The home enteral nutrition (HEN) provides nutritional support to children with chronic diseases who are nutritionally compromised and allows them to be discharged more quickly from hospitals. In ...2003, a web-based registry (Nutrición Enteral Pediátrica Ambulatoria y Domiciliaria, Pediatric Ambulatory and Home Enteral Nutrition -NEPAD-) was created with the objective of gathering information about pediatric HEN practices in Spain.
The aim of this study was to report the implementation of the NEPAD (Nutrición Enteral Pediátrica Ambulatoria y Domiciliaria, Pediatric Ambulatory and Home Enteral Nutrition) registry of pediatric HEN in Spain and to analyze data evolution trends from 2003 to 2010.
The data from the Spanish NEPAD registry were analyzed according to the following variables: demographic data, diagnosis, indication for HEN, nutritional support regime and administration route.
Over the study period, 952 patients (1048 episodes) from 20 Spanish hospitals were included in the NEPAD registry. The most frequent indication for HEN was decreased oral intake (64%), and neurological disease was the most prevalent illness. HEN was delivered via a nasogastric tube in 573 episodes (54.7%), by gastrostomy in 375 episodes (35.8%), oral feeding in 77 episodes (7.3%) and by jejunal access in 23 episodes (2.2%). Significant differences in the mode of administration were observed based on the pathology of the child (χ(2), P<0.0001). The cyclic feeding was the most widely used technique for the administration of HEN. Most of the patients used a pump and a polymeric formula. Transition to oral feeding was the primary reason for discontinuation of this type of support.
Since the NEPAD registry was established in Spain, the number of documented patients has increased more than 25-fold. Many children with chronic illness benefit from HEN, mainly those suffering from neurological diseases.
Standardization of clinical procedures has become a desirable objective in contemporary medical practice. To this effect, the Spanish Society of Parenteral and Enteral Nutrition (SENPE) has ...endeavoured to create clinical practice guidelines and/or documents of consensus as well as quality standards in artificial nutrition. As a result, the SENPE´s Standardization Team has put together the "Document of Consensus in Enteral Access for Paediatric Nutritional Support" supported by the Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition (SEGHNP), the National Association of Pediatric and Neonatal Intensive Care Nursery (ANECIPN), and the Spanish Society of Pediatric Surgery (SECP). The present publication is a reduced version of our work; the complete document will be published as a monographic issue. It analyzes enteral access options in the pediatric patient, reviews the levels of evidence and provides the team-members' experience. Similarly, it details general and specific indications for pediatric enteral support, current techniques, care guidelines, methods of administration and complications of each enteral access. The data published by the American Society for Parenteral and Enteral Nutrition (ASPEN) and several European Societies has also been incorporated.
There is growing evidence showing the importance of the fecal calprotectin assay in differentiating organic from functional gastrointestinal disease. It is a simple, non-invasive biomarker that is ...especially useful in children, who may require general anesthesia for colonoscopy. The aim of this study was to assess the use and sensitivity of fecal calprotectin (FCP) in pediatric patients with signs and symptoms of IBD to avoid unnecessary invasive techniques and to distinguish between organic and functional gastrointestinal pathology.
A single stool sample was collected from 47 children (mean age: 10.1 years) referred for non-specific gastrointestinal symptoms suggestive of organicity. On the basis of clinical criteria 13 children had functional bowel disorders and 34 had organic gastrointestinal disease, 15 with IBD and 19 with other organic (non-IBD) gastrointestinal conditions. Thirty healthy children were included as controls. Calprotectin concentrations were measured by enzyme immunoassay.
Children with IBD had FCP levels median (interquartile range); 1,219 microg/g (322-2,967 microg/g) higher than children with functional gastrointestinal disease 20 microg/g (16-25 microg/g); p < 0.0001, those with organic non-IBD disease 113 microg/g (36-193 microg/g); p = 0.002, and healthy children 25 microg/g (19.2-32.5 microg/g); p < 0.0001. Fecal calprotectin concentration also was significantly higher in children with organic (non-IBD) disease as compared to controls (p = 0.004) and children with functional pathology (p = 0.002). FCP levels were similar in controls and children with functional gastrointestinal disease (p = 0.264).
CPF is a sensitive, but not disease-specific, marker to identify patients with IBD who should undergo diagnostic colonoscopy, and to avoid unnecessary invasive procedures in patients with functional gastrointestinal disorders.
