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Data on ethyl carbamate concentrations in beers purchased and analysed between 1988 and 1990 are presented. The concentrations in draughtbeers were uniformly below the detection limit of 1 mu g/l. Canned beers contained rather more ethyl carbamate (up to 2.5 mu g/l) which is considered to be due to their longer shelf-life and higher alcohol content (in some cases). Bottled beers contained even higher amounts of ethyl carbamate (up to 14.7 mu g/l) and this was considered to be due to the use of azodicarbonamide as a blowing agent in the beer bottle cap liners. It is understood that modifications to the liner haveled to reduced concentrations in bottled beers produced more recently. A survey of bread samples and related cereal products such as rusks, French toasts and pitta bread indicated typical ethyl carbamate concentrations between less than 0.4 and 4.5 mu g/kg. Toasting bread led to increases of between three- and eight-fold in ethyl carbamate concentrations ranging from 3.5 to 33.8 mu g/kg on a wet weight basis.Analysis of the data indicated that commercial bread samples which indicated the use of azodicarbonamide as a flour improver showed statistically significant increases in ethyl carbamate concentrations. Themean increase for treated bread over untreated bread was 66 percent.When these breads were toasted, the mean increase for treated toast over untreated toast was 56 percent. [ABSTRACT FROM AUTHOR]

A series of baking experiments have been undertaken in order to testthe proposition that the use of the flour improver azodicarbonamide influences ethyl carbamate concentrations in baked bread. Samples were prepared in a laboratory and contained 0, 20 and 45 mg azodicarbonamide/kg; 20 mg/kg reflecting normal commercial usage and 45 mg/kg theUK statutory limit. Samples incorporating 0 and 20 mg/kg of the additive were also prepared in a commercial bakery. Toast made from thesebreads was examined since it is known that toasting can lead to increased ethyl carbamate concentrations. Statistical analysis of the data indicated that, at 45 mg/kg, azodicarbonamide led to significant increases in ethyl carbamate concentrations in both bread and the toasts made from it. At 20 mg/kg some small increases in ethyl carbamate were seen for bread and this approached statistical significance for those samples made in the commercial plant. When these breads were toasted an increase in ethyl carbamate was observed but this was not attributable to the use of azodicarbonamide. [ABSTRACT FROM AUTHOR]

Background and aim: Exotic plant species can alter the nitrogen cycle in invaded ecosystems. We assess the differences in nitrogen use strategies and litter production and dynamics among three native riparian trees ( Fraxinus angustifolia, Populus alba and Ulmus minor) and three co-occurring exotics ( Ailanthus altissima, Robinia pseudoacacia and Ulmus pumila), currently spreading throughout river banks in inner Spain. We aim to predict the ecological consequences of a replacement of the natives by the exotics. Methods: We compared the leaf lifespan, nitrogen resorption efficiency in leaves, nitrogen mean residence time, amount and timing of litter production and amount of nitrogen returned to soils between these native and exotic species. Results: We found differences among species in all the variables measured, but not between native or exotic origins. Species were ranked from the most to the least conservative nitrogen use strategy as follows: U. pumila was the most conservative species, followed by the three natives (with an intermediate strategy), A. altissima and finally by the nitrogen-fixer R. pseudoacacia. The studied exotic species would produce contrasting impacts on the nitrogen cycle upon invasion. Conclusions: On the basis of our results, we predict little impacts on the nitrogen cycle if U. pumila dominates the landscape. Despite being nitrogen-fixer R. pseudocacia would not increase soil nitrogen availability in the study area due to its low litter production and litter decomposition rates. In contrast, we predict an increase in nitrogen availability of soils upon A. altissima invasion, as this species produces a high amount of nitrogen rich and labile litter. This study offers a striking example of the contingencies involved in predicting the ecosystem impacts of exotic plant invasion. [ABSTRACT FROM AUTHOR]

