Observational Chart Review Study Research Articles

5051 Clinical Correlation between TSH levels and TAU Imaging

Abstract Disclosure: S. Sunil: None. Background: Tau-PET Scan measures brain tau deposition. TSH levels related to cognitive impairment. We analyzed the correlation of TSH levels to tau-PET imaging in a memory clinic. Hypothesis: Tau-PET positivity correlates with lower TSH values in the clinic patients. Objectives: To assess the correlation of tau-PET positivity to TSH levels in memory clinic patients. Method: Retrospective observational chart review study of patients attending a memory clinic in Boston, MA, with TSH levels and tau-PET scan included for analysis. No stratification based on initial or final diagnosis, severity of cognitive impairment, or tracer used. Baseline TSH levels and a binary PET scan result were analyzed with covariates age, sex and race. Analysis done on ‘R’ v. 2.4.0. Pearson correlation estimated TSH levels to tau-PET status. Kruskal Wallis/Chi square tests for relationship of age, sex, gender and education with TSH levels and tau-PET status. ROC analyses and sensitivity/specificity were obtained. Results: Tau PET positivity did not correlate significantly with TSH levels (r= 0.0655, 95%CI -0.388 to 0.494, p=0.78). Conclusion: Tau PET does not correlate with TSH levels, possibly due to a ceiling effect in the mild impairment subjects. Presentation: 6/2/2024

Abstract PO2-17-06: Real world treatment patterns and clinical outcomes by germline BRCA (gBRCA) mutation status in patients with HER2-negative early breast cancer in the US community oncology setting: a retrospective observational chart-review study

Abstract Background: Women with early-stage breast cancer (eBC) who have inherited BRCA1 or BRCA2 mutations (gBRCAm) are typically diagnosed at a younger age and often require more intensive treatment. In the randomized, double-blind OlympiA trial of HER2-negative (HER2–) gBRCAm patients, olaparib, a targeted poly (ADP-ribose) polymerase inhibitor (PARPi), significantly improved invasive disease free survival (IDFS), distant disease free survival (DDFS) and overall survival (OS) and was subsequently approved for adjuvant treatment of gBRCAm HER2– high-risk eBC patients. This study examined the real-world patient characteristics, treatment patterns and clinical outcomes by gBRCA status among patients with HER2– eBC in a US community oncology setting prior to olaparib US approval for treatment of eBC. Methods: This retrospective observational study used chart review data from The US Oncology Network's iKnowMed database to examine adult patients diagnosed with HER2– eBC (stage I-III) initiating systemic neoadjuvant or adjuvant therapy with chemotherapy and/or endocrine therapy between January 1, 2012 and December 31, 2018. Patients with valid gBRCAm test results (all gBRCAm and randomly selected BRCAwt patients) were included and followed through December 31, 2021. Patients were excluded if they had HER2+ tumors and progressed to stage IV within 6 months after initiation of neoadjuvant therapy or were diagnosed with another primary cancer. Descriptive analyses assessed patient characteristics. Kaplan Meier methods and multivariate Cox proportional hazard models (CPHM) were used to evaluate IDFS, DDFS and OS by gBRCA status and by HR+/HER2– or TNBC eBC subsets. Results: Among 298 BC patients meeting initial criteria, 42% had gBRCAm (n=124, 43% hormone receptor positive [HR+], 56% triple-negative BC [TNBC], 1% unknown), and 58% had gBRCAwt (n=174, 74% HR+, 22% TNBC). Median (interquartile) age at surgery was numerically lower in gBRCAm (45 [36,55] years) than gBRCAwt (48 [41,55] years) patients. A numerically higher proportion of gBRCAm patients received neoadjuvant therapy compared with gBRCAwt (Neoadj: gBRCAm 37.1% vs gBRCAwt 12.6%) but the reverse was true for adjuvant (Adj: gBRCAm 42.7% vs gBRCAwt 65.5%) and neoadjuvant + adjuvant use was numerically similar (Neoadj+Adj: gBRCAm 20.1% vs gBRCAwt 21.8%). The majority of TNBC patients received neoadjuvant therapy while the majority of HR+ patients received adjuvant therapy (Neoadj: TNBC 51.4% vs HR+ 6.6%, Adj: TNBC 29.0% vs HR+ 71.4%, Neoadj+Adj: TNBC 19.6% vs HR+ 22.0%). Median IDFS, DDFS, and OS in both study cohorts were not reached. Median follow-up from surgery was < 5 years (overall 59.0 months; gBRCAm 50.6 months; gBRCAwt 61.3 months). At 60 months, in gBRCAm and gBRCAwt respectively, estimated IDFS were 85.5% and 90.9%, estimated DDFS 88.1% and 92.2%, and estimated survival 91.9% and 95.2%. At 60 months, in HR+/HER2– and TNBC respectively, estimated IDFS were 92.4% and 81.2%, estimated DDFS 93.9% and 85.7%, and estimated survival 96.3% and 90.9%. CPHM results showed that risks of invasive disease (HR 1.74; 95% CI 0.83-3.64; p=0.15), distant disease (HR 1.24; 95% CI 0.50-3.07; p=0.65) and death (HR 1.79; 95% CI 0.52-6.13; p=0.353) were similar between gBRCAm and gBRCAwt patients. Between HR+/HER2– and TNBC patients, risks of invasive disease (HR=0.63; 95% CI 0.21-1.89; p=0.41), distant disease (HR=0.42; 95% CI 0.11-1.67; p=0.22) and death (HR 0.48; 95% CI 0.09-2.70; p=0.41) were similar. Conclusions: This real-world chart review study of data through 2021 (before PARPi approval for eBC) with limited follow up of 5 years found that gBRCAm patients had a numerically shorter survival (IDFS, DDFS and OS) than gBRCAwt, but this difference was not statistically significantly different. Given that the follow-up period was too short to draw conclusions, further studies examining clinical outcomes over a longer follow-up period after approval of PARPi may be of interest. Citation Format: Jay Andersen, Jagadeswara Earla, Nicole Fulcher, Juliet Ndukum, Nicholas J Robert, Mark Robson, Weiyan Li, Jaime Mejia. Real world treatment patterns and clinical outcomes by germline BRCA (gBRCA) mutation status in patients with HER2-negative early breast cancer in the US community oncology setting: a retrospective observational chart-review study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-17-06.

