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Problema de Salud AUGE N°03

Cáncer Cérvico Uterino

ETD2-2019

En personas con cáncer cervicouterino invasor incluyendo la etapa IB2, el Ministerio de Salud SUGIERE realizar estudio ganglionar centinela por sobre realizar linfadenectomía.

El problema ha sido definido como prioritario en el marco de las Garantías Explícitas en Salud (GES), régimen integral de salud que prioriza un grupo de patologías o problemas de salud, garantizando el acceso a tratamiento oportuno y de calidad.

A continuación se presenta la “Tabla de la evidencia a la decisión” con el resumen de los juicios, la evidencia de investigación evaluada, consideraciones adicionales y comentarios planteados por el panel.

 1.- ¿El problema es una prioridad?
No Probablemente no Probablemente sí Varía No lo sé

El problema o condición de salud abordado en la pregunta ha sido definido como prioritario en el marco de las Garantías Explícitas en Salud (GES), régimen integral de salud que prioriza un grupo de patologías o problemas de salud, garantizando el acceso a tratamiento oportuno y de calidad. Además, particularmente, la pregunta «En personas con cáncer cervicouterino invasor incluyendo IB2 ¿Se debe estudio ganglionar centinela en comparación a linfadenectomía?» fue priorizada por un panel de expertos en la materia. Ver detalle en Informe de Priorización de Preguntas de Práctica Clínica.

 2.- ¿Qué tan significativos son los efectos deseables anticipados?
Trivial Pequeño Moderado Grande Varía No lo sé

Moderados: Tomando en cuenta la evidencia identificada, la experiencia clínica y la vivencia de las personas con el problema de salud, el equipo elaborador de la guía estimó que la magnitud de los efectos deseables de «realizar estudio ganglionar centinela» en comparación a «realizar linfadenectomía» son moderados, y probablemente es importante para la mayoría de las personas.

Consideraciones Adicionales

El panel refiere que de todas formas cuando no se encuentra el ganglio centinela se debe hacer linfadenectomia de la hemipelvis en la que no se encontró.

Evidencia de investigación

REALIZAR ESTUDIO GANGLIONAR CENTINELA COMPARADO CON LINFADENECTOMÍA PARA CÁNCER CERVICOUTERINO INVASOR INCLUYENDO IB2.
Población: Mujeres con cáncer cervicouterino invasor incluyendo IB2 (FIGO 2018).
Intervención: Realizar estudio ganglionar centinela.
Comparación: Linfadenectomía.

Impacto diagnóstico

Desenlaces

Efecto

Morbilidad o mortalidad

No se identificaron estudios evaluando el impacto, por lo que el desenlace se estimó en base a la exactitud diagnóstica del test, y de las consecuencias esperadas a partir de cada resultado.

Desenlaces

Prevalencia hipotética 

18%*

Certeza de la evidencia

(GRADE)**

Mensajes clave en términos sencillos

Sensibilidad:  89,2% (IC 95% de 86,3 a 91,6%).

Especificidad: No calculable***

 

46 estudios en una revisión sistemática [4] (No se reporta cantidad total de pacientes).
 Población hipotética de 1000 personas con 200 con compromiso ganglionar y 800 sin compromiso ganglionar.

Pacientes con compromiso ganglionar

(verdaderos positivos)

178

(173 a 183)

image1

Baja

En una población de 1000 pacientes con cáncer cervicouterino IB2 que requieren evaluación de compromiso ganglionar, realizar ganglio centinela podría diagnosticar correctamente a 178 pacientes de los 200 que realmente tienen compromiso ganglionar, pero la certeza de la evidencia es baja.

Pacientes incorrectamente clasificados de no tener compromiso ganglionar

(falsos negativos)

22

(17 a 27)

image1

Baja

En una población de 1000 pacientes con cáncer cervicouterino IB2 que requieren evaluación de compromiso ganglionar, realizar ganglio centinela podría diagnosticar incorrectamente como sin compromiso ganglionar a 22 pacientes de los 200 que realmente tienen compromiso ganglionar, pero la certeza de la evidencia es baja.

