Nutritional management of cancer patients in clinical practice in Spain: patients' and multidisciplinary health care professionals' perceptions.

BACKGROUND/OBJECTIVES: Malnutrition is a prevalent problem in patients with cancer and is associated with poor prognosis. The European Society for Clinical Nutrition and Metabolism (ESPEN) recommends the provision of nutritional support and evaluation. This study aims to describe the nutritional management of patients with cancer, including assessment of adherence, from the perspective of both patients and healthcare professionals (HCPs). SUBJECTS/METHODS: A cross-sectional descriptive observational study was carried out through two surveys addressed to patients and HCPs. RESULTS: A total of 230 cancer patients and 461 HCPs completed the questionnaire. The survey found 55.0% of patients experienced eating problems during treatment and 64.0% reported sequelae affecting nourishment. However, 60.1% of patients and 42.6% of HCPs indicated that nutritional status is not generally assessed. While 86.6% of HCPs stated that nutritional information is provided to patients, only 33.5% of patients reported having received it. Regarding nutritional adherence, 87.4% of HCPs stated that it is assessed whereas only 49.2% of patients receiving nutritional supplements confirmed this. General discomfort or gastrointestinal problems were the main issues hampering correct adherence perceived by both patients (41.8%) and HCPs (95.4%). CONCLUSIONS: Our study demonstrate that different perceptions exist between patients and HCPs about nutritional management in cancer and suggests that in Spain nutritional approach is suboptimal in terms of screening/assessment of malnutrition, nutritional information provided to the patient, nutritional intervention and assessment of adherence to nutritional support. Therefore, measure should be taken to foster the adoption of ESPEN recommendations in clinical practice and to promote nutritional education of HCPs.

A Web-Based Self-assessment Model for Evaluating Multidisciplinary Cancer Teams in Spain: Development and Validation Pilot Study.

BACKGROUND: Tumor boards constitute the main consensus and clinical decision-making body of multidisciplinary teams (MDTs) in cancer care. With the increasing clinical complexity of treatment options (eg, targeted therapies, multimodal treatments) and the progressive incorporation of new areas of intervention (eg, survivorship care), tumor boards are now required to play a central role in all cancer processes. However, although frameworks are in place to evaluate MDT quality, only few web-based tools are available for this purpose; indeed, no web-based MDT evaluation tools have been developed for or adapted to the Spanish National Health System. OBJECTIVE: The first aim of this study was to develop a web-based self-assessment model (Autoevaluación de Equipos Multidisciplinares de Atención al Cáncer [AEMAC]) for evaluating multidisciplinary cancer teams in Spain and the second aim was to validate this tool by testing its metric properties, acceptability, and usability. METHODS: We designed and validated the AEMAC program in 3 stages. In the first stage (research), we reviewed the available scientific evidence and performed a qualitative case study of good practice in multidisciplinary care within the Spanish National Health System (n=4 centers and 28 health care professionals). The results were used to define the thematic areas and quality criteria for the self-evaluation model, which were then discussed and validated by a group of experts. The second stage (development) involved the technological development of a web app that would be accessible from any mobile device. In the third stage (piloting and validation), we conducted 4 pilot tests (n=15 tumor boards, 243 professionals) and used the results to analyze the acceptability and usefulness of the tool. RESULTS: We designed a self-assessment model based on 5 thematic areas encompassing a total of 25 quality components, which users rated on a 3-option development scale. The evaluation process, which was managed entirely from the web app, consisted of individual self-assessment, group prioritization, and creation of an improvement plan. Cronbach alpha (.86), McDonald's omega (0.88), and various fit indices (comparative fit index between 0.95 and 1 and goodness-of-fit index between 0.97 and 0.99 for all 5 aspects) confirmed internal consistency. The mean rating for overall satisfaction with the tool and for consistency between the content of the tool and the reality of tumor boards was 7.6 out of 10. CONCLUSIONS: The results obtained during the period of research and piloting of the AEMAC program showed that it has an appropriate structure and metric properties and could therefore be implemented in a real context and generalized to other hospitals. As a virtual tool, it helps to measure the key aspects of MDT quality, such as effectiveness of collaboration and communication, leadership, and the organizational environment.

[Opinions and experiences of healthcare professionals in the nutritional management of oncology patients: the ONA study]. / Opiniones y experiencias de profesionales sanitarios en el manejo nutricional del paciente oncológico: estudio ONA.

