Pretreatment hemoglobin level as a prognostic factor in patients with locally advanced head and neck squamous cell carcinoma

AimEvaluate pretreatment hemoglobin values as a prognostic factor in patients with locally advanced head and neck squamous cell carcinoma treated with concurrent chemoradiotherapy.BackgroundAnemia is one of the most prevalent laboratory abnormalities in oncological disease. It leads to a decrease in cellular oxygen supply, altering radiosensitivity of tumor cells and compromising therapeutic outcomes.Materials and MethodsRetrospective evaluation of patients with HNSCC treated with cCRT. Primary and secondary endpoint was to evaluate the correlation of Hb levels (≥12.5 g/dL or <12.5 g/dL) at the beginning of cCRT with overall survival (OS) and progression-free survival (PFS), respectively.ResultsA total of 108 patients were identified. With a median follow-up of 16.10 months median OS was 59.70 months for Hb ≥12.5 g/dL vs. 14.13 months for Hb <12.5 g/dL (p = 0.004). PFS was 12.29 months for Hb ≥12.5 g/dL and 1.68 months for Hb <12.5 g/dL (p = 0.016).ConclusionsIn this analysis, Hb ≥12.5 g/dL correlated with significantly better OS and PFS. Further studies are needed to validate these findings.     

Regulation of inflammatory biomarkers by intravenous methylprednisolone in pediatric ARDS patients: Results from a double-blind,placebo-controlled randomized pilot trial

ObjectiveA double-blind, randomized controlled trial showed that low-dose glucocorticoid therapy in pediatric ARDS patients is feasible and may improve both ventilation and oxygenation indices in these patients. However, the molecular mechanisms underlying potential changes in outcomes remain unclear. Based on these clinical findings, this study was designed to examine the effects of intravenous methylprednisolone on circulating inflammatory biomarkers in pediatric ARDS patients.DesignDouble-blind, placebo-controlled randomized trial with blood collection on study entry and day 7.SettingTertiary care children’s hospital.PatientsChildren (0–18 years) with ARDS undergoing mechanical ventilation.Interventions35 children were randomized within 72 h of mechanical ventilation. The glucocorticoid group received methylprednisolone 2 mg/kg loading dose followed by 1 mg/kg/day continuous infusion from days 1 to 7. Both groups were ventilated following the ARDSnet recommendations. WBC and differential cell counts, plasma cytokines and CRP levels, and coagulation parameters were analyzed on days 0 and 7.ResultsAt study entry, the placebo group had higher IL-15 and basophil levels. On day 7, in comparison to study entry, the placebo group had lower IL-1α, IFN-γ and IL-10 levels. The glucocorticoid group had lower INF-α, IL-6, IL-10, MCP-1, G-CSF and GM-CSF levels, and higher IL-17α levels on day 7 in comparison to study entry. Total and differential cell counts remained unchanged within the placebo group between days 0 and 7, whereas in the glucocorticoid group total WBC and platelets counts were increased on day 7. Pearson’s correlation studies within the placebo and glucocorticoid groups revealed positive and negative correlations between cytokine levels, cell counts, coagulation parameters and relevant clinical parameters of disease severity identified in our previous study. Multiple regression models identified several cytokines as predictors for alterations in clinical parameters of disease severity.ConclusionThis pilot study shows the feasibility of simultaneously measuring multiple inflammatory cytokines, cell counts and coagulation parameters in pediatric ARDS patients. We report statistical models that may be useful for future, larger trials to predict ARDS severity and outcomes.     

