SEOM clinical guideline of diagnosis and management of low-grade glioma (2017)

Diffuse infiltrating low-grade gliomas include oligodendrogliomas and astrocytomas, and account for about 5% of all primary brain tumors. Treatment strategies for these low-grade gliomas in adults have recently changed. The 2016 World Health Organization (WHO) classification has updated the definition of these tumors to include their molecular characterization, including the presence of isocitrate dehydrogenase (IDH) mutation and 1p/19p codeletion. In this new classification, the histologic subtype of grade II-mixed oligoastrocytoma has also been eliminated. The precise optimal management of patients with low-grade glioma after resection remains to be determined. The risk-benefit ratio of adjuvant treatment must be weighed for each individual (AU)

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SEOM clinical guideline for treatment of kidney cancer (2017)

The goal of this article is to provide recommendations about the management of kidney cancer. Based on pathologic and molecular features, several kidney cancer variants were described. Nephron-sparing techniques are the gold standard of localized disease. After a randomized trial, sunitinib could be considered in adjuvant treatment in high-risk patients. Patients with advanced disease constitute a heterogeneous population. Prognostic classification should be considered. Both sunitinib and pazopanib are the standard options for first-line systemic therapy in advanced renal cell carcinoma. Based on the results of two randomized trials, both nivolumab and cabozantinib should be considered the standard for second and further lines of therapy. Response evaluation for present therapies is a challenge (AU)

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New clinical trials regulation in Spain: analysis of royal decree 1090/2015

The coming into force of Directive 2001/20/EC represented a step forward in harmonising clinical trial regulation in European countries, guaranteeing a uniform protection of subjects participating in clinical research across Europe. However, it led to a disproportionate increase in the bureaucratization, and thus, it became evident that procedures needed to be simplified without detriment to patient’s safety. Thus, Regulation 536/2014, that repealed Directive 2001/20/EC, with the aim of decreasing the growing bureaucratization and stimulating clinical research in Europe, established simplified procedures, such as regulating a common procedure for authorising trials in Europe, the institution of strict assessment timelines, or the definition of new concepts, such as «low-intervention clinical trial». The legal form of a Regulation allowed the norm to be directly applied to Member States without the need for transposition. By means of the new Royal Decree, the national legislation is adapted to make the application of the regulation feasible and it allows the development of the aspects that the Regulation leaves to national legislation. Both documents seek to stimulate clinical research with medicinal products to foster knowledge, facilitate transparency, and reinforce subjects’ safety. This will surely be the case, but with this revision, we will look at the novelties and key aspects that are most relevant to investigators and we will analyse the consequences for all parties involved in clinical research (AU)

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Panencefalitis esclerosante subaguda de comienzo en la edad adulta: hallazgos clinicopatológicos / Adult-onset subacute sclerosing panencephalitis: clinicopahtological findings

Introduction. Subacute sclerosing panencephalitis is a disease affecting the central nervous system that is produced by persistent infection by a defective measles virus. This disease is very infrequent and its incidence has gone down even further in western countries since the introduction of generalised measles vaccinations. Onset of the disease is usually during infancy or adolescence. Reports of cases beginning during adulthood are scarce. Case report. We describe the case of a 30-year-old female with a slowly progressive subacute clinical picture consisting in behavioural disorders, with defrontalisation, cortico-subcortical cognitive impairment, long tract signs and visual disorders, which led the patient into a vegetative state. Four years after the onset of symptoms the patient died. The different electroencephalogram recordings performed did not show any periodic activity and magnetic resonance imaging of the head revealed cerebral atrophy with hyperintense lesions in T2 sequences in white matter. The histological study of the brain showed a chronic inflammatory infiltration with neuronal loss and demyelination, as well as intranuclear inclusions and neurofibrillary degeneration. Conclusions. The appearance of subacute sclerosing panencephalitis in adulthood is exceptional. Diagnosis requires a high degree of clinical suspicion, above all in the absence of typical symptoms, such as myoclonias or periodic complexes in EEG recordings (AU)

