Clinicopathological characterization of next-generation sequencing detected mutations in lung cancers-a single-center experience.

Background: Despite many advances in molecular procedures many lung cancer patients do not receive full panel testing. This can limit the comprehensive understanding of their disease and potentially hinder personalized treatment options. Methods: In this retrospective analysis, we used results from next-generation sequencing (NGS) testing of 154 patients with adenocarcinoma (AC) or squamous cell carcinoma (SCC) of the lung treated at the University Hospital, Ludwig-Maximilians Universität (LMU) Munich between 2018 and 2021. We compared different clinicopathological features and patients' baseline characteristics with results of NGS testing. We used t-test and analysis of variance (ANOVA) to compare metric- and χ2-test and Fisher's exact test to compare categorical variables. Results: NGS testing found mutations in 107 (69.5%) patients; 44 patients (28.6%) had more than one mutation. The majority (79.2%) of patients had AC and 64.9% were metastasized at diagnosis. Patients with detected mutations had significantly higher PD-L1 expression than those without mutations (36.4% vs. 19.2%, P=0.005). Mean PD-L1 expression also differed between different mutations ranging from 24.0% in EGFR to 56.8% in patients with MET alterations, and increased with the number of different mutations (P=0.07). EGFR mutations were significantly more common in females compared to males (22.9% vs. 9.5%, P=0.04) and PIK3CA mutations significantly more common in SCC (21.9% vs. 2.5%, P=0.004). We found 23 different mutations in AC and 13 different gene mutations in SCC. Conclusions: Mutation profiles differed by histological type and metastases status and were significantly associated with PD-L1 expression. In the context of limited resources, our results may help prioritize patient for testing when tissue material and funding is limited.

Use of Tirzepatide in Adults with Type 2 Diabetes Mellitus: Scientific Evidence and Practical Aspects.

Tirzepatide is a novel antidiabetic medication a single-molecule, agonist to the glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptors. It is approved in the USA and EU for the treatment of type 2 diabetes mellitus (T2DM) and obesity. Due to the potential novelty represented by incorporating tirzepatide to clinical practice, we aim to review practical aspects of tirzepatide use in T2DM and the supporting scientific evidence. A group of ten endocrinologists involved as investigators in the phase 3 SURPASS clinical trial program followed a nominal group technique, a qualitative research methodology designed as a semi-structured group discussion to reach a consensus on the selection of a set of practical aspects. The scientific evidence for tirzepatide has been reviewed with respect to a number of patients' clinical profiles and care goals. Information of interest related to adverse events, special warnings and precautions, and other considerations for tirzepatide use has been included. Finally, information provided to the patients has been summarized. The practical aspects reported herein may be helpful in guiding physicians in the use of tirzepatide and contribute to optimizing the management of T2DM.

Mobocertinib in Patients with EGFR Exon 20 Insertion-Positive Non-Small Cell Lung Cancer (MOON): An International Real-World Safety and Efficacy Analysis.

EGFR exon 20 (EGFR Ex20) insertion mutations in non-small cell lung cancer (NSCLC) are insensitive to traditional EGFR tyrosine kinase inhibitors (TKIs). Mobocertinib is the only approved TKI specifically designed to target EGFR Ex20. We performed an international, real-world safety and efficacy analysis on patients with EGFR Ex20-positive NSCLC enrolled in a mobocertinib early access program. We explored the mechanisms of resistance by analyzing postprogression biopsies, as well as cross-resistance to amivantamab. Data from 86 patients with a median age of 67 years and a median of two prior lines of treatment were analyzed. Treatment-related adverse events (TRAEs) occurred in 95% of patients. Grade ≥3 TRAEs were reported in 38% of patients and included diarrhea (22%) and rash (8%). In 17% of patients, therapy was permanently discontinued, and two patients died due to TRAEs. Women were seven times more likely to discontinue treatment than men. In the overall cohort, the objective response rate to mobocertinib was 34% (95% CI, 24-45). The response rate in treatment-naïve patients was 27% (95% CI, 8-58). The median progression-free and overall survival was 5 months (95% CI, 3.5-6.5) and 12 months (95% CI, 6.8-17.2), respectively. The intracranial response rate was limited (13%), and one-third of disease progression cases involved the brain. Mobocertinib also showed antitumor activity following EGFR Ex20-specific therapy and vice versa. Potential mechanisms of resistance to mobocertinib included amplifications in MET, PIK3CA, and NRAS. Mobocertinib demonstrated meaningful efficacy in a real-world setting but was associated with considerable gastrointestinal and cutaneous toxicity.