Hemoglobin Maintenance with use of Extended Dosing of Epoetin Alfa in Patients with Diabetes and Anemia of Chronic Kidney Disease

ObjectiveTo compare the efficacy of extended epo-etin alfa dosing in maintaining hemoglobin (Hb) concentrations in patients with and without diabetes as the primary cause of chronic kidney disease.MethodsWe undertook a post hoc analysis of the Clinical Evaluation of PROCRIT® for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT) study. The study patients had chronic kidney disease but were not receiving dialysis, had stable Hb levels of ≥ 11.0 g/dL, and had been receiving epoetin alfa for ≥ 2 months. Patients received 1 of 4 epoetin alfa dosing regimens administered subcutaneously for up to 16 weeks: 10,000 U once weekly (QW), 20,000 U every 2 weeks (Q2W), 30,000 U every 3 weeks (Q3W), or 40,000 U every 4 weeks (Q4W). The primary end point was the percentage of patients able to achieve Hb maintenance, defined as a mean Hb level of ≥ 11.0 g/dL from week 2 to final measurement.ResultsAmong 445 evaluable patients, 201 had diabetes and 244 did not have diabetes. Mean baseline Hb was 11.9 g/dL in both groups. The percentage of patients achieving Hb maintenance, stratified by epoetin alfa dosing regimen, was similar in patients with and those without diabetes: QW (90.2% versus 96.5%), Q2W (91.1% versus 87.9%), Q3W (80.0% versus 75.7%), or Q4W (79.2% versus 72.5%). The incidence of adverse events was low and comparable between patients with and those without diabetes.ConclusionApproximately 90% of patients with and without diabetes in the QW and Q2W groups and more than 70% in the Q3W and Q4W groups maintained mean Hb levels of ≥ 11.0 g/dL from week 2 to final measurement. These results demonstrated that patients with diabetes responded in a similar manner as patients without diabetes to extended dosing of epoetin alfa up to Q4W. (Endocr Pract. 2007;13:251-259)     

Comparison of Radioiodine Utilization in Adolescent and Young Adult and Older Thyroid Cancer Patients

ObjectiveDifferentiated thyroid cancer (DTC) is 1 of the most common cancers in adolescents and young adults (AYA, ages 15-39). Although most AYAs with DTC are considered low risk compared to older patients, there are no specific postoperative radioiodine (RAI) treatment recommendations despite the potential adverse effects specific to this age group, namely secondary malignancies and fertility difficulties. This study compares factors influencing RAI utilization in AYA and older patients.MethodsA total of 5,687 primary DTC patients were identified from the SEER (Surveillance, Epidemiology, and End Results) database between January 1, 2004 and January 31, 2009. The 2009 American Thyroid Association (ATA) guidelines were used to classify patients as low (LR) or intermediate/high risk (IHR) based on tumor characteristics. Multivariate logistic regression analysis was performed.ResultsOverall, 56.9% of AYA (n = 1,963) patients received postoperative RAI compared to 52.2% of older (n = 3,724) patients (odds ratio [OR]: 1.21, 95% confidence interval [CI]: 1.09-1.35, P = .001). For AYA patients, having a total thyroidectomy (TTx) (OR: 3.53, 95% CI: 2.7-4.61, P < .001) predicted RAI in a multivariate model whereas LR status (OR: 0.52, 95% CI: 0.43-0.63, P < .001) and northeast residence (OR: 0.39, 95% CI: 0.29-0.52, P < .001) decreased the probability. All 3 factors similarly affected older patients in addition to an increased likelihood after lymph node (LN) dissection. Additionally, after selecting for TTx (n = 1,077), no factor influenced the use of RAI for AYA patients, whereas LR (OR: 0.30, 95% CI: 0.21-0.43, P < .001) and northeast residence (OR: 0.39, 95% CI: 0.19-0.79, P = .008) were associated with decreased RAI use in older patients.ConclusionDespite their excellent prognosis, AYA thyroid cancer patients are more likely to receive postoperative RAI compared to older patients. Increased awareness of the unique survivorship implications for AYA patients will be an important aspect to address going forward. (Endocr Pract. 2014;20:405-411)     

Adding Rapid-Acting Insulin or Glp-1 Receptor Agonist to Basal Insulin: Outcomes in A Community Setting

