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Gut IgA functionally interacts with systemic IgG to enhance antipneumococcal vaccine responses
Get PDFGut IgA; Systemic IgG; Antipneumococcal vaccineIgA intestinal; IgG sistémica; Vacuna antineumocócicaIgA intestinal; IgG sistèmica; Vacuna antipneumocòcicaThe gut microbiota enhances systemic immunoglobulin G (IgG) responses to vaccines, but it is unknown whether this effect involves IgA, which coats intestinal microbes. That IgA may amplify postimmune IgG production is suggested by the impaired IgG response to pneumococcal vaccines in some IgA-deficient patients. Here, we found that antipneumococcal but not total IgG production was impaired in mice with IgA deficiency. The positive effect of gut IgA on antipneumococcal IgG responses started very early in life and could implicate gut bacteria, as these responses were attenuated in germ-free mice recolonized with gut microbes from IgA-deficient donors. IgA could exert this effect by constraining the systemic translocation of gut antigens, which was associated with chronic immune activation, including T cell overexpression of programmed cell death protein 1 (PD-1). This inhibitory receptor may attenuate antipneumococcal IgG production by causing B cell hyporesponsiveness, which improved upon anti–PD-1 treatment. Thus, gut IgA functionally interacts with systemic IgG to enhance antipneumococcal vaccine responses.This work was supported by US National Institutes of Health grants P01 AI61093 to C.C.-R. and A.C., R01 DK123749 to A.C., J.J.F., and S.M., R01 DK114038 to J.C.C., K23 AI137183 to P.J.M., and R21AI168718 to E.K.G.; Crohn’s and Colitis Foundation CDA 877970 to E.K.G.; Ministerio de Ciencia, Innovación y Universidades grant RTI2018-093894-B-I00 and European Advanced grant ERC-2011-ADG-20110310 to A.C.; and the Institute of Health Carlos III-Miguel Servet research program to G.M
Algoritme predictiu per a monitorar i avaluar l’impacte dels tractaments en el trasplantament de ronyó
Get PDFTrasplantament de ronyó; Tractaments renals; AlgoritmeTrasplante de riñón; Tratamientos renales; AlgoritmoKidney transplant; Renal treatments; AlgorithmSíntesi dels principals resultats de l'informe que analitza l’algorisme de predicció iBox™ per estimar la probabilitat de supervivència del trasplantament renal als 3, 5 i 7 anys. Aquest algoritme està basat en múltiples paràmetres que reflecteixen tant la funció de l'empelt renal com la resposta immunitària del receptor del trasplantament, i això permet monitorar i avaluar l'impacte dels tractaments després del trasplantament renal.Síntesis de los principales resultados del informe que analiza el algoritmo de predicción iBox™ para estimar la probabilidad de supervivencia del trasplante renal a 3, 5 y 7 años. Este algoritmo se basa en múltiples parámetros que reflejan tanto la función del injerto renal como la respuesta inmunitaria del receptor del trasplante, lo que permite monitorizar y evaluar el impacto de los tratamientos tras el trasplante renal.Summary of the main findings of the report analyzing the iBox™ prediction algorithm to estimate kidney transplant survival probability at 3, 5, and 7 years. This algorithm is based on multiple parameters that reflect both graft function and the recipient’s immune response, allowing for monitoring and assessment of the impact of treatments following kidney transplantation
Genetic biomarker study of sunvozertinib for clinical prognosis and prediction in NSCLC with EGFR exon 20 insertion mutation
Get PDFNon-small cell lung cancer; Biomarker; SunvozertinibCàncer de pulmó de cèl·lules no petites; Biomarcador; SunvozertinibCáncer de pulmón de células no pequeñas; Biomarcador; SunvozertinibThis is a report of biomarker analysis for sunvozertinib, a leading epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) targeting EGFR exon 20 insertion mutation (exon20ins) non-small cell lung cancer (NSCLC). There is a positive correlation between positive EGFR exon20ins in plasma circulating tumor DNA (ctDNA) and advanced disease. Shorter progression-free survival and lower objective response rate (45.8% vs. 68.0%) were observed in patients with positive EGFR exon20ins compared to those with negative status. Droplet digital PCR analysis showed that the EGFR exon20ins allele in ctDNA decreased over time in 85.7% of patients, with the earliest clearance occurred after 1 week of sunvozertinib treatment. Acquired EGFR C797S is identified as a potential on-target resistance mutation to sunvozertinib. Finally, efforts are undertaken to investigate therapeutic approaches that aim to overcome the putative acquired resistance to sunvozertinib
Pla d'enquestes de percepció, experiència i satisfacció d'usuaris del Servei Català de la Salut (PLAENSA): atenció primària; medicina i infermeria familiar i comunitària
No full textEnquestes de satisfacció; Atenció primària; Infermeria familiar i comunitàriaEncuestas de satisfacción; Atención primaria; Enfermería familiar y comunitariaSatisfaction surveys; Primary care; Family and community nursingLa desena edició de l’estudi de percepció, experiència i satisfacció amb el servei d’atenció primària: medicina i infermeria familiar i comunitària, dut a terme per la Unitat d’Avaluació i Experiència del Pacient en el marc del Pla d’enquestes de percepció, experiència i satisfacció dels usuaris del Servei Català de la Salut (CatSalut), ha mostrat que les persones que han utilitzat aquest servei durant l’any 2024 valoren la satisfacció amb l’atenció rebuda amb un 7,75 sobre 10 de mitjana. A més, de les persones entrevistades, un 86,0 % ha respost que “Sí” a la pregunta: “Si poguéssiu triar, continuaríeu venint a aquest CAP?”.