Regional disparities and risk factors of mortality among patients at high risk of sudden cardiac death in emerging countries: a nonrandomized controlled trial.

BACKGROUND: Comprehensive data on patients at high risk of sudden cardiac death (SCD) in emerging countries are lacking. The aim was to deepen our understanding of the SCD phenotype and identify risk factors for death among patients at high risk of SCD in emerging countries. METHODS: Patients who met the class I indication for implantable cardioverter-defibrillator (ICD) implantation according to guideline recommendations in 17 countries and regions underrepresented in previous trials were enrolled. Countries were stratified by the WHO regional classification. Patients were or were not implanted with an ICD at their discretion. The outcomes were all-cause mortality and SCD. RESULTS: We enrolled 4222 patients, and 3889 patients were included in the analysis. The mean follow-up period was 21.6 ± 10.2 months. There were 433 (11.1%) instances of all-cause mortality and 117 (3.0%) cases of SCD. All-cause mortality was highest in primary prevention (PP) patients from Southeast Asia and secondary prevention (SP) patients from the Middle East and Africa. The SCD rates among PP and SP patients were both highest in South Asia. Multivariate Cox regression modelling demonstrated that in addition to the independent predictors identified in previous studies, both geographic region and ICD use were associated with all-cause mortality in patients with high SCD risk. Primary prophylactic ICD implantation was associated with a 36% (HR = 0.64, 95% CI 0.531-0.802, p < 0.0001) lower all-cause mortality risk and an 80% (HR = 0.20, 95% CI = 0.116-0.343, p < 0.0001) lower SCD risk. CONCLUSIONS: There was significant heterogeneity among patients with high SCD risk in emerging countries. The influences of geographic regions on patient characteristics and outcomes were significant. Improvement in increasing ICD utilization and uptake of guideline-directed medical therapy in emerging countries is urgent. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02099721.

First-line immunotherapy for lung cancer with MET exon 14 skipping and the relevance of TP53 mutations.

BACKGROUND: The efficacy of checkpoint inhibitors for non-small cell lung cancer (NSCLC) with MET exon 14 skipping (METΔ14ex) remains controversial. MATERIALS AND METHODS: 110 consecutive METΔ14ex NSCLC patients receiving first-line chemotherapy (CHT) and/or immunotherapy (IO) in 10 German centers between 2016-2022 were analyzed. RESULTS: Combined CHT-IO was given to 35/110 (32%) patients, IO alone to 43/110 (39%), and CHT to 32/110 (29%) upfront. Compared to CHT, CHT-IO showed longer progression-free survival (median PFS 6 vs. 2.5 months, p = 0.004), more objective responses (ORR 49% vs. 28%, p = 0.086) and numerically longer overall survival (OS 16 vs. 10 months, p = 0.240). For IO monotherapy, OS (14 vs. 16 months) and duration of response (26 vs. 22 months) were comparable to those of CHT-IO. Primary progressive disease (PD) was more frequent with IO compared to CHT-IO (13/43 vs. 3/35, p = 0.018), particularly for never-smokers (p = 0.041). Higher PD-L1 TPS were not associated with better IO outcomes, but TP53 mutated tumors showed numerically improved ORR (56% vs. 32%, p = 0.088) and PFS (6 vs. 3 months, p = 0.160), as well as longer OS in multivariable analysis (HR=0.54, p = 0.034) compared to their wild-type counterparts. Any second-line treatment was administered to 35/75 (47%) patients, with longer survival for capmatinib or tepotinib compared to crizotinib (PFS 10 vs. 3 months, p = 0.013; OS 16 vs. 13 months, p = 0.270). CONCLUSION: CHT-IO is superior to CHT, and IO alone also effective for METΔ14ex NSCLC, especially in the presence of TP53 mutations and independent of PD-L1 expression, but never-smokers are at higher risk of primary PD.

Outcome of First-Line Treatment With Pembrolizumab According to KRAS/TP53 Mutational Status for Nonsquamous Programmed Death-Ligand 1-High (≥50%) NSCLC in the German National Network Genomic Medicine Lung Cancer.

