The academic point-of-care anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel (ARI-0001 cells) shows efficacy and safety in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma.

Varnimcabtagene autoleucel (var-cel) is an academic anti-CD19 chimeric antigen receptor (CAR) product used for the treatment of non-Hodgkin lymphoma (NHL) in the CART19-BE-01 trial. Here we report updated outcomes of patients with NHL treated with var-cel. B-cell recovery was compared with patients with acute lymphoblastic leukaemia (ALL). Forty-five patients with NHL were treated. Cytokine release syndrome (any grade) occurred in 84% of patients (4% grade ≥3) and neurotoxicity in 7% (2% grade ≥3). The objective response rate was 73% at Day +100, and the 3-year duration of response was 56%. The 3-year progression-free and overall survival were 40% and 52% respectively. High lactate dehydrogenase was the only covariate with an impact on progression-free survival. The 3-year incidence of B-cell recovery was lower in patients with NHL compared to ALL (25% vs. 60%). In conclusion, in patients with NHL, the toxicity of var-cel was manageable, while B-cell recovery was significantly prolonged compared to ALL. This trial was registered as NCT03144583.

Results of ARI-0001 CART19 cell therapy in patients with relapsed/refractory CD19-positive acute lymphoblastic leukemia with isolated extramedullary disease.

We evaluated outcomes of 18 patients with isolated extramedullary disease (iEMD) relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) treated with the CD19-directed CAR T cells ARI-0001 in two centers (adult and pediatric), including patients treated in the CART19-BE-01 trial and the consecutive compassionate use program. iEMD was detected by PET-CT in 78% (14/18), and/or by cerebrospinal fluid analysis in 28% (5/18). Patients received cyclophosphamide and fludarabine followed by 1 × 106 ARI-0001 cells/kg, initially as a single dose (first patient) and later split into three fractions (10%, 30%, and 60%). Cytokine release syndrome (CRS) occurred in 50% (9/18) of patients, with no cases of grade ≥3 CRS, and 1 case (6%) of grade 1 neurotoxicity. Tocilizumab was used in 6% of patients (1/18). Procedure-related mortality was 0% at 2 years. Objective responses were seen in 94% (95% confidence interval [CI]: 73%-99%) of patients, with complete responses (CR) seen in 78% (95% CI: 52%-94%) of them. Progression-free and overall survival were 49% (95% CI: 30%-79%) and 61% (95% CI: 40%-92%) at 2 years. In conclusion, the use of ARI-0001 cells in patients with R/R ALL and iEMD was associated with a safety and efficacy profile that is comparable with what is observed in patients with marrow involvement and in line with other CART19 products.

Rol de la enfermera en el anciano con cáncer. Revisión bibliográfica / Role of the nurse in the elderly with cancer. Bibliographic review

El aumento de la incidencia y prevalencia de procesos cancerígenos en los ancianos representa un nuevo reto para las políticas sanitarias y sociales. El presente artículo reflexiona sobre la necesidad de un modelo de atención integral, integrada y multidimensional para el cuidado del anciano con cáncer y su familia. El objetivo principal es identificar, recopilar, analizar y sintetizar la literatura científica más actual y relevante sobre las funciones y/o rol de la enfermera en el cuidado del anciano con cáncer. MATERIAL Y MÉTODO: se realizó una revisión bibliográfica en PubMed (Medline), Cochrane Library Plus, Dialnet y ScienceDirect® (Elsevier), entre enero de 2007 y diciembre de 2017, de la literatura científica sobre las funciones y/o rol de la enfermera en el cuidado del anciano con cáncer. Los estudios fueron seleccionados por revisores pares de forma independiente utilizando el instrumento PRISMA. RESULTADOS: Se identificaron 28 estudios que cumplieron los criterios de inclusión. Toda la bibliografía revisada recomienda el desarrollo e implementación de programas de atención individualizados como el pilar principal de atención al anciano con cáncer. En ellos, las enfermeras desempeñan un papel clave en la gestión y coordinación durante todo el proceso de atención. CONCLUSIONES: El modelo de cuidado de los ancianos con cáncer debe abarcar todo el proceso de atención: prevención, detección precoz, evaluación, tratamiento, educación e investigación. Es esencial el rol de la enfermera como gestora, coordinadora, educadora y cuidadora en la atención al anciano con cáncer

