Impact of Rituximab and Corticosteroids on Late Cytopenias Post-Chimeric Antigen Receptor T Cell Therapy.

Chimeric antigen receptor (CAR) T cell therapy represents a significant advancement in the treatment of patients with relapsed/refractory B cell lymphoid malignancies. Cytokine release syndrome and immune effector cell-associated neurotoxicity represent the most acute serious adverse events post CAR T cell therapy but the occurrence and persistence of cytopenias post CAR T cell therapy represent a significant adverse event and a management challenge. While most patients typically recover blood counts by 30 days, a significant subset of patients have persistent or late cytopenias beyond 30 days. Patients receiving CAR T cell are heavily pre-treated and the impact of prior therapies on late cytopenias is not well understood. In this study, we found an association between increased number of rituximab infusions and/or cumulative rituximab dose received prior to CAR T cell infusion and persistent anemia and thrombocytopenia at 90 and 180 days afterwards. An overall increased number of prior lines of therapy was also associated with persistent lymphopenia and anemia at 90 days while receiving a prior autologous hematopoietic cell transplant was associated with a greater risk of neutropenia and lymphopenia.

Incidence of thrombosis in relapsed/refractory B-cell lymphoma treated with axicabtagene ciloleucel: Mayo Clinic experience.

Chimeric antigen receptor (CAR) T-cell therapy is effective in relapsed/refractory large B-cell lymphoma and results in a unique toxicity profile, namely cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome. The hyper-inflammatory state associated with these toxicities has been suggested to increase the risk of thrombosis. We conducted a retrospective analysis of patients treated with axicabtagene ciloleucel (axi-cel) to assess the rate of thrombosis with axi-cel therapy from the time of CAR T-cell infusion until the end of hospitalization, when performed in the inpatient setting, or up to day +30 when performed in the outpatient setting. Ninety-two (95%) of 97 patients were hospitalized during axi-cel therapy and 85 (88%) developed CRS. Fifty-five patients (57%) received concurrent anticoagulation (53 as prophylaxis). Patients with prior VTE did not have progression or evidence of new VTE. Only 2 (2.1%) patients developed VTE. These results demonstrate a low-risk for thrombosis in axi-cel recipients.

Prevalence and risk of progressive aortic aneurysm and dissection in adults with conotruncal anomalies.

AIMS: Conotruncal anomalies share common embryogenic defects of the outflow tracts and great arteries, which result in a predisposition to aortic aneurysms. The purpose of this study was to describe the prevalence and risk of progressive aortic aneurysms in adults with conotruncal anomalies. METHODS AND RESULTS: Retrospective study of adults with conotruncal anomalies that underwent cross-sectional imaging 2003-20. Aneurysm was defined as aortic root/mid-ascending aorta >2.1 mm/m2/>1.9 mm/m2, progressive aneurysm as increase by >2 mm, and severe aneurysm as dimension >50 mm. Of 2261 patients (38 ± 12 years; male 58%), 1167 (52%) had an aortic aneurysm, and 205 (14%) had a severe aortic aneurysm. Mean annual increase in aortic root/mid-ascending aorta was 0.3 ± 0.1 mm/0.2 ± 0.1 mm. The 3-, 5-, and 7-year cumulative incidence of the progressive aortic aneurysm was 4%, 7%, and 9%, respectively. The rate of aneurysm growth decreased with age, with no significant growth after age 40 years. There was an excellent correlation between aortic indices from cross-sectional imaging and echocardiography. Of 950 females, 184 had ≥1 pregnancy, and 81 (44%) of the 184 patients had aortic aneurysm prior to pregnancy. There was no aortic dissection or progression of the aortic aneurysm during pregnancy. Overall, there was no aortic dissection during 7984 patient-years of follow-up. CONCLUSIONS: Aortic aneurysm was common in patients with conotruncal anomalies. However, the risk of progressive aneurysm or dissection was low. Collectively, these data suggest a benign natural history and perhaps a less frequent need for cross-sectional imaging. Further studies are required to determine the optimal timing for surgical intervention in this population.

Psychological preparedness for pandemic (COVID-19) management: Perceptions of nurses and nursing students in India.