INTRODUCTION: Programmed death-ligand 1 expression currently represents the only validated predictive biomarker for immune checkpoint inhibition in metastatic NSCLC in the clinical routine, but it has limited value in distinguishing responses. Assessment of KRAS and TP53 mutations (mut) as surrogate for an immunosupportive tumor microenvironment (TME) might help to close this gap. METHODS: A total of 696 consecutive patients with programmed death-ligand 1-high (≥50%), nonsquamous NSCLC, having received molecular testing within the German National Network Genomic Medicine Lung Cancer between 2017 and 2020, with Eastern Cooperative Oncology Group performance status less than or equal to 1 and pembrolizumab as first-line palliative treatment, were included into this retrospective cohort analysis. Treatment efficacy and outcome according to KRAS/TP53 status were correlated with TME composition and gene expression analysis of The Cancer Genome Atlas lung adenocarcinoma cohort. RESULTS: Proportion of KRASmut and TP53mut was 53% (G12C 25%, non-G12C 28%) and 51%, respectively. In KRASmut patients, TP53 comutations increased response rates (G12C: 69.7% versus 46.5% [TP53mut versus wild-type (wt)], p = 0.004; non-G12C: 55.4% versus 39.5%, p = 0.03), progression-free survival (G12C: hazard ratio [HR] = 0.59, p = 0.009, non-G12C: HR = 0.7, p = 0.047), and overall survival (G12C: HR = 0.72, p = 0.16, non-G12C: HR = 0.56, p = 0.002), whereas no differences were observed in KRASwt patients. After a median follow-up of 41 months, G12C/TP53mut patients experienced the longest progression-free survival and overall survival (33.7 and 65.3 mo), which correlated with high tumor-infiltrating lymphocyte densities in the TME and up-regulation of interferon gamma target genes. Proinflammatory pathways according to TP53 status (mut versus wt) were less enhanced and not different in non-G12C and KRASwt, respectively. CONCLUSIONS: G12C/TP53 comutations identify a subset of patients with a very favorable long-term survival with immune checkpoint inhibitor monotherapy, mediated by highly active interferon gamma signaling in a proinflammatory TME.

Hyperinflation and reduced diffusing capacity predict prognosis in SCLC: value of extended pre-therapeutic lung function testing.

BACKGROUND: Small cell lung cancer (SCLC) is characterized by aggressive growth and poor prognosis. Although SCLC affects nearly exclusively heavy smokers and leads to frequent respiratory symptoms, the impact of pre-therapeutic lung function testing in SCLC is sparely investigated until now. Therefore, we sought to examine whether we could find prognostic markers in pre-therapeutic lung function testing of SCLC patients. PATIENTS AND METHODS: We retrospectively analysed a cohort of 205 patients with the diagnosis of SCLC between 2010 and 2018. Pre-therapeutic values of spirometry, body plethysmography and measurement of diffusing capacity was extracted from patients' charts. Comparisons between groups were performed using the Mann-Whitney U-test or by chi-square tests as appropriate. Kaplan-Meier analyses and COX-regression models were performed to correlate lung function parameters with patients' outcome. RESULTS: Airway obstruction itself, or the diagnosis chronic obstructive pulmonary disease (COPD) based on GOLD definitions did not correlate with survival in SCLC patients. Hyperinflation measured by increased residual volume and residual volume to total lung capacity ratio (log-rank p < 0.001) and reduced diffusing capacity (log-rank p = 0.007) were associated with reduced survival. Furthermore, patients with hyperinflation as well as impairments in gas exchange representing an emphysematic phenotype had the worst outcome (log-rank p < 0.001). CONCLUSION: We recommend including body plethysmography and measurement of diffusing capacity in the pre-therapeutic assessment of SCLC patients. Our findings suggest that reduction of hyperinflation may lead to better outcome in SCLC patients. Thus, in addition to effective tumour therapy, adequate therapy of the comorbidity of COPD should also be provided. In particular, measures to reduce hyperinflation by means of dual bronchodilation as well as respiratory physiotherapy should be further assessed in this setting.

Tumor seeding following CT- guided transthoracic needle biopsy in lung cancer. A case report.

As a result of advances in the treatment of lung cancer, the life expectancy of lung cancer patients has improved significantly, but it remains the leading cause of cancer death worldwide. For decades, most of the initial tumor biopsies have been obtained by bronchoscopy or computed tomography (CT)-guided transthoracic lung biopsy without concerning reports of cancer seeding following the latter. In this case report we discuss the patient history of a 56-year old women with low-differentiated squamous cell lung cancer who developed tumor seeding following a CT-guided transthoracic biopsy 11 months after the intervention. This is put into context reviewing former and current literature.

