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1.
Clin Transl Oncol ; 26(9): 2351-2359, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38600340

ABSTRACT

INTRODUCTION: ECLIM-SEHOP platform was created in 2017. Its main objective is to establish the infrastructure to allow Spanish participation into international academic collaborative clinical trials, observational studies, and registries in pediatric oncology. The aim of this manuscript is to describe the activity conducted by ECLIM-SEHOP since its creation. METHODS: The platform's database was queried to provide an overview of the studies integrally and partially supported by the organization. Data on trial recruitment and set-up/conduct metrics since its creation until November 2023 were extracted. RESULTS: ECLIM-SEHOP has supported 47 studies: 29 clinical trials and 18 observational studies/registries that have recruited a total of 5250 patients. Integral support has been given to 25 studies: 16 trials recruiting 584 patients and nine observational studies/registries recruiting 278 patients. The trials include front-line studies for leukemia, lymphoma, brain and solid extracranial tumors, and other key transversal topics such as off-label use of targeted therapies and survivorship. The mean time from regulatory authority submission to first patient recruited was 12.2 months and from first international site open to first Spanish site open was 31.3 months. DISCUSSION: ECLIM-SEHOP platform has remarkably improved the availability and accessibility of international academic clinical trials and has facilitated the centralization of resources in childhood cancer treatment. Despite the progressive improvement on clinical trial set-up metrics, timings should still be improved. The program has contributed to leveling survival rates in Spain with those of other European countries that presented major differences in the past.


Subject(s)
Clinical Trials as Topic , Neoplasms , Registries , Humans , Child , Neoplasms/therapy , Spain , Medical Oncology , Observational Studies as Topic , International Cooperation , Patient Selection
2.
An. pediatr. (2003. Ed. impr.) ; 91(2): 127.e1-127.e10, ago. 2019. tab, graf
Article in Spanish | IBECS | ID: ibc-186717

ABSTRACT

La trombocitopenia inmune primaria, anteriormente conocida como púrpura trombocitopénica inmune, es una enfermedad cuyo manejo diagnóstico y terapéutico ha sido siempre controvertido. La Sociedad Española de Hematología y Oncología Pediátricas, a través del grupo de trabajo de la PTI, ha actualizado el documento con las recomendaciones protocolizadas para el diagnóstico y tratamiento de esta enfermedad, basándose en las guías clínicas disponibles actualmente, revisiones bibliográficas, ensayos clínicos y el consenso de sus miembros. El objetivo principal es disminuir la variabilidad clínica en los procedimientos diagnósticos y terapéuticos con el fin de obtener los mejores resultados clínicos, los mínimos efectos adversos y preservar la calidad de vida


Primary immune thrombocytopenia, formerly known as immune thrombocytopenic purpura, is a disease for which the clinical and therapeutic management has always been controversial. The ITP working group of the Spanish Society of Paediatric Haematology and Oncology has updated its guidelines for diagnosis and treatment of primary immune thrombocytopenia in children, based on current guidelines, bibliographic review, clinical assays, and member consensus. The main objective is to reduce clinical variability in diagnostic and therapeutic procedures, in order to obtain best clinical results with minimal adverse events and good quality of life


Subject(s)
Humans , Child , Purpura, Thrombocytopenic, Idiopathic/therapy , Quality of Life , Purpura, Thrombocytopenic, Idiopathic/diagnosis
3.
An. pediatr. (2003. Ed. impr.) ; 89(3): 189.e1-189.e8, sept. 2018. graf, tab
Article in Spanish | IBECS | ID: ibc-177094

ABSTRACT

La trombocitopenia inmune (PTI) es una entidad relativamente frecuente en pediatría. Aunque su evolución suele ser favorable en la mayoría de los casos, el manejo de aquellos pacientes en los que la enfermedad persiste es muy controvertido. Este artículo pretende, a través de una revisión de la literatura más reciente, responder a aspectos relacionados con el tratamiento de la PTI persistente, crónica y refractaria durante la infancia, haciendo especial énfasis en el papel del rituximab, la esplenectomía y los análogos de la trombopoyetina (ar-TPO) en la infancia. La aparición de los ar-TPO (eltrombopag y romiplostim) amplía el arsenal terapéutico de la PTI pediátrica. Además, tras haber demostrado un perfil de seguridad adecuado en ensayos clínicos, retrasa la indicación de esplenectomía o el uso de tratamientos asociados a mayor riesgo de complicaciones, como rituximab. No obstante, se recomienda que su manejo sea supervisado por centros con experiencia de cara a monitorizar complicaciones potenciales a medio y largo plazo ya descritas en el paciente adulto


Immune thrombocytopenia (ITP) is a relatively common disorder in childhood. Although it usually achieves spontaneous remission at this age, the management of persistent or chronic ITP in children is still controversial. The aim of this article is to address current controversies related to the treatment of persistent, chronic, and refractory ITP in children, including the role of rituximab and splenectomy, as well as focusing on a new approach with thrombopoietin receptor agonists (TPO-RAs). Eltrombopag and romiplostim are safe and useful drugs for paediatric ITP. These two TPO-RAs might delay surgery and other treatments such as rituximab. However, the potential side effects described in adult patients should be considered. Paediatric patients with refractory ITP, undergoing new treatments, should be supervised in specialised centres


Subject(s)
Humans , Infant , Thrombocytopenia/immunology , Thrombopoietin/administration & dosage , Purpura, Thrombocytopenic, Idiopathic/drug therapy , Rituximab/administration & dosage , Risk Factors , Receptors, Thrombopoietin/agonists
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