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Medwave2017;17(Suppl1):e6871 doi: 10.5867/medwave.2017.6871
Is primary prevention with antiepileptic drugs effective in brain tumors or brain metastases?
Diego Lobos-Urbina, Lucas Kittsteiner-Manubens, José Peña
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Resumen

Los pacientes con tumores cerebrales, primarios o metastásicos, presentan riego de desarrollar convulsiones durante la evolución de su enfermedad, por lo que se ha propuesto el uso profiláctico de anticonvulsivantes. Sin embargo, el efecto de esta intervención no está claro. Para responder esta pregunta utilizamos la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en múltiples bases de datos. Identificamos 12 revisiones sistemáticas que en conjunto incluyen ochenta estudios primarios. Doce corresponden a estudios aleatorizados, pero sólo dos responden la pregunta de interés. Extrajimos los datos, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. Concluimos que la prevención primaria con anticonvulsivantes podría no disminuir el riesgo de convulsiones en tumores o metástasis cerebrales, y se asocia a efectos adversos frecuentes.


 
Problema

Hasta un 60% de los pacientes con tumores cerebrales pueden llegar a presentar convulsiones. Se han planteado diferentes mecanismos. Por un lado, el tejido neoplásico en sí mismo puede ser el sitio de inicio de una convulsión, especialmente si es de tipo neuronal, y por otra parte, las lesiones intracraneales pueden alterar tanto estructural como funcionalmente el territorio adyacente, ya sea por edema, insuficiencia vascular, inflamación o liberación de moléculas metabólicamente activas que promueven la actividad epileptiforme. Se postula además que la ubicación de las lesiones también influiría en la aparición de convulsiones, siendo especialmente alta entre las de ubicación cortical.

El presente resumen busca responder si es efectivo el uso de anticonvulsivantes como profilaxis primaria en pacientes con tumores cerebrales que no serán sometidos a cirugía.

Métodos

Utilizamos la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en múltiples bases de datos, para identificar revisiones sistemáticas y sus estudios primarios incluidos. Con esta información generamos un resumen estructurado, siguiendo un formato preestablecido, que incluye mensajes clave, un resumen del conjunto de evidencia (presentado como matriz de evidencia en Epistemonikos), metanálisis del total de los estudios, tablas de resumen de resultados con el método GRADE, y tabla de otras consideraciones para la toma de decisión.

Mensajes clave

  • La prevención primaria con anticonvulsivantes podría no disminuir el riesgo de convulsiones en tumores o metástasis cerebrales, pero la certeza de la evidencia existente es baja.
  • El uso de anticonvulsivantes se asocia a efectos adversos frecuentes.
Acerca del conjunto de evidencia para esta pregunta

Cuál es la evidencia. 
Véase matriz de evidencia en Epistemonikos más abajo.

Encontramos 12 revisiones sistemáticas [1],[2],[3],[4], [5],[6],[7],[8],[9],[10],[11],[12] que incluyen 80 estudios primarios [13],[14],[15],[16],[17],[18],[19],[20],[21], [22],[23],[24],[25],[26],[27],[28],[29],[30],[31],[32], [33],[34],[35],[36],[37],[38],[39],[40],[41],[42],[43], [44],[45],[46],[47],[48],[49],[50],[51],[52],[53],[54], [55],[56],[57],[58],[59],[60],[61],[62],[63],[64],[65], [66],[67],[68],[69],[70],[71],[72],[73],[74],[75],[76], [77],[78],[79],[80],[81],[82],[83],[84],[85],[86],[87], [88],[89],[90],[91],[92], entre ellos doce estudios controlados aleatorizados [13],[14],[17],[22],[23],[36], [42],[65],[84],[86],[91],[92]. Para el presente resumen no se consideraron 10 de estos últimos, por evaluar pacientes que serían sometidos a cirugía [17], [22],[23],[36],[42],[65],[84],[86],[91],[92], por lo que sólo se analizaron dos estudios controlados aleatorizados que corresponden a la evidencia directa para nuestra pregunta [13],[14].

Qué tipo de pacientes incluyeron los estudios

Ambos estudios incluyen pacientes mayores de 18 años sin antecedente de convulsión previa, con diagnóstico de tumor primario cerebral, como glioma o glioblastoma (28,2%) o metástasis cerebral (71,8%) y que no fueron sometidos a intervenciones quirúrgicas. 

Ningún estudio reporta la ubicación de las lesiones.

Un estudio [13] incluyó personas con menos de un mes de diagnóstico, y el otro estudio [14] incluyó personas con menos de 14 días de diagnóstico. 