Early mortality in German patients with lung cancer: risk factors associated with 30-and 60-day mortality.

Despite therapeutic advances, early mortality in lung cancer is still prevalent. In this study, we aimed to assess risk factors for 30- and 60-day mortality in German lung cancer patients. In this retrospective cross-sectional analysis, we used data of lung cancer patients treated at LMU Hospital Munich between 2015 and 2019. We categorized patients into 30-day mortality, 60 day-mortality, and longer survival. We used Student's t-test and ANOVA to compare means and Chi2-test to compare frequencies. We used logistic regression analysis to identify factors associated with a risk for early mortality. Of the 2454 lung cancer patients, 2.0% (n = 50) died within 30 and 1.7% (n = 41) within 30 to 60 days of diagnosis. Older age and advanced stage at diagnosis were significantly associated with early mortality in the univariate and the multivariate analysis. Patients in the 30-day mortality group significantly more often did not receive tumor-directed therapy. They were also more likely to die in an acute care setting compared to the 60-day mortality group. The group of patients who died unexpectedly (12.0%) was dominantly female, with a high proportion of patients with unintentional weight loss at the time of diagnosis. Our results suggest that in the treatment of patients with lung cancer there is a need for a greater focus on older patients. Moreover, physicians should pay special attention to females with recent weight loss and patients with a comorbidity of diabetes mellitus or renal impairment. Engaging a case manager focused on detecting patients with the above characteristics could help improve overall care.

Evaluación sensorial de un suplemento nutricional oral específico para diabetescon aceite de oliva virgen extra en pacientes en riesgo nutricional y diabetes mellitustipo 2: ensayo clínico doble ciego, aleatorizado, cruzado y multicéntrico (DIACARE) / Organoleptic evaluation of a diabetes-specific oral nutritional supplement with extra virgin olive oil in patients at nutritional risk and type 2 diabetes mellitus: double-blind, randomized, crossover and multicenter clinical trial (DIACARE)

Introducción: las fórmulas nutricionales específicas para diabetes (FED) suelen presentar una composición que favorece simultáneamente su palatabilidad y el control glucémico y metabólico.Objetivo: comparar la aceptación sensorial de un FED respecto a un suplemento nutricional oral estándar (FE) en pacientes en riesgo de desnutrición con diabetes mellitus tipo 2.Método: ensayo clínico, aleatorizado, doble ciego, cruzado, multicéntrico y controlado. Se evaluó, a través de una escala del 1 al 4, el olor, el sabor y la textura percibida de un FED y de un FE.Resultados: se reclutaron a 29 pacientes y 58 evaluaciones sensoriales de los suplementos. Se observó una mejor valoración de la FED respecto a la FE, aunque no se alcanzaron diferencias estadísticamente significativas: olor, 0,04 (IC 95 %), de -0,49 a 0,56 (p = 0,092); sabor, 0,14 (IC 95 %), de -0,35 a 0,63 (p = 0,561); textura, 0,14, (IC 95 %), de -0,43 a 0,72 (p = 0,619). No se encontraron diferencias cuando se analizaron por orden de aleatorización, sexo, grado de desnutrición, mayor o menor grado de complejidad, mayor o menor tiempo de evolución de la diabetes, ni por ser más o menos mayores. Conclusiones: el suplemento nutricional específico para paciente con diabetes, formulado con aceite de oliva virgen extra, EPA y DHA, una mezcla específica en hidratos de carbono, fibra soluble e insoluble, presentó una adecuada aceptación sensorial del paciente desnutrido con diabetes mellitus tipo 2.(AU)

Introduction: oral nutritional supplements specific for diabetes (DSF) usually have a composition that favors their palatability and simultaneous glycemic and metabolic control. Objective: to compare the sensory acceptability of a DSF with respect to a standard oral nutritional supplement (STF) in patients at risk of malnutrition with type 2 diabetes mellitus. Method: randomized, double-blind, crossover, multicenter, controlled, double-blind clinical trial. Odor, taste and perceived texture of a DSF and a STD were evaluated using a scale of 1 to 4. Results: twenty-nine patients were recruited and 58 organoleptic evaluations of the supplements were registered. A better evaluation of DSF was observed with respect to STD, although no statistically significant differences were reached: odor, 0.04 (CI 95 %) -0.49 to 0.56 (p = 0.092); taste, 0.14 (CI 95 %), -0.35 to 0.63 (p = 0.561); texture, 0.14 (CI 95 %), -0.43 to 0.72 (p = 0.619). No differences were found when analyzed by order of randomization, sex, degree of malnutrition, greater or lesser degree of complexity, greater or lesser time of evolution of diabetes, or by being older or younger. Conclusions: the specific nutritional supplement for diabetic patients formulated with extra virgin olive oil, EPA and DHA, a specific mixture of carbohydrates, and fiber, presented an adequate sensory acceptance by malnourished patients with type 2 diabetes mellitus.(AU)