CLINICAL CORRELATION OF MOCA AND TAU IMAGING

Abstract Background Tau-PET Scan measures brain tau deposition. Montreal Cognitive Assessment (MOCA) is used for cognitive impairment in (MCI) and Alzheimer Disease (AD). We analyzed the correlation of MOCA to tau-PET imaging in a memory clinic. Hypothesis Tau-PET positivity correlates with lower MOCA scores in memory clinic patients Objectives To assess the correlation of tau-PET positivity to MOCA test scores in memory clinic patients To evaluate an MOCA score cut-off that translates optimally to tau-PET positivity Method Retrospective observational chart review study of 34 patients attending a memory clinic in Boston, MA, with MOCA score and tau-PET scan included for analysis No stratification based on initial or final diagnosis, severity of cognitive impairment, or tracer used. Baseline MOCA and a binary PET scan result were analyzed with covariates age, sex and race. Analysis done on ‘R’ v. 2.4.0. Pearson correlation estimated MOCA score to tau-PET status. Kruskal Wallis/Chi square tests for relationship of age, sex, gender and education with MOCA score and tau-PET status. ROC analyses and sensitivity/specificity were obtained. Results Tau PET positivity did not correlate significantly with MOCA score (r= -0.24, 95%CI –0.54 to -0.12, p=0.19). A cut point of 22 on the MOCA estimated tau deposition in the brain by PET scan, with an AUC of 80%, 95% CI –0.6 to –0.99, possibly indicating a ceiling effect on the MOCA. Conclusion Tau PET does not correlate with MOCA scores, possibly due to a ceiling effect in the mild impairment subjects.

Antibiotic resistance profiles and associated factors of Pseudomonas Infections among patients admitted to large tertiary care hospital from a developing country

BackgroundPseudomonas infections are among the most common infections encountered in hospitalized patients, especially those with chronic illnesses or an immunocompromised state. Management of these infections has become challenging due to increased antibiotic resistance. Therefore, this study examines the antibiotic resistance profiles of Pseudomonas spp. and the associated factors among patients admitted to a large tertiary hospital in a developing country.MethodsThis retrospective observational chart review study assessed patients admitted to a large tertiary hospital in a developing country with a positive culture growth of Pseudomonas from anybody site. Antibiotic susceptibility of the isolated Pseudomonas and patient characteristics were studied from the start of 2021 to the end of 2022. The study ground consisted of 185 patients.ResultsThe study included 185 patients with positive Pseudomonas isolates. Males constituted 54.6% of the sample, while 45.4% were females. The median age of the patients was 53 years. Patient comorbidities and risk factors for Pseudomonas infection and multidrug resistance were assessed. Antibiotic resistance to the Pseudomonas regimens showed the highest resistance to meropenem and ciprofloxacin (23.4%, similarly) among isolates of Pseudomonas aeruginosa. Multidrug resistance (MDR) was found in 108 (58.4%) isolates. The most commonly used antibiotic for treatment was piperacillin-tazobactam, accounting for 33.3% of cases, followed by aminoglycosides at 26.6%.ConclusionsPseudomonas aeruginosa isolates were resistant to meropenem and ciprofloxacin. Over half of the isolates were multidrug-resistant, which was worrying. Piperacillin-tazobactam and aminoglycosides were the most often utilized antibiotics, highlighting the significance of susceptibility testing. Implementing antimicrobial stewardship programs and infection control measures can help reduce drug resistance and improve outcomes in Pseudomonas infections.

