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FASGO 2005 CONSENSO CANCER DE ENDOMETRIO AAGO Coordinador Gustavo Maya Expertos Daniel Falugue Gustavo Irico Roberto Orti Jorge Sarrouf 1 Epidemiologia Existe una gran variación en la incidencia en el mundo, 170.000 nuevos casos fueron estimados en el año 1997. Está relacionado con la endocrinología, la obesidad y por lo tanto más frecuente en países desarrollados. Incidencia: Para el 2001 fue de 24.7 por 100.000 (EEUU). Mujeres blancas: 26.1 por 100.000 Mujeres negras: 18.5 por 100.000 Morbimortalidad: De 40.300 casos en el 2004 morirán 7.000 de la enfermedad. Representan el 4º cáncer más común entre las mujeres. Raza: La mortalidad es más alta en las negras 7 de 100.000, en las blancas, 38 de 100.000. Edad: Reproductiva y menopáusica. La edad media es la 7º década pero la mayoría tienen entre 50 y 59 años. Sólo el 5% de las mujeres son menores de 40 años. El 20% se diagnostica antes de la menopausia. Etiología y Factores de Riesgo Parece haber dos tipos patogénicos del cáncer de endometrio. El más frecuente ocurre en mujeres perimenopáusicas, más jóvenes, con antecedentes de exposición a los estrógenos sin oposición, ya sean endógenos o exógenos, se inician como endometrio hiperplásico y progresan a carcinoma. Estos tumores son DEPENDIENTES de los ESTRÓGENOS, tienden a estar mejor diferenciados y su pronóstico es más favorable. El otro tipo de carcinoma endometrial se produce en mujeres que no han recibido estimulación del endometrio. Estos cánceres no se relacionan con las hiperplasias y pueden originarse sobre un fondo atrófico. Están menos diferenciados y se acompañan de peor pronóstico. Estos tumores son INDEPENDIENTES de los ESTRÓGENOS. Múltiples factores de riesgo epidemiológicos han sido identificados. 2 • Factores Endógenos: Obesidad: incrementa el riesgo. Nuliparidad: 2 a 3 veces comparada con la paridad. Menopausia tardía: > 52 Años. • Estrógenos sin oposición: Como terapia hormonal Endógenos (tumores de la granulosa u ovarios poliquísticos) Anovulación • Tamoxifeno Un estudio reciente de control usando el SERM indica que cuando es correctamente utilizado no se incrementa el riesgo de cáncer de endometrio. • Combinación con ACOs disminuye el riesgo de desarrollar cáncer de endometrio, cuando se usa por más de 12 meses y permanece por 12 años después del uso de los ACOs. Es más notable en las mujeres multíparas. • El hábito de fumar aparentemente disminuye el riesgo, las mujeres que fuman tienen la menopausia 1 a 2 años antes que las que no fuman. Epidemiología y factores de riesgo: – Postmenopausia (sólo 7% ca de endometrio premenop.). – Obesidad, hipertensión arterial, diabetes mellitus. – Nuliparidad. – Menarca temprana, menopausia tardía. – Terapia hormonal sin oposición. – Tamoxifeno. – Antecedentes de cáncer de mama, ovario, colon. – Hiperplasias endometriales con atipía. – Cáncer hereditario colorrectal no polipoideo (HNPCC) 25-50%. Screening Los procedimientos para screening no logran reducir la mortalidad por cáncer de endometrio 3 Diagnóstico A continuación mostramos en forma resumida los procedimientos diagnósticos para cáncer de endometrio. Modalidades para evaluar Endometrio Muestreo endometrial: – Dilatación y curetaje-Histeroscopía – Biopsia (Pipelle-cureta de Novack) – Cepillado Ecografía transvaginal Conclusiones • 7% cánceres de endometrio son en mujeres menores de 50 años. • 90% de las portadoras de un Ca. de Endometrio tienen síntomas. • Solamente el 10 al 12% de las pacientes con metrorragia de la postmenopausia son portadoras de un ca de endometrio. • Definir perfil de Riesgo. • ETV suma utilidad en el algorritmo diagnóstico. • Endometrio igual ó menor de 4 mm tiene alta sensibilidad y un V.P negativo alto para excluir ca. de endometrio. • En pacientes con tamoxifeno el grosor promedio es de 8 mm. • Post menopausia, sin sangrado, y sin factores de riesgo: – <11mm. Control (R.Ca.E 0.02%) – >11 mm. Considerar biopsia (R.Ca E 6.7%) Evaluación Preoperatoria • Estudio completo de sangre. • Radiografía de