Coronavirus disease 2019 vaccine in pediatric post-kidney transplantation.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of persons worldwide. Many vaccines have been developed; however, their efficacy in pediatric solid organ transplant recipients is yet to be determined. METHODS: This is a prospective observational, non-interventional single-center study on the safety and efficacy of a COVID-19 vaccine (BNT162b2) in pediatric kidney transplant recipients. The primary aim of this study was to evaluate immunogenicity according to SARS-CoV-2-specific neutralizing antibody titer after two vaccine doses. The secondary aims were to investigate the safety of the vaccines, solicited local and systemic adverse reactions, incidence of COVID-19 post-vaccination, and effects on transplant graft function. Baseline investigations were conducted on pediatric renal transplant recipients, and recruited participants were advised to have the Comirnaty® mRNA vaccine according to protocol. RESULTS: A total of 48 patients (male, n = 31, 64.6%; female, n = 17, 35.4%), median age 14 [12-16] years were included, and all received two doses of the vaccine. The vaccine had a favorable safety and side-effect profile. The S-antibody titer of all patients ranged between .4 and 2,500 U/ml and was > 50 U/ml in 89% of the patients. No difference in the measured antibody immune response was noted between infected and uninfected children. No major side effects were reported. CONCLUSION: The vaccine had a favorable safety profile in 12- to 15-year-old kidney transplant recipients, producing a greater measured antibody response than that in older transplant recipients.

The Effects of Listening to the Qur'an in the Postoperative Management of the Patients Undergoing Laparoscopic Cholecystectomy in the Day Surgery Unit.

PURPOSE: To determine if listening to verses of the Qur'an during the immediate postoperative period has an effect on patients' anxiety levels, the number of opioids used to control pain, and the length of stay (LOS) in the Post Anesthesia Care Unit (PACU). DESIGN: Randomized Control Trial. Adult Muslim patients who had undergone a laparoscopic cholecystectomy through the Day Surgery Unit were randomly selected using computer-generated sequence into two groups, interventional and control groups. METHODS: The control group listened to the natural environment and received Fentanyl for pain relief, and the interventional group listened to the Qur'an recitation and received Fentanyl for pain relief. A total of 112 (79.4%) participants completed the study. The level of the pain and anxiety was measured using the Wong-Baker Faces pain scale and Spielberger State-Trait Anxiety Inventory, respectively. Statistical analysis was conducted using SAS version 9.3 (Statistical Analysis System, SAS Institute Inc, Cary, North Carolina). FINDINGS: This study compared the effects of Qur'an audio therapy on patients' anxiety levels, opioid consumption, pain, and LOS in the PACU. The findings showed that by listening to chosen verses from the Qur'an in the recovery period post-anaesthesia, anxiety scores were significantly reduced (P = .0001), opiate use was reduced (P = .0081), and overall PACU LOS was also reduced (P = .0083). CONCLUSIONS: Adding the use of listening to the Qur'an as a complementary therapy is a simple and cost-effective measure to reduce the need for narcotics in the PACU, and reduce the overall PACU length of stay. This intervention benefits the patient, the PACU, and reduces health care organization costs.

Comparison of the safety and immunogenicity of the BNT-162b2 vaccine and the ChAdOx1 vaccine for solid organ transplant recipients: a prospective study.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its resulting disease, coronavirus disease 2019 (COVID-19), has spread to millions of people worldwide. Preliminary data from organ transplant recipients have shown reduced seroconversion rates after the administration of different SARS-CoV-2 vaccination platforms. However, it is unknown whether different vaccination platforms provide different levels of protection against SARS-CoV-2. To answer this question, we prospectively studied 431 kidney and liver transplant recipients (kidney: n = 230; liver: n = 201) who received either the ChAdOx1 vaccine (n = 148) or the BNT-162b2 vaccine (n = 283) and underwent an assessment of immunoglobulin M/immunoglobulin G spike antibody levels. The primary objective of the study is to directly compare the efficacy of two different vaccine platforms in solid organ transplant recipients by measuring of immunoglobulin G (IgG) antibodies against the RBD of the spike protein (anti-RBD) two weeks after first and second doses. Our secondary endpoints were solicited specific local or systemic adverse events within 7 days after the receipt of each dose of the vaccine. There was no difference in the primary outcome between the two vaccine platforms in patients who received two vaccine doses. Unresponsiveness was mainly linked to diabetes. The rate of response after the first dose among younger older patients was significantly larger; however, after the second dose this difference did not persist (p = 0.079). Side effects were similar to those that were observed during the pivotal trials.

