ABSTRACT
Background
Data from the sentinel surveillance system of severe acute respiratory infections in Spain were used to estimate the impact of administration of nirsevimab to children born from 1 ...April 2023 onwards.
Methods
Estimated RSV hospitalisations in < 1‐year‐olds during weeks 40, 2023, to 8, 2024, were compared to the number that would be expected after accounting for the background change in RSV circulation in the 2023/24 season, compared to 2022/23.
Results
We estimated 9364–9875 RSV hospitalisations less than expected, corresponding to a 74%–75% reduction.
Background
Real‐world data are essential to accurately assessing efficacy and toxicity of approved agents in everyday practice. PRINCIPAL, a prospective, observational study, was designed to confirm ...the real‐world safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC).
Subjects, Materials, and Methods
Patients with clear cell advanced/metastatic RCC and a clinical decision to initiate pazopanib treatment within 30 days of enrollment were eligible. Primary objectives included progression‐free survival (PFS), overall survival (OS), objective response rate (ORR), relative dose intensity (RDI) and its effect on treatment outcomes, change in health‐related quality of life (HRQoL), and safety. We also compared characteristics and outcomes of clinical‐trial‐eligible (CTE) patients, defined using COMPARZ trial eligibility criteria, with those of non‐clinical‐trial‐eligible (NCTE) patients. Secondary study objectives were to evaluate clinical efficacy, safety, and RDI in patient subgroups.
Results
Six hundred fifty‐seven patients were enrolled and received ≥1 dose of pazopanib. Median PFS and OS were 10.3 months (95% confidence interval CI, 9.2–12.0) and 29.9 months (95% CI, 24.7 to not reached), respectively, and the ORR was 30.3%. HRQoL showed no or little deterioration over time. Treatment‐related serious adverse events (AEs) and AEs of special interest occurred in 64 (9.7%), and 399 (60.7%) patients, respectively. More patients were classified NCTE than CTE (85.2% vs. 14.8%). Efficacy of pazopanib was similar between the two groups.
Conclusion
PRINCIPAL confirms the efficacy and safety of pazopanib in patients with advanced/metastatic RCC in a real‐world clinical setting.
Implications for Practice
PRINCIPAL is the largest (n = 657) prospective, observational study of pazopanib in patients with advanced/metastatic renal cell carcinoma, to the authors’ knowledge. Consistent with clinical trial results that often contain specific patient types, the PRINCIPAL study demonstrated that the effectiveness and safety of pazopanib is similarly safe and effective in patients with advanced kidney cancer in a real‐world clinical setting. The PRINCIPAL study showed that patients with advanced kidney cancer who are treated with first‐line pazopanib generally do not show disease progression for approximately 10 months and generally survive for nearly 30 months.
The PRINCIPAL study evaluated the efficacy and safety of pazopanib in patients with advanced/metastatic renal cell carcinoma in a multinational, real‐world clinical setting. Results are reported here.
Abstract In a global world, knowledge of imported infectious diseases is essential in daily practice, both for the microbiologist–parasitologist and the clinician who diagnoses and treats infectious ...diseases in returned travelers. Tropical and subtropical countries where there is a greater risk of contracting an infectious disease are among the most frequently visited tourist destinations. The SEIMC considers it appropriate to produce a consensus document that will be useful to primary care physicians as well as specialists in internal medicine, infectious diseases and tropical medicine who help treat travelers returning from tropical and sub-tropical areas with infections. Preventive aspects of infectious diseases and infections imported by immigrants are explicitly excluded here, since they have been dealt with in other SEIMC documents. Various types of professionals (clinicians, microbiologists, and parasitologists) have helped produce this consensus document by evaluating the available evidence-based data in order to propose a series of key facts about individual aspects of the topic. The first section of the document is a summary of some of the general aspects concerning the general assessment of travelers who return home with potential infections. The main second section contains the key facts (causative agents, diagnostic procedures and therapeutic measures) associated with the major infectious syndromes affecting returned travelers gastrointestinal syndrome (acute or persistent diarrhea); febrile syndrome with no obvious source of infection; localized cutaneous lesions; and respiratory infections. Finally, the characteristics of special traveler subtypes, such as pregnant women and immunocompromised travelers, are described.