Pacientes sin compromiso ganglionar

(verdaderos negativos)

No calculable

 

Pacientes clasificados incorrectamente de tener compromiso ganglionar

(falsos positivos)

No calculable

IC: Intervalo de confianza del 95%.
GRADE: grados de evidencia del GRADE Working Group.
*La prevalencia corresponde al promedio de prevalencia de los estudios de la revisión sistemática [129].
** Certeza de exactitud diagnóstica.
***La linfadenectomía (gold standard) solo se realizó en los pacientes con ganglio centinela positivo (por temas éticos). Por lo cual no es posible calcular la especificidad junto con los verdaderos negativos ni falsos positivos.
1 Se disminuyó dos niveles de certeza de evidencia ya que el gold standard sólo se realizó en pacientes con ganglio centinela positivo.
Fecha de elaboración de la tabla: Septiembre, 2019.

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Búsqueda y Síntesis de Evidencia

 3.- ¿Qué tan significativos son los efectos indeseables anticipados?
Grande Moderado Pequeño Trivial Varía No lo sé

Triviales: Tomando en cuenta la evidencia identificada, la experiencia clínica y de las personas con el problema de salud, el equipo elaborador de la guía estimó que la magnitud de los efectos indeseables de «realizar estudio ganglionar centinela» en comparación a «realizar linfadenectomía» son triviales o probablemente no es relevantes para las personas.

Evidencia de investigación

REALIZAR ESTUDIO GANGLIONAR CENTINELA COMPARADO CON LINFADENECTOMÍA PARA CÁNCER CERVICOUTERINO INVASOR INCLUYENDO IB2.
Población: Mujeres con cáncer cervicouterino invasor incluyendo IB2 (FIGO 2018).
Intervención: Realizar estudio ganglionar centinela.
Comparación: Linfadenectomía.

Impacto diagnóstico

Desenlaces

Efecto

Morbilidad o mortalidad

No se identificaron estudios evaluando el impacto, por lo que el desenlace se estimó en base a la exactitud diagnóstica del test, y de las consecuencias esperadas a partir de cada resultado.

Desenlaces

Prevalencia hipotética 

18%*

Certeza de la evidencia

(GRADE)**

Mensajes clave en términos sencillos

Sensibilidad:  89,2% (IC 95% de 86,3 a 91,6%).

Especificidad: No calculable***

 

46 estudios en una revisión sistemática [4] (No se reporta cantidad total de pacientes).
 Población hipotética de 1000 personas con 200 con compromiso ganglionar y 800 sin compromiso ganglionar.

Pacientes con compromiso ganglionar

(verdaderos positivos)

178

(173 a 183)

image1

Baja

En una población de 1000 pacientes con cáncer cervicouterino IB2 que requieren evaluación de compromiso ganglionar, realizar ganglio centinela podría diagnosticar correctamente a 178 pacientes de los 200 que realmente tienen compromiso ganglionar, pero la certeza de la evidencia es baja.

Pacientes incorrectamente clasificados de no tener compromiso ganglionar

(falsos negativos)

22

(17 a 27)

image1

Baja

En una población de 1000 pacientes con cáncer cervicouterino IB2 que requieren evaluación de compromiso ganglionar, realizar ganglio centinela podría diagnosticar incorrectamente como sin compromiso ganglionar a 22 pacientes de los 200 que realmente tienen compromiso ganglionar, pero la certeza de la evidencia es baja.

Pacientes sin compromiso ganglionar

(verdaderos negativos)

No calculable

 

Pacientes clasificados incorrectamente de tener compromiso ganglionar

(falsos positivos)

No calculable

IC: Intervalo de confianza del 95%.
GRADE: grados de evidencia del GRADE Working Group.
*La prevalencia corresponde al promedio de prevalencia de los estudios de la revisión sistemática [129].
** Certeza de exactitud diagnóstica.
***La linfadenectomía (gold standard) solo se realizó en los pacientes con ganglio centinela positivo (por temas éticos). Por lo cual no es posible calcular la especificidad junto con los verdaderos negativos ni falsos positivos.
1 Se disminuyó dos niveles de certeza de evidencia ya que el gold standard sólo se realizó en pacientes con ganglio centinela positivo.
Fecha de elaboración de la tabla: Septiembre, 2019.

