Prognostic value of molecular biomarkers in patients with metastatic colorectal cancer: a real-world study

Purpose Outcomes for patients with metastatic colorectal cancer (mCRC) have been improved by the identification of biomarkers predictive and prognostic of clinical outcome. The present retrospective analysis was undertaken to assess the utility of key biomarkers and clinical parameters in predicting outcomes in Spanish patients with mCRC. Methods We retrospectively analyzed tumor samples from a series of patients aged > 18 years with mCRC who were treated at the Hospital General Universitario Gregorio Marañón Spain. Real-time polymerase chain reaction was used to detect KRAS, NRAS, BRAF, and PIK3CA mutations. The key outcome of interest was overall survival (OS). Survival curves were estimated using the Kaplan–Meier method and stratified by the variables of greatest clinical interest. Differences were tested using the log-rank test. Results Median OS in the overall population was 24.4 months. Triple WT patients (WT KRAS, NRAS, and BRAF) and quadruple WT patients (WT KRAS, NRAS, BRAF, and PIK3CA) had significantly better OS than those who did not have triple or quadruple WT tumors. OS was significantly better in patients with left- vs. right-sided tumors, patients with resected primary tumors and metastases vs. those without resection, and patients with isolated hepatic and isolated pulmonary metastases. Conclusions This retrospective, observational study has confirmed the prognostic value of the location and resection status of the primary tumor and metastases in Spanish patients with mCRC. Triple WT status, in particular, was prognostic in this patient population, with PIK3CA adding to the prognostic value in the quadruple WT population (AU)

Prognostic value of molecular biomarkers in patients with metastatic colorectal cancer: a real-world study.

PURPOSE: Outcomes for patients with metastatic colorectal cancer (mCRC) have been improved by the identification of biomarkers predictive and prognostic of clinical outcome. The present retrospective analysis was undertaken to assess the utility of key biomarkers and clinical parameters in predicting outcomes in Spanish patients with mCRC. METHODS: We retrospectively analyzed tumor samples from a series of patients aged > 18 years with mCRC who were treated at the Hospital General Universitario Gregorio Marañón Spain. Real-time polymerase chain reaction was used to detect KRAS, NRAS, BRAF, and PIK3CA mutations. The key outcome of interest was overall survival (OS). Survival curves were estimated using the Kaplan-Meier method and stratified by the variables of greatest clinical interest. Differences were tested using the log-rank test. RESULTS: Median OS in the overall population was 24.4 months. Triple WT patients (WT KRAS, NRAS, and BRAF) and quadruple WT patients (WT KRAS, NRAS, BRAF, and PIK3CA) had significantly better OS than those who did not have triple or quadruple WT tumors. OS was significantly better in patients with left- vs. right-sided tumors, patients with resected primary tumors and metastases vs. those without resection, and patients with isolated hepatic and isolated pulmonary metastases. CONCLUSIONS: This retrospective, observational study has confirmed the prognostic value of the location and resection status of the primary tumor and metastases in Spanish patients with mCRC. Triple WT status, in particular, was prognostic in this patient population, with PIK3CA adding to the prognostic value in the quadruple WT population.

Clinical significance and outcome of Aeromonas spp. infections among 204 adult patients.

The objectives of this investigation were to analyze the clinical patterns, risk groups, prognostic factors, and mortality of infections caused by Aeromonas spp. This was a retrospective study of adult patients with Aeromonas spp. isolates attended at the Hospital del Mar in Barcelona, Spain, between January 2006 and December 2012. Epidemiological data, antimicrobial susceptibility, clinical patterns, underlying illnesses, type of infection, admission to the intensive care unit (ICU), number of episodes, coinfection, antimicrobial therapy, and evolution were analyzed. A total of 221 clinical samples from 204 patients were positive for Aeromonas spp. The mean age of the patients was 67.6 years. The main clinical form of presentation was gastrointestinal (78.4%). Malignancy was the main risk group in 69 (33.8%) patients, and 48 (23.5%) were previously healthy. Twenty-one patients (10.3%) were admitted to the ICU. Infections were acquired in the hospital in 52.5% of the patients, and 28.9% were polymicrobial. The overall mortality (after 1 year of follow-up from the first positive culture) was 26.5%. Univariate analysis identified an association between increased mortality and the following variables: age ≥80 years, hospitalization, admission to the ICU, malignancy, extraintestinal infection, and appropriate antimicrobial therapy. In the multivariate analysis, age ≥80 years [odds ratio (OR), 4.37 [95% confidence interval (CI), 1.68-11.35; p = 0.002]], admission to the ICU (OR, 6.59 [95% CI, 2.17-19.99; p = 0.001]), and malignancy (OR, 3.62 [95% CI, 1.32-9.90; p = 0.012]) were significantly associated with mortality. Aeromonas infections are mainly gastrointestinal. The 1-year follow-up mortality rate was high. Old age (age ≥80 years), admission to the ICU, and malignancy were identified as independent risk factors for mortality.