Fasciola hepatica is a digenean trematode which infects a wide variety of domestic animals and also humans. Previous studies have demonstrated that four monoclonal antibodies (Mabs) against the total ...extract of F. hepatica redia (named as 1E4, 6G11, 4E5 and 4G11) also recognized the excretion - secretion antigens (ES Ag) of adult parasites, which is a biologically-relevant mixture of molecules with functional roles during infection and immune evasion on definitive hosts. In the present report we describe the partial characterization of the epitopes recognized by these Mabs by heat treatment, mercaptoethanol reduction, pronase proteolysis and sodium peryodate oxidation, which suggested their predominant protein and conformational nature. Also, a comparative study using immunodetection assays on crude extracts and on histological sections of both rediae and adults of F. hepatica were performed to explore the expression pattern of the antigenic determinants in these developmental stages. From these experiments it was found that the Mabs reacted most likely with the same proteins of approximately 64 and 105 kDa present on both rediae and adult’s extracts. However, the 1E4, 6G11 and 4E5 Mabs also recognized other molecules of the total extract of F. hepatica adults, a fact that constitutes an evidence of the antigenic variation between both stages and points at a certain biological relevance of the recognized antigenic determinants. Immunolocalization studies on histological sections revealed that all Mabs reacted with the tegument of F. hepatica in both rediae and adults stages, while the epitopes recognized by 1E4, 6G11 and 4E5 antibodies were also preferentially localized in the intestinal caeca and in different organs of the reproductive system of adult specimens. The immunogenicity of these antigenic determinants, their conserved status among different stages of the life cycle of F. hepatica and their presence in both tegument and ES Ag of adult parasites, are suitable features that suggest their potential use for developing an epitope-based vaccine for fasciolosis control.
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•The predominant protein and conformational nature of the epitopes was revealed.•Antigenic variations between rediae and adult stages were also recorded.•The antibodies reacted with tegument-associated proteins of rediae and adults.•Other proteins and organs of adult specimens were recognized by some antibodies.•These antigenic determinants could be suitable to develop an epitope-based vaccine.
Resumen: Introducción: La formación práctica en el grado de Medicina se imparte en los últimos cursos y está determinada por numerosos factores condicionantes, entre ellos, la formación MIR. En ...general, la evaluación de la formación práctica recibe mucha menos atención que la teórica, su calidad no es evaluada y el profesorado no recibe retroalimentación. El objetivo de nuestro estudio ha sido conocer la valoración que dan los alumnos a la formación práctica de Neumología después de una rotación de 3 semanas, con el objetivo de obtener información para el proceso de mejora continua. Métodos: El estudio incluye 2 encuestas anónimas realizadas a los alumnos de grado en el mismo curso académico. Una interna, aplicada por el propio Servicio de Neumología y otra externa, por la Unidad de Evaluación de la Calidad Docente de la USAL. Resultados: En la evaluación interna la opinión de los alumnos acerca de la calidad de la formación práctica es alta (8,26) y la utilidad percibida también es elevada (8,23), en una escala de 0 a 10, y no se observan diferencias por el hecho de que tenga lugar en cuarto, quinto o sexto curso. Estos resultados concuerdan con los obtenidos en la evaluación externa, con un valor medio de 4,56 en una escala de 0 a 5. Las preferencias de los alumnos durante su rotación por el servicio son las unidades de hospitalización y consultas, con menor valoración en las áreas técnicas. Conclusiones: La calidad de la docencia práctica es un reto que es necesario evaluar para que los profesores dispongan de la retroalimentación (interna y externa) oportuna. La rotación por los servicios de Neumología constituye una oportunidad para la mejora de la percepción de la especialidad por los alumnos de grado. Es preciso reflexionar acerca de los contenidos de dicha rotación, buscando un equilibrio entre las áreas clínicas y las de técnicas. Abstract: Introduction: Practical training for medical students is provided during the final years of study and is determined by several conditioning factors, including the MIR training that students receive simultaneously. In general, practical training evaluation receives much less attention than the theoretical one; its quality is not evaluated, and the professors do not receive feedback. The objective of our study was to determine how students value practical training in pulmonology rated the experience after completing a three-week rotation, in order to apply the information gained toward a process of continual improvement. Methods: The study included 2 anonymous surveys taken by medical students during the same academic year-one internal, prepared by the Department of Pneumology, itself, and another external one, prepared by the Evaluation Unit for Teaching Excellence at the University of Salamanca. Results: On the internal evaluation, student opinions of their practical training ran high (8.26) and the perceived usefulness was also high (8.23), on a scale of 0 to 10 and no differences were noted according to whether the survey was taken during their fourth, fifth, or sixth year of study. These results agree with those obtained in the external evaluation with a mean value of 4.56 on a scale of 0 to 5. Student preferences during their rotation in the department were for hospitalization and consultation units, with the technical areas being lesser valued. Conclusions: Achieving and maintaining a high quality of practical training is a goal that should be consistently evaluated so that professors may receive feedback (internal and external). Rotations in the Department of Pneumology provide an opportunity to improve the perception that medical students have regarding this specialty. It is imperative to reflect upon the contents of these rotations, seeking a balance between clinical areas and technical areas.