Glycaemic and insulinaemic impact of a diabetes-specific oral nutritional supplement with extra-virgin olive oil in patients with type 2 diabetes mellitus at nutritional risk: a randomized, double-blind, crossover, multicentre clinical trial (DiACARE) / Impacto glucémico e insulinémico de un suplemento nutricional oral con AOVE específico para diabetes en pacientes en riesgo nutricional y con diabetes mellitus tipo 2: ensayo clínico, aleatorizado, doble ciego, cruzado y multicéntrico (DIACARE)

Introduction: there is controversy about the usefulness of specific enteral nutrition formulas in malnourished patients with diabetes. The effects on blood glucose and other aspects of metabolic control are not fully understood in the scientific literature. Objective: the aim of the study was to compare the glycaemic and insulinaemic response of patients with type 2 diabetes at risk of malnutrition after oral feed between a diabetes-specific formula with AOVE (DSF) and a standard one (STF). Methods: A randomized, double-blind, crossover, multicentre clinical trial was conducted in patients with type 2 diabetes at risk of malnutrition (SGA). The patients were randomized to receive either DSF or STF, a week apart. A glycaemia and insulinaemia curve was made at times 0 minutes, 30 min, 60 min, 90 min, 120 min, and 180 min after the patients drank 200 ml of the oral nutritional supplement (ONS). The principal variables were the area under the curve (AUC0-t) of glucose and insulin. Results: 29 patients (51 % women) were included, who were on average 68.84 (SD 11.37) years old. Regarding the degree of malnutrition, 86.2 % presented moderate malnutrition (B) and 13.8 % severe (C). When the patients received the DSF, they had a lower mean of glucose AUC0-t (-3,325.34 mg/min/dl [95 % CI: -4,3608.34 to -2,290.07]; p = 0.016) and also a lower mean of insulin AUC0-t (-451.14 uU/min/ml [95 % CI: -875,10 to -27.17]; p = 0.038). There were no differences in the degree of malnutrition. Conclusion: compared with STF, DSF with AOVE showed a better glycaemic and insulinaemic response in patients with type 2 diabetes at risk of malnutrition.(AU)

Introducción: la utilidad de las fórmulas específicas de nutrición enteral en el paciente desnutrido con diabetes resulta controvertida. Sus efectossobre la glucosa en sangre y otros aspectos del control metabólico no se conocen del todo en la literatura científica.Objetivo: el objetivo del estudio fue comparar la respuesta glucémica e insulinémica de los pacientes con diabetes de tipo 2 (DM2) en riesgode desnutrición tras la ingesta oral de una fórmula específica para diabetes (DSF) con aceite de oliva virgen extra (AOVE) y una estándar (STF).Métodos: ensayo clínico aleatorizado, doble ciego, cruzado y multicéntrico enpacientes con DM2 en riesgo de desnutrición (SGA). Los pacientes seasignaron aleatoriamente para recibir DSF o STF con una semana de diferencia. Se realizó una curva de glucemia e insulinemia en los siguientestiempos: 0 minutos, 30 min, 60 min, 90 min, 120 min y 180 min tras la ingesta de 200 ml del suplemento nutricional oral (SNO). Las variablesprincipales fueron el área bajo la curva (AUC0-t) de glucosa e insulina.Resultados: se incluyeron 29 pacientes (51 % mujeres), con una edad media de 68,84 años (DE 11,37). En cuanto al grado de desnutrición,el 86,2 % presentaba desnutrición moderada (B) y el 13,8 %, severa (C). Cuando los pacientes recibieron DSF tuvieron una media más bajade AUC0-t de glucosa (-3325,34 mg/min/dl [IC 95 %: de -4.3608,34 a -2.290,07]; p = 0,016) y también una media más baja de AUC0-t deinsulina (-451,14 μU/min/ml [IC 95 %: de -875,10 a -27,17]; p = 0,038) respecto a cuando recibieron STF. No hubo diferencias por el gradode desnutrición.Conclusión: la fórmula con AOVE específica para diabetes mostró una mejor respuesta glucémica e insulinémica en pacientes con diabetes detipo 2 en riesgo de desnutrición respecto a una fórmula estándar.(AU)

Phase angle as a marker of outcome in hospitalized pediatric patients. A systematic review of the evidence (GRADE) with meta-analysis.