Efficacy and safety of three times daily dosing of tacrolimus in pediatric kidney transplantation patients: A single-center comparative study.

BACKGROUND/AIM: Several PK studies have shown that most pediatric patients may require higher doses on a mg/kg basis compared to adults to attain similar therapeutic trough concentrations. The aim of this study was to compare the efficacy and safety of three times daily to twice a day dosing of tacrolimus in pediatric kidney transplant recipients at a major tertiary care transplant center. METHODS AND MATERIALS: Retrospective, single-center, and comparative cohort study. All pediatric kidney transplant recipients received either tacrolimus BID (group 1) or tacrolimus TID (group 2). RESULTS: A total of 87 patients were included in this study; 48 patients received BID tacrolimus (group 1), and 39 patients received TID tacrolimus (group 2). The percentage of patients who achieved therapeutic trough concentrations in group 2 did not significantly differ from those in group 1 at day 7 (84.62% TID vs 83.33% BID; P = .42). The median time to reach therapeutic trough concentrations was three days in group 1 compared to four days in group 2. CONCLUSION: No significant difference was observed between tacrolimus BID and TID dosing in the time to reach therapeutic trough concentration or in the proportion of patients achieving therapeutic trough concentrations at day 7.

Does Secondary Antibiotic Prophylaxis Improve Clinical Outcomes in Adult Rheumatic Heart Disease Patients Post-Valve Replacement?

BACKGROUND: Secondary prevention of recurrent rheumatic fever in individuals with rheumatic heart disease (RHD) requires continuous antibiotic prophylaxis. However, the impact of antibiotic prophylaxis on the outcome of patients with severe RHD who underwent heart valve replacement is unknown. The objective of the study was to assess the relationship between the use of antibiotics as secondary prophylaxis in RHD patients who underwent valve replacement and clinical outcomes including mortality, reoperation, and valve-related hospitalization. METHODS: We retrospectively compared outcomes of adult patients who underwent heart valve replacement for RHD at our institution from 1990 through 2014 and who received secondary antibiotic prophylaxis (prophylaxis group) with those who did not receive prophylaxis (nonprophylaxis group) using propensity score matching analysis. RESULTS: A total of 1094 patients (56% females, median age 40 years, range 31-53 years) were included with a median follow-up of 9.6 years (range 2.9-12.6 years). Antibiotic prophylaxis was prescribed in 201 patients (18%). Propensity score matching analysis demonstrated no significant difference in overall survival (95% [92%-98%] vs 97% [95%-99%], respectively; P = .7), valve-related hospitalization-independent survival (72% [range 65%-78%] vs 81% [range 76%-88%]; P = .25), and redo valve surgery-independent survival [76% [range 70%-83%] vs 75% [range 72%-79%]; P = .41) at 10-year follow-up in the nonantibiotic prophylaxis versus the antibiotic prophylaxis group. CONCLUSION: Secondary antibiotic prophylaxis among adult RHD patients following valve replacement is not associated with improved clinical outcomes.

Lung transplantation outcomes in underweight recipients: A single center experience.

Background: Current guidelines recommend a body mass index (BMI) of 16 kg/m2 as the minimum threshold for lung transplantation, despite mixed evidence on outcomes in underweight patients. The current study aimed to describe survival outcomes of underweight patients who underwent lung transplantation at a single center. Methods: This retrospective observational study included adult lung transplant recipients who underwent transplantation for the first time between March 2010 and March 2022 at King Faisal Specialist Hospital and Research Center and excluded patients with obesity. We defined an underweight status as a BMI <17 kg/m2. Results: Forty-eight of the 202 lung transplant recipients were underweight at the time of surgery. The underweight patients had similar lengths of hospital (p = 0.53) and intensive care unit (p = 0.81) stays compared to other patients. Thirty-three percent of underweight patients had died within 5-year follow-up, compared to 34% of patients who were not underweight. There was no significant difference in mortality risk between underweight patients and patients with normal BMIs in our multivariable Cox regression model (adjusted HR 1.57, 95%CI: 0.77-3.20, p = 0.21). Exploratory analyses revealed that a pre-transplant BMI <13 kg/m2 was associated with a trend towards increased 5-year mortality (adjusted HR 4.00, 95%CI: 0.87-18.35, p = 0.07). Conclusions: Our findings suggest that patients with BMIs of 13-17 kg/m2 may be candidates for lung transplantation. Large multi-center cohort studies are needed to confirm the lower BMI limit for safely transplanting patients.

