Primary systemic therapy in HER2-positive operable breast cancer using trastuzumab and chemotherapy: efficacy data, cardiotoxicity and long-term follow-up in 142 patients diagnosed from 2005 to 2016 at a single institution

Objective: The aim of this study was to evaluate the efficacy, cardiotoxicity profile and long-term benefits of neoadjuvant therapy in human epidermal growth factor receptor 2-positive operable breast cancer patients. Patients and methods: A total of 142 patients diagnosed from 2005 to 2016 were included in the study. The treatment consisted of a sequential regimen of taxanes and anthracyclines plus trastuzumab. The clinical and pathological responses were evaluated and correlated with clinical and biological factors. The cardiotoxicity profile and long-term benefits were analyzed. Results: The median age was 49 years, and 4%, 69% and 27% of patients had stage I, II and III breast cancer, respectively, while 10% had inflammatory breast cancer at diagnosis. Hormone receptor (HR) status was negative in 43%, and 62% had grade III breast cancer. The clinical complete response rate was 49% and 63% as assessed using ultrasound and magnetic resonance imaging, respectively, and this allowed a high rate of conservative surgery (66%). The pathological complete response (pCR) rate was 52%, and it was higher in HR-negative (64%) patients than in HR-positive (41%) patients and in grade III breast cancer (53%) patients than in grade I-II breast cancer (45%) patients. Patients who achieved pCR had longer disease-free survival and a trend toward improved overall survival. A total of 2% of patients showed a 10% decrease in left ventricular ejection fraction to <50% during treatment. All patients except one recovered after discontinuation of trastuzumab. Conclusion: A sequential regimen of taxanes and anthracyclines plus trastuzumab was effective, with high pCR rates and long-term benefit, and had a very good cardiotoxicity profile

Una propuesta de aplicación de la estrategia curricular de investigación e informática en la carrera de medicina.

 Introducción: La estrategia curricular de investigación e informática tiene como objetivo fundamental el egresar un médico capaz de utilizar la estadística como herramienta metodológica, sin embargo, la aplicación concreta de ésta, presenta ciertas deficiencias. Objetivo: Diseñar y evaluar una propuesta de aplicación de la estrategia curricular de investigación e informática en la carrera de medicina. Método: Se realizó una experiencia pedagógica en el período de febrero a junio del 2014 y septiembre a diciembre 2015. Se adecuó el P1 de segundo año para comenzar con el tema de Metodología de la investigación, se ofertaron los temas a los estudiantes por parte de la asignatura Psicología y se orientó el seminario en el cual los estudiantes tenían que exponer el perfil de proyecto. Posteriormente se fue revisando por equipos las partes del proyecto que no pudieron ser expuestas en el seminario como: la operacionalización de las variables y el procesamiento estadístico, el cual se entregó y discutió al final del semestre. En el primer semestre de tercer año se ejecutó la investigación. Resultados: El 83,3% de los estudiantes fue evaluado de 4 y 5 puntos en el proyecto y el 100 % en el informe final. Conclusiones: En la defensa de los trabajos se obtuvieron resultados superiores a años anteriores por lo que se considera que lo realizado constituye una implementación adecuada de la misma. Palabras clave: estadística, investigación médica, estrategia curricular.</p

West Nile Virus Isolation in Human and Mosquitoes, Mexico

West Nile virus has been isolated for the first time in Mexico, from a sick person and from mosquitoes (Culex quinquefasciatus). Partial sequencing and analysis of the 2 isolates indicate that they are genetically similar to other recent isolates from northern Mexico and the western United States

Scientific Opinion on the safety and efficacy of L-threonine produced by Escherichia coli strains NRRL B-30843, DSM 26131, KCCM11133P or DSM 25085 for all animal species based on a dossier submitted by AMAC EEIG

This opinion concerns L-threonine as a feed additive produced by four different strains derived from Escherichia coli K-12. Three strains are genetically modified (GM): NRRL B-30843, KCCM11133P and DSM 26131. L-Threonine produced by E. coli DSM 26131 could not be assessed because of the insufficient molecular characterisation of the genetic modification, and the lack of data on both the absence of the production strain and its recombinant DNA from the final product. No safety concerns were found in the products related to the genetic modification of the other GM strains or to antibiotic resistance of the producer strains. L-Threonine products made by fermentation using E. coli strains NRRL B-30843, KCCM11133P and DSM 25085 are free of the production strain and have a high purity (>= 98.8 %). L-Threonine, technically pure, produced by E. coli strains NRRL B-30843, KCCM11133P and DSM 25085 is safe for the target animals when used in appropriate amounts to supplement threonine-deficient feeds, for the consumer of animal products and for the environment. The FEEDAP Panel considers that L-threonine produced by E. coli strains NRRL B-30843, KCCM11133P or DSM 25085 is not an irritant to eyes and skin, and is not a skin sensitiser. There is no risk from inhalation of L-threonine, but concerns may arise from the content of endotoxins in the products. These L-threonine products are considered an efficacious source of the amino acid L-threonine for all animal species. For L-threonine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen. The Panel on Additives and Products or Substances used in Animal Feed ( FEEDAP) has concerns regarding the safety of the simultaneous oral administration of L-threonine via water for drinking and feed