New clinical trials regulation in Spain: analysis of royal decree 1090/2015

The coming into force of Directive 2001/20/EC represented a step forward in harmonising clinical trial regulation in European countries, guaranteeing a uniform protection of subjects participating in clinical research across Europe. However, it led to a disproportionate increase in the bureaucratization, and thus, it became evident that procedures needed to be simplified without detriment to patient’s safety. Thus, Regulation 536/2014, that repealed Directive 2001/20/EC, with the aim of decreasing the growing bureaucratization and stimulating clinical research in Europe, established simplified procedures, such as regulating a common procedure for authorising trials in Europe, the institution of strict assessment timelines, or the definition of new concepts, such as «low-intervention clinical trial». The legal form of a Regulation allowed the norm to be directly applied to Member States without the need for transposition. By means of the new Royal Decree, the national legislation is adapted to make the application of the regulation feasible and it allows the development of the aspects that the Regulation leaves to national legislation. Both documents seek to stimulate clinical research with medicinal products to foster knowledge, facilitate transparency, and reinforce subjects’ safety. This will surely be the case, but with this revision, we will look at the novelties and key aspects that are most relevant to investigators and we will analyse the consequences for all parties involved in clinical research (AU)

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New clinical trials regulation in Spain: analysis of royal decree 1090/2015.

The coming into force of Directive 2001/20/EC represented a step forward in harmonising clinical trial regulation in European countries, guaranteeing a uniform protection of subjects participating in clinical research across Europe. However, it led to a disproportionate increase in the bureaucratization, and thus, it became evident that procedures needed to be simplified without detriment to patient's safety. Thus, Regulation 536/2014, that repealed Directive 2001/20/EC, with the aim of decreasing the growing bureaucratization and stimulating clinical research in Europe, established simplified procedures, such as regulating a common procedure for authorising trials in Europe, the institution of strict assessment timelines, or the definition of new concepts, such as "low-intervention clinical trial". The legal form of a Regulation allowed the norm to be directly applied to Member States without the need for transposition. By means of the new Royal Decree, the national legislation is adapted to make the application of the regulation feasible and it allows the development of the aspects that the Regulation leaves to national legislation. Both documents seek to stimulate clinical research with medicinal products to foster knowledge, facilitate transparency, and reinforce subjects' safety. This will surely be the case, but with this revision, we will look at the novelties and key aspects that are most relevant to investigators and we will analyse the consequences for all parties involved in clinical research.

[Hemodynamic monitoring in the critically patient. Recomendations of the Cardiological Intensive Care and CPR Working Group of the Spanish Society of Intensive Care and Coronary Units]. / Monitorización hemodinámica en el paciente crítico. Recomendaciones del Grupo de Trabajo de Cuidados Intensivos Cardiológicos y RCP de la Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias.

Hemodynamic monitoring offers valuable information on cardiovascular performance in the critically ill, and has become a fundamental tool in the diagnostic approach and in the therapy guidance of those patients presenting with tissue hypoperfusion. From introduction of the pulmonary artery catheter to the latest less invasive technologies, hemodynamic monitoring has been surrounded by many questions regarding its usefulness and its ultimate impact on patient prognosis. The Cardiological Intensive Care and CPR Working Group (GTCIC-RCP) of the Spanish Society of Intensive Care and Coronary Units (SEMICYUC) has recently impulsed the development of an updating series in hemodynamic monitoring. Now, a final series of recommendations are presented in order to analyze essential issues in hemodynamics, with the purpose of becoming a useful tool for residents and critical care practitioners involved in the daily management of critically ill patients.