Development of a Cardiovascular Disease Risk Prediction Model: A Preliminary Retrospective Cohort Study of a Patient Sample in Saudi Arabia.

Saudi Arabia has an alarmingly high incidence of cardiovascular disease (CVD) and its associated risk factors. To effectively assess CVD risk, it is essential to develop tailored models for diverse regions and ethnicities using local population variables. No CVD risk prediction model has been locally developed. This study aims to develop the first 10-year CVD risk prediction model for Saudi adults aged 18 to 75 years. The electronic health records of Saudi male and female patients aged 18 to 75 years, who were seen in primary care settings between 2002 and 2019, were reviewed retrospectively via the Integrated Clinical Information System (ICIS) database (from January 2002 to February 2019). The Cox regression model was used to identify the risk factors and develop the CVD risk prediction model. Overall, 451 patients were included in this study, with a mean follow-up of 12.05 years. Thirty-five (7.7%) patients developed a CVD event. The following risk factors were included: fasting blood sugar (FBS) and high-density lipoprotein cholesterol (HDL-c), heart failure, antihyperlipidemic therapy, antithrombotic therapy, and antihypertension therapy. The Bayesian information criterion (BIC) score was 314.4. This is the first prediction model developed in Saudi Arabia and the second in any Arab country after the Omani study. We assume that our CVD predication model will have the potential to be used widely after the validation study.

Implementation of new indicators of pediatric malnutrition and comparison to previous indicators.

Background: Early identification of childhood malnutrition is imperative to improve overall health outcomes, and more importantly, to start early intervention to decrease the risk of future complications. This study aimed to evaluate new malnutrition Z-score growth indicators for detecting pediatric malnutrition and degrees of severity and compare their accuracy with that of growth chart centiles. Patients and Methods: This retrospective study included 475 pediatric patients from several pediatric nutrition clinics for six months. The participant's weight, height, age, and growth parameters were recorded using both traditional growth charts (centiles) and updated malnutrition indicators (z-scores). The percentage and degree of malnutrition using centiles and Z-scores were compared. Results: In children aged <2 years, the percentage of malnutrition was 4.7% higher when measured using new malnutrition indicators (weight-for-length Z-score) compared with (weight-for-length centiles). Our results also showed 9.6% higher number of malnourished children >2 years of age when BMI-for-age Z-score was used compared to weight-for-height centiles while there were 15.8% higher malnourished children when BMI-for-age Z-score was compared to BMI-for-age centiles for the same group. We found a significant difference (X2 = 202.548, P=<.0001) between the degree of malnutrition in children aged >2 years using BMI-for-age Z-score (normal vs. malnourished) and the degree of malnutrition using BMI centiles (normal vs. malnourished). Approximately 34% of the children classified as normal using centiles were classified as malnourished using Z-scores. Comparing the degrees of Malnutrition, approximately 23% (45 of 196) of children classified as normal based on centiles were classified as having mild malnutrition when Z-scores were used, and 42% (80 of 192) of children who were classified as having mild malnutrition based on centiles were classified as having moderate malnutrition when Z-scores were used. Conclusions: In our study, a higher percentage of children showed malnutrition when assessed using the Z-score (BMI-for-age for children >2 years/weight-for-length for children <2 years of age) than the centiles growth chart.

Population-based survival for cancer patients in Saudi Arabia for the years 2005-2009.