Les preguntes amb una major freqüència de respostes positives es troben dins dels àmbits d’espais, tracte i informació: la “P5. Neteja del CAP”, amb un 95,4 % de respostes positives; la “P14. Tracte personal de les infermeres i infermers”, amb un 94,8 %, i finalment la “P10. S’entenen les explicacions”, amb un 94,1 %.
Aquest estudi compta amb 30.000 casos, procedents del conjunt mínim bàsic de dades del servei d’atenció primària. En l’edició de l’any 2024, s’ha utilitzat un qüestionari validat durant l’any 2023, i que s'ha tornat a validar després de l'edició d'enguany. El treball de camp s’ha dut a terme durant el quart trimestre de l’any 2024, utilitzant un qüestionari web amb invitació per SMS
Comprehensive management of pneumonia in older patients
Get PDFDiagnosis; Older people; PneumoniaDiagnòstic; Gent gran; PneumòniaDiagnóstico; Personas mayores; NeumoníaPneumonia is a leading cause of death and functional decline in the older population. Diagnosis of pneumonia conventionally includes the presence of respiratory signs and symptoms, systemic signs of infection and a radiographic demonstration of lung involvement. Pneumonia diagnosis in the very old patient is compromised by atypical and unspecific presentation, resulting in a high proportion of false positive diagnosis. Chest radiograph is frequently of low quality and inconclusive in older patients. Computed tomography scan and chest ultrasound may provide valuable diagnostic confirmation in uncertain cases. Bacterial pneumonia has been mainly studied, but viruses, among which influenza, SARS-CoV-2, and respiratory syncytial virus, are increasingly recognized as major players. The decision to treat pneumonia is usually based on a triple assessment of diagnostic probability, disease severity and the general assessment of the patient (frailty, comorbidities, place of living, and goals of care). Antimicrobial treatment is probabilistic, targeting common pathogens. The optimal antibiotic treatment depends on epidemiological data, setting of acquisition, comorbidities, risk factors for methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa, or aspiration pneumonia, and severity. Recent controlled trials have demonstrated the non-inferiority of short regimen in non-severe community acquired pneumonia, even in older individuals and a five-day antibiotic treatment is recommended in case of clinical improvement. Pneumonia management in older patients requires a comprehensive approach, including control of comorbidities (particularly cardiovascular), nutritional support, rehabilitation, and prevention of aspiration. Finally, pneumonia may be a pre-terminal event in many patients, requiring advanced-care planning and prompt instauration of palliative management
Safety and Efficacy of the Use of pdVWF/FVIII-C in Patients with von Willebrand Disease: A Prospective, Observational, Post-Authorization Study
Get PDFSangrado; Tratamiento profiláctico; Enfermedad de von WillebrandSagnat; Tractament profilàctic; Malaltia de von WillebrandBleeding; Prophylaxis treatment; Von Willebrand diseaseIntroductionPlasma-derived von Willebrand factor containing FVIII concentrates (pdVWF/FVIII-C) are indicated as replacement therapy for patients with von Willebrand disease (VWD). This study assessed safety and efficacy associated with long-term real-world experience of the pdVWF/FVIII-C, Fanhdi®, in patients with VWD.MethodsThis observational, prospective, post-authorization cohort study was conducted at five centers in Spain. Patients with VWD were treated with the pdVWF/FVIII-C to achieve satisfactory hemostasis for on-demand (bleeding episodes and surgical/invasive procedures) and prophylaxis treatment. Clinical efficacy was evaluated as the response to treatment in both settings. Safety parameters were assessed.ResultsFifteen VWD patients received at least one dose of the pdVWF/FVIII-C and were followed for 12 months. Forty-six bleeding episodes were reported for 9 (60.0%) patients, and 6 surgical/invasive procedures for 5 (33.3%) patients. Most frequently reported bleedings were gastrointestinal (3 [33.0%] patients) and gynecological (3 [33.0%] patients). No complications nor bleeding episodes related to surgical/invasive