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Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study
Get PDFGemcitabine; Locally advanced pancreatic adenocarcinomaGemcitabina; Adenocarcinoma pancreàtic localment avançatGemcitabina; Adenocarcinoma pancreático localmente avanzadoPurpose
Tumor treating fields (TTFields) use alternating electric fields to disrupt cancer cell proliferation. Feasibility of TTFields therapy with gemcitabine/nab-paclitaxel was previously demonstrated in patients with advanced pancreatic adenocarcinoma. PANOVA-3 was designed to confirm safety and efficacy of TTFields in patients with unresectable locally advanced pancreatic adenocarcinoma (LA-PAC).
Methods
In this global phase III trial, 571 patients with newly diagnosed LA-PAC were randomly assigned to receive gemcitabine 1,000 mg/m2 and nab-paclitaxel 125 mg/m2 by intravenous infusion once a day on days 1, 8, and 15 of a 28-day cycle with or without TTFields. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), local PFS, pain-free survival, and overall response rate (ORR). Distant PFS was analyzed post hoc.
Results
OS was significantly prolonged using TTFields with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel (median, 16.2 months [95% CI, 15.0 to 18.0] v 14.2 months [95% CI, 12.8 to 15.4]; hazard ratio [HR], 0.82 [95% CI, 0.68 to 0.99]; P = .039). PFS, local PFS, and ORR were not improved. Pain-free survival was significantly prolonged with TTFields with gemcitabine/nab-paclitaxel (median, 15.2 months [95% CI, 10.3 to 22.8] v 9.1 months [95% CI, 7.4 to 12.7]; HR, 0.74 [95% CI, 0.56 to 0.97]; P = .027), as was distant PFS (median, 13.9 months [95% CI, 12.2 to 16.8] v 11.5 months [95% CI, 10.4 to 12.9]; HR, 0.74 [95% CI, 0.57 to 0.96]; P = .022). Device-related skin adverse events (AEs) were experienced by 76.3% of patients. Most device-related skin AEs were mild to moderate, with 7.7% of patients reporting a grade 3 AE.
Conclusion
This study demonstrated significant OS, pain-free survival, and distant PFS benefits for TTFields with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in patients with unresectable LA-PAC, with no additive systemic toxicity
Lipidomic analysis reveals metabolism alteration associated with subclinical carotid atherosclerosis in type 2 diabetes
Get PDFLipidomics; Type 2 diabetes; Subclinical carotid atherosclerosisLipidòmica; Diabetis tipus 2; Aterosclerosi carotídia subclínicaLipidómica; Diabetes tipo 2; Aterosclerosis carotídea subclínicaDisruption of lipid metabolism contributes to increased cardiovascular risk in diabetes.
We evaluated the associations between serum lipidomic profile and subclinical carotid atherosclerosis (SCA) in type 1 (T1D) and type 2 (T2D) diabetes, and in subjects without diabetes (controls) in a cross-sectional study. All subjects underwent a lipidomic analysis using ultra-high performance liquid chromatography-electrospray ionization tandem mass spectrometry, carotid ultrasound (mode B) to assess SCA, and clinical assessment. Multiple linear regression models were used to assess the association between features and the presence and burden of SCA in subjects with T1D, T2D, and controls separately. Additionally, multiple linear regression models with interaction terms were employed to determine features significantly associated with SCA within risk groups, including smoking habit, hypertension, dyslipidaemia, antiplatelet use and sex. Depending on the population under study, different confounding factors were considered and adjusted for, including sample origin, sex, age, hypertension, dyslipidaemia, body mass index, waist circumference, glycated haemoglobin, glucose levels, smoking habit, diabetes duration, antiplatelet use, and alanine aminotransferase levels.
A total of 513 subjects (151 T1D, 155 T2D, and 207 non-diabetic control) were included, in whom the percentage with SCA was 48.3%, 49.7%, and 46.9%, respectively. A total of 27 unique lipid species were associated with SCA in subjects with T2D, in former/current smokers with T2D, and in individuals with T2D without dyslipidaemia. Phosphatidylcholines and diacylglycerols were the main SCA-associated lipidic classes. Ten different species of phosphatidylcholines were up-regulated, while 4 phosphatidylcholines containing polyunsaturated fatty acids were down-regulated. One diacylglycerol was down-regulated, while the other 3 were positively associated with SCA in individuals with T2D without dyslipidaemia. We discovered several features significantly associated with SCA in individuals with T1D, but only one sterol could be partially annotated.
