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Is There a Role for Mifamurtide in Nonmetastatic High-Grade Osteosarcoma? Results From the Italian Sarcoma Group (ISG/OS-2) and Spanish Sarcoma Group (GEIS-33) Trials
Get PDFMifamurtide; OsteosarcomaMifamurtida; OsteosarcomaMifamurtida; OsteosarcomaPurpose: Outcome of patients with localized osteosarcoma is challenging. The role of mifamurtide is still a matter of debate. Two prospective trials were carried out in Italy (ISG/OS-2) and Spain (GEIS-33) with mifamurtide in ABCB1/P-glycoprotein (Pgp)-positive patients.
Patients and methods: Patients age ≤40 years with localized extremity high-grade osteosarcoma were eligible. Analysis of Pgp expression from diagnostic biopsy was centralized. Patients received two cycles of preoperative methotrexate, doxorubicin, and cisplatinum (MAP) before surgery. Postoperatively, in case of Pgp overexpression (Pgp-positive), mifamurtide was added, combined with doxorubicin (one cycle) and four consecutive cycles of high-dose ifosfamide (HDIFO) for patients with poor histologic response, or with MAP in case of good response. Patients who were Pgp-negative received MAP postoperatively. We present the merged analysis of ISG/OS-2 and GEIS-33 trial, an observational study with same inclusion criteria and treatment of ISG/OS-2. The primary endpoint was 5-year event-free survival (EFS) according to the use of mifamurtide. Secondary endpoint was overall survival (OS).
Results: From March 2013 to April 2018, 398 patients were analyzed. The median age was 14 years (range, 4-40), male/female: 238/160 (1.48/1.0); 211 of 398 (53%) tumors were Pgp-positive, and 204 of 398 (51.3%) patients received mifamurtide. With a median follow-up of 70 months (IQR, 49-90 months), the 5-year EFS and OS were 65.2% (95% CI, 60.1 to 69.8) and 74.8% (95% CI, 69.8 to 79.0), respectively, with superior EFS for patients undergoing mifamurtide and chemotherapy as compared with EFS of patients undergoing chemotherapy alone (5-year EFS 71.4% v 58.3%; P = .0139) not confirmed at multivariable analysis (P = .0593).
Conclusion: In this merged analysis with a risk-adapted strategy for nonmetastatic osteosarcoma, the group with unfavorable prognoses, identified by Pgp expression, performed well when mifamurtide, combined with HDIFO in case of poor response, was administered after surgery.
Trial registration: ClinicalTrials.gov NCT04383288 NCT01459484.Purpose: Outcome of patients with localized osteosarcoma is challenging. The role of mifamurtide is still a matter of debate. Two prospective trials were carried out in Italy (ISG/OS-2) and Spain (GEIS-33) with mifamurtide in ABCB1/P-glycoprotein (Pgp)-positive patients. Patients and methods: Patients age ≤40 years with localized extremity high-grade osteosarcoma were eligible. Analysis of Pgp expression from diagnostic biopsy was centralized. Patients received two cycles of preoperative methotrexate, doxorubicin, and cisplatinum (MAP) before surgery. Postoperatively, in case of Pgp overexpression (Pgp-positive), mifamurtide was added, combined with doxorubicin (one cycle) and four consecutive cycles of high-dose ifosfamide (HDIFO) for patients with poor histologic response, or with MAP in case of good response. Patients who were Pgp-negative received MAP postoperatively. We present the merged analysis of ISG/OS-2 and GEIS-33 trial, an observational study with same inclusion criteria and treatment of ISG/OS-2. The primary endpoint was 5-year event-free survival (EFS) according to the use of mifamurtide. Secondary endpoint was overall survival (OS). Results: From March 2013 to April 2018, 398 patients were analyzed. The median age was 14 years (range, 4-40), male/female: 238/160 (1.48/1.0); 211 of 398 (53%) tumors were Pgp-positive, and 204 of 398 (51.3%) patients received mifamurtide. With a median follow-up of 70 months (IQR, 49-90 months), the 5-year EFS and OS were 65.2% (95% CI, 60.1 to 69.8) and 74.8% (95% CI, 69.8 to 79.0), respectively, with superior EFS for patients undergoing mifamurtide and chemotherapy as compared with EFS of patients undergoing chemotherapy alone (5-year EFS 71.4% v 58.3%; P = .0139) not confirmed at multivariable analysis (P = .0593). Conclusion: In this merged analysis with a risk-adapted strategy for nonmetastatic osteosarcoma, the group with unfavorable prognoses, identified by Pgp expression, performed well when mifamurtide, combined with HDIFO in case of poor response, was administered after surgery. Trial registration: ClinicalTrials.gov NCT04383288 NCT01459484
Ramon Espasa: Conseller de Sanitat i Assistència Social 1977-1980; el Mapa Sanitari de Catalunya
Get PDFRamon Espasa; Planificació sanitària; Mapa Sanitari de CatalunyaRamon Espasa; Planificación sanitaria; Mapa Sanitario de CatalunyaRamon Espasa; Healthcare planning; Healthcare Map of CataloniaAquest llibre recull la trajectòria del Dr. Ramon Espasa com a conseller de Sanitat i Assistència Social entre 1977 i 1980, durant el govern provisional de la Generalitat presidit per Josep Tarradellas. Abans del seu càrrec, Espasa va impulsar un moviment de renovació del pensament sanitari català, en un context de recuperació després de la dictadura franquista. Aquesta etapa es coneix com la “Renaixença sanitària”.