The Saudi Cancer Registry reported in 2007 the 5-year observed survival for the most common cancer sites for the years 1994-2004. In this report we looked at the cancer survival in the period 2005-2009 and evaluated the trend over the 15 years period from 1994 to 2009. Cases of the top 14 cancer sites reported by the population based Saudi Cancer Registry from 1 January 2005 to December 31, 2009, were submitted for survival analysis. The vital status of those patients was collected. Analysis of survival for the above period was compared with the prior reported 2 periods (1994-1999, 2000-2004). In addition, analysis was done according to age, sex, disease stage and the province. Data of 25,969 patients of the commonest cancer sites were submitted. Of those 14,146 patients (54%) had complete demographic data available and vital status was reported. Thyroid cancer had the highest 5- year observed survival of 94% (95% confidence interval (CI) 93-95%)), followed by Breast (72%, 95% CI 71-74%). In hematological malignancies, Hodgkin's Lymphoma had the highest 5-year survival of 86% (95% CI 84-88%). Survival rates has improved in most of the cancers sites for the studied periods except for lung, uterine and Hodgkin's lymphoma which plateaued. Our study confirms a steady improvement in the 5-year observed survival over time for the majority of cancers. Our survival data were comparable to western countries. This data should be used by policy makers to improve on cancer care in the kingdom.

Tacrolimus-Induced Neurotoxicity in Early Post-Liver Transplant Saudi Patients: Incidence and Risk Factors.

BACKGROUND Tacrolimus is a calcineurin inhibitor (CNI) commonly used as an immunosuppressant to prevent the rejection of organ transplants. After liver transplantation, it can cause early neurological complications, known as early calcineurin inhibitor-induced neurotoxicity (ECIIN). Its management requires CNI withdrawal, a measure that can affect post-transplant outcomes, primarily allograft rejection. In addition, it can negatively impact the quality of life. The incidence and risk factor of ECIIN has not been reported in the Saudi population. We investigated the incidence and risk factors of ECIIN after liver transplant in Saudi patients. We also looked at the length of stay in the Intensive Care Unit, hospital, and 30-day mortality as secondary endpoints. MATERIAL AND METHODS This was a retrospective cohort study of adult patients on tacrolimus with mild, moderate, or severe neurological events within the first month after liver transplantation at a single center of patients who meet the inclusion criteria and were over age 14 years. A total of 338 patients were included in the analysis, and the sample size was calculated based on a pilot study. RESULTS Among 338 liver transplantation patients, 63 patients (19%) developed ECIIN. Forty-eight percent of patients had seizures, 23% had agitation, 21% had psychosis, 10% had severe tremors, 13% had confusion, and 6% developed coma. The median time of the incident to develop ECIIN was 9 (IQR: 5-13.5) days after transplant. Thirty-eight patients were managed by switching to cyclosporine, 12 required a reduction in the dose, and 3 were managed temporarily by discontinuing therapy. Autoimmune hepatitis as an underlying liver disease was one of the statistically significant risk factors (P=0.0311). The median length of hospital stay was 31 (IQR: 21-75.5) days, ICU length of stay was 10 (IQR: 5-20.5) days, and 8 patients died within 30 days after transplant. CONCLUSIONS The incidence of ECIIN in Saud Arabia was similar to that reported in other populations with similar risk factors. Electrolyte imbalance, mainly hyponatremia, was significantly associated with developing ECIIN. Therefore, ECIIN may potentially increase hospital and ICU length of stay.

Psychological distress reported by healthcare workers in Saudi Arabia during the COVID-19 pandemic: A cross-sectional study.

INTRODUCTION: Few studies have considered the impact of COVID-19 on the mental health of healthcare workers (HCWs) in the Kingdom of Saudi Arabia (KSA). We estimated the prevalence and severity of psychological distress and characterized predisposing risk factors among HCWs in KSA during the COVID-19 pandemic. METHODS: We conducted a cross-sectional online survey of 1,985 HCWs from 6 hospitals across the country designated with caring for COVID-19 patients between April 16 and June 21, 2020. Our data analysis was performed using logistic regressions. Ordered logistic regressions were also performed using forward stepwise model selection to explore the effects of risk factors on psychological distress. RESULTS: The prevalence of psychological distress reported by HCWs in KSA was high, ranging from mild-moderate to severe in severity. Younger HCWs, women, those in contact with COVID-19 patients, and those who either had loved ones affected or who were themselves affected by COVID-19 were the most at-risk of psychological distress. Risk factors such as insomnia, loneliness, fear of transmission, and separation from loved ones most significantly predicted elevated levels of distress among HCWs. CONCLUSIONS: Increasing psychological distress was commonly reported by HCWs during the early months of COVID-19 pandemic in KSA. Public health policy makers and mental health professionals must give special attention to risk factors that predispose HCWs in KSA to psychological distress.