ObjectiveTo evaluate real-world outcomes in patients with type 2 diabetes mellitus (T2DM) receiving basal insulin who initiate add-on therapy with a rapid-acting insulin (RAI) or a glucagon-like peptide 1 (GLP-1) receptor agonist.MethodsData were extracted retrospectively from a U.S. health claims database. Adults with T2DM on basal insulin who added an RAI (basal + RAI) or GLP-1 receptor agonist (basal + GLP-1) were included. Propensity score matching (with a 1 up to 3 ratio) was used to control for differences in baseline demographics, clinical characteristics, and health resource utilization. Endpoints included prevalence of hypoglycemia, pancreatic events, all-cause and diabetes-related resource utilization, and costs at 1-year follow-up.ResultsOverall, 6,718 matched patients were included: 5,013 basal + RAI and 1,705 basal + GLP1. Patients in both groups experienced a similar proportion of any hypoglycemic event (P = .4079). Hypoglycemic events leading to hospitalization were higher in the basal + RAI cohort (2.7% vs. 1.8%; P = .0444). The basal + GLP-1 cohort experienced fewer all-cause (13.55% vs. 18.61%; P < .0001) and diabetes-related hospitalizations (11.79% vs. 15.68%; P < .0001). The basal + GLP-1 cohort had lower total all-cause health care costs ($18,413 vs. $20,821; P = .0002) but similar diabetes-related costs ($9,134 vs. $8,985; P < .0001) compared with the basal + RAI cohort.ConclusionsAdd-on therapy with a GLP-1 receptor agonist in T2DM patients receiving basal insulin was associated with fewer hospitalizations and lower total all-cause costs compared with add-on therapy using an RAI and could be considered as an alternative to an RAI in certain patients with T2DM who do not achieve effective glycemic control with basal insulin. (Endocr Pract. 2015; 21:68-76)     

Reliability of Early Iodine 123 Uptake for Treatment of Graves Disease in Children

ObjectiveTo determine the reliability of early radioiodine uptake (RAIU) in calculation of the radioiodine ablation dose for pediatric patients with Graves disease.MethodsThis retrospective review of medical records involved 22 pediatric patients with Graves disease, who had undergone early (4 to 8 hours) and late (24 to 26 hours) RAIU studies and were treated with iodine 131 (¹³¹I). Quantitative data are reported as mean ± standard error of the mean. Early and late RAIU and actual administered versus calculated ¹³¹I ablation doses were compared by using the paired t test. The correlation between early and late RAIU was assessed by curvilinear regression analysis. Significance was assessed at P < .05.ResultsMean early RAIU was 57.1% ± 18.2%, and mean late RAIU was 72.1% ± 14.4% (P < .05). Curvilinear regression analysis showed the following: late RAIU = 7.13 + 1.71 × (early RAIU) - 0.01 × (early RAIU)²; r² = 0.75. The mean ablation dose of ¹³¹I based on late RAIU was 9.3 ± 2.0 mCi. The calculated radioiodine dose would have been, on average, 32% higher (12.3 ± 3.8 mCi; P < .05) had early RAIU been used.ConclusionIn children, early RAIU can be much lower than late RAIU. This may be misleading for ablation dose calculations. Therefore, late RAIU should be used to avoid overtreatment in children with Graves disease.(Endocr Pract. 2011;17:541-545)     

Early lymphocyte reconstitution is associated with improved transplant outcome after cord blood transplantation