Introduction: Objectives: an inadequate approach to prevent malnutrition in cancer patients may worsen their quality of life and reduce their response to treatment. This study aims to describe the nutritional management of cancer patients in clinical practice, as well as the opinions of the healthcare professionals (HCPs) involved. Methods: this was an observational, descriptive, cross-sectional study addressed to HCPs in the Spanish healthcare setting. The online questionnaire was designed based on a literature review, one focus group of patients (n = 6), and the experience of the multidisciplinary scientific committee (n = 5), and was distributed by the scientific societies endorsing the study. Results: a total of 461 HCPs answered the survey. Most of them considered that a nutrition expert (95.0 %) is essential for the nutritional management of patients. However, 22.8 % of HCPs did not have access to this expert, and only 49.0 % had received training. Nutritional screening or patient referral for screening was performed by 58.4 % of HCPs. Of the total of HCPs, 86.6 % stated that nutritional information is provided to patients and considered them moderately satisfied with the information received. In malnourished patients or in those at risk of malnutrition, a complete nutritional assessment was performed by HCPs (73.1 %). Most HCPs (87.4 %) reported prescribing or recommending nutritional support if needed, and assessing adherence (86.8 %). Conclusions: despite malnutrition being a common problem in cancer patients, almost half of professionals do not perform any nutritional screening. In addition, patient information and assessment of nutritional adherence appear to be suboptimal.

Introducción: Objetivos: un abordaje inadecuado de la desnutrición en el paciente con cáncer puede conducir a un empeoramiento de su calidad de vida y una respuesta deficiente al tratamiento. El estudio ONA (Oncología, Nutrición y Adherencia) tiene como objetivo describir el manejo nutricional del paciente con cáncer en la práctica clínica, así como las opiniones de los profesionales sanitarios involucrados en el mismo. Métodos: estudio observacional, descriptivo y transversal dirigido a profesionales sanitarios españoles. El cuestionario online fue diseñado a partir de una revisión bibliográfica, un grupo focal de pacientes (n = 6) y un comité científico multidisciplinar (n = 5), y distribuido por las sociedades científicas que avalan el estudio. Resultados: de los 461 profesionales sanitarios participantes, el 95,0 % consideraron fundamental la figura del profesional sanitario con formación específica en nutrición, pero el 22,8 % no tenían acceso a ella y solo el 49,0 % habían recibido formación. El 58,4 % afirmaron realizar el cribado nutricional o derivar al paciente para este fin. El 86,6 % de los participantes indicaron que se informa al paciente sobre aspectos nutricionales y consideraron que este estaba moderadamente satisfecho con la información recibida. En caso de detectarse desnutrición o riesgo de desnutrición, los profesionales afirmaron realizar una evaluación nutricional completa (73,1 %) y, de necesitarse soporte nutricional, este se prescribiría/recomendaría (87,4 %), evaluándose la adherencia al mismo (86,8 %). Conclusiones: a pesar de que la desnutrición es un problema común en el paciente con cáncer, casi la mitad de los profesionales no realizan un cribado nutricional. Además, el proceso de información y evaluación de la adherencia nutricional es subóptimo.

SOLTI-1805 TOT-HER3 Study Concept: A Window-of-Opportunity Trial of Patritumab Deruxtecan, a HER3 Directed Antibody Drug Conjugate, in Patients With Early Breast Cancer.

Background: Preclinical data support a key role for the human epidermal growth factor receptor 3 (HER3) pathway in hormone receptor (HR)-positive breast cancer. Recently, new HER3 directed antibody drug conjugates have shown activity in breast cancer. Given the need to better understand the molecular biology, tumor microenvironment, and mechanisms of drug resistance in breast cancer, we designed this window-of-opportunity study with the HER3 directed antibody drug conjugate patritumab deruxtecan (HER3-DXd; U3-1402). Trial Design: Based on these data, a prospective, multicenter, single-arm, window-of-opportunity study was designed to evaluate the biological effect of patritumab deruxtecan in the treatment of naïve patients with HR-positive/HER2-negative early breast cancer whose primary tumors are ≥1 cm by ultrasound evaluation. Patients will be enrolled in four cohorts according to the mRNA-based ERBB3 expression by central assessment. The primary endpoint is a CelTIL score after one single dose. A translational research plan is also included to provide biological information and to evaluate secondary and exploratory objectives of the study. Trial Registration Number: EudraCT 2019-004964-23; NCT number: NCT04610528.

A Pilot, Phase II, Randomized, Open-Label Clinical Trial Comparing the Neurotoxicity of Three Dose Regimens of Nab-Paclitaxel to That of Solvent-Based Paclitaxel as the First-Line Treatment for Patients with Human Epidermal Growth Factor Receptor Type 2-Negative Metastatic Breast Cancer.