Introducción: la determinación de calprotectina en heces se está afianzando en los últimos años como un marcador no invasivo para el diagnóstico diferencial entre patología gastrointestinal orgánica ...y funcional. Su uso es útil sobre todo en niños que requieren anestesia general para una colonoscopia. El objetivo de este estudio es evaluar la sensibilidad y utilidad de la calprotectina fecal (CPF) en pacientes pediátricos con signos y síntomas sugestivos de enfermedad inflamatoria intestinal (EII) con el fin de evitar técnicas invasivas innecesarias y poder discriminar entre patología gastrointestinal orgánica y funcional. Material y métodos: se determinó la concentración de calprotectina mediante enzimoinmunoanálisis en una única muestra de heces de 47 niños (edad media: 10,1 años) con algún síntoma de patología gastrointestinal sugestivo de organicidad. Trece niños fueron diagnosticados de patología funcional y 34 de patología orgánica. Entre estos, 15 con EII y el resto con patologías orgánicas de distinto origen (no-EII). Se incluyeron 13 niños sanos como controles. Resultados: el grupo de niños con EII presentó valores de CPF mediana (rango interquartil); 1.219 mg/g (322-2.967) significativamente más altos que el grupo con patología gastrointestinal funcional 20 mg/g (16-25); p < 0,0001, el grupo con patología orgánica no-EII 113 mg/g (36-193); p = 0,002 y el control 25 mg/g (19-32); p < 0,0001. Las concentraciones también fueron más altas en el grupo de niños con patología orgánica no-EII respecto al grupo con patología funcional (p = 0,002) y al control (p = 0,004). No hubo diferencias entre el grupo control y los niños con patología funcional (p = 0,264). Discusión: la CPF es un marcador sensible, pero no específico, que permite seleccionar pacientes con EII, que requieren colonoscopia para el diagnóstico definitivo y evitar así pruebas invasivas a pacientes con patología gastrointestinal funcional.
•The capacitated congested strategy-based transit assignment is solved using an MSA method as result of its VI reformulation.•At each iteration a capacitated linear problem is solved using Lagrangian ...relaxation, generating the hyperpaths of the solution.•Solutions are always capacity feasible, even under very high demand levels.•The method behaves better and is computationally as efficient as the one in Cepeda et al. (2001), in any congestion level.•Passenger delay models at stops, derivated from queueing theory, with infinite delays, can be integrated.
This paper addresses the problem of solving the congested transit assignment problem with strict capacities. The model under consideration is the extension made by Cominetti and Correa (2001), for which the only solution method capable of resolving large transit networks is the one proposed by Cepeda et al. (2006). This transit assignment model was recently formulated by the authors as both a variational inequality problem and a fixed point inclusion problem. As a consequence of these results, this paper proposes an algorithm for solving the congested transit assignment problem with strict line capacities. The proposed method consists of using an MSA-based heuristic for finding a solution for the fixed point inclusion formulation. Additionally, it offers the advantage of always obtaining capacity-feasible flows with equal computational performance in cases of moderate congestion and with greater computational performance in cases of highly congested networks. A set of computational tests on realistic small- and large-scale transit networks under various congestion levels are reported, and the characteristics of the proposed method are analyzed.
Purpose: No chemotherapy regimen, including the widely used combination of gemcitabine/cisplatin, confers significantly improved survival
over any other in metastatic non-small cell lung cancer ...(NSCLC); however, the selection of patients according to key genetic
characteristics can help to tailor chemotherapy. Ribonucleotide reductase subunit M1 (RRM1) is involved in DNA synthesis and
repair and in gemcitabine metabolism, and the excision repair cross-complementing group 1 ( ERCC1 ) gene has been related to cisplatin activity.
Experimental Design: Patients were part of a large randomized trial carried out from September 1998 to July 2000, comparing gemcitabine/cisplatin
versus gemcitabine/cisplatin/vinorelbine versus gemcitabine/vinorelbine followed by vinorelbine/ifosfamide. We analyzed RRM1 and ERCC1 mRNA expression in paraffin-embedded
samples obtained from bronchoscopy by real-time quantitative reverse transcription-PCR. Results were correlated with survival
using the Kaplan-Meier method.
Results: A total of 100 patients were assessed. There was a strong correlation between RRM1 and ERCC1 mRNA expression levels (Spearman
r = 0.410; P < 0.001). In the gemcitabine/cisplatin arm, patients with low RRM1 mRNA expression levels had significantly longer median
survival than those with high levels 13.7 versus 3.6 months; 95% confidence interval (CI), 9.6–17.8 months; P = 0.009. Median survival was also significantly longer among patients with low mRNA expression levels of both RRM1 and ERCC1 (not reached), than among those with high levels of both genes (6.8 months; 95% CI, 2.6–11.1 months; P = 0.016).