We revealed a significant disruption of lipid metabolism associated with SCA in subjects with T2D, and a larger SCA-associated disruption in former/current smokers with T2D and individuals with T2D who do not undergo lipid-lowering treatment.This work was funded by Spanish Ministry of Health, Instituto de Salud Carlos III (Madrid, Spain) grants PI15/0625 (to DM and EC), PI17/01362 (to NA), PI18/0328 (to DM), FEDER “Una manera de hacer Europa”, and by Fundació La Marató de TV3 2016 (303/C/2016) (201602.30.31) (to NA). This work was supported by the Grant PID2021-122952OB-I00 funded by AEI https://doi.org/10.13039/501100011033 and by ERDF A way of making Europe (to AP). This research was supported by Biomedical Research Networking Center in Diabetes and Associated Metabolic Disorders (CIBERDEM–CB15/00071) (to DM) and Biomedical Research Networking Center in Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), initiatives of Instituto de Investigación Carlos III (ISCIII); ISCIII (grant AC22/00035) (to AP); and the CERCA Programme / Generalitat de Catalunya. B2SLab is certified as 2021 SGR 01052. Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is accredited by the Generalitat de Catalunya as Centre de Recerca de Catalunya (CERCA)
Entropy, Irreversibility, and Time-Series Deep Learning of Kinematic and Kinetic Data for Gait Classification in Children with Cerebral Palsy, Idiopathic Toe Walking, and Hereditary Spastic Paraplegia
Get PDFCerebral palsy; Deep learning; EntropyParálisis cerebral; Aprendizaje profundo; EntropíaParàlisi cerebral; Aprenentatge profund; EntropiaThe use of gait analysis to differentiate among paediatric populations with neurological and developmental conditions such as idiopathic toe walking (ITW), cerebral palsy (CP), and hereditary spastic paraplegia (HSP) remains challenging due to the insufficient precision of current diagnostic approaches, leading in some cases to misdiagnosis. Existing methods often isolate the analysis of gait variables, overlooking the whole complexity of biomechanical patterns and variations in motor control strategies. While previous studies have explored the use of statistical physics principles for the analysis of impaired gait patterns, gaps remain in integrating both kinematic and kinetic information or benchmarking these approaches against Deep Learning models. This study evaluates the robustness of statistical physics metrics in differentiating between normal and abnormal gait patterns and quantifies how the data source affects model performance. The analysis was conducted using gait data sets from two research institutions in Madrid and Dublin, with a total of 81 children with ITW, 300 with CP, 20 with HSP, and 127 typically developing children as controls. From each kinematic and kinetic time series, Shannon’s entropy, permutation entropy, weighted permutation entropy, and time irreversibility metrics were derived and used with Random Forest models. The classification accuracy of these features was compared to a ResNet Deep Learning model. Further analyses explored the effects of inter-laboratory comparisons and the spatiotemporal resolution of time series on classification performance and evaluated the impact of age and walking speed with linear mixed models. The results revealed that statistical physics metrics were able to differentiate among impaired gait patterns, achieving classification scores comparable to ResNet. The effects of walking speed and age on gait predictability and temporal organisation were observed as disease-specific patterns. However, performance differences across laboratories limit the generalisation of the trained models. These findings highlight the value of statistical physics metrics in the classification of children with different toe walking conditions and point towards the need of multimetric integration to improve diagnostic accuracy and gain a more comprehensive understanding of gait disorders.This research study was funded by Escuela Universitaria de Fisioterapia ONCE-UAM and TACTIC project—FORTALECE ISCIII grant No. FORT23/00034 and grant CNS2023-144775 funded by MICIU/AEI/10.13039/501100011033 by “European Union NextGenerationEU/PRTR”. This project also received funding from the European Research Council (ERC) under the European Union’s Horizon 2020 research and innovation programme (Grant Agreement No. 851255). This work was partially supported by María de Maeztu project CEX2021-001164-M funded by MCIN/AEI/10.13039/501100011033 and FEDER, EU. This research study was supported by a grant for an international stay within the Universidad Autónoma de Madrid travel grants program for participation in International Research Conferences
Evaluación de juegos serios digitales para mejorar la impulsividad y la regulación emocional en pacientes con trastornos de consumo de sustancias o de comportamientos adictivos, de la conducta alimentaria y del control de los impulsos