tórax como parte del chequeo clínico. • La tomografía computada es innecesaria salvo que se sospeche enfermedad extrapélvica. • La resonancia magnética puede ser útil para evaluar involucro ganglionar y la invasión miometrial, pero es innecesaria si la estadificación quirúrgica planeada es completa. • Dosaje de Ca 125 es útil como predictor de invasión extrauterina del cáncer de endometrio y para el seguimiento de las pacientes después de 4 iniciado el tratamiento. Pero no es suficientemente sensible para ocupar el lugar de la estadificación quirúrgica. A partir de 1988 la FIGO estableció la estadificación quirúrgica. La estadificación clínica solo se usa para pacientes inoperables. Estadificación clínica (FIGO 1971): tumor limitado al cuerpo histerometría hasta 8 cm histerometría mayor de 8 cm subtipos histológicos G1-2-3 E II propagado al cuello E III fuera del utero pero dentro de la pelvis E IV fuera de la pelvis o vejiga o recto EI IA IB Estadificación quirúrgica (FIGO 1988) Estadio I - Tumor confinado al cuerpo uterino • IA Tumor limitado al endometrio • IB Tumor invade menos de la mitad del espesor del miometrio • IC Tumor invade más de la mitad del espesor del miometrio Estadio II - Tumor se extiende al cuello uterino • IIA sólo compromiso de las glándulas endocervicales • IIB Invasión del estroma cervical Estadio III - Diseminación locoregional • IIIA tumor compromete serosa y/o anexos (por extensión directa o metástasis) y/o citología peritoneal positiva (ascitis o lavado peritoneal) • IIIB Compromiso vaginal (por extensión directa o metástasis) • IIIC Metástasis a ganglios pelviano y/o lumboaórticos Estadio IV – extensión a otros órganos • IVA Tumor invade mucosa vesical y/o mucosa rectal • IVB Metástasis a disancia (excluyendo metástasis a la vagina, serosa uterina, anexos, e incluyendo metástasis a ganglios intrabdominales otros que los pelvianos y lumboaórticos) Los casos de cáncer de endometrio deberán ser agrupados según el grado de diferenciación del adenocarcinoma en: 5 • • • G1: cuando 5% o menos tienen características de crecimiento sólido no escamoso o no morular. G2: de 6% a 50% tienen características de crecimiento sólido no escamoso o no morular. G3: más del 50% tienen características de crecimiento sólido no escamoso o no modular. En caso de presentar atipía nuclear importante, inapropiada para el grado de diferenciación arquitectónico, se deberá aumentar en 1 el grado tumoral. Aquellos pacientes con diagnóstico de cáncer de endometrio que no puedan ser intervenidas quirúrgicamente y que por ende sean tratadas con radioterapia, deberán estadificarse según la estadificación FIGO 1971, pero se deberá anotar que esa fue la estadificación utilizada ESTADIFICACIÓN QUIRÚRGICA: La estadificación deberá evaluar invasión al miometrio, propagación al cuello uterino y extensión extrauterina. La estadificación quirúrgica descripta por la FIGO incluye: • Incisión mediana • Lavado peritoneal • Examen cuidadoso de cavidad abdominal (omento, hígado, fondos de saco, ovarios) • Anexo histerectomía total extrafacial (AHT) • Linfadenectomía pelviana y lumboaórtica. De esto se derivan varias situaciones, con conductas intraoperatorias diferentes: 1. 2. 3. 4. Enfermedad aparentemente localizada en el cuerpo uterino Extensión a cuello, Enfermedad extrauterina, Tipos histológicos particulares 1. Cuando la enfermedad está aparentemente localizada en el cuerpo uterino: Se realiza la anexo histerectomía total. El compromiso miometral deberá ser valorado por un anátomo patólogo durante el acto quirúrgico. Para la valoración del grado de diferenciación histológica se tomará el de la biopsia de diagnóstico (legrado o histeroscopia). La indicación de la linfadenectomía se basará entonces en la posibilidad de progresión al retroperitoneo. 