L’obra s’estructura en tres parts. La primera analitza les iniciatives sanitàries catalanes entre 1975 i 1980. La segona revisa les polítiques aplicades durant el mandat d’Espasa. La tercera presenta tres textos originals del Dr. Espasa: una ponència al Congrés de Metges i Biòlegs en Llengua Catalana (1976), una conferència sobre la formació del cirurgià, i el pròleg del Mapa Sanitari.This book explores the work of Dr. Ramon Espasa, who served as Minister of Health and Social Welfare from 1977 to 1980 under the provisional Catalan Government led by Josep Tarradellas. Prior to his appointment, Espasa spearheaded a revival of Catalan health policy thinking, marking a post-dictatorship period known as the “Sanitary Renaissance.”
The book is structured in three parts. The first examines health-related initiatives in Catalonia from 1975 to 1980. The second focuses on the policies implemented during Espasa’s tenure. The third features three original writings by Dr. Espasa: a paper presented at the 1976 Congress of Catalan-speaking Doctors and Biologists, a lecture on surgical training, and the foreword to the Health Map.Este libro documenta la labor del Dr. Ramon Espasa como consejero de Sanidad y Asistencia Social entre 1977 y 1980, bajo el gobierno provisional de la Generalitat presidido por Josep Tarradellas. Antes de asumir el cargo, Espasa lideró un movimiento de renovación del pensamiento sanitario catalán, en una etapa de recuperación tras la dictadura franquista, conocida como la “Renaixença sanitaria”.
La obra se divide en tres partes. La primera revisa las propuestas sanitarias en Cataluña entre 1975 y 1980. La segunda analiza las políticas desarrolladas durante el mandato de Espasa. La tercera incluye tres textos originales del Dr. Espasa: una ponencia en el Congreso de Médicos y Biólogos en Lengua Catalana (1976), una conferencia sobre la formación del cirujano, y el prólogo del Mapa Sanitario
EC-IC direct bypass revascularization for intracranial atherosclerosis. Insights beyond the COSS trial
Get PDFIntracranial atherosclerosis; Revascularization; Cerebrovascular hemodynamicsAterosclerosi intracranial; Revascularització; Hemodinàmica cerebrovascularAterosclerosis intracraneal; Revascularización; Hemodinámica cerebrovascularPurpose
Despite the results of the EC-IC Bypass International Trial and the Carotid Occlusion Surgery Study (COSS), high-volume centers continue to treat symptomatic intracranial atherosclerotic patients with bypass revascularization. This study aimed to analyze our data and assess whether patient characteristics and outcomes differ from those in EC-IC Bypass and COSS trials.
Methods
Patients with intracranial atherosclerotic occlusions treated by EC-IC bypass from January 2012 to June 2022 were included. Inclusion criteria were: (1) intracranial atherosclerotic occlusion >70 %, (2) transient or permanent ischemic events in the affected territory, and (3) impaired cerebrovascular reactivity demonstrated by acetazolamide-challenged SPECT.
Results
Forty-nine patients were included. Half presented bilateral occlusions, and 53.1 % had hemodynamic symptoms. Most were asymptomatic or had mild strokes preoperatively. Postoperatively, mRS worsened in 34.78 % of patients without hemodynamic symptoms, compared to 15 % of symptomatic patients. No significant differences in NIHSS or mRS were observed between pre- and postoperative evaluations. The 30-day complication rate was 20.4 %, with one procedure-related death. High rates of bypass patency (97.95 %) and SPECT improvement (87.75 %) were achieved. Long-term ipsilateral ischemic stroke rate was 2 %.