procedures were reported. Overall clinical efficacy of treatment (including on-demand and prophylaxis) achieved 100% excellent and/or good (n = 15 patients), being excellent for 7 (46.7%) patients. There were 27 treatment-emergent adverse events in 8 (53.3%) patients, 11 serious adverse events in 3 (20.0%) patients, but none of them were drug-related. No clinical signs and symptoms of immunogenicity or thromboembolic events were reported.ConclusionsThis real-world evidence study confirmed the efficacy of the pdVWF/FVIII-C as on-demand and/or prophylaxis treatment in patients with bleeding episodes or surgical procedures in VWD. Fanhdi® was well tolerated without any safety concerns.The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: OBH, CM, FJL, MC, MN were study investigators and received f inancial support for the data collection. This study was supported by Grifols, manufacturer of the pdVWF/FVIII concentrate, Fanhdi®
Seguridad alimentaria al cocinar en situaciones de emergencia
Get PDFSeguretat alimentària; Higiene; EmergènciesSeguridad alimentaria; Higiene; EmergenciasFood safety; Hygiene; EmergenciesAquest document de bones pràctiques estableix criteris d’higiene per garantir la seguretat alimentària i prevenir intoxicacions, especialment en el muntatge d’una cuina en situacions d’emergència arran d’una catàstrofe.Este documento de buenas prácticas establece criterios de higiene para garantizar la seguridad alimentaria y prevenir intoxicaciones, especialmente en el montaje de una cocina en situaciones de emergencia tras una catástrofe.This best practices document establishes hygiene criteria to ensure food safety and prevent food poisoning, especially when setting up a kitchen in emergency situations following a disaster
Machine learning for the rElapse risk eValuation in acute biliary pancreatitis: The deep learning MINERVA study protocol
Get PDFAcute biliary pancreatitis; Artificial intelligence; RecurrencePancreatitis biliar aguda; Intel·ligència artificial; RecurrènciaPancreatitis biliar aguda; Inteligencia artificial; RecurrenciaBackground
Mild acute biliary pancreatitis (MABP) presents significant clinical and economic challenges due to its potential for relapse. Current guidelines advocate for early cholecystectomy (EC) during the same hospital admission to prevent recurrent acute pancreatitis (RAP). Despite these recommendations, implementation in clinical practice varies, highlighting the need for reliable and accessible predictive tools. The MINERVA study aims to develop and validate a machine learning (ML) model to predict the risk of RAP (at 30, 60, 90 days, and at 1-year) in MABP patients, enhancing decision-making processes.
Methods
The MINERVA study will be conducted across multiple academic and community hospitals in Italy. Adult patients with a clinical diagnosis of MABP, in accordance with the revised Atlanta Criteria, who have not undergone EC during index admission will be included. Exclusion criteria encompass non-biliary aetiology, severe pancreatitis, and the inability to provide informed consent. The study involves both retrospective data from the MANCTRA-1 study and prospective data collection. Data will be captured using REDCap. The ML model will utilise convolutional neural networks (CNN) for feature extraction and risk prediction. The model includes the following steps: the spatial transformation of variables using kernel Principal Component Analysis (kPCA), the creation of 2D images from transformed data, the application of convolutional filters, max-pooling, flattening, and final risk prediction via a fully connected layer. Performance metrics such as accuracy, precision, recall, and area under the ROC curve (AUC) will be used to evaluate the model.
Discussion
The MINERVA study aims to address the specific gap in predicting RAP risk in MABP patients by leveraging advanced ML techniques. By incorporating a wide range of clinical and demographic variables, the MINERVA score aims to provide a reliable, cost-effective, and accessible tool for healthcare professionals. The project emphasises the practical application of AI in clinical settings, potentially reducing the incidence of RAP and associated healthcare costs.
