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 | 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.
Población: Mujeres con cáncer cervicouterino invasor incluyendo IB2 (FIGO 2018).
Intervención: Realizar estudio ganglionar centinela.
Comparación: Linfadenectomía.
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Impacto diagnóstico |
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Desenlaces |
Efecto |
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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. |
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Desenlaces |
Prevalencia hipotética 18%* |
Certeza de la evidencia (GRADE)** |
Mensajes clave en términos sencillos |
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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). |
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Pacientes con compromiso ganglionar (verdaderos positivos) |
178 (173 a 183) |
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. |
|
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Pacientes incorrectamente clasificados de no tener compromiso ganglionar (falsos negativos) |
22 (17 a 27) |
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. |
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Pacientes sin compromiso ganglionar (verdaderos negativos) |
No calculable |
— |
—
|
|
|
Pacientes clasificados incorrectamente de tener compromiso ganglionar (falsos positivos) |
No calculable |
— |
— |
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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
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
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.
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). |
||||
|
Pacientes con compromiso ganglionar (verdaderos positivos) |
178 (173 a 183) |
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) |
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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Gynecologic oncology. 2008;111(2 Suppl):S116-20. 99. Rob L, Strnad P, Robova H, Charvat M, Pluta M, Schlegerova D, Hrehorcak M. Study of lymphatic mapping and sentinel node identification in early stage cervical cancer. Gynecologic oncology. 2005;98(2):281-8. 100. Roca I, Caresia AP, Gil-Moreno A, Pifarre P, Aguade-Bruix S, Castell-Conesa J, Martínez-Palones JM, Xercavins J. Usefulness of sentinel lymph node detection in early stages of cervical cancer. European journal of nuclear medicine and molecular imaging. 2005;32(10):1210-6. 101. Rossi EC, Ivanova A, Boggess JF. Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study. Gynecologic oncology. 2012;124(1):78-82. 102. Roy M, Bouchard-Fortier G, Popa I, Grégoire J, Renaud MC, Têtu B, Plante M. Value of sentinel node mapping in cancer of the cervix. Gynecologic oncology. 2011;122(2):269-74. 103. Schwendinger V, Müller-Holzner E, Zeimet AG, Marth C. Sentinel node detection with the blue dye technique in early cervical cancer. European journal of gynaecological oncology. 2006;27(4):359-62. 104. Seong SJ, Park H, Yang KM, Kim TJ, Lim KT, Shim JU, Park CT, Lee KH. Detection of sentinel lymph nodes in patients with early stage cervical cancer. Journal of Korean medical science. 2007;22(1):105-9. 105. Sheng XG, Li DP, Liu NF, Li QS, Tang L, Li HQ, Lu CH. [Clinical significance of sentinel lymph nodes detection in patients with early stage cervical cancer]. Zhonghua fu chan ke za zhi. 2004;39(1):10-3. 106. Shiravani, Zahra, Hasanzadeh, Malihe, Yousefi, Zohreh, Kadkhodayan, Sima, Sharifi, Noorieh, Saeedzadeh, Maryam, Attaran, Matin, Dabbagh Kakhki, Vahid Reza, Sadeghi, Ramin. The value of lateral lymphoscintigraphy images of the pelvis for gynecological cancers: Are they necessary?. Iranian Journal of Nuclear Medicine. 2014;22(2):46-50. 107. Silva LB, Silva-Filho AL, Traiman P, Triginelli SA, de Lima CF, Siqueira CF, Barroso A, Rossi TM, Pedrosa MS, Miranda D, Melo JR. Sentinel node detection in cervical cancer with (99m)Tc-phytate. Gynecologic oncology. 2005;97(2):588-95. 108. Sniadecki M, Sawicki S, Wojtylak S, Liro M, Wydra D. Clinical feasibility and diagnostic accuracy of detecting micrometastatic lymph node disease in sentinel and non-sentinel lyph nodes in cervical cancer: outcomes and implications. Ginekologia polska. 2014;85(1):10-3. 109. Somashekhar SP, Naikoo ZA, Zaveri SS, Parameswaran RV, Jaka RC. Role of sentinel lymph node biopsy in early cervical cancer. Indian journal of surgical oncology. 2012;3(4):317-20. 110. Strnad P, Robova H, Skapa P, Pluta M, Hrehorcak M, Halaska M, Rob L. A prospective study of sentinel lymph node status and parametrial involvement in patients with small tumour volume cervical cancer. Gynecologic oncology. 2008;109(2):280-4. 111. Torné A, Puig-Tintoré LM. The use of sentinel lymph nodes in gynaecological malignancies. Current opinion in obstetrics & gynecology. 2004;16(1):57-64. 112. van Dam PA, Hauspy J, Vanderheyden T, Sonnemans H, Spaepen A, Eggenstein G, Dirix L, Verkinderen L. Intraoperative sentinel node identification with Technetium-99m-labeled nanocolloid in patients with cancer of the uterine cervix: a feasibility study. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. 2003;13(2):182-6. 113. van de Lande J, Davelaar EM, von Mensdorff-Pouilly S, Water TJ, Berkhof J, van Baal WM, Kenemans P, Verheijen RH. SCC-Ag, lymph node metastases and sentinel node procedure in early stage squamous cell cervical cancer. Gynecologic oncology. 2009;112(1):119-25. 114. van der Vorst JR, Hutteman M, Gaarenstroom KN, Peters AA, Mieog JS, Schaafsma BE, Kuppen PJ, Frangioni JV, van de Velde CJ, Vahrmeijer AL. Optimization of near-infrared fluorescent sentinel lymph node mapping in cervical cancer patients. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. 2011;21(8):1472-8. 115. Verheijen RH, Pijpers R, van Diest PJ, Burger CW, Buist MR, Kenemans P. Sentinel node detection in cervical cancer. Obstetrics and gynecology. 2000;96(1):135-8. 116. Vieira SC, Sousa RB, Tavares MB, Silva JB, Abreu BA, Santos LG, da Silva BB, Zeferino LC. Preoperative pelvic lymphoscintigraphy is of limited usefulness for sentinel lymph node detection in cervical cancer. European journal of obstetrics, gynecology, and reproductive biology. 2009;145(1):96-9. 117. Vieira SC, Zeferino LC, Silva BB, Santana JO, Santos LG, Carvalho TC, Rocha MC. [Sentinel node study with patent blue in cervical cancer]. Revista da Associacao Medica Brasileira (1992). 2004;50(3):302-4. 118. Wang HY, Sun JM, Lu HF, Shi DR, Ou ZL, Ren YL, Fu SQ. 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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
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 |
|
Verdaderos positivos |
CRÍTICO |
⨁⨁◯◯ |
|
Falsos negativos |
CRÍTICO |
⨁⨁◯◯ |
|
Verdaderos negativos |
CRÍTICO |
⨁⨁◯◯ |
|
Falsos positivos |
CRÍTICO |
⨁⨁◯◯ |
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
Búsqueda y síntesis de evidencia de valores y preferencias de las personas
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 |
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
Búsqueda de costos
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
Búsqueda de costos
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 | 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 | 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» .