INTRODUCTION: The growing COVID-19 pandemic has posed a great threat to millions of people worldwide. Nurses and nursing students are an important group of health professionals who are most likely to face many challenges in this unprecedented scenario. The present study aimed at exploring nurses' and nursing students' perception of psychological preparedness for the pandemic (COVID-19) management. MATERIALS & METHODS: The study employed a quantitative cross-sectional online survey research design. Purposive sampling was used with an attempt to represent the entire nurses (i.e. nursing officers, nurse administrators and nursing teachers) and nursing students' group of India. The survey link including the questionnaires was shared to their email ID and they were invited to participate in the study. Data were collected using Psychological Preparedness for Disaster Threat Scale (PPDTS)-Modified, General Self Efficacy (GSE) Scale, Optimism Scale and Brief Resilient Coping Scale (BRS). Totally 685 responses were received and 676 forms were completed which were analyzed using SPSS software (version 24). RESULTS: The mean age of the subjects was 31.72±9.58 years. Around 20% of the subjects previously had some kind of psychological training and 4% of the subjects had taken care of persons with COVID-19. Findings revealed that mean score for PPDTS, GSE, BRCS and Optimism was 73.44±10.82, 33.19±5.23, 16.79±2.73 and 9.61±2.26 respectively indicating that the subjects had moderate level of psychological preparedness, self-efficacy and resilience but higher level of optimism. Psychological preparedness, self-efficacy, optimism and resilience were positively correlated to each other. Self- efficacy, optimism, and resilience emerged as predictors of psychological preparedness. CONCLUSION: The findings suggested that self-efficacy, optimism and resilience can be considered as predictors for psychological preparedness in pandemic management. Appropriate training could influence self-efficacy while programs addressing resilience and coping may strengthen psychological preparedness which can help in further management of ongoing pandemic.

Elevated Serum Lactate in Patients With Lymphoma: It Is Not Always Infection.

OBJECTIVE: To distinguish between sepsis only vs progressive lymphoma in patients with a history of lymphoma who present to the hospital with lactic acidosis. PATIENTS AND METHODS: We identified patients with non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma from January 2014 to December 2015. Patients were categorized into 2 groups: sepsis only or progressive lymphoma. Two-sided Wilcoxon rank sum test and χ1/Fisher exact test were used to compare the continuous and categorical variables, respectively. Kaplan-Meier analysis was used to estimate overall survival (OS). RESULTS: A total of 51 patients were identified; 33 (65%) patients were categorized into the sepsis only group, and 18 (35%), into the progressive lymphoma group. Values for serum lactate dehydrogenase (LDH) drawn during hospitalization were statistically different between the sepsis only and progressive lymphoma groups (median, 262 vs 665 U/L; P=.005), respectively. The sensitivity and specificity of serum LDH level 2 or more times the upper limit of normal for progressive lymphoma were 56% (95% CI, 33% to 79%) and 85% (95% CI, 73% to 97%), respectively. Serum LDH level was independently predictive of inferior OS (hazard ratio, 27.8; 95% CI, 4.0 to 160.1; P<.001), while serum albumin level (hazard ratio, 0.05; 95% CI, 0.01 to 0.27; P<.001) was independently predictive of improved OS. CONCLUSION: Serum LDH levels used in conjunction with serial serum lactate values may be reliable markers to differentiate patients with progressive lymphomatous disease from patients with lymphoma with sepsis only. The LDH levels should be obtained in all patients with lymphoma who present to the hospital with lactic acidosis.

Impact of hypoalbuminemia on the prognosis of relapsed/refractory B-cell lymphoma treated with axicabtagene ciloleucel.

INTRODUCTION: Hypoalbuminemia is a known adverse prognostic factor in lymphomas. Yet, it is unknown if axicabtagene ciloleucel (axi-cel) overcomes the adverse prognostic impact of hypoalbuminemia in relapsed/refractory large B-cell lymphoma. METHODS: We conducted a retrospective analysis across three Mayo Clinic centers to assess the relationship of hypoalbuminemia (defined as a serum albumin (SA) levels ≤ 3.5 g/dL) on outcomes of patients treated with axi-cel. RESULTS: This analysis included 81 patients. Two patients had no available SA levels preceding axi-cel infusion. Eighteen patients (22.8%) had hypoalbuminemia with a median SA of 3.3 g/dL. Patients with normal SA had a statistically higher ORR than those without hypoalbuminemia (P = .018). There was no difference in 1-year PFS and OS between the group with hypoalbuminemia and the group with normal SA levels (48% vs 49%, P = .81) and (74% vs 73%, P = .97), respectively. There was no difference in the severity or median duration of cytokine release syndrome or neurotoxicity between the two groups. CONCLUSION: Notwithstanding the limitations related to the relatively small sample size, axi-cel therapy appears to overcome the adverse effect of hypoalbuminemia on OS and PFS. Large multicenter clinical studies are certainly needed to validate these findings.

