Impact of intestinal dysbiosis-related drugs on the efficacy of immune checkpoint inhibitors in clinical practice.

PURPOSE: Intestinal dysbiosis has emerged as a biomarker of response to immune checkpoint inhibitors (ICIs). It can be caused by antibiotics, although it may also result from the use of other drugs that have been studied to a lesser extent. The objective of our study was to analyze the association between the use of potentially dysbiosis-related drugs and survival in patients treated with ICIs in the clinical practice. MATERIALS AND METHODS: A retrospective, multicenter, cohort study was conducted. Clinicopathological variables were collected and the concomitant use of drugs was analyzed. A descriptive analysis of variables and overall survival, estimated by the Kaplan-Meier method, was performed, and association with various independent variables was assessed using Cox regression. RESULTS: We included 253 patients, mainly with non-small cell lung cancer and melanoma. The most commonly used drugs were acid reducers, prescribed to 55.3% of patients, followed by corticosteroids (37.9%), anxiolytic drugs (35.6%), and antibiotics (20.5%). The use of acid reducers (9 vs. 18 months, P < .0001), antibiotics (7 vs. 15 months, P < .017), anxiolytic drugs (8 vs. 16 months, P < .015), and corticosteroids (6 vs. 19 months, P < .00001) was associated with poorer overall survival. Furthermore, the greater the number of drugs used concomitantly with ICIs, the higher the risk of death (1 drug: hazard ratio, 1.88; CI 95%, 1.07-3.30; 4 drugs: hazard ratio, 4.19; CI9 5%, 1.77-9.92; P < .001). CONCLUSION: Response to ICIs may be influenced by the use of drugs that lead to intestinal dysbiosis. Although a confirmatory prospective controlled study is required, our findings should be taken into account when analyzing ICI efficacy.

[Impact of the creation of a nutritional support team on the quality, safety and effectiveness of total parenteral nutrition]. / Impacto de la creación de un equipo de soporte nutricional en la calidad, seguridad y efectividad de la nutrición parenteral.

INTRODUCTION: Parenteral nutrition (PN) is an essential component in the treatment of many hospitalized patients; however its use is associated to severe complications. The monitoring of these patients has been demonstrated as an effective method for the success of nutrition therapy; therefore, nutritional support teams play an important role to increase the effectiveness and efficiency of the PN. In Spain, there is no data available about the situation of nutritional support teams in hospitals. OBJECTIVE: Develop a nutritional support team in our hospital and analyze the interventions and outcomes in terms of quality, effectiveness and safety. METHODS: Retrospective, cross-sectional study. Patients with PN were selected during two months, corresponding to the period before and after the creation of the nutritional support team (group 1 and 2, respectively). The functions of the nutritional team include: nutritional evaluation, daily monitoring of vital signs and glycemia, detailed analytical control, management of PN complications, between others. RESULTS: 67% of patients in group 1 (n = 24) maintain the PN < 7 days, versus 22% in group 2 (n = 38). In group 1, no patient had a nutritional assessment, neither daily vital signs monitoring (100% in group 2). Detailed analytical control was carried out in the 4% of group 1 and 79% of group 2. In group 2, albumin and prealbumin levels remain stable or increased in the 66% and 88% of patients, respectively. No patient reached triglyceride > 400 mg/dl. 34% of patients showed glycemia > 140 mg/dl (100% of them were solved), and 26% of patients underwent hepatic dysfunction (50% were solved). No refeeding syndrome was reported (thiamine was added to PN in 34% of patients). DISCUSSION: the nutritional support team work has notably increased the quality, safety and effectiveness of PN. This study demonstrates the need to incorporate multidisciplinary nutritional teams in hospitals and the benefit obtained in the patient medical care.

Impacto de la creación de un equipo de soporte nutricional en la calidad, seguridad y efectividad de la nutrición parenteral / Impact of the creation of a nutritional support team on the quality, safety and effectiveness of total parenteral nutrition

Introducción: La nutrición parenteral (NP) es esencial en muchos pacientes hospitalizados, no estando exenta de complicaciones. El seguimiento de estos pacientes constituye un método eficaz para el éxito de la terapia nutricional, por lo que los equipos de soporte nutricional han incrementado la eficacia y eficiencia de la NP. En España, no existen referencias sobre los equipos de soporte nutricional hospitalarios. Objetivos: Crear un equipo nutricional y analizar las intervenciones realizadas y los resultados obtenidos en términos de calidad, efectividad y seguridad en la NP. Métodos: estudio retrospectivo transversal. Se seleccionaron los pacientes con NP durante dos meses, previos y posterior a la creación del equipo (grupo 1 y 2, respectivamente). Las funciones del equipo incluyen: valoración del paciente, seguimiento diario de constantes vitales y glucemia, control analítico completo, manejo de complicaciones metabólicas, electrolíticas y hepáticas, entre otras. Resultados: La duración de la NP fue < 7 días en el 67% del grupo 1 (n = 24) y en el 22% del grupo 2 (n = 38). Ningún paciente fue valorado, ni tuvo seguimiento diario de constantes vitales en el grupo 1 (100% grupo 2). El control analítico completo se realizó en el 4% del grupo 1 y 79% del grupo 2. En el grupo 2, los niveles de albúmina y prealbúmina se mantuvieron estables o aumentaron en el 66% y 88% de los pacientes, respectivamente. Ningún paciente presentó hipertrigliceridemia. El 34% presentó glucemias > 140 mg/dl (100% fueron resueltas) y el 26% presentó complicaciones hepatobiliares (50% fueron resueltas). Ningún paciente presentó síndrome de realimentación (se añadió tiamina al 34%). Discusión: El equipo nutricional ha incrementado notablemente la calidad, seguridad y efectividad de la NP quedando demostrada la necesidad de dichos equipos multidisciplinares a nivel hospitalario (AU)