Background aimsPrevious studies have shown that rapid recovery of the absolute lymphocyte count (ALC) is associated with improved transplant outcomes after related and unrelated donor allogeneic stem cell transplantation (allo-SCT). No consistent association has been reported between lymphocyte recovery and transplant outcome after cord blood transplantation (CBT)MethodsWe reviewed the records of 40 consecutive CBT patients at our institution to determine the impact of lymphocyte recovery on transplant outcomeResultsThe majority of patients (83%) received CBT for hematologic malignancies. Patients with ALC ≥150/μL at 30 days post-CBT had decreased non-relapse mortality (NRM) (P = 0.011) and improved survival (P = 0.013) compared with ALC < 150/μL. Patients with ALC < 100/μL at 30 days post-CBT had a significantly higher rate of graft failure than those with ALC ≥100/μL (four of 10 versus one of 29; P = 0.011). ALC was positively correlated with the nucleated cell dose and inversely correlated with the patient's age. There was no relationship between disease risk, type of conditioning regimen, anti-thymocyte globulin and number of cord units on ALC recoveryConclusionsOur results indicate that ALC 30 days post-CBT is a surrogate for engraftment, and that low ALC (<150/μL) identifies an ‘at-risk’ population of patients after CBT. Studies are needed to determine ways to increase ALC cell numbers post-CBT, including ex vivo-expanded natural killer cells using adoptive immunotherapy, which might improve outcome after CBT.     

Therapeutic granulocyte transfusions for the treatment of febrile neutropenia in patients with hematologic diseases: a 10-year experience at a single institute

Background aimsThis single-center 10-year retrospective study assessed clinical efficacies and adverse events and determined prognostic factors in patients with hematologic disease and febrile neutropenia treated with granulocyte transfusions (GT) from unrelated healthy donors stimulated with recombinant human granulocyte–colony-stimulating factor (rhG-CSF) and dexamethasone.MethodsBetween September 1999 and June 2009, 1027 therapeutic GT were performed for the treatment of 170 episodes of febrile neutropenia in 157 patients. Efficacy analysis included 979 GT for 138 episodes in 128 patients who received at least three GT per episode. Adverse event analysis included all patients who received at least one GT.ResultsThe median granulocyte dose was 0.96 × 10⁹/kg/transfusion (range 0.47–1.80 × 10⁹/kg/transfusion). Infection was controlled in 73 episodes (52.9%). The 28-day infection-related survival rate was 64.7 ± 4.1%. The dose of granulocytes transfused did not correlate with clinical outcome. Multivariate analysis revealed that septic shock and pneumonia/multiple primary infection sites were related to infection control failure. Furthermore, refractory underlying disease and septic shock were associated with shorter infection-related survival. Massive hemoptysis (3.5%) and respiratory failure (5.9%) occurred in a few patients. Prior pneumonic infiltration, azotemia and a larger volume of daily GT were associated with serious respiratory complications.ConclusionsGT therapy is a viable adjunctive treatment option for febrile neutropenia as a bridge to autologous hematopoietic recovery in patients with hematologic disease with tolerable toxicity. GT therapy requires close monitoring in patients with prior pneumonic infiltration and azotemia. It is recommended that transfusion with higher volumes is avoided.     

The clonogenic potential of hematopoietic stem cells and mesenchymal stromal cells in various hematologic diseases: a pilot study

Background aimsMesenchymal stromal cells (MSC) are the most popular cells used in regenerative medicine and biotechnology. The clonogenic potential of these cells is defined by colony-forming unit-fibroblasts (CFU-F). It is well known that there is an interaction between hematopoietic cells and stromal cells in disease formation pathogenesis. Therefore we hypothesized that there should be a quantitative and qualitative relationship between MSC colonies (CFU-F) and hematopoietic stem cell colonies (colony-forming unit-granulocyte-macrophages; CFU-GM) among patients with and without hematologic diseases.MethodsForty-two patients were included in this study. Patients were divided into three groups: group A, patients with hematologic malignancies (n = 20); group B, patients with bone marrow (BM) failure (n = 11); group C, patients without hematologic diseases (n = 11). BM aspirates were plated in different densities for CFU-F culture. The plating density was the same for CFU-GM culture.ResultsCFU-GM colonies grew in 90% of group A cells and all of group B and C cells (P = 0.0001). CFU-F colonies became visible on the ninth day of plating in group A and on the eight day in groups B and C. There was no statistically significant difference between the groups for the duration of CFU-F colony formation (P = 0.12). There were differences in the morphology of the colonies among the groups.ConclusionsThis is the first study that has compared the clonogenic potential of stromal cells and hematopoietic stem cells in the same subjects with and without hematologic diseases. No correlation was shown between the clonogenic potential of stromal cells and hematopoietic cells.     