Epidemiology and Clinical Characteristics of People with Confirmed SARS-CoV-2 Infection during the Early COVID-19 Pandemic in Saudi Arabia.

This study provides epidemiologic and clinical characteristics of 492 consecutive patients diagnosed with SARS-CoV-2 infection at King Faisal Specialist Hospital and Research Centre in Saudi Arabia between March and September 2020. Data were collected from electronic case reports. The cohort was 54% male, with 20.4% aged >60 years, 19.9% aged 31−40 years, and 17% aged 41−50 years. The median incubation period was 16 days, with upper and lower 95% quartiles of 27 and 10 days, respectively. Most patients (79.2%) were symptomatic. Variables significantly different between symptomatic and asymptomatic patients were age, blood oxygen saturation percentage, hemoglobin level, lymphocyte count, neutrophil to lymphocyte (NTL) ratio, and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level. Asymptomatic patients were mostly younger, with lower body mass index and ALT and AST levels but higher lymphocyte counts, NTL ratio, and CD4, CD8, natural killer cell, IgG, and IgM levels. Factors associated with increased risk of mortality were age (>42 years) and comorbidities, particularly diabetes mellitus and hypertension. Patients who were not given an antiviral regimen were associated with better prognosis than patients who received an antiviral regimen (HR, 0.07; 95% CI, 0.011−0.25). These findings will help clinicians and policymakers adopt best management and treatment options for SARS-CoV-2 infection.

Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial.

BACKGROUND: Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated. AIMS: To compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol. METHODS: Prospective, randomized, double blind, non-inferiority, controlled clinical trial EXPECTED OUTCOMES: 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. SECONDARY OUTCOMES: a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) TRIAL REGISTRATION: The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.

Spontaneous Coronary Artery Dissection: Does Being Unemployed Matter? Insights from the GSCAD Registry.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) has emerged as an important cause of acute coronary syndrome (ACS) and sudden cardiac death. Physical or emotional stressors are the most commonly reported triggers for SCAD. Unemployment has been identified as a source of emotional stress and is linked to poor mental and physical health. OBJECTIVE: To examine the association between employment status and in-hospital and follow-up adverse cardiovascular events in patients with SCAD. METHODS: We conducted a retrospective, multi-center, observational study of patients undergoing coronary angiography for ACS between January 2011 and December 2017. The total number of patients enrolled was 198,000. Patients were diagnosed with SCAD based on angiographic and intravascular imaging modalities whenever available. There were 83 patients identified with SCAD from 30 medical centers in 4 Arab gulf countries. In-hospital (myocardial infarction, percutaneous intervention, ventricular tachycardia/ventricular fibrillation, cardiogenic shock, death, internal cardioverter/ defibrillator placement, dissection extension) and follow-up (myocardial infarction, de novo SCAD, death, spontaneous superior mesenteric artery dissection) cardiac events were compared among those who were employed and those who were not. RESULTS: The median age of patients in the study was 44 (37- 55) years. There were 42 (50.6%) female patients, and 41 (49.4) male patients. Of the cohort, 50 (60%) of the patients were employed and the remaining 33 (40%) were unemployed. 66% of all men were employed and 76% of all women were unemployed. After adjusting for gender unemployment was associated with worse in- -hospital and follow-up cardiac events (adjusted OR 7.1, [1.3, 37.9]), p = 0.021. CONCLUSION: Adverse cardiovascular events were significantly worse for patients with SCAD who were unemployed.

JC virus infection in colorectal neoplasia that develops after liver transplantation.