The increase in the incidence and prevalence of carcinogenic processes in the elderly represents a new challenge for health and social policies. This article reflects on the need for a comprehensive, integrated and multidimensional care model for the care of the elderly with cancer and his family. The main objective is to identify, compile, analyse and synthesize the most current and relevant scientific literature on the roles and/or role of the nurse in the care of the elderly person with cancer. MATERIAL AND METHOD: a bibliographic review was made in PubMed (Medline), Cochrane Library Plus, Dialnet and ScienceDirect® (Elsevier) between January 2007 and December 2017 of the literature on the functions and/or roles of the nurse in the care of the elderly with cancer. The studies were selected by peer reviewers independently using the PRISMA instrument. RESULTS: Twenty-eight studies that met the inclusion criteria were identified. All the revised literature recommends the development and implementation of individualized care programs as the main pillar of care for the elderly with cancer. In them, nurses play a key role in the management and coordination throughout the entire care process. CONCLUSIONS: The model of the care of the elderly with cancer must cover the whole process of attention: prevention, early detection, evaluation, treatment, education and research. The role of the nurse is essential as a manager, coordinator, educator and caregiver in the care of the elderly with cancer

Integrated Management of Pain in Advanced Dementia.

AIM: Develop and evaluate the implementation of a protocol for comprehensive management of pain in advanced dementia. METHOD: Quasi-experimental study carried out between September 2015 and May 2016 in an acute geriatric unit. Following development of the protocol and nurse training, 22 participants were recruited through consecutive sampling to form the intervention group (IG). Pain assessment was performed using the Pain Assessment in Advanced Dementia Spanish version (PAINAD-Sp) instrument and by nurse report-rating using the Numeric Rating Scale (NRS) and control group, with pain assessment through nurse-report using an NRS. Interventions carried out following perception of pain were done according to the actions algorithm created for this purpose. Follow-up was carried out daily during the hospital stay. RESULTS: Some 98% of the actions were performed correctly following the protocol. All (100%) of patients had a scheduled prescription for analgesics. Significant differences between mean pain scores at admission and discharge were found through PAINAD-Sp using a Wilcoxon sign test of -2.9543 (p = .004). Analysis of pain perception scores revealed a statistically significant positive correlation between the number of nonpharmacological actions performed and the pain score values obtained in the IG (rho Spearman: 0.617, p < .001) and the control group (rho Spearman: 0.922, p < .001). A high correlation was also observed in the IG between assessments conducted using PAINAD-Sp and NRS (intraclass correlation coefficient: 0.921). CONCLUSIONS: The implementation of an agreed-upon, standardized protocol for comprehensive pain management in advanced dementia, including nurse training, leads to systematic application of all the protocol stages, and therefore better pain management.

Competencias de la enfermera de práctica avanzada de hematología en la terapia CAR-T / Competencies of the Hematology Advanced Nurse Practitioner in CAR-T therapy

La terapia celular CAR-T es una inmunoterapia personalizada de última generación. Se basa en la modificación genética de linfocitos T autólogos del paciente para expresar un antígeno quimérico que identifique a las células cancerosas y las destruya. El rápido progreso de nuevos tratamientos de inmunoterapia ha generado una oportunidad a las enfermeras para que aporten su experiencia y sus competencias para liderar y facilitar la coordinación, educación y continuidad de cuidados a los pacientes beneficiarios de estas terapias. La enfermera de práctica avanzada de hematología en terapia CAR-T (EPACAR-T) es esencial para garantizar la continuidad de cuidados y la seguridad en la atención a pacientes tratados con CAR-T. En el presente trabajo se describen las competencias de la EPACAR-T basadas en el marco conceptual de Hamric y se determinan sus funciones en las diferentes etapas del proceso (acogida y valoración, leucoaféresis, producción celular y terapia puente, tratamiento linfodeplectivo, infusión de linfocitos T modificados, seguimiento y vigilancia activa), con el objetivo principal de ofrecer un plan de cuidados centrados en la persona y coordinar la atención, colaboración y comunicación entre centros remitentes y proveedores y conseguir su manejo exitoso

The CAR T-cell therapy is a personalized last-generation immunotherapy. It consists in the genetic modification of the patient's autologous T-lymphocytes in order to express a chimeric antigen that will identify cancer cells and destroy them. The fast progress of new immunotherapy treatments has created an opportunity for nurses to provide their experience and skills to lead and ensure coordination, education, and continuity of care for patients who will benefit of said therapies. The Hematology Advanced Nurse Practitioner in CAR-T therapy is essential to ensure continuity and safety of care for patients treated with CAR-T. The present article describes the competencies of the Hematology Advanced Nurse Practitioner in CAR-T therapy based on the conceptual framework by Hamric, and determines their role in the different stages of the process (reception and assessment, leukapheresis, cell production and bridge therapy, lymphodepletion treatment, infusion of modified T-lymphocytes, follow-up and active monitoring), with the main objective to offer a plan of care focused on the patient, and coordinate the care, collaboration and communication between referring centers and providers, and achieve a successful management