Anorectal pressures measured with high-resolution manometry in healthy people-Normal values and asymptomatic pelvic floor dysfunction.

BACKGROUND: High-resolution manometry (HRM) is used to measure rectoanal pressures in defecatory disorders and fecal incontinence. This study sought to define normal values for rectoanal HRM, ascertain the effects of age and BMI on rectoanal pressures, and compare pressures in asymptomatic women with normal and prolonged balloon expulsion time (BET). METHODS: High-resolution manometry pressures and BET were measured in 163 asymptomatic healthy participants. Women (96) and men (47) with normal BET were used to estimate normal values and the effects of age/BMI on pressures using a Medtronic 4.2-mm-diameter rectoanal catheter. KEY RESULTS: Age is associated with lower resting pressure, higher rectal pressure during evacuation, and a higher rectoanal gradient during evacuation in women and men. In women, the BET is also inversely correlated with age while the BMI is correlated with a higher threshold volume for discomfort and a longer BET. The anal squeeze pressure increment, squeeze duration, and HPZ length are higher in men than women. The rectoanal gradient during evacuation is also lower (ie, more negative) in asymptomatic women with an abnormal than a normal BET. CONCLUSIONS & INFERENCES: These findings provide an expanded database of normal values for anorectal HRM in men and women. Age and sex affect anal resting and squeeze pressures, respectively; rectal pressure during evacuation is also higher in older people. Less than 15% of asymptomatic people have BET >60 seconds, which is associated with manometry features of impaired evacuation.

Clinical profile of human immunodeficiency virus patients with opportunistic infections: A descriptive case series study.

BACKGROUND: Human immunodeficiency virus (HIV) virus, causative agent in acquired immunodeficiency syndrome, is fast becoming a major threat in the Indian subcontinent, with an estimated 3.7 million persons being infected with HIV. HIV infection is complicated by various opportunistic infections (OIs) such as tuberculosis (TB), candidiasis, herpes zoster, Pneumocystis jirvoceii, cytomegalovirus (CMV) etc., This study carried out to know the clinical profile of HIV patients with OIs. METHODS: A case series study was carried out at a tertiary care hospital in Bellary, Karnataka, India. A hospital based case series study was conducted among 164 HIV patients with OIs admitted to various wards as well as attending outpatient department at Vijayanagara Institute of Medical Sciences Hospital, Bellary during Jan 2013 to Nov 2013. Both primary and secondary data was collected to gather information on clinical profile. The statistical tests used were descriptive statistics and independent t test. RESULTS: Among 164 patients, 29.3% were females and 68.3% males. High proportions of patients were observed in 28-37 years of age group and heterosexual route was the most common mode of transmission. TB (50%) is the most frequent OI followed by candidiasis (49%), pneumocystis (16%) and others. The mean CD4 cell count in TB was 237.02/mL and in candidiasis 189.07/mL. Low values were observed in promyelocytic leukemia (18.10/mL), CMV (18.5/mL) and in toxoplasmosis (73.1/mL). CONCLUSIONS: Respiratory system was the most common system involved by OIs and most of patients with OIs had CD4 T cell count below 200/mL, whereas there were no patients in the study with counts above 500/mL.

Socio-demographic and other risk factors of pre eclampsia at a tertiary care hospital, karnataka: case control study.

BACKGROUND: Pre-eclampsia is one of the leading causes of maternal and infant morbidity and mortality worldwide. The aetiopathogenesis of this condition involves combination of genetic predisposition and environmental factors. The aim of the study was to determine the socio demographic and other risk factors of pre-eclampsia. MATERIALS AND METHODS: A case control study was conducted at a tertiary care hospital, Karnataka among 100 cases of pre-eclampsia and 200 controls without pre eclampsia. Non probability purposive sampling technique was adopted to select the study subjects. Data was collected by using a pre tested semi structured questionnaire which included information related to socio-demographic and other known risk factors of pre eclampsia. Primary data was collected by interviewing study subjects and secondary data of cases was obtained from case records. Data was analysed using SPSS. RESULTS: Study subjects included 100 cases and 200 controls. Age of less than 20 y (OR=3.8), monthly income of less than Rs4000 (OR=6.8), age of menarche of less than 12 y (OR=13.1), family h/o pre eclampsia (OR=36.0), family h/o Diabetes (OR=44.9), family h/o hypertension (OR=16.7) and previous h/o PIH (OR=58.5) are found to be significant risk factors of pre eclampsia. CONCLUSION: The significant risk factors may be used for screening pre-eclampsia during registration of pregnancy.