Scientific Opinion on the safety and efficacy of sorbic acid and potassium sorbate when used as technological additives for all animal species based on two dossiers from Nutrinova Nutrition Specialties &amp; Food Ingredients GmbH

Sorbic acid and potassium sorbate are already authorised for use in food and feed as preservatives. Sorbic acid and potassium sorbate are safe when used at the maximum proposed dose in feed for pigs, poultry, dogs and cats (2 500 (sorbic acid) and 3 400 (potassium sorbate) mg/kg complete feed) and young ruminants (6 700 (sorbic acid) and 9 000 (potassium sorbate) mg/kg complete feed). This conclusion is extended to all other animal species at maximum concentrations of 2 500 (sorbic acid) and 3 400 (potassium sorbate) mg/kg complete feed. Both additives are considered safe for target animals when used in water for drinking, provided that the same maximum exposure is respected. No residues of sorbic acid or potassium ions are expected in edible products of food-producing animals when fed sorbic acid or potassium sorbate at the maximum proposed concentrations. Therefore, their use in feed up to the maximum proposed level is considered safe for the consumer. Sorbic acid and potassium sorbate are skin, eye and respiratory tract irritants. The use of sorbic acid and its potassium salt in animal nutrition would not pose a risk to the environment. As sorbic acid and potassium sorbate are food additives authorised within the EU for use as preservatives, it is reasonable to expect that the effect in food will be observed in feed when used at comparable concentrations and under similar conditions. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has reservations about the effectiveness of sorbic acid and its potassium salt as preservatives in complete feedingstuffs with a moisture content of <= 12 %

Safety and efficacy of Bacillus&#160;subtilis DSM&#160;28343 as a feed additive for chickens for fattening

The additive is a preparation containing viable spores of a strain of Bacillus subtilis which has never been authorised in the EU. It is intended to be used in feeds for chickens for fattening at the recommended dose of 1 9 109 colony-forming unit (CFU)/kg complete feedingstuffs. The bacterial species B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the active agent has been established and the susceptibility to antibiotics and lack of toxigenic potential have been demonstrated, the use of Bacillus subtilis DSM 28343 can be presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Bacillus subtilis DSM 28343 is not an eye/ skin irritant but should be considered as a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the skin sensitisation potential. Bacillus subtilis DSM 28343 at the proposed dose has the potential to be efficacious in improving growth of chickens for fattening. B. subtilis DSM 28343 is compatible with the coccidiostats lasalocid A sodium, diclazuril, monensin sodium, maduramicin ammonium, decoquinate, nicarbazin, robenidine hydrochloride and halofuginone hydrobromide

Safety and efficacy of Calsporin((R)) (Bacillus subtilis DSM 15544) as a feed additive for laying hens and avian species for laying EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

The additive Calsporin (R) is a preparation containing viable spores of a single strain of Bacillus subtilis. The product was previously assessed by the European Food Safety Authority and is currently authorised for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds. The present application is for an extension of use in feed for laying hens and minor avian species for laying and for game, sporting and ornamental birds for laying. No evidence of toxigenic potential or resistance to antibiotics of human and veterinary importance was found, as judged by the current guidelines. Thus the conclusion reached in previous opinions that this strain of B. subtilis is presumed safe for target animals, consumers and the environment is still considered valid. This conclusion automatically covers the use of the additive in feed for laying hens and for all avian species for laying. Use of the additive in feed for laying hens and for all avian species for laying will not introduce hazards for users not already considered. In the three trials conducted with laying hens the amount of feed needed to produce a unit of egg mass was significantly reduced when Calsporin (R) was included at the minimum recommended dose of 3 x 10(8) colony-forming units per kilogram of feed. While the Panel notes that one of the studies involved layers in the second half of production rather than from the onset of laying, the positive outcome is taken to indicate a potential for efficacy over the entire laying period. This conclusion on efficacy for laying hens can be extended to all avian species for laying when the additive is used at the same minimum dose

Scientific Opinion on the safety and efficacy of Bacillus subtilis KCCM 10673P and Aspergillus oryzae KCTC 10258BP as feed additives for all animal species