Conclusion
EC-IC bypass remains a viable option in carefully selected patients with symptomatic intracranial stenosis and impaired cerebrovascular reserve. Patient selection based on clinical and functional criteria is essential. Our results contrast with those of the COSS trial, showing lower recurrence of ipsilateral ischemic stroke, neurological stability in most patients, and favorable outcomes in individuals with hemodynamic symptoms and contralateral stenosis
Rediscovering the carotid pulse: unlocking hidden insights in the era of AI-driven healthcare
Get PDFArtificial intelligence; Carotid artery; Pulse wave velocityInteligencia artificial; Arteria carótida; Velocidad de la onda de pulsoIntel·ligència artificial; Artèria caròtide; Velocitat de l'ona de polsFrom ancient Chinese medicine to medieval European practice, the carotid pulse has long been recognized as a vital window into vascular health. Yet in modern clinical medicine, this rich physiological signal has been largely overlooked. While artificial intelligence (AI) has transformed healthcare through advanced data interpretation, it has also inadvertently diverted focus from acquiring novel physiological data-particularly from the carotid artery. This review highlights the underutilized potential of carotid hemodynamics and explores how emerging sensor technologies, combined with AI, can transform stroke prevention, real-time cerebrovascular monitoring, and broader vascular care. As a central conduit between the heart and brain, the carotid artery conveys dynamic hemodynamic information relevant not only to neurology, but also to cardiology and pulmonary medicine. Recent advances in non-invasive, continuous monitoring now enable real-time assessment of vascular stiffness, pulse wave patterns, and early cerebrovascular compromise-capabilities that were previously inaccessible with traditional, intermittent evaluation methods. Focusing on the neurological context, this review outlines emerging opportunities in carotid monitoring, identifies key hemodynamic markers, and evaluates the clinical consequences of their underuse. By integrating AI with enhanced, continuous data acquisition from the carotid artery, the medical community may pursue new diagnostic and predictive pathways, advancing toward proactive, precision-based care and improved patient outcomes.This work was supported by state funding from the Israeli Innovation Authority and the European Innovation Council, both of which provided financial support for research and development activities
Foamy Macrophages and Blue Histiocytes as Diagnostic Clues to Acid Sphingomyelinase Deficiency
Get PDFAcid sphingomyelinase deficiency; Bone marrow pathology; Blue histiocytesDeficiencia de esfingomielinasa ácida; Patología de la médula ósea; Histiocitos azulesDeficiència d'esfingomielinasa àcida; Patologia de la medul·la òssia; Histiòcits blausWe report the case of a 54‐year‐old Spanish male, born to consanguineous parents, with no relevant medical history, who presented with progressive interstitial lung disease, hepatosplenomegaly with portal hypertension, and pruritic cutaneous lesions. Laboratory tests revealed microcytic anaemia (haemoglobin 89 g/L, MCV 79 fL) and thrombocytopenia (platelets 93 ×10⁹/L), with a normal white blood cell count. Viral hepatitis and full autoimmune screenings were negative except for an elevated angiotensin‐converting enzyme (ACE), low‐titre positive anti‐nuclear antibodies (ANA), and polyclonal hypergammaglobulinaemia. Whole‐body CT scan showed splenic lesions and paravertebral masses.
Differential diagnoses included systemic autoimmune conditions, connective tissue disorders, sarcoidosis, infections (e.g., Leishmania, tuberculosis), and haematological malignancies, such as lymphoproliferative or myeloproliferative disorders.
The peripheral blood smear showed no abnormalities. Bone marrow aspirate was markedly hypercellular, with preserved trilineage haematopoiesis, reversed myeloid–erythroid ratio, and mild dyserythropoiesis (14%). Strikingly, numerous scattered foamy macrophages coexisted with characteristic blue histiocytes—displaying deeply basophilic cytoplasm on May–Grünwald Giemsa stain
This case underscores the diagnostic value of bone marrow morphology in patients with cytopenias and systemic findings. The concurrent presence of foamy macrophages and blue histiocytes should raise suspicion for lipid storage diseases, particularly ASMD, and prompt timely metabolic and genetic investigations to establish a final diagnosis and start early treatment
Time-resolved dual transcriptomics of Pseudomonas aeruginosa biofilm formation in cystic fibrosis