Get PDFJocs digitals; Addicció; Trastorns de la conducta alimentàriaDigital games; Addiction; Eating disordersJuegos digitales; Adicción; Trastornos de la conducta alimentariaAquest informe d'avaluació de tecnologies sanitàries té l'objectiu d'analitzar la seguretat clínica i tècnica, eficàcia, efectivitat clínica, i eficiència de l'ús de JS digitals en el tractament de pacients amb els trastorns per consum de substàncies, trastorns per comportaments addictius, transtorns de la conducta alimentària i trastorns del control dels impulsos.Este informe de evaluación de tecnologías sanitarias tiene como objetivo analizar la seguridad clínica y técnica, eficacia, efectividad clínica, y eficiencia del uso de JS digitales en el tratamiento de pacientes con los trastornos por consumo de sustancias, trastornos por comportamientos adictivos, trastornos de la conducta alimentaria y trastornos del control de los impulsos.This health technology assessment report aims to analyze the clinical and technical safety, efficacy, clinical effectiveness, and efficiency of the use of digital JS in the treatment of patients with substance use disorders, addictive behavior disorders, eating disorders, and impulse control disorders
Informe sobre l’indicador d'inicis de tractament ambulatori amb substància o sense: any 2024
Get PDFTractament ambulatori; Drogodependències; IndicadorOutpatient treatment; Drug addictions; IndicatorTratamiento ambulatorio; Drogodependencias; IndicadorL’objectiu principal de la informació recollida és descriure les característiques sociodemogràfiques, els patrons de consum de drogues o d’altres conductes addictives, els comportaments de risc i els problemes associats de les persones que inicien el tractament per la seva addicció
A New Prognostic Score Based on Cell-Mediated Immunity for Cytomegalovirus Infection After Transplantation
Get PDFBreastfeeding; Breast cancerLactancia materna; Cáncer de mamaLactància materna; Càncer de mamaBackground: We investigated safety of breastfeeding after breast cancer in patients carrying germline BRCA pathogenic or likely pathogenic variants.
Methods: This was an international, multicentre, hospital-based, retrospective cohort study including BRCA carriers diagnosed with stage I-III invasive breast cancer at age 40 years or younger between January 2000 and December 2020 (NCT03673306). Locoregional recurrences and/or contralateral breast cancers, disease-free survival (DFS) and overall survival (OS) were compared between patients who breastfed after delivery and those who did not.
Results: Among 4732 patients included from 78 centres worldwide, 659 had a pregnancy after breast cancer diagnosis, of whom 474 delivered a child. After excluding patients with uptake of bilateral risk-reducing mastectomy prior to delivery (n = 225) or unknown breastfeeding status (n = 71), 110 (61.8%) breastfed (median duration 5 months) and 68 (38.2%) did not breastfeed. Compared to patients in the no breastfeeding group, those who breastfed were more frequently nulliparous at breast cancer diagnosis (61.8% vs 45.6%) and did not report prior smoking habit (71.8% vs 57.4%).After a median follow up of 7.0 years following delivery, 7-year cumulative incidence of locoregional recurrences and/or contralateral breast cancers was 29% in the breastfeeding group and 37% in the no breastfeeding group (adjusted subdistribution hazard ratio[HR]=1.08, 95%CI 0.57-2.06). No difference in DFS (aHR = 0.83, 95%CI 0.49-1.41) nor in OS (aHR = 1.32, 95%CI 0.31-5.66) was observed.
Conclusions: Breastfeeding did not appear to be associated with a higher risk of developing locoregional recurrences or contralateral breast cancers, emphasizing the possibility of achieving a balance between maternal and infant needs without compromising oncological safety.LD received a research fellowship grant from the “Instituto de Salud Carlos III” [FI22/00252]. OB’s research activity is partly supported by Instituto de Salud Carlos III (ISCII) (grant numbers PI19/01710 and PI22/01019) (Cofunded by European Regional Development Fund, ERDF-ESF, a way to build Europe) and RICORS (redes de Investigación Cooperativa Orientadas a Resultados en Salud) consortia by the Instituto de Salud Carlos III. In addition, the work was partially funded by a European Union’s Horizon 2020 research and innovation program under grant agreement No 754995 (EUTRAIN). The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the funding institutions
Estudi qualitatiu sobre l’impacte de la COVID persistent en el rendiment laboral dels professionals sanitaris [cartell]
Get PDFCovid persistent; Professionals de la salut; Rendiment laboralCOVID persistente; Profesionales de la salud; Rendimiento laboralLong COVID; Healthcare professionals; Work performanceAquest document és el tercer d'una sèrie de tres infografies que resumeixen un projecte de recerca sobre l'impacte de la COVID persistent en l'acompliment laboral del personal sanitari procedent de diversos hospitals en el Sistema Nacional de Salut.