Introduction: Parenteral nutrition (PN) is an essential component in the treatment of many hospitalized patients; however its use is associated to severe complications. The monitoring of these patients has been demonstrated as an effective method for the success of nutrition therapy; therefore, nutritional support teams play an important role to increase the effectiveness and efficiency of the PN. In Spain, there is no data available about the situation of nutritional support teams in hospitals. Objective: Develop a nutritional support team in our hospital and analyze the interventions and outcomes in terms of quality, effectiveness and safety. Methods: Retrospective, cross-sectional study. Patients with PN were selected during two months, corresponding to the period before and after the creation of the nutritional support team (group 1 and 2, respectively). The functions of the nutritional team include: nutritional evaluation, daily monitoring of vital signs and glycemia, detailed analytical control, management of PN complications, between others. Results: 67% of patients in group 1 (n = 24) maintain the PN < 7 days, versus 22% in group 2 (n = 38). In group 1, no patient had a nutritional assessment, neither daily vital signs monitoring (100% in group 2). Detailed analytical control was carried out in the 4% of group 1 and 79% of group 2. In group 2, albumin and prealbumin levels remain stable or increased in the 66% and 88% of patients, respectively. No patient reached triglyceride > 400 mg/dl. 34% of patients showed glycemia > 140 mg/dl (100% of them were solved), and 26% of patients underwent hepatic dysfunction (50% were solved). No refeeding syndrome was reported (thiamine was added to PN in 34% of patients). Discussion: the nutritional support team work has notably increased the quality, safety and effectiveness of PN. This study demonstrates the need to incorporate multidisciplinary nutritional teams in hospitals and the benefit obtained in the patient medical care (AU)

Respuesta parcial de etanercept en el tratamiento de la hidradenitis supurativa / No disponible

Objetivo Revisión del tratamiento de la hidradenitis pupurativa y papel de etanercept en términos de eficacia y seguridad. Métodos Estudio descriptivo transversal retrospectivo. Se incluyeron pacientes diagnosticados de hidradenitis supurativa tratados con etanercept (indicación fuera de ficha técnica) hasta junio de 2009. Las variables estudiadas fueron: edad, sexo, tratamientos anteriores y posteriores a etanercept, respuesta, efectos adversos, duración y motivo de suspensión. Resultados Como primera línea de tratamiento se emplearon antibióticos, anticonceptivos, corticoides, isotretinoína o sulfonas orales. Ante la falta de respuesta mantenida se solicitó el uso de etanercept. Fue bien tolerado, pero únicamente permitió obtener una mejoría inicial, por lo que fue suspendido. Las siguientes opciones que se emplearon incluyeron corticoides, antibióticos, isotretinoína, anticonceptivos, inmunosupresores y antiandrógenos. Los pacientes tratados con adalimumab e infliximab como alternativa presentaron reactivación de las lesiones. Como última opción se plantea el tratamiento quirúrgico. Actualmente, la mayoría de los pacientes están en terapia de mantenimiento con tratamientos orales. Conclusiones El tratamiento de la hidradenitis supurativa se basa en antibióticos, corticoides o anticonceptivos con los que se obtiene un control transitorio de la enfermedad. El etanercept es bien tolerado, pero su eficacia se limita a una mejoría inicial. Se han obtenido resultados similares con infliximab y adalimumab. La cirugía permite obtener un control en la zona intervenida. Por tanto, el papel de los anti-TNF en el tratamiento de la hidradenitis supurativa es controvertido (AU)

Objective To review the treatment of hidradenitis suppurativa and the role of etanercept in terms of efficacy and safety. Methods Descriptive, cross-sectional and retrospective study. Patients diagnosed with hidradenitis suppurativa who were treated with etanercept (indication not on its Summary of Product Characteristics) until June 2009 were included in the study. The study variables were: age, sex, treatments before and after etanercept, response, adverse effects, duration and reason for stopping treatment. Results Antibiotics, contraceptives, corticosteroids, isotretinoin or oral sulfones were used as the first-line treatment. When patients no longer responded to these treatments, the use of etanercept was requested. It was well tolerated but it only led to an initial improvement. It was, therefore, suspended. The options employed included the following: corticosteroids, antibiotics, isotretinoin, contraceptives, immunosuppressive drugs and antiandrogens. Patients who were treated with adalimumab and infliximab as an alternative treatment found that their lesions flared up. Surgery was considered as a last option. At present, the majority of patients are undergoing maintenance therapy with oral treatments. Conclusions The treatment of hidradenitis suppurativa is based on antibiotics, corticosteroids or contraceptives. These are able to control the disease temporarily. Etanercept is well tolerated but it only results in an initial improvement. Similar results have been found with infliximab and adalimumab. The affected areas can be controlled with surgery. Therefore, the role of TNF inhibitors in the treatment of hidradenitis suppurativa is controversial (AU)