PURPOSE: Liver transplant recepients (LTRs) have an increased risk of colorectal neoplasia. The mechanism responsible for this is unknown. JCV encodes for TAg and has been implicated in colorectal carcinogenesis. We hypothesized that the use of immunosuppression in LTRs facilitates activation of JCV and is responsible for the increased risk of neoplasia. EXPERIMENTAL DESIGN: JCV TAg DNA and protein expression were determined in normal colonic epithelium (n = 15) and adenomatous polyps (n = 26) from LTRs and compared with tissue samples from control patients (normal colon, n = 21; adenomas, n = 40). Apoptosis and proliferation were determined by M30 and Ki-67 immunoreactivity, respectively. RESULTS: JCV TAg DNA was found in 10 of 15 (67%) of normal colonic mucosa from LTRs compared with 5 of 21 (24%) of control normal mucosa (P = 0.025). JCV TAg DNA was detected in 16 of 26 (62%) of the adenomas from LTRs and in 20 of 40 (50%) of control adenomas. JCV TAg protein was expressed in 13 of 26 (50%) adenomas from LTRs versus 2 of 40 (5%) of adenomas from controls (P < 0.001). In adenomas from LTRs, the mean proliferative activity was higher compared with controls (60.3 +/- 3.2% versus 42.7 +/- 2.8%, P < 0.001), whereas mean apoptotic indices were lower in LTRs (0.29 +/- 0.08% versus 0.39 +/- 0.06%, P = 0.05). CONCLUSIONS: The presence of JCV in the colorectal mucosa and adenomas from LTRs, in concert with the use of immunosuppressive agents, suggests that JCV may undergo reactivation, and the subsequent TAg protein expression might explain the increased risk of colorectal neoplasia in LTRs.

Evaluating the Impact of a Workplace Wellness Program in Saudi Arabia: An Intra-Department Study.

OBJECTIVE: There is limited evidence on how workplace health promotion is implemented and evaluated in the Arab countries of the Gulf Cooperation Council (GCC). The present study aimed to improve the overall well-being of employees at a departmental level in a hospital setting in Riyadh, Saudi Arabia. METHODS: Using a pre-post longitudinal design, a wellness program was implemented, assessing physical activity, diet, work productivity, absenteeism, workplace satisfaction, and stress. RESULTS: Significant improvement was observed in physical functioning of the employees; with a significant increase in average intake of water/d and fruit consumption, significant decrease in average number of soft drinks consumed/wk, and significant decrease in the days of absence in the last 3 months. CONCLUSIONS: There were trends in improvement overall on the wellness measures with significant impact on the physical functioning and dietary habits of the employees.

Impact of clinical preventive services in the ambulatory setting.

Indicators of the performance of clinical preventive services (CPS) have been adopted in the ambulatory setting to improve quality of care. The impact of CPS was evaluated in a network of 49 primary care practices providing care to an estimated 245,000 adults in the Dallas-Fort Worth area through a sample chart review to determine delivery of recommended evidence-based CPS combined with medical literature estimates of the effectiveness of CPS. In this population in 2005, CPS were estimated to have prevented 36 deaths and 97 incident cases of cancer; 420 coronary heart disease events (including 66 sudden deaths) and 118 strokes; 816 cases of influenza and pneumonia (including 24 hospital admissions); and 87 osteoporosis-related fractures. Thus, CPS have substantial benefits in preventing deaths and illness episodes.

Phase II study of belagenpumatucel-L, a transforming growth factor beta-2 antisense gene-modified allogeneic tumor cell vaccine in non-small-cell lung cancer.

PURPOSE: Belagenpumatucel-L is a nonviral gene-based allogeneic tumor cell vaccine that demonstrates enhancement of tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. PATIENTS AND METHODS: We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV non-small-cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 x 10(7) cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored. RESULTS: Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received > or = 2.5 x 10(7) cells/injection (P = .0069). Focusing on the 61 late-stage (IIIB and IV) assessable patients, a 15% partial response rate was achieved. The estimated probabilities of surviving 1 and 2 years were 68% and 52%, respectively for the higher dose groups combined and 39% and 20%, respectively, for the low-dose group. Immune function was explored in the 61 advanced-stage (IIIB and IV) patients. Increased cytokine production (at week 12 compared with patients with progressive disease) was observed among clinical responders (interferon gamma, P = .006; interleukin [IL] -6, P = .004; IL-4, P = .007), who also displayed an elevated antibody-mediated response to vaccine HLAs (P = .014). Furthermore, positive enzyme-linked immunospot reactions to belagenpumatucel-L showed a correlation trend (P = .086) with clinical responsiveness in patients achieving stable disease or better. CONCLUSION: Belagenpumatucel-L is well tolerated, and the survival advantage justifies further phase III evaluation.

Metabolic consequences of date snack before a meal: A traditional Arab practice.

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