Concomitant chemo-radiotherapy for unresectable oesophageal cancer: A mono-institutional study on 40 patients

Background/AimTo analyse clinical response, overall (OS) and disease free survival (DFS) and toxicity in patients with unresectable oesophageal cancer treated by concomitant chemo-radiotherapy (CRT).Materials and methodsForty patients with stage IIa–IVa biopsy proven oesophageal carcinoma were treated with CRT. All patients were studied with endoscopy and CT and judged unresectable after multidisciplinary discussion. CRT consisted of 3 cycles of cisplatin 100 mg/m² or carboplatin 300 mg/m² on day 1 and 5-fluorouracil 1000 mg/m² as a continuous infusion of 96 h associated with concurrent 3D-conformal RT. By using 15 MeV X-rays, a total dose of 60–66 Gy was delivered with daily fractions of 1.8–2.0 Gy.ResultsComplete response (CR), partial response (PR) and no response (NR) were observed in 50%, 20% and 20% of cases, respectively. Of the 20 patients with CR, 15 developed loco-regional recurrent disease. OS and DFS rates at 3 and 5 years were 38%, 8%, 49% and 10%, respectively. Total radiation dose ≥60 Gy improved loco-regional control and complete response (CR vs. PR + NR; p = 0.004) influenced both DFS and loco-regional control. Grade 3 gastrointestinal and haematological acute toxicity occurred in 3/40 patients (7.5%). One patient developed grade 4 renal failure. Late toxicity was reported in 2/40 patients (5.0%), consisting of grade 3 radiation pneumonitis.ConclusionsConcomitant CRT for unresectable oesophageal cancer can result in an acceptable loco-regional control with limited toxicity. Response after treatment and total radiation dose influenced the outcome.     

A phase II study of allogeneic natural killer cell therapy to treat patients with recurrent ovarian and breast cancer

BackgroundNatural killer (NK) cells derived from patients with cancer exhibit diminished cytotoxicity compared with NK cells from healthy individuals. We evaluated the tumor response and in vivo expansion of allogeneic NK cells in recurrent ovarian and breast cancerMethodsPatients underwent a lymphodepleting preparative regimen: fludarabine 25 mg/m² × 5 doses, cyclophosphamide 60 mg/kg × 2 doses, and, in seven patients, 200 cGy total body irradiation (TBI) to increase host immune suppression. An NK cell product, from a haplo-identical related donor, was incubated overnight in 1000 U/mL interleukin (IL)-2 prior to infusion. Subcutaneous IL-2 (10 MU) was given three times/week × 6 doses after NK cell infusion to promote expansion, defined as detection of ≥100 donor-derived NK cells/μL blood 14 days after infusion, based on molecular chimerism and flow cytometryResultsTwenty (14 ovarian, 6 breast) patients were enrolled. The median age was 52 (range 30–65) years. Mean NK cell dose was 2.16 × 10⁷cells/kg. Donor DNA was detected 7 days after NK cell infusion in 9/13 (69%) patients without TBI and 6/7 (85%) with TBI. T-regulatory cells (Treg) were elevated at day +14 compared with pre-chemotherapy (P = 0.03). Serum IL-15 levels increased after the preparative regimen (P = < 0.001). Patients receiving TBI had delayed hematologic recovery (P = 0.014). One patient who was not evaluable had successful in vivo NK cell expansionConclusionsAdoptive transfer of haplo-identical NK cells after lymphodepleting chemotherapy is associated with transient donor chimerism and may be limited by reconstituting recipient Treg cells. Strategies to augment in vivo NK cell persistence and expansion are needed.     

