A phase II trial evaluating the efficacy of high-dose Radioiodinated Tositumomab (Anti-CD20) antibody,etoposide and cyclophosphamide followed by autologous transplantation,for high-risk relapsed or refractory non-hodgkin lymphoma

Radiation is the most effective treatment for localized lymphoma, but treatment of multifocal disease is limited by toxicity. Radioimmunotherapy (RIT) delivers tumoricidal radiation to multifocal sites, further augmenting response by dose-escalation. This phase II trial evaluated high-dose RIT and chemotherapy prior to autologous stem-cell transplant (ASCT) for high-risk, relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL). The primary endpoint was progression free survival (PFS). Secondary endpoints were overall survival (OS), toxicity, and tolerability. Patients age < 60 years with R/R NHL expressing CD20 were eligible. Mantle cell lymphoma (MCL) patients could proceed to transplant in first remission. Patients received I-131-tositumomab delivered at ≤25Gy to critical normal organs, followed by etoposide, cyclophosphamide and ASCT. A group of 107 patients were treated including aggressive lymphoma (N = 29), indolent lymphoma (N = 45), and MCL (N = 33). After a median follow-up of 10.1 years, the 10-year PFS for the aggressive, indolent, and MCL groups were 62%, 64%, 43% respectively. The 10-year OS for the aggressive, indolent, and MCL groups were 61%, 71%, 48% respectively. Toxicities were similar to standard conditioning regimens and non-relapse mortality at 100 days was 2.8%. Late myeloid malignancies were seen in 6% of patients. High-dose I-131-tositumomab, etoposide and cyclophosphamide followed by ASCT appeared feasible, safe, and effective in treating NHL, with estimated PFS at 10-years of 43%-64%. In light of novel cellular therapies for R/R NHL, high-dose RIT-containing regimens yield comparable efficacy and safety and could be prospectively compared.     

Feasibility of Accessing Data in Hospitalized Patients to Support Diagnosis of Malnutrition by the Academy‐A.S.P.E.N. Malnutrition Consensus Recommended Clinical Characteristics

Background: The feasibility of accessing data in hospitalized patients to support a malnutrition diagnosis using the new Academy of Nutrition and Dietetics–American Society for Parenteral and Enteral Nutrition (AND‐A.S.P.E.N.) consensus recommended clinical characteristics of malnutrition is largely unknown. We sought to characterize baseline practice to guide the development of appropriate interventions for implementation of the recommended approach. Materials and Methods: A cross‐sectional survey was conducted of 262 consecutive adults who were referred for dietitian or nutrition support team assessments at 2 tertiary teaching hospitals in Pennsylvania. The availability of data to support the proposed AND‐A.S.P.E.N. approach and the resulting malnutrition diagnoses were examined. Results: Mean ± SD age was 58.2 ± 17.1 years, and half were female. Food intake history was available for 76%, weight history for 67%, and physical examination for loss of fat and muscle mass for 94% and for edema for 84%. Hand‐grip strength was not available. The prevalence of malnutrition among the patients referred for nutrition assessment was 6.7% moderate, 7.6% severe with acute illness; 12.2% moderate, 11% severe with chronic illness; and 0.8% moderate, 0.4% severe with social circumstances. Decline in typical food intake and weight loss were the most commonly used clinical characteristics. Conclusion: Data could generally be accessed to support the AND‐A.S.P.E.N. consensus clinical characteristics for malnutrition diagnosis, but further testing in multiple care settings is needed before these observations may be generalized. Training in assessment methods and dissemination of the necessary tools will be necessary for full implementation.     

Malnutrition Diagnoses in Hospitalized Patients

Malnutrition is common among hospitalized patients in the United States, and its coded prevalence is increasing. Malnutrition is known to be associated with increased morbidity, mortality and healthcare costs. Although national data indicate that the number of malnutrition diagnoses among hospital discharges has been steadily rising, an in‐depth examination of the demographic and clinical characteristics of these patients has not been conducted. We examined data from the 2010 Healthcare Cost and Utilization Project (HCUP), the most recent nationally‐representative data describing U.S. hospital discharges. Using ICD‐9 codes, we constructed a composite variable indicating a diagnosis of malnutrition. Based on our definition, 3.2% of all U.S. hospital discharges in 2010 had this diagnosis. Relative to patients without a malnutrition diagnosis, those with the diagnosis were older, had longer lengths of stay and incurred higher costs. These patients were more likely to have 27 of 29 comorbidities assessed in HCUP. Finally, discharge to home care was twice as common among malnourished patients, and a discharge of death was more than 5 times as common among patients with a malnutrition diagnosis. Taken together, these nationally representative, cross‐sectional data indicate that hospitalized patients discharged with a diagnosis of malnutrition are older and sicker and their inpatient care is more expensive than their counterparts without this diagnosis.     

Sesame Oil Therapeutically Ameliorates Cardiac Hypertrophy by Regulating Hypokalemia in Hypertensive Rats

Background: Hypokalemia and hypertension are common manifestations of preclinical cardiovascular conditions that have a predictive value for cardiovascular morbidity and mortality. Cardiac hypertrophy, an important risk factor in heart failure, is attributed to long‐term hypokalemia and hypertension. Sesame oil is rich in nutrients and possesses potent antihypertensive activities. Methods: We investigated the therapeutic potential of sesame oil using a hypertensive model created by subcutaneously injecting deoxycorticosterone acetate (DOCA; 15 mg/mL/kg in mineral oil; twice weekly for 5 weeks) and supplementing with 1% sodium chloride drinking water (DOCA/salt) to uninephrectomized rats. Sesame oil was administered by oral gavage (0.5 or 1 mL/kg/d for 7 days) after 4 weeks of DOCA/salt treatment. Systolic blood pressure (SBP) and diastolic blood pressure (DBP), electrocardiography (ECG), and K⁺ and Mg²⁺ levels were assessed 24 hours after the last dose of sesame oil. Heart tissue was collected for histologic analysis. Results: Sesame oil effectively reduced the SBP/DBP and ECG abnormalities and increased the serum levels of K⁺ and Mg²⁺ while limiting the urinary excretion of K⁺ in DOCA/salt‐induced hypertensive rats. In addition, sesame oil decreased the heart mass, the thickness of the left ventricle, and the diameter of cardiomyocytes, indicating the regression of left ventricular hypertrophy in the hypertensive rats. Conclusion: We demonstrate that sesame oil therapeutically ameliorates cardiac hypertrophy by regulating hypokalemia in hypertensive rats.