RESUMO
The study analyzes the current status of personalized medicine in pediatric oncology in Spain. It gathers national data on the tumor molecular studies and genomic sequencing carried out at diagnosis and at relapse, the centers that perform these studies, the technology used and the interpretation and clinical applicability of the results. Current challenges and future directions to achieve a coordinated national personalized medicine strategy in pediatric oncology are also discussed. Next generation sequencing-based (NGS) gene panels are the technology used in the majority of centers and financial limitations are the main reason for not incorporating these studies into routine care. Nowadays, the application of precision medicine in pediatric oncology is a reality in a great number of Spanish centers. However, its implementation is uneven and lacks standardization of protocols; therefore, national coordination to overcome the inequalities is required. Collaborative work within the Personalized Medicine Group of SEHOP is an adequate framework for encouraging a step forward in the effort to move precision medicine into the national healthcare system.
Assuntos
Hematologia , Neoplasias , Criança , Consenso , Sequenciamento de Nucleotídeos em Larga Escala , Humanos , Neoplasias/genética , Neoplasias/patologia , Neoplasias/terapia , Medicina de Precisão/métodos , EspanhaRESUMO
PURPOSE: Early phase trials are crucial in developing innovative effective agents for childhood malignancies. We report the activity in early phase paediatric oncology trials in Spain from its beginning to the present time and incorporate longitudinal data to evaluate the trends in trial characteristics and recruitment rates. METHODS: Members of SEHOP were contacted to obtain information about the open trials at their institutions. The study period was split into two equal periods for analysis: 2007-2013 and 2014-2020. RESULTS: Eighty-one trials and two molecular platforms have been initiated. The number of trials has increased over the time of the study for all tumour types, with a predominance of trials available for solid tumours (66%). The number of trials addressed to tumours harbouring specific molecular alterations has doubled during the second period. The proportion of industry-sponsored compared to academic trials has increased over the same years. A total of 565 children and adolescents were included, with an increasing trend over the study period. For international trials, the median time between the first country study approval and the Spanish competent authority approval was 2 months (IQR 0-6.5). Fourteen out of 81 trials were sponsored by Spanish academic institutions. CONCLUSIONS: The number of available trials, and the number of participating patients, has increased in Spain from 2007. Studies focused on molecular-specific targets are now being implemented. Barriers to accessing new drugs for all ranges of age and cancer diseases remain. Additionally, opportunities to improve academic research are still required in Spain.
Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Oncologia/tendências , Neoplasias/terapia , Pediatria/tendências , Adolescente , Adulto , Criança , Seguimentos , Humanos , Estudos Longitudinais , Neoplasias/patologia , Sociedades Médicas , Adulto JovemRESUMO
BACKGROUND: Wheezing constitutes a common respiratory symptom in children, and several risk factors have been associated with the prevalence of recurrent wheezing (RW) and its severity, especially viral respiratory infections and second-hand smoke (SHS) exposure. OBJECTIVE: To analyze the relationship between smoking patterns in the home and wheezing, in infants from the city of Córdoba, Argentina, during their first year of life. METHODS: Parents of infants were invited to complete a standardized questionnaire voluntarily and anonymously (WQ-P1-EISL). Wheezing in the first 12 months of life was classified as occasional wheezing (OW) when having one or two episodes during the first 12 months of life; recurrent wheezing (RW) if having three or more, and more frequent wheezing (MFW) ≥6 episodes. RESULTS: 409 infants (39.0%) had one or more episodes of wheezing in the first 12 months. Of these, 214 infants (52.3%) presented occasional wheezing (OW), 135 (33%) had recurrent wheezing (RW), and 60 (14.7%) more frequent wheezing (MFW). SHS was significantly related to MFW, especially if the mother smoked (OR=2.7; IC 95%: 1.4-5.18; p=0.0009) or if she smoked during pregnancy (OR=4; IC 95%: 1.8-8.5; p=0.0001). This group of MFW was also associated with SHS as well as having been to the emergency room for wheezing (40.87%, p=0.0056). CONCLUSION: The results indicate that second-hand tobacco smoke is a significant risk factor for the presence of wheezing in infants, and for its severity. Our findings have significant implications for public health, as smoking is a modifiable behavior.