Phase angle (PhA) is a valuable tool for evaluating the nutritional and inflammatory status, which can accompany acute and severe disorders. PhA is a cellular health biomarker, whose value is particularly substantial due to the negative consequences of these situations in the pediatric population. Relevant literature was collected with the aim of comprehensively analysing the evidence on the association between an altered PhA can serve as a predictive-marker for mortality and poor-outcomes in at-risk-pediatric patients. Understanding this relationship could have significant implications for identifying high-risk individuals and implementing timely interventions. A systematic review with meta-analysis was conducted in the primary electronic databases from inception until January 2023. Overall, four studies with a total of 740 patients were eligible for our analysis. Evidence demonstrates that PhA is associated with nutritional status, reflecting undernutrition and changes in body composition related to illness. This review suggests that PhA can indeed be used as an indicator of nutritional status and a tool for predicting prognosis, including mortality and poor-outcomes, in hospitalized pediatric patients. A low PhA was associated with a significant mortality risk [RR:1.51;95%CI (1.22-1.88),p = 0.0002;I2 = 0%,(p = 0.99)] and an increased complications risk [OR:8.17;95%CI (2.44-27.4),p = 0.0007;I2 = 44%,(p = 0.18)]. These findings highlight the importance of taking a comprehensive approach to clinical nutrition, integrating multiple evaluation aspects to establish an accurate diagnosis and personalized therapeutic plans. While PhA emerges as a valuable tool for assessing the risk of malnutrition and as a prognostic-indicator for poor-outcomes in pediatric patients. Further future studies are needed to focus on investigating this relationship in larger and diverse population to strengthen the evidence base.

[Organoleptic evaluation of a diabetes-specific oral nutritional supplement with extra virgin olive oil in patients at nutritional risk and type 2 diabetes mellitus: Double-blind, randomized, crossover and multicenter clinical trial (DIACARE)]. / Evaluación sensorial de un suplemento nutricional oral específico para diabetes con aceite de oliva virgen extra en pacientes en riesgo nutricional y diabetes mellitus tipo 2: ensayo clínico doble ciego, aleatorizado, cruzado y multicéntrico (DIACARE.

Introduction: Introduction: oral nutritional supplements specific for diabetes (DSF) usually have a composition that favors their palatability and simultaneous glycemic and metabolic control. Objetive: to compare the sensory acceptability of a DSF with respect to a standard oral nutritional supplement (STF) in patients at risk of malnutrition with type 2 diabetes mellitus. Method: randomized, double-blind, crossover, multicenter, controlled, double-blind clinical trial. Odor, taste and perceived texture of a DSF and a STD were evaluated using a scale of 1 to 4. Results: twenty-nine patients were recruited and 58 organoleptic evaluations of the supplements were registered. A better evaluation of DSF was observed with respect to STD, although no statistically significant differences were reached: odor, 0.04 (CI 95 %) -0.49 to 0.56 (p = 0.092); taste, 0.14 (CI 95 %), -0.35 to 0.63 (p = 0.561); texture, 0.14 (CI 95 %), -0.43 to 0.72 (p = 0.619). No differences were found when analyzed by order of randomization, sex, degree of malnutrition, greater or lesser degree of complexity, greater or lesser time of evolution of diabetes, or by being older or younger. Conclusions: the specific nutritional supplement for diabetic patients formulated with extra virgin olive oil, EPA and DHA, a specific mixture of carbohydrates, and fiber, presented an adequate sensory acceptance by malnourished patients with type 2 diabetes mellitus.

