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COSMIC-021 Phase Ib Study of Cabozantinib Plus Atezolizumab: Results from the Locally Advanced or Metastatic Urothelial Carcinoma Cohorts
Get PDFCabozantinib; Atezolizumab; Urothelial carcinomaCabozantinib; Atezolizumab: Carcinoma urotelialCabozantinib; Atezolizumab; Carcinoma urotelialPurpose
The COSMIC-021 study assessed the safety and efficacy of cabozantinib plus atezolizumab in advanced solid tumors. Presented here are results from the expansion cohorts with advanced urothelial carcinoma (UC).
Methods
This phase Ib study (ClinicalTrials.gov identifier: NCT03170960) enrolled patients with inoperable locally advanced/metastatic UC into four tumor cohorts: first-line cisplatin-eligible (cis-eligible), first-line cisplatin-ineligible (cis-ineligible), previous platinum-containing chemotherapy (previous chemotherapy-treated), and previous immune checkpoint inhibitor (ICI)–treated. Patients received oral cabozantinib 40 mg once daily and intravenous atezolizumab 1,200 mg once every 3 weeks. The primary end point was objective response rate (ORR), as assessed by the investigator per RECIST v1.1 every 6 weeks for 12 months and every 12 weeks thereafter; the secondary end point was safety.
Results
A total of 121 patients (previous ICI-treated cohort, n = 31, and each of the other cohorts, n = 30) received study treatment from March 2018 to November 2021. The ORR (95% CI) was 30% (15 to 49) for cis-eligible, 20% (8 to 39) for cis-ineligible, 27% (12 to 46) for previous chemotherapy-treated, and 10% (2 to 26) for previous ICI-treated cohorts. The median progression-free survival (95% CI) was 5.5 (1.6 to 11.6), 5.6 (3.1 to 11.1), 5.4 (1.6 to 7.6), and 3.0 (1.8 to 5.5) months, respectively. Grade 3 or 4 treatment-related adverse events (TRAEs) were experienced by 43%, 67%, 57%, and 45% of patients, respectively. TRAEs led to discontinuation of all treatment components in 17%, 13%, 3%, and 19%, respectively. No grade 5 TRAEs were reported in any cohort.
Conclusion
The novel combination of cabozantinib plus atezolizumab exhibited clinical activity in advanced UC that is cis-eligible, cis-ineligible, or previously treated with platinum-containing chemotherapy; clinical activity in previous ICI-treated UC was modest. The toxicity profile was consistent with that previously reported for the combination
Non-contrast dual-energy CT iodine quantification for lung injury characterization after balloon pulmonary angioplasty
Get PDFBalloon angioplasty; Computed tomography; Pulmonary thromboembolismAngioplastia con balón; Tomografía computarizada; Tromboembolismo pulmonarAngioplàstia amb baló; Tomografia computeritzada; Tromboembolisme pulmonarObjectives; This study aimed to identify differences in iodine concentrations in new-onset pulmonary injuries and normal lung parenchyma after balloon pulmonary angioplasty (BPA) for chronic thromboembolic pulmonary hypertension (CTEPH) using non-contrast dual-energy CT (NC-DECT) between patients with pulmonary hemorrhage and reperfusion pulmonary edema.
Methods: Patients undergoing NC-DECT after BPA between January 2019 and April 2023 due to hemoptysis or clinical worsening were retrospectively evaluated for inclusion. Patients were divided based on the presence or absence of BPA-related hemoptysis. Intralesional iodine concentrations were measured in new-onset lung injuries, adjacent normal parenchyma, same lobe, and contralateral lung. CT morphological features, including lesion shape, imaging pattern, absolute density, and ROI size, were recorded. Statistical comparisons were performed using Mann-Whitney U, Friedman, and Wilcoxon signed-rank tests.
Results: Thirteen patients with 32 new-onset post-BPA lung injuries were included. Median iodine concentration in lung injuries was significantly higher in patients with hemoptysis than those without (3.4 mg/mL versus 0.6 mg/mL; p < 0.001). In the hemoptysis group, iodine concentration in lung injuries was significantly higher compared with the different locations of normal lung parenchyma (p < 0.001). In the non-hemoptysis group, no significant differences in iodine concentration were observed between lung injuries and normal parenchyma (p = 0.167; p = 0.351; p = 0.246). Absolute density (p = 0.767), lesion shape (p = 0.610), imaging appearance (p = 0.530), ROI area (p = 0.452), and halo sign (p = 0.810) showed no significant correlation with hemoptysis.
Conclusion: NC-DECT identifies iodine concentration differences in lung injuries between patients with and without hemoptysis after BPA. Elevated iodine concentrations may serve as an imaging marker for post-procedural pulmonary hemorrhage.