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Sons Respiratórios/etiologia , Poluição por Fumaça de Tabaco/efeitos adversos , Argentina/epidemiologia , Estudos Transversais , Feminino , Inquéritos Epidemiológicos , Humanos , Lactente , Masculino , Pais , Prevalência , Recidiva , Fatores de Risco , Fatores Socioeconômicos , Poluição por Fumaça de Tabaco/estatística & dados numéricosRESUMO
INTRODUCTION: Cancer and blood disorders in children are rare. The progressive improvement in survival over the last decades largely relies on the development of international academic clinical trials that gather the sufficient number of patients globally to elaborate solid conclusions and drive changes in clinical practice. The participation of Spain into large international academic trials has traditionally lagged behind of other European countries, mainly due to the burden of administrative tasks to open new studies, lack of financial support and limited research infrastructure in our hospitals. METHODS: The objective of ECLIM-SEHOP platform (Ensayos Clínicos Internacionales Multicéntricos-SEHOP) is to overcome these difficulties and position Spain among the European countries leading the advances in cancer and blood disorders, facilitate the access of our patients to novel diagnostic and therapeutic approaches and, most importantly, continue to improve survival and reducing long-term sequelae. ECLIM-SEHOP provides to the Spanish clinical investigators with the necessary infrastructural support to open and implement academic clinical trials and registries. RESULTS: In less than 3 years from its inception, the platform has provided support to 20 clinical trials and 8 observational studies, including 8 trials and 4 observational studies where the platform performs all trial-related tasks (integral support: trial setup, monitoring, etc.) with more than 150 patients recruited since 2017 to these studies. In this manuscript, we provide baseline metrics for academic clinical trial performance that permit future comparisons. CONCLUSIONS: ECLIM-SEHOP facilitates Spanish children and adolescents diagnosed with cancer and blood disorders to access state-of-the-art diagnostic and therapeutic strategies.
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Ensaios Clínicos como Assunto/estatística & dados numéricos , Cooperação Internacional , Estudos Multicêntricos como Assunto/estatística & dados numéricos , Estudos Observacionais como Assunto/estatística & dados numéricos , Objetivos Organizacionais , Sociedades Médicas/organização & administração , Adolescente , Sobreviventes de Câncer , Criança , Neoplasias Hematológicas/terapia , Hematologia/organização & administração , Humanos , Oncologia/organização & administração , Neoplasias/terapia , Pediatria/organização & administração , EspanhaRESUMO
BACKGROUND: Lymphoma is the third most common malignancy in children (0-14 years) and the first in adolescents (15-19 years). This population-based study-the largest ever done in Spain-analyses incidence and survival of lymphomas among Spanish children and adolescents. PATIENTS AND METHODS: 1664 lymphoma cases (1983-2007) for incidence and 1030 for survival (1991-2005) followed until 31/12/2010, were provided by 11 cancer registries. Age-adjusted incidence rates (ASRw) to the world standard population were obtained; incidence trends were modelled using the Joinpoint programme, observed survival (OS) was estimated with Kaplan-Meier and trends tested with a log-rank test. Results are presented according to the International Classification of Childhood Cancer-3. RESULTS: In Spain, the ASRw0-14 for lymphomas was 17.5 per 1.000.000 child-years and 50.0 the specific rate for adolescents. Overall incidence increased significantly during 1983-1997 with no increases thereafter. Patients over 9 years old showed significant rising trends for all subtypes, except for Burkitt lymphoma (BL) in adolescents. During 2001-2005 (age 0-19 years), 5-year OS was 94 (90-98), 73 (64-83) and 86 (78-94) for Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL) and BL, respectively. No improvement in survival was found. The incidence in Spain was higher than overall European rates, but within the range of that in Southern Europe. Comparing OS in Spain 1991-1995 and 2001-2005 with results for Europe of the Automated Childhood Cancer Information System (ACCIS) (1988-1997) and the European cancer registry-based study on survival and care of cancer patients (EUROCARE) (2000-2007), it was similar for HL and lower for NHL and BL. CONCLUSIONS: Systematic monitoring and analysis of lymphoma paediatric data would provide clinical and epidemiological information to improve the health care of these patients and the outcomes for these malignancies in Spain.