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Búsqueda y Síntesis de Evidencia

 4.- ¿Cuál es la certeza general de la evidencia sobre efectos?
Muy baja Baja Moderada Alta Ningún estudio incluido

Baja: Existe incertidumbre de que la evidencia identificada es suficiente para apoyar una recomendación determinada, dado que existen pocos estudios o estos tienen limitaciones.

Evidencia de investigación

Desenlaces

Importancia

Certeza en la evidencia
 (GRADE)

Verdaderos positivos

CRÍTICO

⨁⨁◯◯
BAJAa

Falsos negativos

CRÍTICO

⨁⨁◯◯
BAJAa

Verdaderos negativos

CRÍTICO

⨁⨁◯◯
BAJAa

Falsos positivos 

CRÍTICO

⨁⨁◯◯
BAJAa

a.Se disminuyó dos niveles de certeza de evidencia ya que el gold standard sólo se realizó en pacientes con ganglio centinela positivo.

 5.- ¿Hay incertidumbre importante o variabilidad sobre qué tanto valora la gente los desenlaces principales?
Variabilidad importantes Posiblemente hay incertidumbre o variabilidad importantes Probablemente no hay incertidumbre ni variabilidad importantes No hay variabilidad o incertidumbre importante

Probablemente no hay variabilidad importante: Tomando en cuenta la evidencia identificada, la experiencia clínica y la vivencia de las personas con el problema de salud, el equipo elaborador de la guía consideró que probablemente no existe variabilidad en como las personas, correctamente informadas, podrían valorar los efectos deseables e indeseables de «realizar estudio ganglionar centinela».

Evidencia de investigación

No se identificaron estudios que respondan la pregunta de manera directa o indirecta en todas las estrategias de búsqueda realizadas.

Búsqueda y Síntesis de Evidencia

 6.- El balance entre efectos deseables e indeseables favorece la intervención o la comparación?
Favorece la comparación Probablemente favorece la comparación No favorece la intervención ni la comparación Probablemente favorece la intervención Favorece la intervención Varía No lo sé

Favorece la intervención: Tomando en cuenta la magnitud de los efectos deseables e indeseables, así como los valores y preferencias de las personas, el equipo elaborador de la guía consideró que «realizar estudio ganglionar centinela» es la mejor alternativa».

Evidencia de investigación

El panel considera que, a pesar de la evidencia baja, la experiencia clínica y algunos estudios locales han demostrado que el balance riesgo beneficio de realizar ganglio centinela sería superior.

 7.- ¿Qué tan grandes son los recursos necesarios (costos)?
Costos extensos Costos moderados Costos y ahorros pequeños Ahorros moderados Ahorros extensos Varía No lo sé

Costos moderados: La diferencia del costo entre «realizar estudio ganglionar centinela» y »realizar linfadenectomía» es igual o superior a $674.672 y menor a $4.502.112 al año. Por lo cual el equipo elaborador de la guía consideró que implementar» realizar estudio ganglionar centinela» traeria costos moderados para el sistema de salud.

Evidencia de investigación

A continuación se muestran los costos referenciales de las prestaciones sanitarias de usar tratamiento vía oral y usar tratamiento endovenoso de modo que el equipo elaborador de la Guía se pudiese pronunciar al respecto y no debe ser utilizado para otros fines.

Tabla N° 1 Precios referenciales

ítem

Realizar estudio ganglio centinela

Linfadenectomía pélvica completa 

Biopsia Linfonodo Centinela
(Pabellón y Honorarios médicos)1

1.232.083

Tratamiento quirúrgico cáncer cervicouterino invasor2

1.435.310

Total

1.232.083

1.435.310

*El porcentaje de cobertura del seguro de salud sobre el precio de la(s) prestación (es) sanitaria(s), dependerá del tipo de seguro de cada paciente.
Fuente:
1 Precio indicado por Clínica Privada (Red Clínica UC Christus, 2019)
2 Precio obtenido de la base de datos del Programa de Prestaciones Valoradas (PPV GES). Este precio agrupa varias prestaciones.

Búsqueda y Síntesis de Evidencia

 8.- ¿La costo-efectividad de la intervención beneficia la intervención o la comparación?
Favorece la comparación Probablemente favorece la comparación No favorece la intervención ni la comparación Probablemente favorece la intervención Favorece la intervención Varía Ningún estudio incluido

Probablemente favorece la intervención: Tomando en cuenta la evidencia identificada y la experiencia clinica, el equipo elaborador de la guía consideró que »realizar estudio ganglionar centinela» es probablemente la opción más costo-efectiva.