Performances diagnostiques des tomoscintigraphies myocardiques de stress,réalisées avec une caméra à semi-conducteurs et un protocole très faible dose

IntroductionThis retrospective study aimed to assess the performances in the detection of coronary artery disease patients of the stress myocardial perfusion imaging (MPI) performed with a semiconductor camera, a very low dose stress-rest protocol and short recording times.Material and methodsWe analyzed consecutive MPI exams, which has been routinely planed with the “D-SPECT” semiconductor camera, a 1-day stress-rest protocol, very low doses of Sestamibi-^99mTc (120 MBq at stress and 360 MBq at rest for a 75 kg body weight patient) and short acquisition-times targeting the recording of 500 myocardial kcounts (on average, 8 min for stress and 3 min for rest). The ability to detect coronary artery stenosis (> 50% diameter reduction) was assessed in a group of 118 patients, who had coronary angiography at ≤ 3 months from MPI, and normalcy rate was assessed in a group of 74 patients showing a low pretest probability of coronary artery disease (< 10%).ResultsSensitivity, positive predictive value and global accuracy for identifying the 81 patients with ≥ 1 coronary artery stenosis were 85%, 83% and 78%, respectively; and normalcy rate was 96%. Mean effective doses were: (1) 4.9 ± 1.4 mSv in the group with coronary angiography and where most exams (90%) comprised both stress and rest MPI; and (2) 1.9 ± 1.5 mSv in the low probability group and where most exams (70%) comprised only stress MPI.ConclusionWhen performed with a sensitive semiconductor camera and a very low dose stress-rest protocol, MPI provides high diagnostic performances, equivalent to those documented with conventional cameras in the same study setting, but with dramatic reduction of patients’ radiation.     

Body mass index,iron absorption and iron status in childbearing age women

BackgroundThe prevalence of obesity has increased at an alarming rate worldwide. Some studies have observed an association between iron (Fe) deficiency (ID) and obesity, however more research is needed.ObjectiveTo assess whether body mass index (BMI) is associated with both Fe absorption and Fe status.MethodsA cross sectional sample of 318 Chilean childbearing age women was studied. The women received either a single dose of 0.5 mg of Fe (n = 137, group 1) or 3 mg of Fe plus ascorbic acid (1:2 molar ratio) (n = 181, group 2), both as FeSO₄ with labeled radioisotopes. Fe absorption was assessed through radio Fe erythrocyte incorporation. Fe status was determined by hemoglobin (Hb), mean corpuscular volume, serum Fe, total iron binding capacity, transferrin saturation, erythrocyte Zn protoporphyrin and serum ferritin (SF).Results29%, 47% and 24% of the women were classified as normal, overweight or obese, respectively. Fe absorption was significantly lower in obese women (p < 0.05). In group 1, the geometric mean and range ±1 SD of the percentage of Fe absorption for normal-weight women was 32.9% vs. 19.7% in obese. For group 2, this percentage was 36% vs. 30%, respectively (2-way ANOVA: BMI classification and Fe dose p < 0.05; interaction p = 0.34). Although Fe absorption was lower in obese women, they had higher SF (p < 0.01) and Hb (p < 0.05) concentrations.ConclusionAlthough we did not observe a relationship between BMI and Fe status, obese women displayed lower Fe absorption compared with overweight and normal weight women, possibly due to subclinical inflammation associated with obesity.     