Conclusions: RRM1 mRNA expression is a crucial predictive marker of survival in gemcitabine/cisplatin-treated patients. Genetic testing of
RRM1 mRNA expression levels can and should be used to personalize chemotherapy.
The tyrosine kinase inhibitor erlotinib improves the outcomes of patients with advanced non-small-cell lung carcinoma (NSCLC) harbouring epidermal growth factor receptor (EGFR) mutations. The ...coexistence of the T790M resistance mutation with another EGFR mutation in treatment-naive patients has been associated with a shorter progression-free survival to EGFR inhibition than in the absence of the T790M mutation. To test this hypothesis clinically, we developed a proof-of-concept study, in which patients with EGFR-mutant NSCLC were treated with the combination of erlotinib and bevacizumab, stratified by the presence of the pretreatment T790M mutation.
BELIEF was an international, multicentre, single-arm, phase 2 trial done at 29 centres in eight European countries. Eligible patients were aged 18 years or older and had treatment-naive, pathologically confirmed stage IIIB or stage IV lung adenocarcinoma with a confirmed, activating EGFR mutation (exon 19 deletion or L858R mutation). Patients received oral erlotinib 150 mg per day and intravenous bevacizumab 15 mg/kg every 21 days and were tested centrally for the pretreatment T790M resistance mutation with a peptide nucleic acid probe-based real-time PCR. The primary endpoint was progression-free survival. The primary efficacy analysis was done in the intention-to-treat population and was stratified into two parallel substudies according to the centrally confirmed pretreatment T790M mutation status of enrolled patients (T790M positive or negative). The safety analysis was done in all patients that have received at least one dose of trial treatment. This trial was registered with ClinicalTrials.gov, number NCT01562028.
Between June 11, 2012, and Oct 28, 2014, 109 patients were enrolled and included in the efficacy analysis. 37 patients were T790M mutation positive and 72 negative. The overall median progression-free survival was 13·2 months (95% CI 10·3-15·5), with a 12 month progression-free survival of 55% (95% CI 45-64). The primary endpoint was met only in substudy one (T790M-positive patients). In the T790M-positive group, median progression-free survival was 16·0 months (12·7 to not estimable), with a 12 month progression-free survival of 68% (50-81), whereas in the T790M-negative group, median progression-free survival was 10·5 months (9·4-14·2), with a 12 month progression-free survival of 48% (36-59). Of 106 patients included in the safety analysis, five had grade 4 adverse events (one acute coronary syndrome, one biliary tract infection, one other neoplasms, and two colonic perforations) and one died due to sepsis.
The BELIEF trial provides further evidence of benefit for the combined use of erlotinib and bevacizumab in patients with NSCLC harbouring activating EGFR mutations.
European Thoracic Oncology Platform, Roche.
To address whether preoperative chemotherapy plus surgery or surgery plus adjuvant chemotherapy prolongs disease-free survival compared with surgery alone among patients with resectable ...non-small-cell lung cancer.
In this phase III trial, 624 patients with stage IA (tumor size > 2 cm), IB, II, or T3N1 were randomly assigned to surgery alone (212 patients), three cycles of preoperative paclitaxel-carboplatin followed by surgery (201 patients), or surgery followed by three cycles of adjuvant paclitaxel-carboplatin (211 patients). The primary end point was disease-free survival.
In the preoperative arm, 97% of patients started the planned chemotherapy, and radiologic response rate was 53.3%. In the adjuvant arm, 66.2% started the planned chemotherapy. Ninety-four percent of patients underwent surgery; surgical procedures and postoperative mortality were similar across the three arms. Patients in the preoperative arm had a nonsignificant trend toward longer disease-free survival than those assigned to surgery alone (5-year disease-free survival 38.3% v 34.1%; hazard ratio HR for progression or death, 0.92; P = .176). Five-year disease-free survival rates were 36.6% in the adjuvant arm versus 34.1% in the surgery arm (HR 0.96; P = .74).
In early-stage patients, no statistically significant differences in disease-free survival were found with the addition of preoperative or adjuvant chemotherapy to surgery. In this trial, in which the treatment decision was made before surgery, more patients were able to receive preoperative than adjuvant treatment.
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