La infografia presenta els principals resultats i conclusions del subestudi qualitatiu, que recull les experiències expressades pels diferents actors implicats, s'identifiquen barreres i facilitadors per a la seva reincorporació al lloc de treball, així com necessitats no cobertes en la seva atenció i gestió.Este documento es el tercero de una serie de tres infografías que resumen un proyecto de investigación sobre el impacto de la COVID persistente en el desempeño laboral del personal sanitario procedente de varios hospitales del Sistema Nacional de Salud.
La infografía presenta los principales resultados y conclusiones del subestudio cualitativo, que recoge las experiencias expresadas por los diferentes actores implicados, identifica barreras y facilitadores para su reincorporación al puesto de trabajo, así como necesidades no cubiertas en su atención y gestión.This document is the third in a series of three infographics that summarize a research project on the impact of long COVID on the job performance of healthcare staff from several hospitals within the National Health System.
The infographic presents the main results and conclusions of the qualitative sub-study, which gathers the experiences expressed by the different stakeholders involved, identifies barriers and facilitators to their return to work, as well as unmet needs in their care and management
Three-year survival follow-up of patients with gastrointestinal cancer treated during the COVID-19 pandemic in Spain: data from the PANDORA-TTD20 study
Get PDFCoronavirus disease; Gastrointestinal cancer; Spatial frailtiesMalaltia per coronavirus; Càncer gastrointestinal; Fragilitats espacialsEnfermedad por coronavirus; Cáncer gastrointestinal; Fragilidades espacialesIntroduction
The initial SARS-CoV-2 pandemic wave in Spain in 2020 precipitated significant paradigm shifts in gastrointestinal oncology patient management. This study captures the “Zeitgeist” of this period by analyzing adaptive strategies, treatment modifications, and survival outcomes, leveraging a 3-year follow-up perspective to extract insights from this unprecedented experience.
Methods
We conducted a multicenter, retrospective cohort study utilizing the RETUD-TTD registry, encompassing 703 patients across 19 Spanish centers in April 2020. We evaluated alterations in clinical practice, therapeutic approaches, coronavirus disease 2019 (COVID-19)-related impacts, and patient survival. A Bayesian hierarchical model was employed to identify potential regional-specific frailties.
Results
The peak of the pandemic in April 2020 catalyzed substantial shifts in oncological care delivery. Outpatient consultations decreased by 13%, with a notable selection bias toward cases with more favorable prognostic indicators. Multidisciplinary tumor board discussions were significantly curtailed (eg, mean monthly colorectal cancer cases discussed was reduced from 40 to 23), compromising qualitative care measures. This occurred concurrently with an average of over 3 oncologists per center on medical leave. Contrary to initial concerns, the healthcare system demonstrated remarkable resilience. The majority of patients received standard-of-care therapies with regulatory approval, albeit with regimen modifications in 15% of cases. These adaptations included extended dosing intervals, dose intensity modulations, and transitions to oral formulations while maintaining unexpectedly stable long-term survival outcomes. The Bayesian frailty model detected minimal unmeasured prognostic factors related to geographic location, and the type of pandemic-induced adaptation did not significantly impact survival. The model revealed that coronavirus disease 2019’s impact was less pronounced than other core prognostic variables.
Conclusions
The decentralized Spanish healthcare system exhibited substantial robustness in managing pre-pandemic diagnosed gastrointestinal malignancies, despite asymmetrical, and occasionally severe organizational disruptions. The insights gleaned from this experience could inform future crisis preparedness strategies and optimize care provision during subsequent public health emergencies.This study has been facilitated and funded by the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD), based in Madrid, Spain
Increased posterior tibial slope is a risk factor for anterior cruciate ligament injury and graft failure after reconstruction: A systematic review
Get PDFKnee; Meniscal slope; OsteotomyGenoll; Pendent meniscal; OsteotomiaRodilla; Pendiente meniscal; OsteotomíaImportance: Anterior cruciate ligament (ACL) injury and ACL reconstruction (ACLR) graft failure are important clinical concerns that result in long recovery periods, potential long-term knee instability, and poor patient outcomes. Identifying risk factors such as posterior tibial slope (PTS), meniscal slope (MS), and meniscal bone angle (MBA) is important for improving risk stratification, guiding management decisions, and reducing the incidence of both ACL injury and ACLR graft failure.
Objective: This systematic review and meta-analysis aim to determine whether increased PTS, increased MS, and decreased MBA serve as independent predictors of both ACL injury and ACLR graft failure.
Evidence review: A comprehensive search of the literature was conducted following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. For evaluating ACL injury, the review included comparative studies measuring PTS, MS, or MBA between ACL injury patients and ACL-intact controls. For ACLR graft failure, studies comparing these measurements between patients with ACLR graft failures and those with successful ACLR outcomes were included. Data were pooled using a random-effects model to calculate the overall mean difference (MD) between groups.