Critical relevance statement: This exploratory study demonstrates the potential of NC-DECT in distinguishing between pulmonary hemorrhage and reperfusion pulmonary edema in lung injuries after BPA in patients with CTEPH. The ability to quantify iodine concentrations in lung lesions offers a novel imaging biomarker for pulmonary hemorrhage, which could play a pivotal role in improving clinical decision-making and management strategies for patients undergoing BPA
Comparison Between Dynamic Models for Predicting Response to Corticosteroids in Alcohol-Associated Hepatitis: A Global Cohort Study
Get PDFAlcoholic cirrhosis; End‐stage liver disease; Outcome predictionCirrosis alcohólica; Enfermedad hepática terminal; Predicción de resultadosCirrosi alcohòlica; Malaltia hepàtica terminal; Predicció de resultatsSeveral dynamic models predict mortality and corticosteroid response in alcohol-associated hepatitis (AH), yet no consensus exists on the most effective model. This study aimed to assess predictive models for corticosteroid response and short-term mortality in severe AH within a global cohort. We conducted a multi-national study of patients with severe AH treated with corticosteroids for at least 7 days, enrolled between 2009 and 2019. Dynamic models—Lille-4, Lille-7, trajectory of serum bilirubin (TSB), and neutrophil-to-lymphocyte ratio (NLR)—were used to estimate 30- and 90-day mortality. Lille-7 demonstrated the highest accuracy for both 30- and 90-day mortality.Marco Arrese receives support from the Chilean government through the Fondo Nacional de Desarrollo Científico y Tecnológico (FONDECYT 1241450)
Endotoxin hemoadsorption in refractory septic shock with multiorgan dysfunction and extreme endotoxin activity
Get PDFEndotoxin activity; Hemoadsorption; Refractory septic shockActivitat d'endotoxines; Hemoadsorció; Xoc sèptic refractariActividad de endotoxinas; Hemoadsorción; Choque séptico refractarioEndotoxin septic shock is marked by severe organ failure and mortality rate that exceeds fifty percent, underscoring the critical need to tailor management strategies. Monitoring -endotoxin activity can guide the initiation and direction of adjunctive treatment for refractory septic shock through hemoadsorption. Thus, intervening based on the pathophysiological foundation may potentially improve outcomes. This represents a step towards precision medicine in the management of septic shock adjunctive therapies, addressing a knowledge gap in this pathology that remains insufficiently defined. Despite its potential, in the setting of refractory septic shock and multiorgan dysfunction with extreme endotoxin activity (EAA ≥ 0.9), the data about efficacy of endotoxin hemoadsorption is scarce
New systemic treatment paradigms in advanced biliary tract cancer and variations in patient access across Europe
Get PDFBiliary tract cancer; Immunotherapy; Molecularly targeted therapyCàncer del tracte biliar; Immunoteràpia; Teràpia molecular dirigidaCáncer del tracto biliar; Inmunoterapia; Terapia molecular dirigidaIn recent years, treatment options for patients with advanced biliary tract cancer (BTC) have increased significantly due to the positive results from phase 2/3 clinical trials of immune checkpoint inhibitors, combined with chemotherapy, and molecularly targeted agents. These advances have led to the need for molecular testing to identify actionable alterations and patients amenable to targeted therapies. However, these improvements have brought with them many questions and challenges, including the identification of resistance mechanisms and therapeutic sequences. In this Series paper we aim to provide an overview of the current systemic treatment options for patients with BTC, highlighting disparities in access to innovative treatments and molecular testing across European countries, which lead to inequalities in the possibilities of treating patients with advanced BTC. We also discuss how ongoing European collaborative projects, such as the COST Action Precision-BTC-Network CA22125, supported by COST (European Cooperation in Science and Technology), linked to the European Network for the Study of Cholangiocarcinoma (ENSCCA), can help overcome these disparities and improve the current scenario.This publication is based upon work from the European Network for the Study of Cholangiocarcinoma and the COST Action Precision-BTC-Network CA22125, supported by COST (European Cooperation in Science and Technology; www.cost.eu)
Acsa brief - 2025, 02-març-abril
No full textAliments; Riscos emergents; Seguretat alimentàriaFood; Food safety; Food risk assessmentAlimentos; Riesgos emergentes; Seguridad alimentariaEl bisfenol A (BPA)El bisfenol A (BPA
Butll Farmacovigil Cat
No full textFarmacologia; Medicaments; Reaccions adversesPharmacology; Drug; Adverse ReactionsFarmacología; Medicamentos; Reacciones adversasAcidosis láctica inducida por salbutamol. Comunicaciones sobre riesgos a medicamentos notificadas por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) y otras informaciones sobre seguridad.Acidosi làctica induïda per salbutamol / Comunicacions sobre riscos a medicaments notificades per l’Agència Espanyola de Medicaments i Productes Sanitaris (AEMPS) / Altres informacions sobre seguretat
Natural history of SGCE-associated myoclonus dystonia in children and adolescents
Get PDFMyoclonus dystonia; ChildrenDistonía mioclónica; NiñosDistonia mioclònica; NensAim: To investigate the natural progression of SGCE-associated myoclonus dystonia from symptom onset in childhood to early adulthood.