Protocolos de gestión del dolor en demencia avanzada / Advanced dementia pain management protocols

La gestión del dolor en demencia avanzada es compleja debido a los déficits neurológicos presentes en este tipo de pacientes, siendo las enfermeras directamente responsables de proporcionar intervenciones para la evaluación, manejo y alivio del dolor a las personas que sufren este problema de salud. Para facilitar y ayudar a la toma de decisiones, los expertos en dolor recomiendan la utilización de protocolos estandarizados que guíen en el manejo del dolor, pero en España no se han desarrollado protocolos integrales de gestión de dolor en demencia avanzada. El presente artículo reflexiona sobre la necesidad de que exista una gestión integral del dolor en demencia avanzada. De la revisión y análisis de los estudios más actuales y relevantes de la literatura, realizamos una aproximación a las escalas para la determinación del dolor en estos pacientes, siendo la escala observacional PAINAD la más recomendada para ámbito hospitalario. Además, proporcionamos una visión general para la gestión integral del dolor en la demencia avanzada, a través del marco conceptual «la jerarquía de evaluación del dolor de McCaffery y Pasero», para el desarrollo e implementación de protocolos estandarizados, que incluye un proceso cíclico formado por cuatro fases (evaluación, planificación/actuación, revaloración y registro), lo que puede facilitar el correcto manejo del dolor en estos pacientes

Pain management in advanced dementia is complex because of neurological deficits present in these patients, and nurses are directly responsible for providing interventions for the evaluation, management and relief of pain for people suffering from this health problem. In order to facilitate and help decision-makers, pain experts recommend the use of standardized protocols to guide pain management, but in Spain, comprehensive pain management protocols have not yet been developed for advanced dementia. This article reflects the need for an integrated management of pain in advanced dementia. From the review and analysis of the most current and relevant studies in the literature, we performed an approximation of the scales for the determination of pain in these patients, with the observational scale PAINAD being the most recommended for the hospital setting. In addition, we provide an overview for comprehensive management of pain in advanced dementia through the conceptual framework «a hierarchy of pain assessment techniques by McCaffery and Pasero» for the development and implementation of standardized protocols, including a four-phase cyclical process (evaluation, planning/performance, revaluation and recording), which can facilitate the correct management of pain in these patients

Advanced dementia pain management protocols. / Protocolos de gestión del dolor en demencia avanzada.

Pain management in advanced dementia is complex because of neurological deficits present in these patients, and nurses are directly responsible for providing interventions for the evaluation, management and relief of pain for people suffering from this health problem. In order to facilitate and help decision-makers, pain experts recommend the use of standardized protocols to guide pain management, but in Spain, comprehensive pain management protocols have not yet been developed for advanced dementia. This article reflects the need for an integrated management of pain in advanced dementia. From the review and analysis of the most current and relevant studies in the literature, we performed an approximation of the scales for the determination of pain in these patients, with the observational scale PAINAD being the most recommended for the hospital setting. In addition, we provide an overview for comprehensive management of pain in advanced dementia through the conceptual framework «a hierarchy of pain assessment techniques by McCaffery and Pasero¼ for the development and implementation of standardized protocols, including a four-phase cyclical process (evaluation, planning/performance, revaluation and recording), which can facilitate the correct management of pain in these patients.

Efecto de una intervención formativa interactiva para enfermeras en gestión del dolor en demencia avanzada / Impact of an interactive training intervention for nurses in pain management in advanced dementia