Estimación del gasto cardíaco. Utilidad en la práctica clínica. Monitorización disponible invasiva y no invasiva / Estimating cardiac output. Utility in the clinical practice. Available invasive and non-invasive monitoring

Esta revisión pretende profundizar en el conocimiento del gasto cardíaco, sus variables y sus condicionantes, así como repasar exhaustivamente las diferentes técnicas disponibles para su monitorización y establecer las situaciones en que el conocimiento del gasto cardíaco nos aporta una información fundamental en el manejo del paciente crítico. La técnica de Fick, utilizada en los inicios para calcular el gasto cardíaco de los pacientes, ha sido sustituida hoy en día en la práctica clínica por los métodos de termodilución (transcardíacao transpulmonar), litiodilución, biorreactancia, la tecnología basada en el efecto Doppler ola ecocardiografía. El análisis de la onda de pulso ha permitido la obtención de una medida continua y mínimamente invasiva del gasto cardíaco. Otros métodos, como la biorrectancia,el Doppler o la ecocardiografía nos permiten, en la actualidad, obtener medidas del gastocardíaco de forma no invasiva, rápida y fiable (AU)

This aim of this review is to provide a detailed review of the physiologic conditions and variables of the cardiac output, as well as review the different techniques available for its measurement. We also want to establish the clinical situations in which the measurement of cardiac output can add valuable information for the management of critically ill patients. The Fick technique, used in the beginning to calculate cardiac output, has been replaced today by thermodilution techniques (transcardiac or transpulmonary), lithium dilution, bioreactance, Doppler technique or echocardiography. Pulse wave analysis allows a continuous minimally invasive cardiac output measurement. Other methods, such bioreactance, Doppler technique or echocardiography currently provide a valid, fast and non-invasive measurement of cardiac output (AU)

[Estimating cardiac output. Utility in the clinical practice. Available invasive and non-invasive monitoring]. / Estimación del gasto cardíaco. Utilidad en la práctica clínica. Monitorización disponible invasiva y no invasiva.

This aim of this review is to provide a detailed review of the physiologic conditions and variables of the cardiac output, as well as review the different techniques available for its measurement. We also want to establish the clinical situations in which the measurement of cardiac output can add valuable information for the management of critically ill patients. The Fick technique, used in the beginning to calculate cardiac output, has been replaced today by thermodilution techniques (transcardiac or transpulmonary), lithium dilution, bioreactance, Doppler technique or echocardiography. Pulse wave analysis allows a continuous minimally invasive cardiac output measurement. Other methods, such bioreactance, Doppler technique or echocardiography currently provide a valid, fast and non-invasive measurement of cardiac output.

[Intermediate care units. Health care consequences in a reference hospital]. / Unidades de Cuidados Intermedios. Consecuencias asistenciales en un hospital de referencia.

INTRODUCTION: Intermediate Care Units are forms to provide health care services to potentially critical patients that allow for improved cost-benefit ratio of the care offered by Intensive Medicine Departments. OBJECTIVE: Analyze heart care repercussion that the permanent opening of this type of unit had in a reference teaching center. DESIGN: Prospective. PERIOD: From the beginning of 2003 to the end of 2005. SCOPE: Intensive Medicine Department (IMD), with teaching accreditation, which has 15 conventional ICU beds and 4 intermediate care beds. PATIENTS AND METHODS: Analysis of demographic data (gender and age, type of patient, and origin or admission), of severity (SAPS 2), prognosis (MPM II 0 and SAPS2) and health care burden (NEMS) in 3,392 consecutive admissions to IMD. Specific analysis of the stay and mortality (intra- and post ICU). RESULTS: Permanent opening of an intermediate care unit is associated with an increase of patients seen by the IMD and makes it possible to clearly identify two different types of patients according to the site linked to the cause of the admission. The patients seen in the Intermediate Care Unit have a shorter stay, less seriousness, greater survival prognosis and less care burden. However, the initiation of this service does not decrease the interval of total mortality (intra+post- ICU). CONCLUSION: Initiating an intermediate care unit depending on an IMD increases its health care capacity and that of the center it gives service to without affecting global mortality.