Method: Myoclonus and dystonia were monitored using rating scales in two cohorts of participants from Spain and the Netherlands. Individual annualized rates of change were calculated and longitudinal trends were assessed using Bayesian mixed models. Psychiatric features were evaluated cross-sectionally in the Spanish cohort.
Results: Thirty-eight patients (21 males, 17 females) were evaluated at a mean age (SD) of 10 years (4 years 7 months; range 2-21 years) and 14 years 2 months (4 years 8 months; range 4-25 years). We observed a significant worsening of action myoclonus, global dystonia, and dystonia during writing (mean annual increases of 1.356, 0.226, and 0.518 in the Unified Myoclonus, Burke-Fahn-Marsden, and Writer's Cramp Rating Scales respectively). Accordingly, participants perceived a significant worsening in their speech, writing, and walking abilities. Twenty-six of 32 participants suffered from anxiety (n = 13), obsessive-compulsive disorder (n = 9), and attention-deficit/hyperactivity disorder (n = 8).
Interpretation: This study demonstrates that, unlike in the adult population, myoclonus dystonia syndrome in childhood and adolescence follows a progressive course that can be debilitating in the early stages of life. These findings, along with a high prevalence of psychiatric symptoms, highlight the need for early therapeutic interventions to prevent long-term motor and psychological sequelae.Myoclonus Dystonia Spanish association (ALUDME). Grant Numbers: FORT23/00034, PI24/01083, PI21/00248. Agència de Gestió d'Ajuts Universitaris i de Recerca. Grant Number: 2022 FI_B 00996. Instituto de Salud Carlos III. Grant Numbers: FORT23/00034, PI21/00248, PI24/01083
Perceptions and Experiences of Parents of Preterm Infants with Umbilical Venous Catheter Undergoing Skin-to-Skin Contact
Get PDFNeonatal unit; Parental experiences; Preterm infantUnitat neonatal; Experiències parentals; Nadó prematurUnidad neonatal; Experiencias parentales; Bebé prematuroBackground: Skin-to-skin contact (SSC) is established as a standard of care due to its demonstrated benefits for preterm newborns, with evidence showing that earlier and more prolonged skin-to-skin contact correlates with reduced morbidity in neonates. Preterm newborns frequently require an umbilical venous catheter, and decisions regarding SSC implementation often depend on nursing staff discretion, given the limited evidence on the safety of SSC in infants with umbilical venous catheters.
Aim: The primary endpoint is to explore the experiences and perceptions of parents of preterm infants with umbilical venous catheter (UVC) who engaged in SSC.
Methods: This mixed-method, cross-sectional observational study. Conducted from February 2021 to January 2023 at Vall d'Hebron Hospital. The study recruited 190 participants, all progenitors of preterm neonates with umbilical venous catheters, who completed an ad-hoc survey with open and closed questions between the 7th and 10th days of the neonate's life.
Results: Descriptive analysis indicated that 74% of progenitors-initiated skin-to-skin contact within the first 48 h of life; 88.4% reported enhanced emotional well-being during hospitalization while engaging in SSC; 80.4% considered SSC a safe method; and 46.6% were satisfied with the available support furniture. Additionally, 80.4% perceived skin-to-skin contact as beneficial for the developmental progress of their preterm newborn. Phenomenological analysis identified three key categories: perceptions, support and environment.
Conclusions: Promoting SSC provides substantial benefits for preterm neonates. Initiating skin-to-skin contact while the infant has an UVC supports earlier initiation and increased hours of SSC. Positive family feedback on SSC with UVC adds value to promoting this practice in neonatal units. SSC with UVC venous catheter is a safe and positive experience for parents. Information, practical support and the integration of the parents' perspective will be key in the realization of SSC. These findings should encourage other neonatal units to review protocols and actively promote early SSC with UVC
Guía de antídotos para los centros hospitalarios de Cataluña
Get PDFIntoxicació aguda; Emergències toxicològiques; Serveis d'urgènciesAcute poisoning; Toxicological emergencies; Emergency serviceIntoxicación aguda; Emergencias toxicológicas; Servicios de urgenciass’ha establert una llista d’antídots que inclou 47 fàrmacs, a partir dels quals s’ha elaborat la Guia d’antídots, comuna a tots els hospitals. Per a cada antídot es disposa d’informació sobre les indicacions toxicològiques principals, tant en població adulta com en pediàtrica, i si es tracta d’una indicació fora o no de la fitxa tècnica del fàrmac (FFT). Es disposa de diversos apartats addicionals relatius a la posologia, les reaccions adverses descrites, i advertiments durant l’embaràs i la lactància, així com un apartat amb observacions com ara precaucions, contraindicacions i condicions de conservació