Published data supports the use of very high dose intensity modulated radiotherapy (IMRT) in achieving high efficacy and low toxicity for high-risk prostate cancer (HRPCa). This phase II multi-institutional non-randomized prospective dose escalation study using intensity modulated radiotherapy (IMRT) for high risk N0M0 prostate cancer was designed to investigate dose escalation using 1.8 Gy increments from baseline 75.6 Gy up to maximum 81 Gy, once dose volume constraints were adhered to. Inclusion criteria were patients undergoing a radical course of RT for high and very high-risk disease, defined as one or more of the criteria ≥ T3*, ≥ Gleason 8, Prostate specific antigen (PSA) > 20ng/ml. All patients received Androgen Deprivation Therapy (ADT) and none had radiological evidence of distant metastatic disease. The primary objective was to determine if dose escalated IMRT for high risk localized prostate cancer could provide freedom from biochemical relapse (BR; PSA rising > nadir +2ng/mL or initiation of salvage hormone therapy) similar to that reported in the literature. The Kaplan-Meier method was used to estimate survival times. Secondary objectives included OS, Disease Free Survival (DFS), and the incidence and severity of Genito-urinary (GU), Gastro-intestinal (GI) and erectile dysfunction (ED) toxicities (CTCAE v.3). Toxicities and performance status were collected and graded weekly during RT, 2 months after completing RT, 8 months' post RT, and 6 monthly thereafter to year five and annually thereafter to year nine. A total of 230 evaluable patients were enrolled between April 2009 and June 2016. The median follow-up was 7.3 years. The cumulative proportion of patients surviving without BR at 5 years was 91% (95% Confidence Interval (CI): 86% to 94%). Overall survival at 5 and 7 years was 92% (88% to 95%) and 89% (83% to 92%) respectively, while the cumulative proportion of patients free from disease was 89% (84% to 93%) at 5 years and 81% (75% to 86%) at 7 years. The incidence of acute G2 and G3 toxicities were; GU; 57.8% G2, 12.6% G3, GI; 15.2% G2, 0.4% G3, ED; 30.0% G2 and 61.7% G3. The incidence of late G2, G3 and G4 toxicities were; GU; 40.9% G2, 8.7% G3, GI; 36.5% G2, 2.2% G3, 0.4% G4, ED; 11.7% G2 and 86.1% G3. The percentage of patients receiving each dose level was; 3.5% received 75.6Gy in 42 fractions, 2.2% received 77.4Gy in 43 fractions, 93% received 81Gy in 45 fractions. The findings indicate that high-dose IMRT is well tolerated and is associated with excellent long-term tumor-control outcomes in patients with localized high and very high-risk prostate cancer, with 91% of patients surviving at 5 years without biochemical relapse. The rates of long term G3 GU and GI toxicity were low at 8.7% and 0.4% respectively. [ABSTRACT FROM AUTHOR]

Background: The optimal primary external beam radiation therapy (EBRT) radiation schedule for malignant epidural spinal cord compression (MSCC) remains to be determined. The ICORG 05-03 trial assessed if a 10Gy single fraction radiation schedule was not inferior to one with 20 Gray (Gy) in five daily fractions, in terms of functional motor outcome, for the treatment of MSCC in patients not proceeding with surgical decompression. This article reports on two of the secondary endpoints, Quality of life (QoL), assessed according to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) version 3.0 (EORTC Data Center, Brussels, Belgium) and pain control assessed using a visual analog scale. Methods: A randomized, parallel group, multicenter phase III trial was conducted by Cancer Trials Ireland (formerly All-Ireland Cooperative Oncology Research Group, ICORG), across five hospital sites in Ireland and Northern Ireland. Patients were randomized to 10 Gy single fraction of EBRT or 20Gy in five fractions in a 1:1 ratio. Patients with baseline and 5-week follow up QoL data are included in this analysis. Findings: From 2006 to 2014, 112 eligible patients were enrolled for whom 57 were evaluated for this secondary analysis. After adjusting for pre-intervention scores, there was no statistically significant difference in post-treatment Summary scores (excl. FI and QL), or pain scores between the two RT schedules at 5 weeks and 3 months following EBRT. There was a statistically significant relationship between the pretreatment and post-treatment Summary scores (p¼ .002) but not between the pre-treatment and post-treatment pain scores. Interpretation: Primary radiotherapy for the treatment of MSCC significantly improves QoL in patients not proceeding with surgical decompression. After adjusting for pre-intervention scores, there was no statistically significant difference between a 10 Gy single fraction radiation schedule and one with 20 Gy in five daily fractions on post-treatment QoL Summary scores. For most patients, an effective treatment with low burden would be desirable. A single fraction schedule should be considered for this group of patients. [ABSTRACT FROM AUTHOR]