Findings: Out of 1,683 initially identified studies, 75 studies were selected for detailed analysis, 53 analyzing ACL injury and 24 studies analyzing ACLR graft failure. The meta-analysis revealed that increased PTS significantly increases the risk of both ACL injury (MD 1.64°; 95% CI: 1.08-2.20, p < 0.01) and ACLR graft failure (MD 1.76°; 95% CI: 1.03-2.48, p < 0.01). This is statistically significant for both lateral and medial PTS, and across both radiograph and magnetic resonance imaging. A higher lateral MS (MD 3.25°; 95% CI: 1.70-4.80, p < 0.01) and a lower lateral MBA (MD -3.85°; 95% CI: -6.38-1.32, p < 0.01) were also significantly associated with an increased risk of ACL injury. However, no statistically significant differences were observed for MS or MBA between ACLR graft failure and successful ACLR groups.
Conclusion and relevance: The findings indicate that increased PTS, whether measured medially or laterally, is a statistically significant risk factor for both ACL injury and ACLR graft failure. Additionally, increased lateral MS and decreased lateral MBA are associated with ACL injury. This evidence supports the consideration of tibial slope in risk assessment, preoperative planning, and surgical decision-making for both prevention of ACL injury and ACLR procedures. Further research is necessary to fully understand the role of MS and MBA in ACL injury.
Level of evidence: Level IV; systematic review of level III-IV studies
Economic Evaluation Methodologies of Remote Patient Monitoring for Chronic Conditions: Scoping Review
Get PDFConsolidated Health Economic Evaluation Reporting Standards; Remote patient monitoring; Budget impact analysisEstándares Consolidados de Reporte de Evaluaciones Económicas Sanitarias; Monitorización remota de pacientes; Análisis de impacto presupuestarioEstàndards Consolidats de Report d'Avaluacions Econòmiques Sanitàries; Monitoratge remot de pacients; Anàlisi d'impacte pressupostariRemote patient monitoring (RPM) offers a potential solution to manage the increasing prevalence of chronic condition challenges in health care systems worldwide, but its economic evaluation remains challenging.
This scoping review aimed to explore the methodologies used in economic evaluations of RPM interventions for chronic conditions, with a particular focus on cost identification, measurement and valuation, and reporting quality.
A scoping review was conducted following the Joanna Briggs Institute methodology for scoping reviews. Systematic searches were carried out in Embase, MEDLINE, CINAHL, and Web of Science in week 40 of 2023, with no restrictions on the start date. No geographical restrictions were applied beyond requiring English-language publications. Studies were included if they reported a full or partial economic evaluation of an RPM intervention targeting patients with one or more chronic conditions. Screening and selection were performed independently by 2 reviewers. A total of 5473 records were identified, of which, 41 records met inclusion criteria after screening. Data were synthesized into key themes: study characteristics (design, population, setting), economic evaluation methods (types of analysis, comparator, perspectives, and outcome measures), cost estimation (identification, measurement, valuation), and adherence to the CHEERS (Consolidated Health Economic Evaluation Reporting Standards) 2022. Discrepancies were resolved through discussion. The review protocol was registered in the Open Science Framework.
A total of 41 papers, representing 40 studies, were included in the final review. Studies used diverse evaluation methods, such as cost-effectiveness analysis (20 studies), within which, 13 studies specifically conducted cost-utility analysis. Other approaches included cost-consequence analysis (7 studies), cost-minimization analysis (3 studies), cost-benefit analysis (2 studies), cost analysis (8 studies), and budget impact analysis (1 study). Cost estimation approaches varied across studies, with differences in cost identification, measurement, and valuation. Cost estimation methodologies varied, both in terms of which cost components were included and how costs were identified, measured, and valued. Commonly reported costs related to health care resource use and technology, but the data sources used, and the level of transparency provided, varied. Studies reported a range of outcome measures, including quality-adjusted life years, mortality, and financial indicators. Some studies reported multiple outcomes. Reporting inconsistencies were observed, and adherence to updated CHEERS 2022 standards was limited, particularly in sensitivity analyses and cost data transparency.
This review highlights the diversity and methodological variability in economic evaluations of RPM interventions for chronic conditions. Key limitations include inconsistent cost methodologies and inadequate adherence to reporting standards, complicating cross-study comparisons. Future research should adopt more standardized, transparent reporting protocols to improve the reliability and utility of economic evidence for decision-makers considering RPM implementation