La formación práctica en el grado de Medicina se imparte en los últimos cursos y está determinada por numerosos factores condicionantes, entre ellos, la formación MIR. En general, la evaluación de la ...formación práctica recibe mucha menos atención que la teórica, su calidad no es evaluada y el profesorado no recibe retroalimentación. El objetivo de nuestro estudio ha sido conocer la valoración que dan los alumnos a la formación práctica de Neumología después de una rotación de 3semanas, con el objetivo de obtener información para el proceso de mejora continua.
El estudio incluye 2encuestas anónimas realizadas a los alumnos de grado en el mismo curso académico. Una interna, aplicada por el propio Servicio de Neumología y otra externa, por la Unidad de Evaluación de la Calidad Docente de la USAL.
En la evaluación interna la opinión de los alumnos acerca de la calidad de la formación práctica es alta (8,26) y la utilidad percibida también es elevada (8,23), en una escala de 0 a 10, y no se observan diferencias por el hecho de que tenga lugar en cuarto, quinto o sexto curso. Estos resultados concuerdan con los obtenidos en la evaluación externa, con un valor medio de 4,56 en una escala de 0 a 5. Las preferencias de los alumnos durante su rotación por el servicio son las unidades de hospitalización y consultas, con menor valoración en las áreas técnicas.
La calidad de la docencia práctica es un reto que es necesario evaluar para que los profesores dispongan de la retroalimentación (interna y externa) oportuna. La rotación por los servicios de Neumología constituye una oportunidad para la mejora de la percepción de la especialidad por los alumnos de grado. Es preciso reflexionar acerca de los contenidos de dicha rotación, buscando un equilibrio entre las áreas clínicas y las de técnicas.
Practical training for medical students is provided during the final years of study and is determined by several conditioning factors, including the MIR training that students receive simultaneously. In general, practical training evaluation receives much less attention than the theoretical one; its quality is not evaluated, and the professors do not receive feedback. The objective of our study was to determine how students value practical training in pulmonology rated the experience after completing a three-week rotation, in order to apply the information gained toward a process of continual improvement.
The study included 2anonymous surveys taken by medical students during the same academic year-one internal, prepared by the Department of Pneumology, itself, and another external one, prepared by the Evaluation Unit for Teaching Excellence at the University of Salamanca.
On the internal evaluation, student opinions of their practical training ran high (8.26) and the perceived usefulness was also high (8.23), on a scale of 0 to 10 and no differences were noted according to whether the survey was taken during their fourth, fifth, or sixth year of study. These results agree with those obtained in the external evaluation with a mean value of 4.56 on a scale of 0 to 5. Student preferences during their rotation in the department were for hospitalization and consultation units, with the technical areas being lesser valued.
Achieving and maintaining a high quality of practical training is a goal that should be consistently evaluated so that professors may receive feedback (internal and external). Rotations in the Department of Pneumology provide an opportunity to improve the perception that medical students have regarding this specialty. It is imperative to reflect upon the contents of these rotations, seeking a balance between clinical areas and technical areas.