6 • • Tumores bien diferenciados (G1), sin invasión o con invasión menor al 50% del miometrio (M0 o M1) es el grupo en el que puede no realizarse la linfadenectomía. (riesgo de progresión a retroperitoneo menor al 5%) En los tumores con invasión menor al 50% (M1), G2, G3 o tumores con invasión mayor al 50% del miometrio (M2) independientemente del grado de diferenciación, la probabilidad de progresión al retroperitoneo justifica la realización de la linfadenectomía sistemática El abordaje laparoscópico es factible si es llevado a cabo por cirujano experimentado conservando los mismos criterios oncológicos que en la cirugía a cielo abierto Estadificación por laparoscopia Se ha establecido por distintos autores que es posible realizarla con toda seguridad.Falta por determinar todavía si es el procedimiento más adecuado. Para ello se está realizando un estudio comparativo prospectivo y aleatorio, en el que la única variable diferencial es la vía de abordaje (GOG).Se realiza así el mismo estudio de extensión, siendo los objetivos la distribución por estadios y si existen diferencias entre supervivencias entre estos estadios. Vía laparoscópico-vaginal La combinación del acceso laparoscópico con la vía vaginal permite la realizacion, con menos riesgo para la paciente, de todos los objetivos que, hoy en día, se estima deberían formar parte del plan lógico de tratamiento del adenocarcinoma de endometrio.El alcance del tiempo laparoscópico y del vaginal, varía, dentro de límites, en función de las condiciones operatorias y de la experiencia, laparoscópica o vaginal, del cirujano. El abordaje laparoscópico permite llevar a cabo una exploración abdominal sistemática, la realización de lavados peritoneales con fines de verificación citológica, la anexectomía y la linfadenectomía pélvica, lumbo-aórtica, según criterios oncológicos protocolizados en cada centro, así como preparar la extirpación del útero por vía vaginal. El grado de asistencia laparoscópica puede variar desde una simple lisis de adherencias hasta la resección total del útero. Sin embargo, la principal ventaja del acceso laparoscópico, además de la realización de todos aquellos gestos que forman parte del estadiaje quirúrgico y que no son practicables por vía vaginal, es el tratamiento de los anexos. Al igual que en cirugía abierta, el principal factor limitante de la práctica de la linfadenectomía (pélvica y paraórtica) por vía laparoscópica es la obesidad. Por otra parte, los factores de riesgo quirúrgico que contraindican la vía abdominal son los mismos que pueden hacer desaconsejable -o incluso contraindicar formalmente- la práctica de la laparoscopia. 7 El procedimiento laparoscópico-vaginal sólo debe ser realizado por quienes posean la capacitación y experiencia necesaria para la práctica de la linfadenectomía con técnica abierta. No puede ni debe haber "límites" entre la cirugía laparoscópica y la convencional sino que, por el contrario, hay que contar con el conocimiento y dominio de ambos métodos operatorios. Los resultados preliminares del tratamiento laparoscópico - transvaginal parecen demostrar que los índices de supervivencia obtenidos con esta nueva estrategia son similares a los registrados en los controles tradicionales. Por otra parte, si se respetan los criterios de efectuar la intervención por cirujanos expertos en oncología y laparoscopia quirúrgica avanzada, el uso de instrumentos adecuados y la estricta selección de las pacientes, las complicaciones pueden reducirse al mínimo. El GOG ha diseñado sendos estudios clínicos aleatorizados con el objetivo de responder a los interrogantes actualmente abiertos sobre la factibilidad y morbilidad de esta modalidad terapéutica. La ventaja potencial (o justificación) de la linfadenectomía sistemática es: primero, que de documentar la ausencia de retroperitoneo comprometido, se evitaría la necesidad de realizar radioterapia adyuvante y segundo, el potencial rol terapéutico de la linfadenectomía No hay sin embargo unanimidad entre las diferentes sociedades internacionales en la recomendación de la linfadenectomía sistemática o del sampling ganglionar. 