Balloon Catheter Position and its Relationship with Esophageal Temperature during Pulmonary Vein Isolation using High-Intensity Focused Ultrasound

BackgroundHIFU can achieve PVI, but severe esophageal complications have happened. We analyzed relative position of HIFU balloon catheter (BC) to esophageal temperature (ET) probe and correlated it to ET changes.Methods and ResultsBefore each ablation relative position of HIFU BC to ET probe was recorded in RAO 30° and LAO 40°. We compared ablations where ET at end of ablation was < 38.5°C or ≥ 38.5°C and < 40.0°C or ≥ 40.0°C.A total of 600 images from 311 ablations in 28 patients (18 male, age 63 ± 7 years), were analyzed. ET ≥ 38.5°C was reached when distance from BC to ET probe was: < 20 mm in LAO for RSPV and < 29 mm in LAO for RIPV. For RIPV ET ≥ 38.5°C was reached when angle between BC and ET probe was significantly smaller in LAO and RAO. ET ≥ 40.0°C was reached when distance of BC to ET probe was: < 20 mm in LAO for RIPV, < 14 mm in RAO for RIPV, < 18 mm in RAO for LIPV. ET increased to ≥ 40.0°C when distance from BC to ET probe was significantly longer in LAO for LIPV. For RIPV ET ≥ 40.0°C was reached when angle between BC and ET probe was significantly smaller in LAO.ConclusionsThere is a relationship between distance/angle of HIFU BC to ET probe and ET: shorter distances and smaller angles can cause higher ET.     

A cross-sectional survey among patients and prescribers on insulin dosing irregularities and impact of mild (self-treated) hypoglycemia episodes in Spanish patients with type 2 diabetes as compared to other European patients

Background and objectiveIn Spain, data suggest that 13.8% of adults have diabetes. Two important aspects in diabetes management are mild hypoglycemic episodes and poor treatment adherence. This study assesses the impact of missed insulin doses and prevalence of mistimed and reduced insulin doses and mild hypoglycemia in patients with type 2 diabetes treated with basal insulin analogues in Spain, and compares the data collected to pooled data from 8 other European countries (OECs).Materials and methodsGAPP2 was an international, online, cross-sectional study of diabetic patients aged ≥40 years treated with long-acting insulin analogues and their healthcare professionals. Patients and healthcare professionals were recruited from online research panels. Data reported in Spain are compared to pooled data from 8 OECs.ResultsIn Spain, 1–3% of patients reported they had reduced, missed, or mistimed at least one insulin does in the previous month. Significantly more OEC patients reported dosing irregularities (15–23%; all P < 0.01). In Spain, 77% of patients were worried and 59% felt guilty for missing a dose of basal insulin, while 24% reported that they were very worried about nocturnal hypoglycemia. Significantly fewer OEC patients reported worrying (47%; P < 0.01) and feeling guilty (37%; P < 0.01) about missing an insulin dose, or worry about nocturnal hypoglycemia (12%; P < 0.01).ConclusionsIn Spain, patients with type 2 diabetes report fewer dosing irregularities and hypoglycemic episodes as compared to patients from OECs. However, Spanish patients appear to have a reduced quality of life related to hypoglycemia as well as worry and guilt related to insulin dosing irregularities.     

Real-time monitoring of non-viable airborne particles correlates with airborne colonies and represents an acceptable surrogate for daily assessment of cell-processing cleanroom performance

Background aimsAirborne particulate monitoring is mandated as a component of good manufacturing practice. We present a procedure developed to monitor and interpret airborne particulates in an International Organization for Standardization (ISO) class 7 cleanroom used for the cell processing of Section 351 and Section 361 products.MethodsWe collected paired viable and non-viable airborne particle data over a period of 1 year in locations chosen to provide a range of air quality. We used receiver operator characteristic (ROC) analysis to determine empirically the relationship between non-viable and viable airborne particle counts.ResultsViable and non-viable particles were well-correlated (r² = 0.78), with outlier observations at the low end of the scale (non-viable particles without detectable airborne colonies). ROC analysis predicted viable counts ≥ 0.5/feet³ (a limit set by the United States Pharmacopeia) at an action limit of ≥ 32 000 particles (≥ 0.5 µ)/feet³, with 95.6% sensitivity and 50% specificity. This limit was exceeded 2.6 times during 18 months of retrospective daily cleanroom data (an expected false alarm rate of 1.3 times/year). After implementing this action limit, we were alerted in real time to an air-handling failure undetected by our hospital facilities management.ConclusionsA rational action limit for non-viable particles was determined based on the correlation with airborne colonies. Reaching or exceeding the action limit of 32 000 non-viable particles/feet³ triggers suspension of cleanroom cell-processing activities, deep cleaning, investigation of air handling, and a deviation management process. Our full procedure for particle monitoring is available as an online supplement.     