Introducción. La panencefalitis esclerosante subaguda es una enfermedad del sistema nervioso central producida por la infección persistente de un virus del sarampión defectivo. Enfermedad muy infrecuente, su incidencia ha disminuido en los países occidentales con la generalización de la vacuna contra el sarampión. El debut de la enfermedad suele ser en la infancia o la adolescencia. Existen pocos casos descritos de comienzo en la edad adulta. Caso clínico. Se trata de una mujer de 30 años de edad, con un cuadro subagudo lentamente progresivo consistente en alteraciones de la conducta, con desfrontalización, deterioro cognitivo corticosubcortical, piramidalismo y alteraciones visuales, que llevaron a la paciente a un estado vegetativo hasta que falleció, cuatro años después del inicio de la sintomatología. Varios electroencefalogramas realizados no demostraron actividad periódica y la resonancia magnética craneal reveló atrofia cerebral con lesiones hiperintensas en secuencias T2 en la sustancia blanca. El estudio histológico del cerebro mostró un infiltrado inflamatorio crónico con pérdida neuronal y desmielinización, así como inclusiones intranucleares y degeneración neurofibrilar. Conclusión. La presentación de la panencefalitis esclerosante subaguda en la edad adulta es excepcional. El diagnóstico exige una alta sospecha clínica sobre todo si están ausentes manifestaciones clínicas tan típicas como las mioclonías o los complejos periódicos electroencefalográficos (AU)

Homocisteína y enfermedad cerebrovascular / Homocysteine and cerebrovascular disease

Objetivo. En la búsqueda de nuevos factores de riesgo vascular potencialmente tratables, la presencia de una elevación de los niveles plasmáticos de homocisteína total (tHc) en sangre se ha postulado como uno de ellos en los últimos años, y ha generado numerosa bibliografía y controversia. El origen de esta hipótesis se basa en la observación de que los pacientes con trastornos congénitos del metabolismo de la homocisteína (Hc) padecían aterosclerosis precoz. En la presente revisión se analizan los estudios publicados sobre Hc y enfermedad cerebrovascular (ECV). Desarrollo. Un importante número de estudios retrospectivos, casos-control, han encontrado una asociación fuerte y dosis dependiente entre los niveles plasmáticos de Hc y ECV, coronaria y tromboembólica periférica. Sin embargo, los estudios prospectivos publicados observan una asociación entre homocisteinemia y ECV débil o inexistente. Además, algunas observaciones cuestionan la relación de causalidad entre hiperhomocisteinemia y aterotrombosis, que explican los hallazgos de los estudios retrospectivos como resultado de la elevación de la Hc tras un ictus o su incremento por factores de riesgo vascular clásicos. A pesar de todo, el conocimiento de que la ingesta de ácido fólico, vitamina B12 y piridoxina disminuyen los niveles plasmáticos de tHc, ha llevado a iniciar ensayos clínicos que evalúan los efectos de este tratamiento sobre el riesgo vascular. Conclusión. La relación entre los niveles plasmáticos de Hc y la ECV es controvertida. Nuevos estudios y el resultado de los ensayos clínicos con tratamiento vitamínico aclararán en los próximos años esta relación (AU)

Aims. In the search for new, potentially treatable, vascular risk factors, one of the most recent to be put forward is the presence of increased total homocysteine (tHc) levels in blood plasma and this has also given rise to a large amount of literature and controversy. The origin of this hypothesis lies in the observation that patients with congenital disorders affecting homocysteine (Hc) metabolism suffered from early atherosclerosis. In this paper we analyse the studies that have been published about Hc and cerebrovascular disease (CVD). Development. An important number of retrospective case-control studies have found a strong dose-dependent link between levels of Hc in plasma and cerebrovascular, heart and peripheral thromboembolic disease. Yet the prospective studies that have been published to date note only a weak or inexistent link between homocysteine and CVD. Moreover, some observations question the causal relationship between hyperhomocysteinemia and atherothrombosis and account for the findings in the retrospective studies as being a result of the rise in Hc following a stroke or its increasing because of classical vascular risk factors. In any case, knowing that the ingestion of folic acid, vitamin B12 and pyridoxine lowers tHc levels in plasma has led to clinical trails being set up that evaluate the effects of this treatment on vascular risk. Conclusion. The relation between Hc levels in plasma and CVD is open to controversy. New studies and the findings of clinical studies with vitamin therapy will allow this relation to be fully explained in coming years (AU)