several comorbidities were also assessed. RESULTS: Two percent (107) of patients had been diagnosed with a stroke. Stroke patients were older (mean (M) = 56.0, standard deviation (SD) = 11.2) than the rest of the sample (M = 43.3, SD = 15.4), p < 0.001 and a majority were men (n = 62, 58%). Of the stroke patients with hypertension (n = 79), 81% (n = 64) were receiving anti-hypertensive medications. Of the stroke patients with diabetes (n = 43), 72% (n = 31) were receiving diabetes medications. Among all stroke patients, 44% were receiving aspirin therapy (n = 47). Similarly, 39% of all stroke patients (n = 42) were taking statins. CONCLUSIONS: Uninsured patients with a history of stroke may not be receiving adequate secondary prevention highlighting the risk and vulnerability of uninsured patients. This finding identifies an area for improvement in secondary stroke prevention in free clinics.

Substance Use in Uninsured Cancer Survivors: A Multicenter Cross-Sectional Study of Free Clinics.

Introduction Substance use disorders occur in about 5% of the cancer population and can decrease treatment adherence, impede pain management, and undermine a cancer survivor's network of social support. Although current literature demonstrates substance use is associated with socioeconomic disparity, there is limited research on the prevalence of alcohol, tobacco, and illicit drug use among uninsured cancer survivors in the United States. Our multicenter cross-sectional study describes the prevalence of substance use in uninsured cancer survivors in the Tampa Bay Area. Methods A comprehensive retrospective chart review of electronic medical records and paper charts was conducted at nine free clinics in the Tampa Bay Area of Florida between January 1, 2016, and December 31, 2017. Substance use prevalence was compared between uninsured cancer survivors and uninsured patients without reported cancer history after adjusting for available demographic risk factors. Results There were 222 patients with a history of cancer and 6,768 patients without a history of cancer included for analysis. Cancer survivors had a median age of 55 years (interquartile range 48-61 years), were mostly female (n = 146, 66.1%), and of Hispanic ethnicity (n = 94, 52.5%). Cancer survivors were more likely to be current smokers (n = 42, 25.1%) compared to patients without a cancer history (n = 759, 16.1%). Patients with a history of cancer were more likely to be current drinkers (n = 34, 26%) compared to non-cancer patients (n = 942, 22.9%). There was no significant difference in illicit drug use history between the two groups. Conclusions Our study demonstrates that uninsured cancer survivors are more likely to be smokers and alcohol consumers than uninsured patients without a history of cancer. There was no significant difference in illicit drug use in cancer survivors and patients without a history of cancer. Future educational interventions should target substance use among uninsured cancer survivors.

Aspirin use for cardiovascular disease prevention in the uninsured population.

INTRODUCTION: Aspirin is an effective anti-inflammatory and antiplatelet agent as an irreversible inhibitor of cyclooxygenase. In 2016, the U.S. Preventive Services Task Force recommended aspirin for primary prevention of cardiovascular disease in patients aged 50-69 years with a 10% or greater 10-year cardiovascular disease risk. Current guidelines for patients with prior myocardial infarction or coronary artery disease recommend aspirin use for the secondary prevention of cardiovascular disease. Due to the lack of literature describing adherence to these recommendations in the uninsured patient population, we studied aspirin use for cardiovascular disease prevention in free medical clinics. METHODS: We conducted a cross sectional study of uninsured patients who visited nine free medical clinics in 2016-2017. Data from the records of 8857 patients were combined into a database for analysis. 10-year Framingham risk scores for coronary artery disease were calculated for the 50-69-year-old population to evaluate which patients qualified for aspirin usage. Aspirin use was assessed for patients with prior myocardial infarction or coronary artery disease. RESULTS: In total, 1443 patients met the criteria to take aspirin for primary prevention of cardiovascular disease, but just 17% of these patients aged 50-59 years were on the medication. About 15% of the patients aged 60-69 years were taking aspirin. Of the 297 patients who had prior myocardial infarction or coronary artery disease, 50% were taking aspirin for secondary prevention. CONCLUSION: Among the uninsured population, there are low rates of aspirin use for risk reduction of cardiovascular disease. This study demonstrates that improvements are needed to increase adherence to current guidelines and address barriers uninsured patients may face in maintaining their cardiovascular health.

New Insights Into the Complex Mutational Landscape of Sézary Syndrome.

Sézary syndrome (SS) is a genetically and clinically distinct entity among cutaneous T-cell lymphomas (CTCL). SS is characterized by more aggressive disease compared to the most common indolent type of CTCL, mycosis fungoides. However, there are limited available genomic data regarding SS. To characterize and expand current mappings of the genomic landscape of CTCL, whole exome sequencing (WES) was performed on peripheral blood samples from seven patients with SS. We detected 21,784 variants, of which 21,140 were novel and 644 were previously described. Filtering revealed 551 nonsynonymous variants among 525 mutated genes-25 recurrent mutations and 1 recurrent variant. Several recurrently mutated genes crucial to pathogenesis pathways, including Janus kinase (JAK)/signal transducers and activators of transcription (STAT), peroxisome proliferator-activated receptors (PPAR), PI3K-serine/threonine protein kinases (AKT), and fibroblast growth factor receptors (FGFR), were identified. Furthermore, genetic mutations spanned both known and novel genes, supporting the idea of a long-tail distribution of mutations in lymphoma. Acknowledging these genetic variants and their affected pathways may inspire future targeted therapies. WES of a limited number of SS patients revealed both novel findings and corroborated complexities of the "long-tail" distribution of previously reported mutations.