Background: Neoadjuvant therapy is increasingly the standard of care in the management of locally advanced adenocarcinoma of the oesophagus and junction (AEG). In randomised controlled trials (RCTs), the MAGIC regimen of pre- and postoperative chemotherapy, and the CROSS regimen of preoperative chemotherapy combined with radiation, were superior to surgery only in RCTs that included AEG but were not powered on this cohort. No completed RCT has directly compared neoadjuvant or perioperative chemotherapy and neoadjuvant chemoradiation. The Neo-AEGIS trial, uniquely powered on AEG, and including comprehensive modern staging, compares both these regimens.Methods: This open label, multicentre, phase III RCT randomises patients (cT2-3, N0-3, M0) in a 1:1 fashion to receive CROSS protocol (Carboplatin and Paclitaxel with concurrent radiotherapy, 41.4Gy/23Fr, over 5 weeks). The power calculation is a 10% difference in favour of CROSS, powered at 80%, two-sided alpha level of 0.05, requiring 540 patients to be evaluable, 594 to be recruited if a 10% dropout is included (297 in each group). The primary endpoint is overall survival, with a minimum 3-year follow up. Secondary endpoints include: disease free survival, recurrence rates, clinical and pathological response rates, toxicities of induction regimens, post-operative pathology and tumour regression grade, operative in-hospital complications, and health-related quality of life. The trial also affords opportunities for establishing a bio-resource of pre-treatment and resected tumour, and translational research.Discussion: This RCT directly compares two established treatment regimens, and addresses whether radiation therapy positively impacts on overall survival compared with a standard perioperative chemotherapy regimen Sponsor: Irish Clinical Research Group (ICORG).Trial Registration: NCT01726452 . Protocol 10-14. Date of registration 06/11/2012. [ABSTRACT FROM AUTHOR]

The aim of the study was to compare the use of 3D-CRT and IMRT in pre-operative long course chemo-radiotherapy for locally advanced rectal cancer. We herein evaluate the impact of the two treatment modalities on quality of life (QOL), a secondary objective of the study. 94 patients with rectal adenocarcinoma were enrolled in a prospective randomized phase II trial across three institutions between 2014 and 2020. Eligible patients had stage T3-4, N(any) or circumferential resection margin at risk with no evidence of metastatic disease. All patients were prescribed 50.4Gy in 28 fractions with concomitant 5-fluorouracil or capecitabine. Patients were randomly assigned (1:1) to 3D-CRT and IMRT planning techniques. QOL was assessed using the EORTC QLQ C30 and QLQ CR29 questionnaires at baseline, during the final week of radiotherapy and at six and twelve months after radiotherapy. A paired sample t test was used to compare differences in QOL from baseline to each follow-up. One-way between-group analyses of covariance (ANCOVA) were conducted to compare the effect of the trial arms on each QOL score. At a median follow-up of 14 months, the trial was terminated early due to failure to establish efficacy in the primary outcome, acute gastrointestinal toxicity. The median age was 59 years and 72/94 (77%) were male. 86/94 (91%) patients completed the baseline and at least one other QOL assessments. QOL data at one year was available in 55/94(58%). At baseline, there was no difference in QOL scores between trial arms. Overall, emotional functioning had improved at six months but physical, cognitive, role and social functioning had declined. At six months, there was a significant improvement in constipation, blood and mucous in stool, bloating, urinary frequency, buttock pain and anxiety scores compared to baseline. There was a significant deterioration in dyspnea, fatigue, nausea/vomiting, taste, hair loss, erectile dysfunction, body image and global health scores from baseline to 6-month follow-up. After adjusting for pre-intervention score, the IMRT arm had better physical functioning (p=0.038) and role functioning (p=0.014) during the final week of radiotherapy compared to the 3DCRT arm. The end of radiotherapy embarrassment score, for those without a stoma, was significantly worse in the IMRT arm (p=0.032). There was no other significant difference in QOL scores between the two arms, at either the final week of radiotherapy or at 6 months, after adjustment for pre-intervention scores. The limitations of the study include its early termination, the potential for type 1 error and the possible influence of other factors on QOL data such as chemotherapy and postoperative complications. There are limited QOL benefits of IMRT compared to 3D-CRT in the neoadjuvant setting for rectal cancer. [ABSTRACT FROM AUTHOR]