Background Atrial fibrillation (AF) may exist before or occur early in the course of pulmonary embolism (PE). We determined the PE outcomes based on the presence and timing of AF. Methods and Results ...Using the data from a multicenter PE registry, we identified 3 groups: (1) those with preexisting AF, (2) patients with new AF within 2 days from acute PE (incident AF), and (3) patients without AF. We assessed the 90-day and 1-year risk of mortality and stroke in patients with AF, compared with those without AF (reference group). Among 16 497 patients with PE, 792 had preexisting AF. These patients had increased odds of 90-day all-cause (odds ratio OR, 2.81; 95% CI, 2.33-3.38) and PE-related mortality (OR, 2.38; 95% CI, 1.37-4.14) and increased 1-year hazard for ischemic stroke (hazard ratio, 5.48; 95% CI, 3.10-9.69) compared with those without AF. After multivariable adjustment, preexisting AF was associated with significantly increased odds of all-cause mortality (OR, 1.91; 95% CI, 1.57-2.32) but not PE-related mortality (OR, 1.50; 95% CI, 0.85-2.66). Among 16 497 patients with PE, 445 developed new incident AF within 2 days of acute PE. Incident AF was associated with increased odds of 90-day all-cause (OR, 2.28; 95% CI, 1.75-2.97) and PE-related (OR, 3.64; 95% CI, 2.01-6.59) mortality but not stroke. Findings were similar in multivariable analyses. Conclusions In patients with acute symptomatic PE, both preexisting AF and incident AF predict adverse clinical outcomes. The type of adverse outcomes may differ depending on the timing of AF onset.
Background: Diffuse large B-cell lymphoma (DLBCL) is the most common non-Hodgkin lymphoma subtype. Early stage (I/II) disease is seen in up to 30% of all DLBCL cases, and although outcomes in this ...subgroup have been reported as optimal, relapses can still occur. Prognostic models such as the International Prognostic Index (Miller, NEJM, 1998) continues to be utilized for risk stratification in DLBCL. However, despite its limitations and lack of validation in specific demographic groups such as Latin American patients, no prognostic models exist for the evaluation of limited stage DLBCL. Therefore, we aim to investigate different clinico-epidemiological and laboratory variables and its impact on survival in early stage DLBCL.
Methods: We conducted a retrospective study of newly diagnosed patients with early stage DLBCL. Using the Grupo de Estudio Latinoamericano de Linfroproliferativos (GELL) database, we selected patients that had early stage disease, defined as non-bulky stage I or II. The variables analyzed included demographic and clinical variables (e.g., age, ECOG performance status), the International Prognostic Index (IPI), and laboratory variables such as serum albumin, serum lactate dehydrogenase (LDH), serum beta-2-microglobulin, the lymphocyte-monocyte ratio (LMR), the neutrophil-lymphocyte ratio (LNR), and the platelet-lymphocyte ratio (PLR). To determine the variables associated with mortality, univariate and multivariate Cox regression (step-wise type) analysis was performed. Kaplan-Meier and log-rank test were used for survival analysis. Outcomes with a p-value <0.05 were considered statistically significant.
Results: We identified 1,375 patients with DLBCL; 503 were identified as early stage DLBCL of whom 498 had sufficient data for analysis. Almost all cases (n=483, 96%) had nodal disease as the primary site, and 15 (4%) extranodal, all within the gastrointestinal tract. There was a slight female predominance (51.8%). The median age at diagnosis was 64 (IQR: 50 -73) with 57.4% older than >65 years. ECOG performance status of <2 was seen in 77.2% of cases; elevated serum LDH in 32.4%; and elevated serum beta-2-microglobulin in 5.6% (n=11/192). Based on previous data, we evaluated and calculated variables that have been suggested as independent negative prognostic factors for overall survival; the proportion of patients with serum albumin <3.5 mg/dL; LMR <2, NLR >4, and PLR >376 was 34.4%, 10.3%, 9.2%, and 4.7% respectively. With a median follow-up of 45 months, the median 5-year overall survival (OS) rate was 72%. The therapy approaches used, response rates and outcomes with these approaches will be presented at the meeting. Results of the univariate and multivariate analysis are summarized in Table 1. We found that age over 65, ECOG performance status, serum albumin level, beta-2-microglobulin level, LDH ratio, LMR, NLR, PLR, and BCL-2 positivity by immunohistochemistry (IHC) were prognostic factors for OS in the univariate analysis. However, in the multivariate analysis, only NLR, serum albumin level and ECOG performance status were independent factor for worse prognosis. Survival rates were significantly shorter in patients with serum albumin <3.5 g/dL (5-year OS of 49% versus 79%, respectively; p<0.0001); NLR >4 (5-year OS of 46% versus 73%, respectively: p=0.0013); and ECOG performance status ≥2 (5-year OS of 51% versus 74%, respectively; p<0.0001) (Figures 1 to 3).
