One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study

Cancer; Constipation; PainCàncer; Restrenyiment; DolorCáncer; Estreñimiento; DolorAbstract Objectives Naloxegol is a peripherally acting µ-opioid receptor antagonist (PAMORA) for treatment of opioid-induced constipation (OIC). The main objective was to analyse the long-term efficacy, quality of life (QOL) and safety of naloxegol in patients with cancer in a real-world study. Methods This one-year prospective study included patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky≥50 and OIC with inadequate response to treatment with laxative (s). All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation QOL questionnaire (PAC-QOL), the PAC symptoms (PAC-SYM), the response rate at day 15, and months 1-3-6-12, and global QOL (EuroQoL-5D-5L). Results A total of 126 patients (58.7% males) with a mean age of 61.5 years (95% CI 59.4 to 63.7) were included. PAC-SYM and PAC-QOL total score and all their dimensions improved from baseline (p<0.0001). At 12 months, 77.8% of the patients were responders to naloxegol treatment. Global QOL was conserved from baseline. A total of 28 adverse reactions, mainly gastrointestinal were observed in 15.1% of the patients (19/126), being 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) appeared the first 15 days of treatment. Conclusion The results of this first long-term and real-world-data study in patients with cancer, showed the sustained efficacy and safety of naloxegol for the treatment of OIC in this group of patients.This study was sponsored by Kyowa Kirin Farmacéutica S.L., Spain. The funders participated in the design of the study and the drafting of the manuscript

Efficacy of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: a 3-month follow-up analysis

Objectives: Opioid-induced constipation (OIC) can affect up to 63% of all patients with cancer. The objectives of this study were to assess quality of life as well as efficacy and safety of naloxegol, in patients with cancer with OIC. Methods: An observational study was made of a cohort of patients with cancer and with OIC exhibiting an inadequate response to laxatives and treated with naloxegol. The sample consisted of adult outpatients with a Karnofsky performance status score ≥50. The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) and the Patient Assessment of Constipation Symptoms (PAC-SYM) were applied for 3 months. Results: A total of 126 patients (58.2% males) with a mean age of 61.3 years (range 34-89) were included. Clinically relevant improvements (>0.5 points) were recorded in the PAC-QOL and PAC-SYM questionnaires (p<0.0001) from 15 days of treatment. The number of days a week with complete spontaneous bowel movements increased significantly (p<0.0001) from 2.4 to 4.6 on day 15, 4.7 after 1 month and 5 after 3 months. Pain control significantly improved (p<0.0001) during follow-up. A total of 13.5% of the patients (17/126) presented some gastrointestinal adverse reaction, mostly of mild (62.5%) or moderate intensity (25%). Conclusions: Clinically relevant improvements in OIC-related quality of life, number of bowel movements and constipation-related symptoms were recorded as early as after 15 days of treatment with naloxegol in patients with cancer and OIC, with a good safety profile

Estudio multicéntrico español sobre la seguridad del tratamiento ambulatorio de la embolia pulmonar en el paciente con cáncer

La embolia pulmonar (EP) es frecuente en pacientes con cáncer, y constituye una causa de morbilidad y mortalidad relevante en esta población. En este contexto, el manejo clínico de la EP resulta más complejo debido al mayor riesgo de retrombosis y sangrados graves durante la anticoagulación. Además, el cáncer es un factor de riesgo de muerte independiente en series de pacientes con EP sintomática. La introducción de la tomografía computerizada multidetector (TCMD) ha aumentado la tasa de detección de EPs incidentales en pacientes oncológicos, cuyo significado e historia natural no se conoce bien. Algunos estudios retrospectivos sugieren que estos casos pueden equipararse a la EP sintomática. Sin embargo, no se dispone de suficientes series prospectivas dirigidas a evaluar su significado clínico a corto y largo plazo. Por otro lado, la demostración de que el manejo ambulatorio de la trombosis venosa profunda (TVP) es tan seguro como el hospitalario ha despertado el interés de extender el manejo domiciliario a los pacientes con EP de bajo riesgo. Para clasificar a los pacientes con EP agudo sintomático se han desarrollado varias escalas, como el Pulmonary Embolism Severity Index (PESI) y el Geneva Pulmonary Embolism Prognostic Index (GPS). Sin embargo, estas escalas incluyen al cáncer como uno de los predictores más importantes, lo que implica que prácticamente todos los pacientes son calificados “de alto riesgo”, por lo que no permiten discriminar entre unos pacientes y otros. Para solventar este problema se han desarrollado escalas específicas del paciente oncológico como el POMPE-C y la escala del grupo RIETE, que podrían contribuir a mejorar la clasificación de estos casos. Sin embargo, quedaría aún por integrar la embolia incidental y paucisintomática, que representa actualmente hasta el 50% de los casos que ocurren en pacientes con cáncer, desconociéndose la utilidad de las anteriores escalas pronósticas en la clasificación de estos episodios. En este contexto, la presente tesis tiene como objetivos: 1. Caracterizar a los pacientes con EP y cáncer tratados en el hospital o en domicilio. 2. Evaluar la seguridad del tratamiento ambulatorio a través de la tasa de complicaciones a 15 días. 3. Evaluar la mortalidad, la tasa de retrombosis y hemorragia mayor a 30 días en ambas cohortes de pacientes analizados. 4. Constatar la heterogeneidad de criterio en la decisión de manejo hospitalario versus ambulatorio. Resumen 16 5. Caracterizar a un grupo de pacientes tratados en el hospital susceptible de haber sido tratado de manera segura en domicilio. 6. Describir las razones de hospitalización de dicho grupo de pacientes. Conocer las características de una población con EP y cáncer tratada con éxito de manera ambulatoria, nos permitiría contribuir a definir una población de bajo riesgo candidata a recibir tratamiento extrahospitalario de manera segura, mejorando su calidad de vida y ahorrando los costes asociados

Therapeutic impact and routine application of next-generation sequencing: A single institute study.