PepSoyGen-C is described as pure cultures of Aspergillus oryzae and Bacillus subtilis added simultaneously to feed materials to reduce antinutritional factors. The applicant is seeking its authorisation as a technological additive, under a newly proposed, currently non-existent functional group, "substances for the reduction of antinutritional factors". The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the two microbial cultures should be regarded as two independent feed additives that are the subject of the evaluation. The additives are poorly characterised. The inclusion level is likely to be 2 % by weight of the total substrate. The ratio of the two cultures is described as 50/50 on a weight basis. A dose expressed in colony-forming units per kilogram of feed is not proposed. No evidence of toxigenic potential or resistance to antibiotics of human and veterinary importance was found, according to the current guidance documents. Therefore, the B. subtilis additive is presumed safe for target animals, consumers of products fed the additive and the environment. The B. subtilis additive should be considered as having the potential to be a skin and eye irritant and a skin sensitiser and be treated accordingly. In the absence of data on production of toxic secondary metabolites in A. oryzae, the FEEDAP Panel cannot draw conclusions on its safety for the target species and consumers of products fed the additive. The A. oryzae additive should be considered as having the potential to be a skin and eye irritant and a skin and respiratory sensitiser and be treated accordingly. The use of the additive as a technological feed additive is not expected to pose a risk to the environment. The FEEDAP Panel cannot draw conclusions on the efficacy of the additives in reducing antinutritional factors in soybean and other feed materials

Older Adult Patients in the Emergency Department: Which Patients should be Selected for a Different Approach?

Background: While multidimensional and interdisciplinary assessment of older adult patients improves their short-term outcomes after evaluation in the emergency department (ED), this assessment is time-consuming and ill-suited for the busy environment. Thus, identifying patients who will benefit from this strategy is challenging. Therefore, this study aimed to identify older adult patients suitable for a different ED approach as well as independent variables associated with poor short-term clinical outcomes. Methods: We included all patients >= 65 years attending 52 EDs in Spain over 7 days. Sociodemographic, comorbidity, and baseline functional status data were collected. The outcomes were 30 -day mortality, re -presentation, hospital readmission, and the composite of all outcomes. Results: During the study among 96,014 patients evaluated in the ED, we included 23,338 patients >= 65 years-mean age, 78.4 +/- 8.1 years; 12,626 (54.1%) women. During follow-up, 5,776 patients (24.75%) had poor outcomes after evaluation in the ED: 1,140 (4.88%) died, 4,640 (20.51) returned to the ED, and 1,739 (7.69%) were readmitted 30 days after discharge following the index visit. A model including male sex, age >= 75 years, arrival by ambulance, Charlson Comorbidity Index >= 3, and functional impairment had a C -index of 0.81 (95% confidence interval, 0.80-0.82) for 30 -day mortality. Conclusion: Male sex, age >= 75 years, arrival by ambulance, functional impairment, or severe comorbidity are features of patients who could benefit from approaches in the ED different from the common triage to improve the poor short-term outcomes of this population

Association of Candidate Gene Polymorphisms With Chronic Kidney Disease: Results of a Case-Control Analysis in the Nefrona Cohort

Chronic kidney disease (CKD) is a major risk factor for end-stage renal disease, cardiovascular disease and premature death. Despite classical clinical risk factors for CKD and some genetic risk factors have been identified, the residual risk observed in prediction models is still high. Therefore, new risk factors need to be identified in order to better predict the risk of CKD in the population. Here, we analyzed the genetic association of 79 SNPs of proteins associated with mineral metabolism disturbances with CKD in a cohort that includes 2, 445 CKD cases and 559 controls. Genotyping was performed with matrix assisted laser desorption ionizationtime of flight mass spectrometry. We used logistic regression models considering different genetic inheritance models to assess the association of the SNPs with the prevalence of CKD, adjusting for known risk factors. Eight SNPs (rs1126616, rs35068180, rs2238135, rs1800247, rs385564, rs4236, rs2248359, and rs1564858) were associated with CKD even after adjusting by sex, age and race. A model containing five of these SNPs (rs1126616, rs35068180, rs1800247, rs4236, and rs2248359), diabetes and hypertension showed better performance than models considering only clinical risk factors, significantly increasing the area under the curve of the model without polymorphisms. Furthermore, one of the SNPs (the rs2248359) showed an interaction with hypertension, being the risk genotype affecting only hypertensive patients. We conclude that 5 SNPs related to proteins implicated in mineral metabolism disturbances (Osteopontin, osteocalcin, matrix gla protein, matrix metalloprotease 3 and 24 hydroxylase) are associated to an increased risk of suffering CKD