Conclusion: In this large cohort of Latin American patients with early stage DLBCL most patients were older than 65, had nodal disease as the primary site, good performance status, with only a third of patients exhibiting elevated LDH. Moreover, we found serum albumin <3.5 g/dL, NLR >4 and ECOG ≥2 as negative prognostic factors for poor survival in early stage DLBCL. We are currently validating our findings in a prospective cohort of Latin American DLBCL patients and to improve clinical decision-making in those deemed at high-risk for early mortality.
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Otero: Astra Zeneca: Current Employment. Oliver: Roche: Other: conference support and fees ; Abbvie: Other: conference support and fees . Castillo: Abbvie: Consultancy, Research Funding; BeiGene: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding; Janssen: Consultancy; Roche: Consultancy; TG Therapeutics: Research Funding.
Introduction: High-dose chemotherapy followed by autologous stem-cell transplantation (auto-HCT) is standard of care for patients with relapsed or primary refractory classical Hodgkin lymphoma (cHL). ...Brentuximab vedotin (BV) consolidation after auto-HCT improves progression-free survival of cHL patients with primary refractory disease and high risk for relapse as seen in the AETHERA trial. There are no published reports of BV consolidation post auto-HCT in cHL patients treated in developing countries. The aim of this study is to determine the clinical outcomes and safety of BV consolidation after auto-HSCT in a cohort of Colombian patients with relapsed or refractory (R/R) cHL.
Methods: A retrospective cohort study was conducted at ten tertiary referral centers in five cities in Colombia. Data from patients with R/R cHL who underwent auto-HCT followed by BV consolidation was collected and analyzed. Descriptive statistics were used to analyze patient's demographic characteristics. The Kaplan-Meier method was used to assess overall survival (OS) and progression-free survival (PFS) rates and log-rank test was used to compare survival between groups. All data were analyzed by R Studio software.
Results: Fifty-three patients with a confirmed diagnosis of cHL were included, 49,1% were women. Median of age at auto-HCT was 29 years (range 17 - 66). The most frequently used frontline regimen was ABVD 90,6%. Median number of treatment lines including auto-HCT was 3 (range 2 to 7). 83% of patients had BV consolidation after 1stAUtoHCT and 17% after 2 auto-HCT. The most common high-risk feature before auto-HCT was primary refractory cHL (54,7%). Responses were determined by Lugano criteria. However, unconfirmed complete responses (uCR) per 2007 IWC criteria were used due to lack of PET-CT availability of evaluation in some centers, where CT scan were used. The overall rate (ORR) before auto-HCT was 94,4% with complete response (CR) in 28,3%, uCR 20,8% and partial response (PR) in 45,3% of patients. The ORR after auto-HCT was 90,5% with CR in 52,8%, uCR in 22,6%, and PR 15,1%. Table1.
A total of 531 BV cycles were administered as post auto-HCT consolidation with a median of 11 cycles (range 1-16). A median of 23 days between each cycle was documented (range 7-210 days). The most common grade 3-4 toxicities were peripheral neuropathy (18,8%), fatigue (9,4%), weight loss (5,6%).
OS at 132 months was 92,5% (CI95%: 4,9 - NR) (Figure A), and the median PFS was not reached (CI 95%: 36.5 months - Not reached) with 75,5% PFS at 132 months, with a mean of follow-up of 23,5 months (Range: 4,2 - 133,2 months) (Figure B). There was a trend towards worse PFS in patients treated with ≥ 3 regimens before auto-HCT Median: 38.7 months, (CI 95%: 36.5 - NA) Vs. 2 lines: Median: NR (CI 95%: 4,2-NR) P= 0.4.(Figure C). Also patients that required a second transplant followed by BV consolidation had a worse PFS, compared to the ones that underwent BV consolidation post first auto-HCT: median: 13.6 months (CI 95%: 6.7- NR)Vs. median: NR (CI95%: 38,7 - NR) respectively p=0,009 (Figure D). Twelve patients relapsed and 4 patients died form disease progression.