Trial registration
ClinicalTrials.gov ID: NCT06124989.The study is sponsored by the University of Cagliari (Italy), Naples Federico II (Italy), and Naples Università della Campania “Luigi Vanvitelli” (Italy) and funded by the Fondo per il Programma Nazionale di Ricerca e Progetti di Rilevante Interesse Nazionale (PRIN) under grant number 202273A4YP
PATH classification: a proposal for patients with HNSCC treated with salvage surgery
Get PDFHead and neck cancer; Postoperative prognostic classification; Salvage surgeryCáncer de cabeza y cuello; Clasificación pronóstica postoperatoria; Cirugía de rescateCàncer de cap i coll; Classificació pronòstica postoperatòria; Cirurgia de rescatPurpose
The aim of this study is to propose a classification for patients with recurrent head and neck squamous cell carcinoma (HNSCC) treated with salvage surgery based on the location of the primary tumor and data commonly found in the pathological report of the resection.
Methods
Retrospective study of 665 patients with HNSCC treated with a salvage surgery after a local and/or regional recurrence of the tumor.
Results
We propose a new postoperative classification for patients with recurrent HNSCC treated with salvage surgery. PATH classification stratifies patients into 4 stages based on the glottic or non-glottic location of the primary tumor, the local and regional pathologic extension of the tumor, the status of the surgical margins, and the presence of lymph node metastases with extracapsular spread. The PATH classification was more homogeneous in the prognosis of patients included in each of its stages, and it had a better prognostic discrimination capacity between stages than the rpTNM classification. According to the PATH classification, the 5-year disease-specific survival was: PATH I (n = 306) 82.8%; PATH II (n = 119) 47.1%; PATH III (n = 202) 24.4%; PATH IV (n = 38) 3.7%. For the rpTNM classification, the 5-year disease-specific survival was: stage I (n = 119) 85.1%; stage II (n = 134) 68.4%; stage III (n = 111) 59.5%; stage IV (n = 301) 33.3%.
Conclusion
The PATH classification for HNSCC patients with local and/or regional recurrence treated with salvage surgery had a better prognostic capacity than the rpTNM classification.
Level of evidence
Level IV.Open Access Funding provided by Universitat Autonoma de Barcelona
A Randomized clinical trial evaluating the impact on survival and quality of life of 177Lutetium[Lu]-edotreotide versus everolimus in patients with neuroendocrine tumors of the lung and thymus: the LEVEL study (GETNE T-2217)
Get PDFEverolimus; Neuroendocrine tumors; Targeted radioligand therapyEverolimus; Tumors neuroendocrins; Teràpia amb radiolligands dirigitsEverolimus; Tumores neuroendocrinos; Terapia con radioligandos dirigidosBackground
Everolimus is the only approved therapy for patients with advanced neuroendocrine tumors (NET) of lung and thymus and new treatment options are urgently needed. Expression of somatostatin receptor 2 (SSTR2) is frequently seen in functional imaging in lung-NETs opening the opportunity to treat SSTR2 positive patients with radioligand therapies (RLT). Retrospective data suggest a potential meaningful benefit of RLT directed to SSTR2 in lung-NET patients.
Methods
The LEVEL trial is a randomized, open-label, phase III international trial of 177Lu-edotreotide versus everolimus in patients with progressive, locally advanced or metastatic, and well/moderately differentiated NETs of lung (typical/atypical) or thymic origin. Patients could be treatment-naïve or have progressed (PD) on somatostatin analogues or ≤ 2 additional systemic treatments. Prior RLT or mTOR inhibitors are not permitted.
Eligible patients are randomly assigned 3:2 to 6 cycles of 177Lu-edotreotide (total administered activity 7.5 ± 0.7 GBq / cycle) or to oral everolimus 10 mg once daily until PD or unacceptable toxicity. Only patients with positivity in somatostatin receptor imaging will be included. CT or MRI scans are performed every 12 weeks until PD. Blood samples are analyzed at baseline, at 1st tumor assessment, and at PD for pharmacodynamic endpoints. Archival tumor tissue samples will be analyzed for ancillary studies.
The primary endpoint is progression-free survival (PFS) according to RECIST v1.1 based on local investigator assessment. Secondary endpoints include overall survival, overall response rate, safety, and quality of life (EORTC QLQ-C30).
The expected sample size is 120 patients to demonstrate statistical significant risk reduction of 46.4% (HR = 0.536) in PFS with the experimental treatment using an overall 5% two-sided alpha error with 80% power. An interim PFS analysis was included using the Lan-DeMets with O’Brian-Fleming-like boundaries.
Discussion
The LEVEL trial will investigate if 177Lu-edotreotide has the potential to be incorporated as a standard treatment option for patients with NETs from the lung and Thymus.
Trial Registration
EU CT: 2022–502154-13–00 / www.clinicaltrials.gov: NCT05918302 (June 23rd, 2023).This work was sponsored by the Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE) with the collaboration of ITM Oncologics GmbH