Unidades de Cuidados Intermedios. Consecuencias asistenciales en un hospital de referencia / Intermediate care units. Health careconsequences in a reference hospital

Introducción. Las Unidades de Cuidados Intermedios constituyen formas de prestación asistencial a pacientes potencialmente críticos que permiten mejorar la relación coste-beneficio de la asistencia ofertada por los Servicios de Medicina Intensiva (SMI). Objetivo. Analizar la repercusión asistencial que en un centro docente de referencia ha tenido la apertura estable de una Unidad de este tipo. Diseño. Prospectivo. Período. Desde el inicio de 2003 a finales de 2005. Ámbito. Servicio de Medicina Intensiva, con acreditación docente, dotado de 15 camas de Unidad de Cuidados Intensivos (UCI) convencional y 4 camas de cuidados intermedios. Pacientes y método. Análisis, en 3.392 ingresos consecutivos en el SMI de datos demográficos (sexo y edad, tipo de paciente y procedencia del ingreso), de gravedad (SAPS 2), pronóstico (MPM II 0 y SAPS 2) y carga asistencial (NEMS). Análisis específico de la estancia y de la mortalidad (intra y post UCI). Resultados. La apertura estable de una Unidad de Cuidados Intermedios se asocia con un incremento de pacientes atendidos por el SMI, y permite identificar claramente dos tipos distintos de pacientes conforme la ubicación ligada a la causa de ingreso. Los pacientes atendidos en la Unidad de Cuidados Intermedios tienen una menor estancia, una menor gravedad, un mejor pronóstico de supervivencia y una menor carga asistencial. Sin embargo, la puesta en marcha de esta prestación no disminuye el intervalo de mortalidad total (intra + post UCI). Conclusión. La puesta en marcha de una Unidad de Cuidados Intermedios dependiente de un SMI incrementa la capacidad asistencial del mismo y del centro al que presta servicio sin afectar a la mortalidad global

Introduction. Intermediate Care Units are forms to provide health care services to potentially critical patients that allow for improved cost-benefit ratio of the care offered by Intensive Medicine Departments. Objective. Analyze heart care repercussion that the permanent opening of this type of unit had in a reference teaching center. Design. Prospective. Period. From the beginning of 2003 to the end of 2005. Scope. Intensive Medicine Department (IMD), with teaching accreditation, which has 15 conventional ICU beds and 4 intermediate care beds. Patients and methods. Analysis of demographic data (gender and age, type of patient, and origin or admission), of severity (SAPS 2), prognosis (MPM II 0 and SAPS2) and health care burden (NEMS) in 3,392 consecutive admissions to IMD. Specific analysis of the stay and mortality (intra- and post ICU). Results. Permanent opening of an intermediate care unit is associated with an increase of patients seen by the IMD and makes it possible to clearly identify two different types of patients according to the site linked to the cause of the admission. The patients seen in the Intermediate Care Unit have a shorter stay, less seriousness, greater survival prognosis and less care burden. However, the initiation of this service does not decrease the interval of total mortality (intra + post- ICU). Conclusion. Initiating an intermediate care unit depending on an IMD increases its health care capacity and that of the center it gives service to without affecting global mortality

Home total parenteral nutrition in a "no-bowel" patient in Spain.

OBJECTIVE: To report a case of a patient with no functional bowel who was receiving home total parenteral nutrition in a country that has had a few professional experiences in this area of therapy. CASE SUMMARY: A woman with a history of scattered colonic polyposis developed a mesenteric tumor that caused intestinal obstruction. Tumor withdrawal required the excision of 1.5 m of jejunum-ileum. Postoperative complications required further surgical intervention and subtotal intestinal resection. Duodenocolic anastomosis was not possible and a high output and permanent fistula remained. DISCUSSION: The complications of home parenteral nutrition addressed in the literature are reviewed. The problems encountered in our patient have been resolved. CONCLUSIONS: After three years of postoperative survival, we believe the quality of life of our patient has increased and the parenteral nutrition team members are much better prepared to manage patients with similar problems.