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Linfoma/epidemiologia , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Estimativa de Kaplan-Meier , Masculino , Sistema de Registros , Espanha/epidemiologiaRESUMO
BACKGROUND: Wheezing is a very common respiratory symptom in infants. The prevalence of wheezing in infants, conducted in developed countries shows prevalence rates ranging between 20% and 30%. However, we do not know the risk factors in our population of wheezing infants. METHODS: A standardised written questionnaire (WQ-P1-EISL) in infants between 12 and 18 months of age residing in the city of Cordoba was used; population/sample included 1031 infants. Recurrent wheezing (RW) was defined as three or more episodes of wheezing reported by the parents during the first 12 months of life. Data obtained were coded in Epi-Info™ (version 7) and statistically analysed with SPSS (version 17.5) software in Spanish. Parametric tests (one-way ANOVA) were performed for identifying significantly associated variables. RESULTS: The prevalence of wheezing infants was 39.7%; recurrent wheezing 33%; and severe wheezing 14.7%; 13.7% had pneumonia before the first year and of these 6.3% were hospitalised, multiple variables as risk factors for wheezing were found such as: >6 high airway infections and bronchiolitis in the first three months of life, smokers who smoke in the home among other risk factors and protective factors in those who have an elevated socioeconomic status. CONCLUSION: It is known that persistent respiratory problems in children due to low socioeconomic status is a risk factor for wheezing, pneumonia and could be a determining factor in the prevalence and severity of RW in infants. Research suggests that there are areas for improvement in the implementation of new educational strategies.
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Asma/epidemiologia , Sons Respiratórios , Argentina/epidemiologia , Feminino , Humanos , Lactente , Masculino , Prevalência , Infecções Respiratórias/complicações , Fatores de Risco , Fatores Socioeconômicos , Inquéritos e Questionários , Poluição por Fumaça de Tabaco/efeitos adversosRESUMO
Atopy is the major predisposing factor for asthma identified up to now, and allergen exposure, particularly indoor allergens, is considered as a causal factor for asthma. Food allergy is frequently underestimated in association with asthma, however food allergy has been shown to trigger or exacerbate broncho-obstruction in 2 to 8.5% of children with asthma. There is also evidence that double-blind placebo-controlled oral challenge is able to increase unspecific bronchial hyperresponsiveness. Sensitization to food can occur early in life involving T cell response, mainly of the Th2 phenotype, but also IgE-mediated hypersensitivity. Moreover, it has been shown that sensitization to food allergens early in life is a risk factor for sensitization to inhalent allergens and respiratory symptoms later on. Epidemiological studies suggest that changes in the dietary composition, such as trans-fatty acids, could be involved in the increase of asthma prevalence. The introduction of formula during the first trimester of life increases the risk of having asthma. The diagnosis of food allergy associated with asthma is not easy, nevertheless is important for allergists, pulmonologists and paediatricians to consider food allergy in children with respiratory symptoms, especially when asthma symptoms start early in life and when they are associated with other manifestations of food allergy. Children sensitized to cow's milk proteins and also having atopic eczema are at higher risk for asthma. Since avoidance of the offending food is the first step in the management of children with asthma associated with food allergy, a careful identification should be done in order to avoid unnecessary elimination of foods.