Long-Term Drug Survival and Effectiveness of Secukinumab in Patients with Moderate to Severe Chronic Plaque Psoriasis: 42-Month Results from the SUPREME 2.0 Study.

SUPREME, a phase IIIb study conducted in Italy, demonstrated safety and high efficacy of secukinumab for up to 72 weeks in patients with moderate-to-severe plaque-type psoriasis. SUPREME 2.0 study aimed to provide real-world data on the long-term drug survival and effectiveness of secukinumab beyond 72 weeks. SUPREME 2.0 is a retrospective observational chart review study conducted in patients previously enrolled in SUPREME study. After the end of the SUPREME study, eligible patients continued treatment as per clinical practice, and their effectiveness and drug survival data were retrieved from medical charts. Of the 415 patients enrolled in the SUPREME study, 297 were included in SUPREME 2.0; of which, 210 (70.7%) continued secukinumab treatment throughout the 42-month observation period. Patients in the biologic-naïve cohort had higher drug survival than those in the biologic-experienced cohort (74.9% vs 61.7%), while HLA-Cw6-positive and HLA-Cw6-negative patients showed similar drug survival (69.3% and 71.9%). After 42 months, Psoriasis Area and Severity Index (PASI) 90 was achieved by 79.6% of patients overall; with a similar proportion of biologic-naïve and biologic-experienced patients achieving PASI90 (79.8% and 79.1%). The mean absolute PASI score reduced from 21.94 to 1.38 in the overall population, 21.90 to 1.24 in biologic-naïve and 22.03 to 1.77 in biologic-experienced patients after 42 months. The decrease in the absolute PASI score was comparable between HLA-Cw6-positive and HLA-Cw6-negative patients. The baseline Dermatology Life Quality Index scores also decreased in the overall patients (10.5 to 2.32) and across all study sub-groups after 42 months. Safety was consistent with the known profile of secukinumab, with no new findings. In this real-world cohort study, secukinumab showed consistently high long-term drug survival and effectiveness with a favourable safety profile.

Real-World Treatment Patterns and Outcomes in Patients with Immune Thrombocytopenia Treated with Avatrombopag in the United States: Real-AVA 2.0 Study Design

Background: Thrombopoietin-receptor agonists (TPO-RAs) are used in the treatment of chronic immune thrombocytopenia (ITP), a disorder characterized by prolonged low platelet counts (PCs) that pose a risk of serious bleeding events. The TPO-RAs eltrombopag (ELT) and romiplostim (ROMI) have been available for more than 10 years. ELT is an oral medication with food restrictions and carries a boxed warning for hepatoxicity, requiring hepatic laboratory monitoring and a potential need for statin dosing adjustments. ROMI, an injectable, is typically administered in a health care practitioner's office on a weekly basis without food restrictions. Avatrombopag (AVA), an oral medication taken with food, is the most recently approved TPO-RA for the treatment of chronic ITP (2019 by FDA and 2021 by EMA). Hence, the real-world evidence on AVA treatment and its clinical effectiveness in broader and more diverse ITP patient populations have been limited, and additional studies are warranted. REAL-AVA 2.0 is a retrospective chart review which will gather a substantially greater amount of platelet counts per patient than either a claims database review or an electronic medical record review. More granular efficacy data with more patients, more platelet counts per patient, and in a broader population will be used to better assess the clinical effectiveness of AVA in the real-world. This study will also describe the demographic and clinical characteristics of adult patients with primary ITP treated with AVA in the United States (US), and assess treatment patterns and clinical outcomes of these patients. Methods: This retrospective, observational medical chart review study will include patients treated in the US with AVA in a non-clinical trial setting from approximately 20 centers (both academic and community). The study aims to include approximately 200 ITP patients (at least 25 with an ITP disease duration < 12 months) treated with at least one dose of AVA between July 2019 and March 2023. The date the patient initiated treatment with AVA is defined as the index date. The period from the index date through the study end date, end of data availability for the patient or date of death, whichever occurs first, is defined as the post-index period. Results: The primary objective of the study is to describe treatment patterns and response to AVA. Primary outcome measures to be assessed include: achievement of meaningful PC thresholds (PC ≥ 30 X10 9/µL and ≥ 50 X10 9/µL) at any time during AVA treatment, time to achieve an initial platelet response with AVA based on achieving meaningful PC thresholds (PC ≥ 30X10 9/µL and ≥ 50 X10 9/µL) after AVA index date and before AVA discontinuation, durability of platelet response among patients who respond to AVA, and reduction in the use of concomitant steroids or immunosuppressant agents from the index date. The secondary objectives include: assessment of the demographic and clinical characteristics of patients treated with AVA, assessment of changes in PCs following the index date, ITP-related medication use prior to and following the index date, and treatment patterns with AVA (including treatment persistence and changes in dose/frequency). The exploratory objectives include assessment of AVA effectiveness in specific subpopulations (e.g. prior number of ITP treatments, persistent vs chronic ITP, switch from particular ITP treatments, gender, race, age) and, if feasible, to evaluate social determinants of health among ITP patients treated with AVA (including assessment of treatment response among those subpopulations of interest) [ Table 1]. Summary/Conclusions: The study aims to fill current gaps in knowledge by assessing treatment patterns and outcomes, clinical, and demographic characteristics of patients treated with AVA in a real-world clinical setting in the US. We look forward to presenting this data at upcoming scientific meetings.