Genomic sequencing of tumor tissues provides information on actionable gene aberrations that have diagnostic and therapeutic significance and may guide clinical management through the use of targeted therapies. The indications for these techniques and their possible limitations for application in daily practice should be established as a priority. In the present study, a group of patients with few suitable therapeutic options who were eligible for a next-generation sequencing (NGS) analysis were analyzed, and the molecular targets identified and their therapeutic impact are described. A series of 26 patients treated at the Virgen Macarena Hospital for whom an NGS study was requested between January 2017 and December 2019 were reviewed. Actionable molecular alterations were identified in 20 of the cases, and 4 patients received NGS-guided treatment. NGS techniques represent a novel opportunity for guiding treatment in cancer patients. Patients with few therapeutic alternatives, either due to diagnosis, atypical evolution or resistance to standard therapy, may be suitable candidates

Epidemiology and prognosis of patients with a history of cancer admitted to intensive care. A multicenter observational study

Objetivo Conocer la epidemiología y evolución al alta de los pacientes oncológicos que precisan ingreso en UCI. Diseño Estudio descriptivo observacional de datos del registro ENVIN-HELICS combinado con variables registradas específicamente. Se comparan pacientes con y sin neoplasia. Se identifican grupos de pacientes neoplásicos con peor evolución. Ámbito UCI participantes en ENVIN-HELICS del año 2018 con participación voluntaria en el registro oncológico. Pacientes Ingresados más de 24 horas. Entre estos aquellos diagnosticados de neoplasia en los últimos 5 años. Variables principales Las generales epidemiológicas del registro ENVIN-HELICS y variables relacionadas con la neoplasia. Resultados En las 92 UCI con datos completos se seleccionaron 11.796 pacientes, de los que 1.786 (15,1%) son pacientes con neoplasia. La proporción de pacientes con cáncer por unidad fue muy variable (rango: 1-48%). La mortalidad en UCI de los pacientes oncológicos fue superior a los no oncológicos (12,3% versus 8,9%; p < 0,001). En pacientes oncológicos predominaron los ingresados en el postoperatorio programado (46,7%) o urgente (15,3%). Los pacientes con proceso patológico médico fueron más graves, con mayor estancia y mortalidad (27, 5%). Aquellos ingresados en UCI por enfermedad no quirúrgica relacionada con el cáncer tuvieron la mortalidad más alta (31,4%). Conclusión Existe una gran variabilidad en el porcentaje de pacientes oncológicos en las diferentes UCI. El 46,7% de los pacientes ingresa tras someterse a cirugía programada. La mayor mortalidad corresponde a pacientes con enfermedad médica (27,5%) y a los ingresados por complicaciones relacionadas con el cáncer (31,4%).Objective To assess the epidemiology and outcome at discharge of cancer patients requiring admission to the Intensive Care Unit (ICU). Design A descriptive observational study was made of data from the ENVIN-HELICS registry, combined with specifically compiled variables. Comparisons were made between patients with and without neoplastic disease, and groups of cancer patients with a poorer outcome were identified. Setting Intensive Care Units participating in ENVIN-HELICS 2018, with voluntary participation in the oncological registry. Patients Subjects admitted during over 24 hours and diagnosed with cancer in the last 5 years. Primary endpoints The general epidemiological endpoints of the ENVIN-HELICS registry and cancer-related variables. Results Of the 92 ICUs with full data, a total of 11,796 patients were selected, of which 1786 (15.1%) were cancer patients. The proportion of cancer patients per Unit proved highly variable (1-48%). In-ICU mortality was higher among the cancer patients than in the non-oncological subjects (12.3% versus 8.9%; P < .001). Elective postoperative (46.7%) or emergency admission (15.3%) predominated in the cancer patients. Patients with medical disease were in more serious condition, with longer stay and greater mortality (27.5%). The patients admitted in ICU due to nonsurgical disease related to cancer exhibited the highest mortality rate (31.4%). Conclusions Great variability was recorded in the percentage of cancer patients in the different ICUs. A total of 46.7% of the patients were admitted after undergoing scheduled surgery. The highest mortality rate corresponded to patients with medical disease (27.5%), and to those admitted due to cancer-related complications (31.4%)

SEOM-GETTHI clinical guideline for the practical management of molecular platforms (2021).

The improvement of molecular alterations in cancer as well as the development of technology has allowed us to bring closer to clinical practice the determination of molecular alterations in the diagnosis and treatment of cancer. The use of multidetermination platforms is spreading in most Spanish hospitals. The objective of these clinical practice guides is to review their usefulness, and establish usage guidelines that guide their incorporation into clinical practice