2. Cuando la enfermedad está extendida al cuello uterino: • • Cuando hay diagnóstico previo de compromiso cervical y factibilidad quirúrgica se podrá realizar una anexo histerectomía radical más linfadenectomía pelviana y lumboaórtica Cuando en la biopsia por congelación de la pieza de AHT, se detecta el compromiso cervical, se deberá realizar la linfadenectomía pelviana y lumboaórtica. Igual criterio (AHT más linfadenectomia pelviana y lumboaórtica), en los casos con imposibilidad de realización de histerectomía radical). 3. Enfermedad extrauterina En el caso de hallazgo de enfermedad extrauterina intraoperatoria: • MTS en ovario o pelvis: agregar linfadenectomía pelviana y lumboaórtica • Ante difusión extrauterina macroscopica pelviana o abdominal se deberá realizar la citoreducción quirúrgica 8 4. Estadificación en tipos histológicos especiales En el caso de diagnóstico patológico de tumor seroso papilar o tumor de células claras se agregará a la estadificación quirúrgica completa la realización de la omentectomía y biopsias peritoneales (incluyendo subdiafragmáticas), estadificación similar a la del cáncer de ovario. MANEJO POR ESTADIOS (INDICACIÓN DE TRATAMIENTO ADYUVANTE) ESTADIO I (estadificación completa) IA IB IC G1 G2 G3 G1 G2 G3 Seguimiento seguimiento Seguimiento o RT cúpula vaginal Seguimiento Seguimiento o RT cúpula vaginal RT cúpula vaginal G1 G2 G3 Seguimiento o RT cúpula vaginal Seguimiento o RT cúpula vaginal RT pelviana ± RT cúpula vaginal ESTADIO I (estadificación incompleta) IB G2 G3 Seguimiento o RT en cúpula RT pelviana ± RT cúpula vaginal IC RT pelviana ± RT cúpula vaginal o reestadificación ESTADIO II (estadificación completa + Op Wertheim Meigs) IIA IIB Similar manejo que en estadio I G1 G2 G3 Seguimiento o RT cúpula vaginal RT pelviana ± RT cúpula vaginal RT pelviana ± RT cúpula vaginal ESTADIO II (estadificación incompleta o realización de anexohisterectomia total no radical) IIA RT pelviana ± RT cúpula vaginal IIB RT pelviana ± RT cúpula vaginal 9 ESTADIO III (estadificación completa) IIIA • • sólo por compromiso de citologia, M0, cervix negativo: seguimiento Todos los otros IIIA: RT pelviana ± RT cúpula vaginal IIIB RT pelviana ± RT cúpula vaginal IIIC Ganglios pelvianos (+) RT pelviana hasta bifurcación aórtica ± RT cúpula vaginal Ganglios lumboaórticos (+) RT pelviana y lumboaórtica ± RT cúpula vag. ESTADIO III (estadificación incompleta) • • Sin evidencia clínica de enfermedad persistente: RT pelviana y lumboaórtica ± RT cúpula vaginal Si hay evidencia clínica de enfermedad macroscópica, se deberá plantear reestadificación quirúrgica. ESTADIO IV Control local de la enfermedad Tratamiento sistémico AHT RT adbominopelviana Quimioterapia Hormonoterapia CARCINOMA SEROSO PAPILAR Estadio IA RT cúpula vagina o RT pelviana Estadio IB, IC, II RT pelviana ± RT cúpula vaginal Estadio III, IV Quimioterapia o RT abdominopelviana PACIENTES INOPERABLES: Estadíos I y II RT pelviana + RT intracavitaria En los tipos histológicos desfavorables (seroso papilar y celulas claras) considerar, según performance status, tratamiento sistémico con QT: CT (Carboplatino-Paclitaxel) AP (Doxirrubicina-Cis -Platino) TAP(Paclitaxel- Doxirrubicina-Cis-platino) Se estadifican clínicamente según FIGO Si se confirmaran GLAO+ y/o múltiples GP+ ( por ejemplo: por punción biopsia guiada) se agrega RT de campo extendido a 10 región para-aórtica y se considera administrar tratamiento sistémico Si el performance status lo permite: Considerar QT (idealmente dentro de protocolos de investigación) Si el performance status no admite QT: Considerar Hormonoterapia , especialmente en tumores endometroides G1-G2 con RPG+: Acetato de Medroxiprogesterona Estadíos III y IVA RT externa con dosis adicional en parametrio (dependiendo de la evidencia clínica de invasión parametrial) + RT intracavitaria. Si hay GLAO + o enfermedad en el abdomen superior: RT de campo extendido o WART. Si el performance status lo permite: Considerar QT Si el performance status no lo permite: considerar HT. Estadíos IV B El tratamiento es considerado paliativo. Tratamiento locorregional y abdomen: RT: GLAO+: RT pelvis + campo extendido o WART Si se verifica enfermedad en el abdomen superior: WART