Ningún estudio reportó el tratamiento para la patología de base utilizado.

Qué tipo de intervenciones incluyeron los estudios

Un estudio [13] realizó la prevención con fenitoína 15mg/kg vía oral de carga y luego 5mg/kg/día vía oral, realizando un seguimiento por 5,4 meses.

Un estudio [14] utilizó ácido valproico con el objetivo de niveles plasmáticos de 50-100ug/ml, realizando un seguimiento por siete meses.

Un estudio comparó contra placebo [14] y el otro no realizó tratamiento en el grupo control [13].

Qué tipo de desenlaces midieron

El principal desenlace analizado fue la incidencia de convulsiones.

Otro desenlace analizado fue la incidencia de efectos adversos como rash cutáneo, náuseas, mielosupresión, vértigo, ataxia y visión borrosa.

Ningún estudio evaluó calidad de vida ni mortalidad.
Resumen de los resultados

La información sobre los efectos de los anticonvulsivantes está basada en dos estudios aleatorizados [13],[14] que incluyen 174 pacientes. Ambos estudios midieron la aparición de convulsiones y la presencia de efectos adversos. Ninguno evaluó calidad de vida ni mortalidad.

El resumen de resultados es el siguiente:

  • La prevención primaria con anticonvulsivantes podría no disminuir el riesgo de convulsiones en tumores o metástasis cerebrales, pero la certeza de la evidencia es baja.
  • El uso de anticonvulsivantes se asocia a efectos adversos frecuentes. La certeza de la evidencia es alta.

Otras consideraciones para la toma de decisión

A quién se aplica y a quién no se aplica esta evidencia
  • Las conclusiones de este resumen se aplican a pacientes adultos que cursan con tumores cerebrales, ya sean primarios del sistema nervioso central o metástasis cerebrales, que no son sometidos a cirugía, y que no han tenido convulsiones.
Sobre los desenlaces incluidos en este resumen
  • Los desenlaces incluídos en este resumen son los que fueron considerados por los autores como críticos para la toma de decisiones.
  • Inicialmente se planificó incorporar los desenlaces mortalidad y calidad de vida, pero estos no fueron reportados por los estudios incluidos en este resumen.
Balance riesgo/beneficio y certeza de la evidencia
  • No es posible realizar un adecuado balance riesgo/beneficio ya que la certeza de la evidencia sobre cualquier beneficio es baja, sin embargo, es razonable suponer que una intervención que podría no tener efectos sobre la aparición de convulsiones y que sí presenta efectos adversos tenga un balance negativo.
Qué piensan los pacientes y sus tratantes
  • Si bien muchos pacientes y tratantes debieran inclinarse en contra del uso de esta intervención en base a la evidencia presentada en este resumen, existen factores que probablemente introducirán amplia variación en las decisiones reales. Por ejemplo, esta intervención suele ser indicada por los médicos (oncólogos, neurocirujanos o neurólogos) hasta en un 25% de los casos, con un sustento fisiopatológico para respaldar la intervención. De hecho, una práctica habitual es indicar los anticonvulsivantes en caso de lesiones localizadas en relación a la corteza cerebral [94]. Es probable que, considerando las limitaciones de la evidencia sobre esta pregunta, muchos clínicos no modifiquen esta conducta.
  • Es particularmente importante informar al paciente sobre la incertidumbre existente.
Consideraciones de recursos
  • No es posible hacer una evaluación costo beneficio adecuada debido a la incertidumbre existente.
  • Probablemente este factor no será lo más relevante para la decisión, dado que la intervención es de bajo costo; no obstante, cualquier beneficio está aún por demostrarse.
Diferencias entre este resumen y otras fuentes
  • Las conclusiones de nuestro resumen concuerdan parcialmente con las conclusiones de la mayoría de las revisiones identificadas, las cuales plantean que existe incertidumbre o que se necesitan más estudios [1],[4], o que no se recomiendan porque no tienen beneficio [2],[3],[5],[10]. Sólo una revisión plantea que ciertos anticonvulsivantes profilácticos sí tendrían beneficio, basándose en estudios observacionales para apoyar su conclusión [11].
  • Las conclusiones de este resumen estan en concordancia con las principales guías clínicas actuales sobre el tema. La guía clínica de la National Comprehensive Cancer Network [95] recomienda no usar anticonvulsivantes profilácticos en estos pacientes; la misma recomendación que emite el European Handbook of Neurological Management [96].
¿Puede que cambie esta información en el futuro?
  • La probabilidad de que esta evidencia cambie en el futuro es alta ya que la certeza de la misma es baja o muy baja, principalmente por la escasa cantidad de estudios que han abordado este tema. Sin embargo, actualmente no hay esfuerzos activos por estudiarlo.
  • Se realizó una búsqueda en los registros de WHO International Clinical Trials Registry Platform. En la actualidad, no hay estudios clínicos en curso que aborden este tema.
  • Mediante una búsqueda en PubMed no logramos identificar estudios primarios no incluídos en las revisiones sistemáticas analizadas.
  • Es importante notar que a la fecha no existen estudios que comparen nuevos anticonvulsivantes (como levetiracetam o topiramato) contra placebo para profilaxis primaria; éstos, al no interactuar farmacologicamente con las terapias de base de estos pacientes, sí podrían tener efecto en la prevención de las convulsiones.
Cómo realizamos este resumen