Antenatal corticosteroid therapy, delivery intervals and perinatal mortality in low-resource settings.

Uncertainty exists regarding the ideal interval between the administration of antenatal corticosteroids (ACS) and delivery. The study's objective was to assess the risks of perinatal mortality and respiratory distress syndrome (RDS) among preterm neonates whose mothers gave birth within 48 h of the administration of ACS and those whose mothers gave birth between 48 h and 7 days. The study design was a secondary analysis of data from an observational prospective chart review study that was carried out in Tanzania in 2020. Preterm infants born to mothers who got at least one dose of ACS between 28 and 34 weeks of pregnancy were included. A total of 346 preterm neonates (294 singletons and 52 twins) were exposed to ACS. Compared to infants born 48 h following the first dose of ACS, those exposed to the drug between 48 h and 7 days had significantly decreased rates of perinatal mortality and RDS. Multivariable analysis revealed that infants exposed ACS between 48 h and 7 days prior to delivery had lower risk of perinatal mortality (aRR 0.30, 95% CI 0.14-0.66) and RDS (aRR 0.27, 95% CI 0.14-0.52). The first dose of ACS given between 48 h and 7 days before delivery was associated with a lower risk of perinatal mortality and RDS than when the first dose was given <48 h before delivery. To improve neonatal outcomes, healthcare providers should consider administering ACS to mothers at the appropriate time.

Treatment patterns of triple-class refractory (TCR) multiple myeloma (MM) across the United States (US), Canada, and western Europe: A real-world observational chart review study.

e18827 Background: Most patients with MM eventually become refractory to the three main therapy classes used to treat the disease: proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and anti-CD38 monoclonal antibodies (mAbs). The objective of the present study was to describe the management of patients who have become TCR and how treatment strategies vary across countries. Methods: A retrospective chart review study was conducted across the US, Canada (CA), the UK, France (FR), Germany (DE), Spain (ES), Belgium (BE), the Netherlands (NL), and Sweden (SE). Oncologists/hematologists were recruited to abstract medical chart information from eligible patients (eg, diagnosed with MM, clinician-reported refractoriness to ≥1 IMiD, ≥1 PI, and ≥1 anti-CD38 antibody treatment) into an electronic case report form. Patients had to initiate their first (index) therapy after becoming TCR between 11/1/2015 and 12/31/2019. Chart abstractions were performed from February through October 2022. Demographics, baseline clinical characteristics, and treatment patterns were descriptively analyzed. Results: A total of 718 patients with TCR MM were included (61.4% male; median age at index = 64.2 years); 25.8% had an ECOG score of 2 and 28.7% had high cytogenetic risk [ie, t(4:14), t(14:16), and/or del(17p)]. Patients received a median of 3 treatment lines prior to their index therapy (19.4% were penta-exposed). In the post TCR setting, the most frequently used treatments included IMiDs (52.5%), PIs (40.8%), chemotherapy (CT; 27.3%), and mAbs (16.3%). Treatment class usage also varied significantly by country (Table 1). Conclusions: Our global chart review indicated that many patients reach TCR status after only a few lines of therapy and, after this point, retreating with IMiDs, PIs, and mAbs was common practice. The diversity of treatment classes used in this setting underscores the challenges across countries with managing a TCR population due to the lack of a clear standard of care. [Table: see text]

Use of hospital resources in ICU inpatients with infections caused by carbapenem-resistant Gram-negative bacteria: A real clinical practice-based study in Spain

IntroductionCarbapenem-resistant Gram-negative bacteria (CRGN) are an urgent public health threat because of the limited treatment options, its rapid spreading and high clinical impact and mortality rates. However, the burden and the use of resources of these infections have not been investigated. The aim of the current study is to understand the use of resources associated to the clinical management of CRGN infections in real clinical practice conditions. MethodsAn observational retrospective chart review study was performed. Data regarding patient demographics, clinical management and use of resources associated to hospitalization were retrieved from clinical charts of ICU inpatients with a confirmed CRGN infection. Three reference Spanish hospitals were selected according to their patient volume and geographical coverage. Descriptive analyses of the clinical management and the use of resources and its cost were performed and then total costs by type of resource were calculated. ResultsA total of 130 patients were included in the study. The higher number of patients (n=43; 33%) were between 61 and 70 years old. Ninety-four (72%) patients were male and 115 (88%) suffered from comorbidities. The mean total cost associated to the resources used in patients with CRGN infections hospitalized in ICU was 96,878€ per patient. These total costs included 84,140€ of total hospital stay, 11,021€ of treatments (558€ of antibiotics; 10,463€ of other treatments) and 1717€ costs of diagnostic tests. ConclusionsCRGN infection causes a high use of hospital resources, being the length of stay either in hospital wards or ICU the driver of the total costs. Diagnostic tests and treatments, including antibiotics, represent the lowest part of the use of resources and costs (13% of total costs).