Objetivo. Evaluar la eficacia de una intervención formativa interactiva sobre gestión del dolor en pacientes con demencia avanzada para profesionales de enfermería de Medicina Interna del Hospital Clínic de Barcelona (HCB). Método. Estudio cuasiexperimental transversal realizado en abril-mayo de 2015.La muestra estuvo formada por 16 enfermeros y enfermeras titulados de unidades de Medicina Interna MI (grupo control GC) y 8 enfermeros y enfermeras de la Unidad de Geriatría Aguda UGA (grupo intervención GI). El GI recibió formación específica sobre la gestión del dolor en demencia avanzada (DA) en enero de 2015, a través de una intervención formativa interactiva incluida en la fase inicial de un proyecto de gestión del dolor en demencia avanzada. Los conocimientos y creencias del dolor se recogieron a través del cuestionario Knowledge and beliefs about pain in elderly with dementia (PKBQ-Sp). Resultados. Se obtuvieron 24 cuestionarios correctamente cumplimentados por los enfermeros y enfermeras tras firmar el consentimiento informado. La puntuación media de respuesta al PKBQ-Sp del GI fue 59.50 (d.t. 7.82) y del GC fue 47.94 (d.t. 4.07), existiendo diferencias estadísticamente significativas (t de Student p < 0.001). Se encontró correlación positiva a través del signo de Spearman: entre estatus (pertenecer a GC o GI) y puntuación total al PKBQSp (rho = 0.85 y p < 0.001) y formación específica de dolor y puntuación total al PKBQ-Sp (rho = 0.47 y p = 0.019), y correlación negativa entre experiencia y puntuación total al PKBQ-Sp (rho = -0.481 y p = 0.017). Conclusión. Una intervención formativa interactiva sobre gestión del dolor en demencia avanzada dirigida a enfermeros y enfermeras ha aumentado los conocimientos y creencias sobre la gestión del dolor en dichos profesionales comparándolos con otros profesionales que no realizaron la formación específica (AU)

Objective. Evaluate the efficiency of a formative interactive intervention on pain management in advanced dementia for professional nurses from internal medicine in Hospital Clínic de Barcelona. Method. Transverse quasi-experimental study realized between April and May 2015. The sample consisted of 16 internal medicine nurses (Control Group CG) and 8 nurses from the Acute Geriatric Unit (Inter- Efecto de una intervención formativa interactiva para enfermeras vention Group IG). The IG group received specific training on pain management in advanced dementia in January 2015. Training consisted in an interactive formative intervention (IFI) included in the initial phase of a project regarding pain management in patients with advanced dementia. Knowledge and beliefs about pain were collected through the Knowledge and Beliefs about Pain in Elderly with dementia questionnaire (PKBQ - Sp). Results. 24 properly answered questionnaires were obtained from the nurses after signing an informed consent. The average answer to PKBQ-Sp from the IG was 59.50 (s.d 7.82) and for CG 47.94 (s.d 4.07) with statistically significative differences (t-Student p < 0.001). A positive correlation was found through Spearman's sign: between status (belonging to CG or IG) and total score to PKBQ-Sp (rho 0.85; p < 0.001) and specific training in pain and total score to PKBQ-Sp (rho 0.47; p 0.019), as well as a negative correlation between experience and total score to PKBQ-Sp (rho -0481; p 0.017). Conclusion. Nurses’ knowledge and beliefs about pain management in advanced dementia increased thanks to the formative interactive intervention compared to professionals who didn't participate in such training (AU)

Calidad de la información sobre el diagnóstico al paciente oncológico terminal / Quality of diagnosis information given to terminal cancer patients

OBJETIVO: Determinar la información que posee el paciente oncológico terminal sobre su diagnóstico, identificando las palabras utilizadas y cuantificando la conspiración de silencio. MÉTODO: Estudio analítico transversal a través de la revisión de la base de datos del equipo de soporte de cuidados paliativos donde constan los datos procedentes de la historia clínica y de una entrevista semiestructurada realizada a pacientes oncológicos terminales en una primera visita del equipo de soporte, incluyendo variables sociodemográficas y clínicas (diagnóstico oncológico, síntomas, número de síntomas, funcionalidad, calidad de vida y palabras utilizadas para la información). RESULTADOS: De una muestra final compuesta por 723 registros, el 77,87% (IC 95%: 74,70-80,74) presentó información sobre el diagnóstico. Las palabras más reportadas por los pacientes con las que describen los conocimientos del diagnóstico fueron: cáncer (26%), tumor (51,59%) e inflamación (10,65%). Se observó asociación entre la edad, el sexo, el diagnóstico de cáncer y el servicio de procedencia del paciente con la información sobre el diagnóstico que explicitaba. CONCLUSIONES: Los pacientes oncológicos terminales presentan conocimientos sobre su diagnóstico, generando que la conspiración de silencio se dé en un grado menor. Estos conocimientos son transmitidos utilizando diferentes palabras y con la presencia de eufemismos