Mediante métodos automatizados y colaborativos recopilamos toda la evidencia relevante para la pregunta de interés y la presentamos en una matriz de evidencia.

Siga el enlace para acceder a la versión interactiva: Fármacos anticonvulsivantes para pacientes con tumores cerebrales

Notas

Si con posterioridad a la publicación de este resumen se publican nuevas revisiones sistemáticas sobre este tema, en la parte superior de la matriz se mostrará un aviso de “nueva evidencia”.  Si bien el proyecto contempla la actualización periódica de estos resúmenes, los usuarios están invitados a comentar en Medwave o contactar a los autores mediante correo electrónico si creen que hay evidencia que motive una actualización más rápida.

Luego de crear una cuenta en Epistemonikos, al guardar las matrices recibirá notificaciones automáticas cada vez que exista nueva evidencia que potencialmente responda a esta pregunta. El detalle de los métodos para elaborar este resumen están descritos aquí: http://dx.doi.org/10.5867/medwave.2014.06.5997.

La Fundación Epistemonikos es una organización que busca acercar la información a quienes toman decisiones en salud, mediante el uso de tecnologías. Su principal desarrollo es la base de datos Epistemonikos (www.epistemonikos.org).

Los resúmenes de evidencia siguen un riguroso proceso de revisión por pares interno.

Declaración de conflictos de intereses
Los autores declaran no tener conflictos de intereses con la materia de este artículo.

Licencia Creative Commons Esta obra de Medwave está bajo una licencia Creative Commons Atribución-NoComercial 3.0 Unported. Esta licencia permite el uso, distribución y reproducción del artículo en cualquier medio, siempre y cuando se otorgue el crédito correspondiente al autor del artículo y al medio en que se publica, en este caso, Medwave.

 

Los pacientes con tumores cerebrales, primarios o metastásicos, presentan riego de desarrollar convulsiones durante la evolución de su enfermedad, por lo que se ha propuesto el uso profiláctico de anticonvulsivantes. Sin embargo, el efecto de esta intervención no está claro. Para responder esta pregunta utilizamos la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en múltiples bases de datos. Identificamos 12 revisiones sistemáticas que en conjunto incluyen ochenta estudios primarios. Doce corresponden a estudios aleatorizados, pero sólo dos responden la pregunta de interés. Extrajimos los datos, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. Concluimos que la prevención primaria con anticonvulsivantes podría no disminuir el riesgo de convulsiones en tumores o metástasis cerebrales, y se asocia a efectos adversos frecuentes.

Authors: Diego Lobos-Urbina[1,2], Lucas Kittsteiner-Manubens[1,2], José Peña[2,3,4]

Affiliation:
[1] Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
[2] Proyecto Epistemonikos, Santiago, Chile.
[3] Departamento Hemato-Oncología, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
[4] Centro de Cáncer Nuestra Señora de la Esperanza, Red de Salud UC-Christus, Santiago, Chile.

E-mail: jepena@uc.cl

Author address:
[1] Facultad de Medicina
Pontificia Universidad Católica de Chile
Lira 63
Santiago Centro
Chile

Citation: Lobos-Urbina D, Kittsteiner-Manubens L, Peña J. Is primary prevention with antiepileptic drugs effective in brain tumors or brain metastases?. Medwave2017;17(Suppl1):e6871 doi: 10.5867/medwave.2017.6871

Submission date: 28/12/2016

Acceptance date: 28/12/2016

Publication date: 21/3/2017

PubMed record

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July 2022, Vol 22, Issue 6
icon Research papers
Association of biomarkers and severity of COVID-19: A crosssectional study

Systematization of initiatives in sexual and reproductive health about good practices criteria in response to the COVID-19 pandemic in primary health care in Chile

Clinical, psychological, social, and family characterization of suicidal behavior in Chilean adolescents: a multiple correspondence analysis

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