Introducción: Introducción: las fórmulas nutricionales específicas para diabetes (FED) suelen presentar una composición que favorece simultáneamente su palatabilidad y el control glucémico y metabólico. Objetivo: comparar la aceptación sensorial de un FED respecto a un suplemento nutricional oral estándar (FE) en pacientes en riesgo de desnutrición con diabetes mellitus tipo 2. Método: ensayo clínico, aleatorizado, doble ciego, cruzado, multicéntrico y controlado. Se evaluó, a través de una escala del 1 al 4, el olor, el sabor y la textura percibida de un FED y de un FE. Resultados: se reclutaron a 29 pacientes y 58 evaluaciones sensoriales de los suplementos. Se observó una mejor valoración de la FED respecto a la FE, aunque no se alcanzaron diferencias estadísticamente significativas: olor, 0,04 (IC 95 %), de -0,49 a 0,56 (p = 0,092); sabor, 0,14 (IC 95 %), de -0,35 a 0,63 (p = 0,561); textura, 0,14, (IC 95 %), de -0,43 a 0,72 (p = 0,619). No se encontraron diferencias cuando se analizaron por orden de aleatorización, sexo, grado de desnutrición, mayor o menor grado de complejidad, mayor o menor tiempo de evolución de la diabetes, ni por ser más o menos mayores. Conclusiones: el suplemento nutricional específico para paciente con diabetes, formulado con aceite de oliva virgen extra, EPA y DHA, una mezcla específica en hidratos de carbono, fibra soluble e insoluble, presentó una adecuada aceptación sensorial del paciente desnutrido con diabetes mellitus tipo 2.

Glycaemic and insulinaemic impact of a diabetes-specific oral nutritional supplement with extra-virgin olive oil in patients with type 2 diabetes mellitus at nutritional risk: a randomized, double-blind, crossover, multicentre clinical trial (DIACARE).

Introduction: Introduction: there is controversy about the usefulness of specific enteral nutrition formulas in malnourished patients with diabetes. The effects on blood glucose and other aspects of metabolic control are not fully understood in the scientific literature. Objective: the aim of the study was to compare the glycaemic and insulinaemic response of patients with type 2 diabetes at risk of malnutrition after oral feed between a diabetes-specific formula with AOVE (DSF) and a standard one (STF). Methods: A randomized, double-blind, crossover, multicentre clinical trial was conducted in patients with type 2 diabetes at risk of malnutrition (SGA). The patients were randomized to receive either DSF or STF, a week apart. A glycaemia and insulinaemia curve was made at times 0 minutes, 30 min, 60 min, 90 min, 120 min, and 180 min after the patients drank 200 ml of the oral nutritional supplement (ONS). The principal variables were the area under the curve (AUC0-t) of glucose and insulin. Results: 29 patients (51 % women) were included, who were on average 68.84 (SD 11.37) years old. Regarding the degree of malnutrition, 86.2 % presented moderate malnutrition (B) and 13.8 % severe (C). When the patients received the DSF, they had a lower mean of glucose AUC0-t (-3,325.34 mg/min/dl [95 % CI: -4,3608.34 to -2,290.07]; p = 0.016) and also a lower mean of insulin AUC0-t (-451.14 uU/min/ml [95 % CI: -875,10 to -27.17]; p = 0.038). There were no differences in the degree of malnutrition. Conclusion: compared with STF, DSF with AOVE showed a better glycaemic and insulinaemic response in patients with type 2 diabetes at risk of malnutrition.

Introducción: Introducción: la utilidad de las fórmulas específicas de nutrición enteral en el paciente desnutrido con diabetes resulta controvertida. Sus efectos sobre la glucosa en sangre y otros aspectos del control metabólico no se conocen del todo en la literatura científica. Objetivo: el objetivo del estudio fue comparar la respuesta glucémica e insulinémica de los pacientes con diabetes tipo 2 (DM2) en riesgo de desnutrición tras la ingesta oral de una fórmula específica para diabetes (DSF) con aceite de oliva virgen extra (AOVE) y una estándar (STF). Métodos: ensayo clínico aleatorizado, doble ciego, cruzado y multicéntrico enpacientes con DM2 en riesgo de desnutrición (SGA). Los pacientes se asignaron aleatoriamente para recibir DSF o STF con una semana de diferencia. Se realizó una curva de glucemia e insulinemia en los siguientes tiempos: 0 minutos, 30 min, 60 min, 90 min, 120 min y 180 min tras la ingesta de 200 ml del suplemento nutricional oral (SNO). Las variables principales fueron el área bajo la curva (AUC0-t) de glucosa e insulina. Resultados: se incluyeron 29 pacientes (51 % mujeres), con una edad media de 68,84 años (DE 11,37). En cuanto al grado de desnutrición, el 86,2 % presentaba desnutrición moderada (B) y el 13,8 %, severa (C). Cuando los pacientes recibieron DSF tuvieron una media más baja de AUC0-t de glucosa (-3325,34 mg/min/dl [IC 95 %: de -4.3608,34 a -2.290,07]; p = 0,016) y también una media más baja de AUC0-t de insulina (-451,14 uU/min/ml [IC 95 %: de -875,10 a -27,17]; p = 0,038) respecto a cuando recibieron STF. No hubo diferencias por el grado de desnutrición. Conclusión: la fórmula con AOVE específica para diabetes mostró una mejor respuesta glucémica e insulinémica en pacientes con diabetes tipo 2 en riesgo de desnutrición respecto a una fórmula estándar.