AIM: To determine the information that terminal cancer patients have about their diagnosis, identifying key words used, and quantifying the conspiracy of silence. METHOD: A cross-sectional, analytical study was conducted by reviewing the hospice support team data base which contains the medical history and a semi-structured interview with terminal cancer patients in the first visit to the hospice. Demographic and socioeconomic data was collected, as well as relevant clinical information (diagnosis, prevalent symptoms, number of symptoms, patient functionality, QoL, information given, and words used). RESULTS: Out of total of sample of 723 records, 77.87% (95% CI: 74.70-80.74) of the patients were properly informed about their diagnosis. The most used words were cancer in 26% of the patients, tumour in 51.59%, and for the remaining 10.65%, the word inflammation was used. Statistically significant differences of information were found between sexes, age, types of cancer, and hospital ward. CONCLUSIONS: Terminal cancer patients have knowledge on their diagnosis, suggesting that the conspiracy of silence is present to a lesser extent. This knowledge is transmitted using different words and with euphemisms

[Quality of diagnosis information given to terminal cancer patients]. / Calidad de la información sobre el diagnóstico al paciente oncológico terminal.

AIM: To determine the information that terminal cancer patients have about their diagnosis, identifying key words used, and quantifying the conspiracy of silence. METHOD: A cross-sectional, analytical study was conducted by reviewing the hospice support team data base which contains the medical history and a semi-structured interview with terminal cancer patients in the first visit to the hospice. Demographic and socioeconomic data was collected, as well as relevant clinical information (diagnosis, prevalent symptoms, number of symptoms, patient functionality, QoL, information given, and words used). RESULTS: Out of total of sample of 723 records, 77.87% (95% CI: 74.70-80.74) of the patients were properly informed about their diagnosis. The most used words were cancer in 26% of the patients, tumour in 51.59%, and for the remaining 10.65%, the word inflammation was used. Statistically significant differences of information were found between sexes, age, types of cancer, and hospital ward. CONCLUSIONS: Terminal cancer patients have knowledge on their diagnosis, suggesting that the conspiracy of silence is present to a lesser extent. This knowledge is transmitted using different words and with euphemisms.

Dolor y demencia avanzada. Revisión bibliográfica / Pain and advanced dementia. Literature review

La pérdida de habilidades de comunicación y la capacidad de cuantificar la experiencia del dolor en el anciano con demencia avanzada representa un serio obstáculo para la gestión efectiva del dolor y posiciona a esta población en alto riesgo de no detectarlo ni aplicar tratamientos adecuados. En este trabajo se describe la gravedad de este problema definiendo las poblaciones en riesgo, las estrategias y recursos para la gestión adecuada del dolor y las funciones de las enfermeras como gestoras de su manejo. Material y método: se realizó una revisión bibliográfica en PubMed (Medline), Cochrane Library Plus, Dialnet y ScienceDirect(R) (Elsevier) entre enero de 2000 y diciembre de 2014 de la literatura reciente y relevante sobre la gestión del dolor en los ancianos con demencia avanzada. Resultados: los últimos estudios neurológicos nos guían en la diferente vivencia del dolor que presenta la persona mayor, según el tipo de demencia. La gestión del dolor es un proceso complejo y dinámico. La valoración y diagnóstico del tipo de dolor, la intensidad y el efecto que tiene sobre la persona son necesarios para poder planificar una intervención o tratamiento adecuado, un correcto registro y una reevaluación sistemática. El éxito para una correcta gestión y manejo del dolor es la formación al personal enfermero responsable del cuidado de la persona mayor y la utilización de logaritmos de actuación definidos. Conclusiones: la gestión eficaz del dolor requiere evaluación minuciosa, intervención adecuada, reevaluación sistemática y registro constante

The loss of communication skills and the ability to quantify the experience of pain in the elderly with advanced dementia, is a serious obstacle to effective pain management and positions this population at high risk of not detecting it or apply appropriate treatments. In this work the severity of this problem by defining populations at risk, strategies and resources for adequate pain management and the roles of nurses as managers of their management is described. Material and Methods: A literature review in PubMed (Medline), Cochrane Library, Dialnet and ScienceDirect(R) (Elsevier) was conducted between January 2000 and March 2014 and the recent relevant literature on pain management in the elderly with advanced dementia. Results: Recent neurological studies lead us to the different experience of pain that presents the greatest person, depending on the type of dementia. Pain management is a complex and dynamic process. The assessment and diagnosis of the type of pain, severity and the effect it has on the individual, are required in order to plan appropriate intervention or treatment, a correct record and a systematic reevaluation. Success for the proper management and pain management is training staff nurse responsible for the care of the elderly and use of logarithms defined performance. Conclusions: Effective pain management requires careful assessment, appropriate intervention, and constant reassessment systematic registration