Conclusions: BV consolidation after auto-HCT in high-risk R/R cHL patients treated in a developing country setting seems to be a safe and effective treatment. Although OS and PFS were slightly superior to the ones reported in the AETHERA trial, the mean of follow-up in our analysis is shorter. Another shortcoming of our analysis are the inherit limitation of a retrospective cohort. These retrospective results need to be assessed in prospective trials that specifically includes Latin-American with high-risk patients with R/R cHL.
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Patiño:Amgen: Speakers Bureau. Enciso-Olivera:Takeda: Speakers Bureau. Otero-de la Hoz:Takeda: Speakers Bureau. Martínez Cordero:Takeda: Speakers Bureau. Karduss:Takeda: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Abello:Takeda: Other: Participation in advisory board meeting. Sandoval-Sus:Seattle Genetics: Membership on an entity's Board of Directors or advisory committees.
Abstract
Disclosure: A. Fernandez-Pombo: None. G. Rodriguez-Carnero: None. N. Otero Mato: None. J. Cameselle Teijeiro: None. L. Loidi: None. Z. Nogareda Seoane: None. V. Pubul Nunez: None. M. ...Martinez Olmos: None. J. Cabezas Agricola: None.
Introduction: The recommendations of the clinical practice guidelines regarding the management of SDHAF2-related familial paraganglioma syndrome are based on what is described in the literature in relation to two carrier families of the p.Gly78Arg variant in this gene. To date, among other characteristics, paragangliomas (PGLs) have been thought to occur exclusively in the head and neck, with no metastatic disease observed. Objective: To describe the clinical profile of SDHAF2-related familial paraganglioma syndrome in order to increase knowledge of this disorder. Subjects and Methods: A total of 64 individuals were evaluated after the detection of 7 index cases with the same pathogenic variant (p.Gly78Arg) in the SDHAF2 gene. The clinical data of the 46 patients found to be carrying this variant were collected. In addition to the molecular study, these patients underwent a biochemical evaluation, as well as anatomical imaging. PET with 68Ga-DOTA- TOC and 18F-DOPA were also carried out. The surgical specimens were analyzed. Results: A total of 27 patients developed the disease, with a mean age of 37.0 ± 17.2 years at diagnosis (59.2% women). Inheritance in affected patients was of paternal origin in all known cases. All patients manifested PGLs in the head and neck (96.3% carotid bifurcation, 25.9% jugulotympanic and 14.8% glomus vagale), with a high frequency of multifocality (85.2%). Six patients also manifested mediastinal PGLs (retrocardiac, paraaortic, epicardial, paratracheal, phrenic nerve) and two normetanephrine-secreting pheochromocytomas. All extraadrenal PGLs were non-functioning, with the exception of one case with hypersecretion of 3-methoxytyramine. Throughout the follow-up, three patients manifested distant metastasis (bone and lung metastases). Surgical treatment occurred in 85.1% of cases, radiotherapy in 29.6%, radiosurgery in 14.8% and sunitinib in one case, and 58.3% patients reported some type of complication. 68Ga-DOTA-TOC PET was superior to 18F-DOPA PET in identifying extraadrenal PGLs and metastatic involvement, with an overall detection rate of 100% in the case of 68Ga-DOTA-TOC PET (SUVmax 87.6 ± 60.3 g/ml) and 61.0% in the case of 18F-DOPA PET (SUVmax 19.0 ± 16.2 g/ml), p <0.0001. Regarding the immunohistochemical analysis, no positivity for SDHB was observed and Ki-67 index was <3% in all cases. Conclusions: Certain phenotypic variations have been observed in the current study regarding SDHAF2-related familial paraganglioma syndrome, which have not previously been described and which will contribute to modifying the management of this disease.
Presentation: Friday, June 16, 2023
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