The primary aim of this trial was to compare the incidence of grade 2 or above acute gastrointestinal (GI) toxicity for patients undergoing 3DCRT versus IMRT in the preoperative setting for locally-advanced rectal cancer. Secondary objectives included quality of life and other acute and late toxicity. The trial was designed to have 80% power to detect a difference between a hypothesized 37% acute toxicity rate in the 3DCRT arm (Bosset et al, 2006) and 20% in the IMRT arm, with a sample size of 120 per arm, and a 0.05 two-sided level of significance. Eligible participants were adults aged 18 or over scheduled to receive pre-operative pelvic chemo-radiotherapy for histologically-confirmed rectal adenocarcinoma. Exclusion criteria included prior pelvic radiotherapy, inflammatory bowel disease, hip replacements, and previous bowel surgery. Prescription dose was 50.4 Gray in 28 fractions over 5.5 weeks with concurrent 5-fluorouracil or capecitabine chemotherapy. Participants were centrally randomized 1:1 to receive 3DCRT or IMRT. Each individual radiotherapy volume and plan was reviewed centrally to ensure compliance with the trial's RTQA specifications. Toxicity was graded and reported according to CTCAE version 4.0 (National Institutes of Health National Cancer Institute). Acute toxicity was assessed weekly during radiotherapy, and at 2- and 4-weeks post-treatment. 94 patients were enrolled. 77% were male and median age was 59.4. Two participants from the 3DCRT arm did not complete radiotherapy as planned and were excluded from analysis. 25 (56%) of participants from the 3dCRT arm and 23 (49%) from the IMRT arm experienced acute grade 2 or above GI toxicity (p=.670). Rates for grade 3 GI toxicity were 8 (18%) and 5 (11%) for 3dCRT and IMRT, respectively (p=.494). Grade 3 GI events included diarrhea (n=11), nausea (n=2), intestinal obstruction (n=1), oral mucositis (n=1), and rectal pain (n=1). The study closed early due to absence of evidence of a difference between arms at the interim analysis. No significant difference in rates of acute GI toxicity with IMRT versus 3DCRT for locally advanced rectal cancer was seen. Although IMRT can reduce dose to organs at risk, it appears to be similarly safe in terms of acute GI toxicity to deliver this treatment with 3DCRT. [ABSTRACT FROM AUTHOR]

Aims: To assess the impacts of Ailanthus altissima and Robinia pseudoacacia on the whole litterfall process and on soil properties of riparian ecosystems of Central Spain by comparing invaded and non-invaded forests. Methods: We selected 3-4 plots of four different types of forests: invaded by A. altissima or R. pseudoacacia, or dominated by the native Fraxinus angustifolia or Populus alba. In each plot we collected the litter monthly over 2 years and separated the litter from different plant organs. We calculated annual inputs of litter, nitrogen (N) and phosphorus (P) to soil. We also analyzed soil pH, organic matter (OM), N and P. Results: Most litter fractions from the two invasive trees contained over twice as much N as those from the native P. alba. Although not significantly different, the annual inputs of N in invaded forests were 1.7-2.2 times higher than in native forests. In the invaded forests, extra litterfall peaks were found in summer and/or late-spring (June), corresponding to reproductive and/or leaf litter fractions. The percentage of annual litter represented by these peaks was over twice those in native forests. Soil OM, N and P were higher in invaded than in P. alba forests. In addition, forests invaded by R. pseudoacacia had higher soil OM and N than F. angustifolia forests. Conclusions: This study showed the capability of A. altissima and R. pseudoacacia to alter soil properties and litterfall dynamics in riparian ecosystems. [ABSTRACT FROM AUTHOR]