Get PDFDual transcriptomics; Pseudomonas aeruginosa; Cystic fibrosisTranscriptómica dual; Pseudomonas aeruginosa; Fibrosis quísticaTranscriptòmica dual; Pseudomonas aeruginosa; Fibrosi quísticaPseudomonas aeruginosa biofilms cause severe infections in the airways of patients suffering from cystic fibrosis (CF) that are difficult to eradicate, even with intensive antibiotic therapy. The main goal of this study was to define the dual transcriptional response associated with the formation of P. aeruginosa biofilms in a polarized lung epithelium monolayer. We analyzed the dual response of healthy and CF epithelium after infection with P. aeruginosa isolates from acute and chronic infections. Our results show that strains of P. aeruginosa isolated from chronic infections specifically increase the expression of secretion systems of type I, III and VI to hijack the host response. Conversely, strains associated with acute illness use ABC transporters to counteract the antimicrobial response. In return, a distinctive expression pattern in the CF epithelium, including a high degree of cytokine secretion and keratinization, is largely observed in acute infections. Our results show that both host and pathogen genomic backgrounds contribute to the outcome of infection and specific transcriptional signatures could be used in the diagnosis, particularly in CF patients.This study was funded by a Research Grant 2022 of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the Spanish Ministerio de Ciencia e Innovación (PID2020-114627RB-I00 funded by MCIN/AEI/10.13039/501100011033; PID2023-152706OB-I00 funded by MICIU/AEI/10.13039/501100011033 and FEDER, UE), all to MT. NC was a recipient of a pre-doctoral PIF scholarship from UAB
A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
Get PDF3D printing; Paediatrics; Personalized medicationsImpresión 3D; Pediatría; Medicamentos personalizadosImpressió 3D; Pediatria; Medicaments personalitzatsThe integration of 3D printing (3DP) technologies into personalized medicine manufacture at the point-of-care is garnering significant interest due to its potential to create tailored drug products with precise dosages and other unique attributes. Both preclinical and clinical studies have demonstrated promising outcomes, including pharmacokinetic bioequivalence, improved patient acceptability, enhanced adherence, and the ability to produce consistent, reproducible dosage forms with accurate drug distribution. Some compounding pharmacies around the world are already incorporating 3DP into standard practice for simpler therapeutic treatments. However, further clinical evaluation is required for more complex treatments, such as multi-drug polypills. Conducting clinical trials involving 3DP technologies presents several challenges, including navigating evolving regulatory frameworks, addressing ethical and legal concerns, and complying with new point-of-care manufacturing guidelines. Although regulatory agencies are beginning to adapt their policies to accommodate 3DP, the absence of a comprehensive framework still creates uncertainty for pharmacists and healthcare providers. This article explores the planning and execution of clinical trials involving 3D printed medicines, with a focus on regulatory barriers, patient recruitment, compliance, and the integration of specialized equipment and expertise. It also discusses the implementation of 3DP for personalized drug manufacturing within hospital settings and offers guidance for obtaining clinical trial approval from the Spanish Agency for Medicine and Health Products (AEMPS). By providing these insights and recommendations, this article aims to support international harmonization and facilitate the adoption of 3DP technologies in clinical trials globally.Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. MCIN [PID2023-149544OB-C22], FEDER and Xunta de Galicia [ED431C 2024/09]
Evaluación de la seguridad, eficacia, efectividad e impacto económico de los centros de nacimiento como alternativa a la atención al parto de bajo riesgo (al inicio del trabajo de parto) en el ámbito hospitalario
Get PDFCentres de naixement; Parts; ObstetríciaCentros de nacimientos; Partos; ObstetriciaBirth centers; Births; ObstetricsL'objectiu general de l'informe és avaluar l'atenció al part de baix risc, concretament a l'inici del treball de part, en els centres de naixement hospitalaris -també coneguts en anglès com alongside midwifery units- i com a alternativa a l'atenció al part en unitats obstètriques en l'àmbit hospitalari.El objetivo general del informe es evaluar la atención al parto de bajo riesgo, concretamente al inicio del trabajo de parto, en los centros de nacimiento hospitalarios —también conocidos en inglés como alongside midwifery units— y como alternativa a la atención al parto en unidades obstétricas en el ámbito hospitalario.The general objective of the report is to assess care for low-risk childbirth, specifically at the onset of labour, in hospital birth centres —also known in English as alongside midwifery units— and as an alternative to childbirth care in hospital obstetric units
Bol Prev Errores Medicación Cataluña
No full textErrors de medicació; Prescripció de medicamentsMedication errors; Drug prescriptionErrores de medicación; Prescripción de medicamentosTratamiento de la infección probable en un recién nacido expuesto a un caso de tuberculosis pulmonar. Caso clínico: PROPRANOLOL, no es lo mismo prescribir en ml que en mgTractament d’infecció probable en un nounat exposat a un cas de tuberculosi pulmonar. Cas clínic: PROPRANOLOL, no és el mateix prescriure en ml que en mg
Acsa brief - 2025, 04-setembre-octubre
No full textAliments; Riscos emergents; Seguretat alimentàriaFood; Food safety; Food risk assessmentAlimentos; Riesgos emergentes; Seguridad alimentariaEl virus de la grip aviar H5N1 i la seguretat alimentària.El virus de la gripe aviar H5N1 y la seguridad alimentaria