Helical tomotherapy re-irradiation for patients affected by local radiorecurrent prostate cancer

BackgroundSalvage re-irradiation in patients affected by radiorecurrent prostate cancer might be a valid as well as challenging treatment option. The aim of this study was to evaluate feasibility and toxicity of salvage external beam radiotherapy (EBRT) re-treatment in patients affected by radiorecurrent prostate cancer within the prostate gland or the prostate bed.Materials and Methods15 patients underwent EBRT re-treatment using helical tomotherapy (HT), with daily Megavolt computed tomography image-guidance. We registered toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Biochemical relapse was defined as a PSA increase > 20% compared with the pre-EBRT re-treatment value. Survival curves were calculated using the Kaplan-Meier method.ResultsAll patients received a total dose of 50 Gy (25 × 2 Gy), and 7 (46.6%) had concomitant androgen deprivation therapy (median duration of 12 months). With a median follow-up of 40.9 months, the 2-year and 4-year biochemical relapse-free survival were 55% and 35%, respectively. Acute and late genito-urinary (GU) toxicity ≥2 were recorded in 4 (26.6%) and 5 (33.3%) patients, respectively, and the 4-year late GU toxicity was 30%. Acute gastrointestinal toxicity ≥2 was recorded in 2 (13.3%) cases, whereas no patient experienced late toxicity.ConclusionsDespite the inherent bias of a retrospective analysis, our long-term results showed a low toxicity profile with a relatively low rate of biochemical control for HT re-treatment in patients affected by local radiorecurrent prostate cancer. Prospective trials are needed to investigate the role of EBRT in this setting.     

Sentinel Lymph Node Biopsy Status Correlates With Postoperative Stimulated Thyroglobulin Levels in Low-Risk Papillary Thyroid Cancer Patients

ObjectiveRadioactive iodine (RAI) remnant ablation in low-risk papillary thyroid cancer (PTC) is controversial. Current patient selection guidelines recommend the use of postoperative stimulated thyroglobulin (stim-Tg), neck dissections, and sonography but fail to include sentinel lymph node biopsy (SLNB). The objective of this study was to evaluate the correlation between SLNB status and postoperative stimulated thyroglobulin as a surrogate marker of clinical outcome.MethodsRetrospective chart review of low-risk PTC patients who underwent a total thyroidectomy with SLNB at the McGill Thyroid Cancer Center. SLNBs were obtained using methylene blue dye. Biochemical measurements were acquired between 4 and 12 weeks postoperatively. Statistical analyses were performed using logistic regression models and receiver operating characterisitc (ROC) curves. A P-value < .05 was considered significant.ResultsNinety-six patients were included in this study. The positive SLNB rate was 14.6%. The mean postoperative Tg level was 1.41 μg/L. There were no significant correlations between the SLNB and the covariates analyzed (age, gender, histology, tumor size, and thyrotropin levels). Patients with negative SLNB were significantly more likely to have a lower stim-Tg (P < .0001). When postoperative Tg was analyzed as a categorical variable, a threshold of < 1 μg/L was significantly associated with a negative SLNB, with a sensitivity and specificity (determined by ROC curves) of 0.86 and 0.88, respectively.ConclusionThere exists a correlation between SLNB and postoperative Tg. This creates the possibility of a new approach to RAI administration among low-risk PTC patients incorporating SLNB to the current guidelines. (Endocr Pract. 2014;20:399-404)