The role of surgery (metastasectomy) in advanced BRAF positive melanoma during modern therapy.

e21512 Background: Improved overall survival in patients undergoing metаstasectomy for melanoma have been reported in several retrospective studies before era of modern therapy in melanoma. Rapid progress in BRAF and MEK targeted therapy (TT) and immunotherapy (IT) has led to significant improvements in objective response rates and survival rates in advanced melanoma patients. Unfortunately, part of patients have a resistance to modern therapy in one or more lesions. In 2019 Nelson DW et al published data when surgery followed by modern therapy in 47 matched pairs was associated with higher 5-year melanoma-specific survival (MSS) versus modern therapy alone (58.8% vs. 38.9%, p = 0.049). But data about modern therapy in BRAF + advanced melanoma with metastasectomy during therapy are limited. Methods: We conducted an observational retrospective chart review study and evaluated a subset of patients which underwent surgery (metastasectomy) with V600 BRAF-mutant advanced melanoma, who received therapy in a real-world setting in Russia. Survival analyses were performed using the Kaplan-Meier method, Log-rank, chi-square and Fisher exact tests were used for comparison between groups. Results: The observed population included 382 patients in Russia. The date of the first enrollment after all approvals was 8 October 2018, and the date of the last completed register was 27 April 2019. Among 382 patients, 107 (28%) patients received surgical treatment for advanced melanoma during modern therapy (removal of metastases from the brain, lungs, soft tissues and other organs). Surgery during first line therapy was performed in 60pts (56%), as second – in 25pts (23.4%) and third or higher line in 22pts (20.6%). Comparison of overall survival curves for all patients depending on the surgical treatment showed that the survival in the subgroup of patients with the presence of surgical treatment was higher than among patients who did not undergo metastasectomy: 24-months OS was 76.7 (95%CI, 65.6 – 84.6) and 53.7% (95%CI, 46.4-60.4), p = 0,0027). Conclusions: Our findings suggest that resection of distant metastases associated with improved overall survival despite all limitations in retrospective nature of the study. While modern systemic therapy have improved outcomes in advanced melanoma, metastasectomy remains associated with favorable survival. Surgery have to be a part of multidisciplinary care for patients with advanced melanoma.

Predictors of biomarker testing among patients (pts) with metastatic non–small cell lung cancer (mNSCLC).

9130 Background: The MYLUNG (Molecularly Informed Lung Cancer Treatment in a Community Cancer Network) Consortium pragmatic study assessed real-world biomarker testing rates for mNSCLC within The US Oncology Network of over 1,000 providers. We previously reported that 90% of pts had at least one test performed for ALK, BRAF, EGFR, ROS1, or PD-L1, but only 46% had testing for all 5. We examined patient factors associated with rates of biomarker testing. Methods: Retrospective observational chart review study of pts with mNSCLC initiating first-line systemic therapy between 04/01/2018 and 03/31/2020. Patient characteristics including age, sex, race, geographic location, BMI, laboratory values, histology, performance status, stage at diagnosis, and comorbidities were obtained from iKnowMed electronic health records. Predictors of biomarker testing were identified using multivariable logistic regression. Results: Of the 3474 adults included in the study, median age was 69 years (range 23-90), 51% female, 65% White, 8% Black or African American, and 46% treated in the South US census region. Histology was adenocarcinoma in 74% and squamous cell carcinoma in 19%. Modeling for any biomarker testing resulted in histology and geographic region as significantly associated with increased likelihood of testing: adenocarcinoma vs squamous cell, odds ratio (OR) 1.76 (CI 1.33-3.23, p&lt;0.0001) and Midwest vs South, OR 2.04 (CI 1.24-3.34, p=0.005). For comprehensive testing of all 5 biomarkers, increased albumin, adenocarcinoma or not otherwise specified histology, Midwest, Northeast or West geographic regions, and larger practice size were all significantly associated with increased likelihood of testing, while Black or African American race was associated with significantly decreased likelihood of testing (Table). Conclusions: Black or African American race, smaller practice size, Southern practice, and squamous cell histology were significantly associated with lower comprehensive biomarker testing rates. Understanding clinical and social determinants of health will be important when evaluating interventions to improve testing rates in the prospective phases of the MYLUNG study. [Table: see text]

The vulnerability of maintenance dialysis patients with COVID-19: mortality and risk factors from a developing country