BACKGROUND: This study aimed to characterize the neurotoxicity of three different regimens of nab-paclitaxel compared with a standard regimen of solvent-based (sb) paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer based on the Total Neurotoxicity Score (TNS), a tool specifically developed to assess chemotherapy-induced neurotoxicity. MATERIALS AND METHODS: This was a randomized, open-label study testing 4-week cycles of 80 mg/m2 sb-paclitaxel (PACL80/w) on days 1, 8, and 15; 100 mg/m2 nab-paclitaxel on days 1, 8, and 15 (NAB100/w); 150 mg/m2 nab-paclitaxel on days 1, 8, and 15 (NAB150/w); and 150 mg/m2 nab-paclitaxel on days 1 and 15 (NAB150/2w). In addition to the TNS, neuropathy was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Tumor response and quality of life were also evaluated. RESULTS: Neurotoxicity, as evaluated by the TNS, did not significantly differ between the sb-paclitaxel group and any of the nab-paclitaxel groups. The frequency of (any grade) polyneuropathy, as measured by the NCI-CTCAE, was lower in the PACL80/w (n = 7, 50%) and NAB150/2w (n = 10, 62.5%) groups than in the NAB100/w (n = 13, 81.3%) or NAB150/w (n = 11, 78.6%) group. Although the differences were not statistically significant, compared with the other groups, in the NAB150/w group, the time to occurrence of grade ≥2 polyneuropathy was shorter, and the median time to recovery from grade ≥2 polyneuropathy was longer. Dose delays and reductions due to neurotoxicity and impact of neurotoxicity on the patients' experience of symptoms and functional limitations was greater with NAB150/w. Among the seven polymorphisms selected for genotyping, the variant alleles of EPHA5-rs7349683, EPHA6-rs301927, and EPHA8-rs209709 were associated with an increased risk of paclitaxel-induced neuropathy. CONCLUSION: The results of this exploratory study showed that, regardless of the dose, nab-paclitaxel did not differ from sb-paclitaxel in terms of neurotoxicity as evaluated with the TNS. However, results from NCI-CTCAE, dose delays and reductions, and functional tools consistently indicate that NAB150/w regimen is associated with a greater risk of chemotherapy-induced neuropathy. Thus, our results question the superiority of the TNS over NCI-CTCAE for evaluating chemotherapy-induced neuropathy and guiding treatment decisions in this context. The selection of the nab-paclitaxel regimen should be individualized based on the clinical context and potentially supported by pharmacogenetic analysis. Registry: EudraCT, 2012-002361-36; NCT01763710 IMPLICATIONS FOR PRACTICE: The results of this study call into question the superiority of the Total Neurotoxicity Score over the National Cancer Institute Common Terminology Criteria for Adverse Events for evaluating chemotherapy-induced neuropathy and guiding treatment decisions in this context and suggest that a regimen of 150 mg/m2 nab-paclitaxel administered on days 1, 8, and 15 is associated with a greater risk of chemotherapy-induced neuropathy and hematological toxicity compared with other lower-dose nab-paclitaxel regimens or a standard regimen of solvent-based paclitaxel. The selection of the nab-paclitaxel regimen should be individualized based on the clinical context and could benefit from pharmacogenetics analysis.

Los pacientes en las guías de práctica clínica / The patients in clinical practice guides

En las últimas décadas, las políticas sanitarias de los países desarrollados y los profesionales están orientando sus actividades hacia el ciudadano como eje del sistema sanitario. Los ciudadanos, a su vez, demandan un papel activo en la toma de decisiones relacionadas con su salud. En este contexto, el desarrollo y la utilización de guías de práctica clínica (GPC) se están orientando también como instrumento de encuentro entre políticas, ciudadanos y profesionales, lo que plantea no pocas dificultades metodológicas y operativas. El objetivo de este trabajo es proporcionar pautas generales que ayuden a los distintos actores en la incorporación de los pacientes para el desarrollo de las GPC y adaptarlas a una versión de pacientes (GPC-P). Se ha realizado una revisión estructurada de documentos metodológicos sobre GPC y documentos orientados a la elaboración de GPC-P o similares. Tras la síntesis de información, se proponen tres áreas de desarrollo (contenidos, diseño y evaluación) y dos ámbitos en la participación del paciente en GPC: como un miembro más del grupo que elabore la guía y/o como miembro del grupo de la elaboración de la GPC-P. El proceso de participación de ciudadanos no es sencillo, requiere planificación y sensibilidad de los implicados, pero no cabe duda que añade valor en la implantación de las GPC

In the last decades the health policies of developed countries and those of professionals are directing their activities towards the citizen as the focal point of the health system. The citizens also demand an active role in health related decision-making processes. In this context, the development and use of clinical practice guidelines (CPGs) are instruments of encounter between policies, citizens and professionals but they create many methodological and operational difficulties. The objective of this work is to provide general guidelines to help the different players to incorporate patients in the development of CPGs and to adapt the patient CPG version (CPG-P). A structured review has been carried out on methodological documents on CPGs and documents oriented towards the production of CPG-P (or related documents). After analysing the information, we propose three areas of development (contents, design and evaluation) and two areas for the participation of patients in CPGs: patients as a members of the guideline development group and/or as members of the CPG-P development group. The process of participation of citizens is not a simple one, it requires planning and sensitivity to those involved, but there is no doubt that it adds value to the introduction of CPGs