Guideline adherence of tumor board recommendations in lung cancer and transfer into clinical practice.

PURPOSE: Evaluating patients and treatment decisions in a multidisciplinary tumor board has led to better quality of care and longer survival in cancer patients. The aim of this study was to evaluate tumor board recommendations for thoracic oncology patients regarding guideline adherence and transferal of recommendations into clinical practice. METHODS: We evaluated tumor board recommendations of the thoracic oncology tumor board at Ludwig-Maximilians University (LMU) Hospital Munich between 2014 and 2016. We compared patient characteristics between guideline-adherent and non-guideline-adherent recommendations, as well as between transferred and non-transferred recommendations. We used multivariate logistic regression models to evaluate factors associated with guideline adherence. RESULTS: Over 90% of recommendations by the tumor board were either adherent to the guidelines (75.5%) or over fulfilling guidelines (15.6%). Almost 90% of recommendations were transferred to clinical practice. If a recommendation was not according to the guidelines, the reason was mostly associated with the general condition (age, Charlson comorbidity index, ECOG) of the patient or due to the patients' request. Surprisingly, sex also had a significant influence on the guideline adherence of recommendations, with females being more likely to get recommendations not according to the guidelines. CONCLUSION: In conclusion, the results of this study are promising, as the guideline adherence of recommendations as well as the transferal of recommendations into clinical practice were high. In the future, a special focus should be put on fragile patients as well as female patients.

Nutritional ultrasound®: Conceptualisation, technical considerations and standardisation.

Nutritional ultrasound® is a new concept that uses ultrasound to assess body composition. It is composed of the evaluation of fat-free mass and fat mass. It is an emerging, economical, portable, non-invasive technique that evaluates the musculoskeletal area with linear, broadband, multifrequency probes, with a depth field of 20-100mm. It quantifies muscle modifications in malnutrition and provides information on functional changes (echogenicity). Although there are no validated specific cut-off points, the anterior rectum area of the quadriceps can be used as a criterion for malnutrition. The distribution of adipose tissue provides information on the energy reserve and the inflammatory pattern. It is important to integrate nutritional ultrasound® measures in clinical practice adapted to different settings and pathologies. It is necessary to establish training plans in nutritional ultrasound® for use by Endocrinology and Nutrition Specialists, with the aim of improving the diagnosis and treatment of their patients.

Phase angle and COVID-19: A systematic review with meta-analysis.

Phase angle (PhA) has been identified as a poor prognostic factor in patients with COVID-19. This study aimed to achieve a systematic review, where we discussed the potential role of PhA value as a prognostic marker of adverse clinical outcomes such as mortality and complication in hospitalized with SARS-CoV2 infection and established the strength of recommendations for use. A systematic literature review with meta-analysis was done in the main electronic databases from 2020 to January 2023. The selected articles had to investigate adverse consequences of the COVID-19 population and raw bioimpedance parameters such as PhA and published in peer-reviewed journals. GRADE tools regarded the quality of the methodology. The review protocol was registered in PROSPERO. Only eight studies, 483 studies, were eligible for the analysis. In general, differences in PhA were seen between the comparative study groups. Patients with a low PhA experienced poor outcomes. A low PhA was associated with a significantly increased mortality risk [RR: 2.44; 95% CI (1.20-4.99), p = 0.01; I2 = 79% (p = 0.0008)] and higher complications risk [OR: 3.47, 95% CI (1.16 - 10.37), p = 0.03; I2 = 82% (p = 0.004)] in COVID-19 patients. Our analysis showed four evidence-based recommendations on the prognostic value of PhA with two strong recommendations, one of moderate and another of low-moderate quality, for predicting mortality and complications, respectively. We recommend using PhA as a prognostic marker for mortality and complications in this population. Although the results are promising, future studies must identify the PhA cut-off to guide therapeutic decisions more precisely.Registration code in PROSPERO: CRD42023391044.