Evidencia de investigación

Estudio 

Limitaciones

Incremental

Incertidumbre

Valoración del estudio

Brar, 2017

Intervención: Histerectomía radical más biopsia de nodo centinela con Tc 99 con tinte azul vs Comparador: Histerectomía radical más linfanedectomia pélvica

 

El estudio posee limitaciones serias. No realizan descuento ni para costos ni para beneficios

Costos

CAN $-1.263,52 (esto implica que la intervención es más barata o costo ahorrativa que el comparador)

Dólares canadienses 2015

Efectos

0,07 QALYs

(beneficio generado por la intervención)

Costo-efectividad

Genera un ICER negativo, porque la alternativa es costo ahorrativa y más efectiva que el comparador. Esta alternativa domina al resto de las alternativas.

Los resultados fueron robustos a los análisis de sensibilidad. Siempre resulta costo efectiva la intervención.

 Sin embargo, los resultados hay que verlos con precaución dado que no informan si consideraron o no tasa de descuento tanto para costos como para beneficios.

 

A pesar que el estudio a primera vista incluye todas las etapas de un análisis de costo efectividad, no reportan haber incluido descuento, ni para costos ni para beneficios, lo cual es un error grave, dado que consideran un horizonte temporal de 5 años, por lo tanto sus resultados hay que considerarlos con mucha precaución.

 

Del mismo estudio realizaron otra comparación

Intervención: Histerectomía radical más biopsia de nodo centinela solo con Tc99 vs Comparador: Histerectomía radical más linfanedectomia pélvica

 

El estudio posee limitaciones serias. No realizan descuento ni para costos ni para beneficios

Costos

CAN $-890,9 (esto implica que la intervención es más barata o costo ahorrativa que el comparador)

Dólares canadienses 2015

Efectos

0,06 QALYs

(beneficio generado por la intervención)

Costo-efectividad

Genera un ICER negativo porque la alternativa es costo ahorrativa y más efectiva que el comparador.

Esta alternativa es dominada por la alternativa anterior.

Los resultados fueron robustos a los análisis de sensibilidad. 

Esta alternativa también resultó ser costo efectiva respecto del comparador.

 Sin embargo, los resultados hay que verlos con precaución dado que no informan si consideraron o no tasa de descuento tanto para costos como para beneficios.

 

A pesar que el estudio a primera vista incluye todas las etapas de un análisis de costo efectividad, no reportan haber incluido descuento, ni para costos ni para beneficios, lo cual es un error grave, dado que consideran un horizonte temporal de 5 años, por lo tanto sus resultados hay que considerarlos con mucha precaución.

Referencia
H. B, L. H. Cost-effectiveness of sentinel node biopsy and pathological ultrastaging in patients with early-stage cervical cancer. Cancer [Internet]. 2017;123(10):1751–9. Available from: http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1097-0142

Búsqueda y Síntesis de Evidencia

 9.- ¿Cuál sería el impacto en equidad en salud?
Reducido Probablemente reducido Probablemente ningún impacto Probablemente aumentado Aumentado Varía No lo sé

Probablemente aumentada: El equipo elaborador de la guía consideró que la equidad en salud probablemente aumentaría si se recomendase »realizar estudio ganglionar centinela» , dado que en la actualidad existe acceso a ella, pero es una intervención que en ocasiones no se utiliza en poblaciones desventajadas.

 10.- ¿La intervención es aceptable para las partes interesadas?
No Probablemente no Probablemente sí Varía No lo sé

Sí: El equipo elaborador de la guía consideró que »realizar estudio ganglionar centinela» sÍ es aceptable para las partes interesadas (profesionales de la salud, gestores de centros de salud, directivos de centros de salud, pacientes, cuidadores, seguros de salud, otros).

 11.- ¿Es factible implementar la intervención?
No Probablemente no Probablemente sí Varía No lo sé

Probablemente sí: Tomando en cuenta la capacidad de la red asistencial y los recursos humanos y materiales disponibles, el equipo elaborador de la guía consideró que probablemente SI es factible implementar »realizar estudio ganglionar centinela» .