Patients on maintenance dialysis therapy are especially vulnerable to COVID-19 and its complications. This study aimed to assess the incidence, epidemiological characteristics, and mortality rate of COVID-19 among maintenance dialysis patients. This retrospective observational chart review study included 548 patients from all dialysis units in the West Bank of Palestine who acquired COVID-19 between 5 March 2020, and 11 August 2021. We collected data on patients' demographics, clinical features, and outcomes. A multivariable logistic regression model was used to assess independent risk factors for COVID-19-related mortality. The incidence of COVID-19 among maintenance dialysis patients was 35.3%, as 548 out of 1554 patients have tested positive during the study period. Patients on haemodialysis were three times riskier to get infected than those on peritoneal dialysis (37% vs 11.3%). Half (50.2%) of infected patients required hospitalisation, and 24.5% were admitted to an intensive care unit, while the mortality rate stood at 26.8%. Old age, male sex, central venous catheter use, comorbid diabetes, smoking, and having an RH negative blood group type were determined to be significantly associated with increased risk of mortality. In conclusion, the incidence of COVID-19 among Palestinian maintenance dialysis patients was notably high, especially among haemodialysis patients. High rates of hospitalisation, ICU admission, intubation and death were observed, and predictive factors for COVID-19-related mortality were identified. Therefore, the implementation of strict infection control measures and promotion of home dialysis are warranted to reduce the infection rate. KEY MESSAGES The incidence of COVID-19 among Palestinian maintenance dialysis patients was notably high; more than one-third of the total dialysis population acquired COVID-19, with haemodialysis patients being three times more likely to get infected compared to their peritoneal dialysis counterparts. The mortality rate among maintenance dialysis patients was 26.8%, more than 25 times higher than that of the general population. The risk of mortality was significantly increased with age, male sex, smoking, diabetes, and having central venous catheter as vascular access for haemodialysis. Strict infection control measures, as well as the promotion of home dialysis, are necessary to reduce the risk of infection.

Tolerability and epidemiology of nephrotoxicity associated with conventional amphotericin B therapy: a retrospective study in tertiary care centers in Palestine

BackgroundIn the light of recent years, an increase in the number of life-threatening infections due to various fungi has been observed, especially in tertiary care centres. With Amphotericin B labelled as the first choice in treating these infections, one of its common side effects, nephrotoxicity, along with hypokalemia, were studied to determine the epidemiology, risk factors, and protective measures.MethodologyThe study was a retrospective observational chart review study in which patients were receiving conventional Amphotericin B in two tertiary hospitals in Palestine from January 2018 to December 2020 were evaluated for the development of hypokalemia and nephrotoxicity; according to the KDIGO criteria. A total of 117 patients were included in the study. Patients who have received the drug intermittently, in fewer than two doses, through non-IV routes and patients under the age of 12 were excluded. The data collected included, but were not limited to, age, gender, comorbidities, Amphotericin B treatment details, medications, COVID-19 status, risk factors, and hypothesized protective measures.ResultsThe incidence of conventional Amphotericin B nephrotoxicity and hypokalemia was 46% and 33%, respectively. With a roughly equal representation of both genders and a median age of 52 years in a range of 13–89. No association between the variables and the development of nephrotoxicity was found. However, a 3.4 increased risk (p-value = 0.01) of developing hypokalemia in females compared to males was observed.ConclusionOur research has shown a relatively lower yet consistent, incidence of conventional amphotericin B nephrotoxicity and hypokalemia compared to literature with gender being a risk factor for developing hypokalemia.

Safety And Efficacy of Clonidine for Acute Hypertensive Urgency in an Older and Hospitalized Population.

Objective To describe the use of clonidine in hospitalized older people for acute management of hypertension. Methods This was an observational retrospective cross-sectional chart review study. Older people hospitalized between November 2017 and November 2018, with a one-time or as-needed clonidine order were eligible, and a random sample of these patients were included. Hospitalized patients could be admitted for hypertensive urgency or emergency, or for other reasons. Results During the 12-month study period, 546 charts were identified as having at least one clonidine prescription, 248 were screened and 205 were included. The mean age was 75 years of age ± 8 years of age and men made up 53% (n = 109) of the group. One hundred fifty-one patients (74%) received at least one dose of clonidine and the remaining patients has a clonidine prescription but did not reach the blood pressure threshold for clonidine administration. The mean number of doses per patient was 1.8 ± 2.0. Twenty-nine percent of clonidine doses were given when systolic and diastolic blood pressure was below 180 mmHg and 120 mmHg respectively. A total of 25 patients (17%) had a potential adverse reaction following clonidine administration. One patient had a stroke and two patients fell. Sixty-eight patients had evidence of target organ dysfunction related to hypertension prior to clonidine administration. Conclusions Clonidine remains widely prescribed in hospitalized older people. It is possibly due to its rapid onset and little need for dosing adjustment. Clinical interventions should be designed and implanted to reduce its prescription.

Association between antenatal corticosteroids use and perinatal mortality among preterm singletons and twins in Mwanza, Tanzania: an observational study

ObjectivesTo examine the association between antenatal corticosteroids (ACS) use and perinatal mortality in singletons and twins delivered before 35 weeks of gestation.DesignSecondary analysis of data from an observational prospective chart...

Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network

ObjectivesThe MYLUNG (Molecularly Informed Lung Cancer Treatment in a Community Cancer Network) consortium pragmatic study assessed real-world biomarker testing rates and turnaround times within a large community-based oncology network. Materials and MethodsThis retrospective observational chart review study investigated patients with mNSCLC initiating first-line (1L) systemic therapy between 01-April-2018 and 31-March-2020. Biomarker testing rates and timing relative to 1L therapy for EGFR, ALK, ROS1, BRAF, and PD-L1 were assessed, including use of next-generation sequencing (NGS). ResultsAmong 3474 adults: 74% had adenocarcinoma and 76% had a documented ECOG performance status of 0 or 1. Ninety percent had testing for at least one biomarker, and 46% received all 5 biomarker tests. Changes in testing rates from 2018 to 2020 were 71% to 71% for EGFR, 71% to 70% for ALK, 69% to 67% for ROS1, 51% to 59% for BRAF, 82% to 84% for PD-L1, and 42% to 49% for all 5 biomarkers. NGS testing increased from 33% to 45% (p < 0.0001). Median time from mNSCLC diagnosis to 1L therapy was 35 days. Median turnaround times from biomarker testing orders to results ranged from 10 to 15 days for the individual biomarkers and 18 days for NGS. ConclusionIn this real-world study, while most patients received at least one biomarker test prior to 1L, <50% received all 5 tests. NGS testing also occurred in < 50% of patients but appeared to increase over time. The next phase of MYLUNG will evaluate contemporary ordering practices and turnaround times prospectively.

Antenatal Corticosteroid Use and Perinatal Mortality According to Gestational Age among Preterm Singletons Born at 27 to 34 Weeks of Gestation in Hospitals in Tanzania

Background: Antenatal corticosteroid (ACS) treatment has been proven to decrease rates of adverse perinatal outcomes when administered to pregnant women at risk for preterm delivery. Given the uncertainty about the benefit of ACS according to gestational age, we aimed to examine whether there was any benefit of ACS on perinatal mortality and respiratory distress syndrome (RDS) according to different gestational ages at birth. Methods: Secondary analysis of data from an observational prospective chart review study was conducted in four hospitals located in the Mwanza region, Tanzania. The study population consisted of singleton infants delivered between 27 and 34 weeks of gestation between July 2019 and February 2020. Sociodemographic and medical data were recorded from participants’ medical records. Results: Over an eight-month period, 838 preterm singletons were delivered between 27 and 34 weeks of gestation. Three hundred and twelve (37.2%) pregnant women received at least one dose of ACS. Among infants exposed to ACS, perinatal mortality rates were significantly lower than those without exposure at the 27th week (27.8% vs 94.4%, P Conclusion: Our findings add to the literature about the benefits of ACS for preterm infants of various gestational ages in low-resource settings. Compared to unexposed infants, those exposed to ACS and born at 27th and 34th weeks of gestation experienced lower rates of perinatal mortality. Future research, especially among infants born before the 27th week of pregnancy, is a priority.

Use of hospital resources in ICU inpatients with infections caused by carbapenem-resistant Gram-negative bacteria: A real clinical practice-based study in Spain

IntroductionCarbapenem-resistant Gram-negative bacteria (CRGN) are an urgent public health threat because of the limited treatment options, its rapid spreading and high clinical impact and mortality rates. However, the burden and the use of resources of these infections have not been investigated. The aim of the current study is to understand the use of resources associated to the clinical management of CRGN infections in real clinical practice conditions. MethodsAn observational retrospective chart review study was performed. Data regarding patient demographics, clinical management and use of resources associated to hospitalization were retrieved from clinical charts of ICU inpatients with a confirmed CRGN infection. Three reference Spanish hospitals were selected according to their patient volume and geographical coverage. Descriptive analyses of the clinical management and the use of resources and its cost were performed and then total costs by type of resource were calculated. ResultsA total of 130 patients were included in the study. The higher number of patients (n=43; 33%) were between 61 and 70 years old. Ninety-four (72%) patients were male and 115 (88%) suffered from comorbidities. The mean total cost associated to the resources used in patients with CRGN infections hospitalized in ICU was 96,878€ per patient. These total costs included 84,140€ of total hospital stay, 11,021€ of treatments (558€ of antibiotics; 10,463€ of other treatments) and 1717€ costs of diagnostic tests. ConclusionsCRGN infection causes a high use of hospital resources, being the length of stay either in hospital wards or ICU the driver of the total costs. Diagnostic tests and treatments, including antibiotics, represent the lowest part of the use of resources and costs (13% of total costs).