Tratamiento sistémico: QT u HT según perfomance status ESTADIOS AVANZADOS OPERABLES: est. quir., citorred. y trat. adyuvante Estadío IIIA: Sólo citología peritoneal +: T. endometroides G1-G2, sin otros factores de riesgo: Observación T. Endom. con fact. riesgo (G3, Invasión miometrial profunda, ILV) : WART Seroso pap. y cel. claras si el performance status lo permite: RT pelviana + QT Estadío IIIA con mts. anexial o serosa uterina: RT pelviana QT u HT según perf. status Estadío IIIB: RT pelviana y Braquiterapia. QT u HT según perfomance status Estadíos IIIC: GP+ : RT pelviana GLAO+: RT pelviana + RT campo extendido o WART QT u HT según perfomance status Estadío IV: IVA operables (con citorreducciòn óptima): Exenteración pelviana IVB intraabdominal (con citorreduciòn óptima): WART QT u HT según perf. status. 11 ENF. RECURRENTE Y METASTASICA. Recurrencias a distancia o IVB Pacientes SIN RT previa: Recurrencia vaginal aislada: Evaluación quir. Pelv. y abd.: resecable: agregar RT pelviana más BT irresecable: RT pelviana más BT. Si en la evaluación quirúrgica aparece enfermedad extravaginal: Si es GP+: RT pelviana más BT Si es GLAO+: ídem más RT de campo extendido Si hay recurrencia en abd. sup.:citorr. óptima seguida de RT : WART En la enfermedad metastásica a distancia: en general el tratamiento es paliativo, aunque en ocasiones se logran sobrevidas prolongadas. El tratamiento es sistémico. A veces es necesario efectuar RT localizada en el sitio de la MTS para disminuir síntomas. En todos los casos (enf. recurrente y met.): QT u HT según perfomance status Pacientes CON RT previa: Exenteraciòn (excepcional, sólo con intento curativo) Evaluar RT acorde a tipo y dosis de RT previa QT u HT según perfomance status SEGUIMIENTO LUEGO DEL TRATAMIENTO: Consulta y exámen físico cada 3 a 6 meses por 2 años. Luego cada 6 meses a 1 año. Si el CA 125 estaba elevado de entrada, solicitarlo en cada visita. Rx tórax anual PAP vaginal cada 6 meses por 2 años, luego anualmente. Avisar a las pacientes que concurran si hay síntomas (dolor, sangrado,pérdida de peso o disminución del apetito, edemas, tos), y estudiar los síntomas a fondo. Asociar al seguimiento específico, el cuidado de la salud (TA, peso, DBT, etc,) así como hacer screening de otros cánceres asociados al endometrial (mama, colon, etc) 12 APÉNDICE Grados de Recomendación basados en la Evidencia disponible Recomendacion grado sobre la Significado que se basa Grado Existe evidencia satisfactoria, por lo Hay buena o muy buena general de nivel 1 (meta-análisis o evidencia A para ensayos clínicos randomizados y recomendarla. controlados) que sustenta la recomendación. (*) Grado Evidencias de nivel 2 (ensayos Existe evidencia clínicos bien diseñados y controlados razonable B para aunque no randomizados) recomendarla. Grado Existe pobre evidencia. Hallazgos Después de analizar las inconsistentes. Deben ser sometidas evidencias C disponibles a la aprobación del grupo de con relación a posibles consenso. sesgos, el grupo de consenso las admite y recomienda la intervención. Grado Existe muy pobre evidencia. Los estudios disponibles Evidencia empírica pobre o no no pueden ser utilizados D sistemática. como evidencia, pero el grupo de consenso considera por experiencia que la intervención es favorable y la recomienda (*) En situaciones muy especiales, cuando el evento es mortalidad, especialmente ante una enfermedad previamente fatal, ésta puede deberse a evidencias de menor nivel. CATEGORÍAS DEL CONSENSO Categoría 1: El consenso es uniforme entre los especialistas, basado en alto nivel de evidencia que la recomendación es apropiada Categoría 2: El consenso es uniforme entre los especialistas, basado en bajo nivel de evidencia y en la experiencia clínica que la recomendación es apropiada Categoría 3: El consenso no es uniforme entre los especialistas, basado en bajo nivel de evidencia y en la experiencia clínica que la recomendación es apropiada. A pesar de lo anterior no existe importante desacuerdo. 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