Real-World Treatment Patterns and Outcomes in Patients with Hemophagocytic Lymphohistiocytosis (HLH) and Other Clinical Conditions Treated with Emapalumab: The Real-HLH Study Design

Introduction: Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening hyperinflammatory syndrome characterized by overactivation of the immune system due to systemic release of proinflammatory cytokines, especially of interferon gamma (IFNγ), and persistent activation of macrophages/histiocytes and T cells. Emapalumab, a fully human, anti-IFNγ monoclonal antibody that binds to both free and receptor-bound IFNy, neutralizing its biologic activity, was approved by the Food and Drug Administration (FDA) in 2018 for the treatment of adult and pediatric patients with primary HLH with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. The safety and efficacy of emapalumab was based on results from a pivotal phase 2/3 trial which reported a 63% overall response in patients treated with emapalumab. Since approval, no study has evaluated the use of emapalumab in a larger cohort of patients in the real-world clinical setting.Aim: To assess real-world treatment patterns and outcomes, clinical and demographic characteristics among patients treated with emapalumab.Method: This retrospective, non-interventional, observational medical chart review study will include patients treated across treatment centers in the US with emapalumab in a non-clinical trial setting. The study aims to include more than 100 patients who have been treated with at least one dose of emapalumab between November 20, 2018 and December 31, 2020 (patient identification period). The date that the patient initiates treatment with emapalumab within the patient identification period is defined as the index date. The post-index date is defined as the period from the index date through to the study end date (June 30, 2021), end of data availability for the patient, or date of death, whichever occurs first. Patients will be classified into three groups (i.e. primary HLH, secondary HLH, or non-HLH) based on the information obtained from their charts, the HLH 2004 diagnostic criteria, and adjudication by the REAL-HLH Steering Committee.Results: The primary objective of the study is to describe treatment patterns in patients with HLH treated with emapalumab in a real-world clinical setting, including emapalumab dose, treatment duration, and reasons for initiating or discontinuing treatment. The secondary objectives are to describe demographic and clinical characteristics of patients with HLH treated with emapalumab, and their outcomes. The exploratory objectives include detailing the demographic, clinical characteristics, treatment patterns, and outcomes of patients with non-HLH clinical conditions treated with emapalumab (Table 1). Demographics and clinical characteristics will be analyzed at the time of diagnosis. Treatment patterns and outcomes will be analyzed during the post-index date.Conclusion: The study aims to assess treatment patterns and outcomes, clinical and demographic characteristics among patients treated with emapalumab, a novel IFNγ blocking agent, in real-world clinical settings in the US. [Display omitted] DisclosuresAllen: Sobi: Consultancy. Leiding: Sobi: Consultancy. Chandrakasan: Sobi: Consultancy. Walkovich: X4 Pharmaceuticals: Other: Local PI for clinical trial involving mavorixafor and patients with neutropenia; Swedish Orphan Biovitrum AB (Sobi): Consultancy, Honoraria; Pharming: Honoraria, Membership on an entity's Board of Directors or advisory committees; Horizon Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees. Oladapo: Sobi: Current Employment. Yee: Sobi: Current Employment. Pednekar: Sobi: Consultancy; PRECISIONheor: Current Employment. Raza: Sobi: Consultancy; PRECISIONheor: Current Employment. Jordan: Sobi: Consultancy.

Clinicopathological Characteristics and Prognostic Factors in Ovarian Metastases from Right- and Left-Sided Colorectal Cancer.

Background: Secondary tumors of the ovary (STOs) account for 10–25% of all ovarian malignancies, including metastases from primary gynecological tumors. Colorectal cancer (CRC) has been recognized as one of the most common causes of STOs in Western countries. Despite it being well-known that CRC originating from the right versus left side of the colon/rectum differ substantially, there is a paucity of information regarding the effect of the primary tumor sidedness on the clinicopathological characteristics of STOs. Methods: This retrospective, observational chart review study included patients with histologically confirmed STOs of CRC origin diagnosed between January 2000 and December 2019. The clinicopathological characteristics of STOs originating from left-sided and right-sided CRC were compared. Univariable and multivariable analyses employing elastic net Cox proportional hazard models were used to evaluate potential prognostic factors. Further, the role of imaging methods in STOs diagnostics was evaluated. Results: Fifty-one patients with STOs of colorectal origin were identified. The primary tumor originated in the right and left colon/rectum in 39% and 61% of the cases, respectively. STOs originating from right-sided primary tumors were more frequently bilateral, associated with peritoneal carcinomatosis, had the ovarian surface affected by the tumor, and contained a mucinous component. The independent prognostic factors for overall survival in the whole cohort included: the presence of macroscopic residual disease after cytoreductive surgery, menopausal status, the application of systemic therapy, and the application of targeted therapy. In 54% of cases, the imaging methods failed to determine the laterality of the STOs correctly as compared to pathological reports and/or intraoperative findings. Conclusion: STOs originating from left-sided and right-sided CRC show distinct clinicopathological characteristics. Moreover, different metastatic pathways might be employed according to the primary tumor sidedness. Considering the discrepancies between radiological assessment and histopathological findings regarding the laterality of STOs, bilateral adnexectomy should be advised whenever feasible.