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Informe de David Josephy

Traducción: Michael Josephy

En nombre del Life Raft Group USA y del Life Raft Group Canada, tuve el privilegio de asistir a la reunión “Sarcoma & GIST 2016”, organizada por la ESMO (Sociedad Europea de Oncología Médica), en Milán, Italia, el 16 y 17 de febrero de 2016.

Hubo 369 participantes en la reunión. La mayoría de los asistentes eran oncólogos médicos. También hubo varios representantes de los grupos de pacientes con GIST, incluyendo activistas de GIST como Gabriella Tedone y Anna Costato de Italia; Markus Wartenberg de Alemania; Helga Meier de Suiza; y yo mismo.

Los participantes procedían de 41 países– principalmente de Europa Occidental, pero también incluyendo muchos oradores de los EE.UU.

Las sesiones de la reunión se dividieron aproximadamente 50/50 entre los GIST y los STS (sarcomas de tejidos blandos). El progreso en la comprensión y el tratamiento de GIST ha sido tan notable que el tema en muchas de las ponencias de STS fue, ¿Cómo podemos construir a partir del modelo de GIST? Lamentablemente, para la mayoría de los STS metastásicos, existen pocas opciones, principalmente los medicamentos de quimioterapia citotóxica del estilo antiguo.

Este artículo no es un reporte completo de la reunión, sino se enfocará en algunos de los aspectos más destacados, desde mi punto de vista– se centra en GIST y no en STS.

El lunes, antes de la reunión principal, asistí a la “preceptoria”, una sesión de todo el día, donde los médicos con más experiencia dieron una introducción a los GIST y los STS, dirigida a jóvenes oncólogos médicos. El Dr. Paolo Dei Tos, de Treviso, Italia, habló sobre la patología de los GIST. Ya en 1962, el patólogo estadounidense Arthur Purdy Stout, en un artículo titulado “Bizarre Smooth Muscle Tumors of the Stomach”, ya había reconocido los tumores ahora conocidos como GIST, a pesar de que los llamó “leiomioblastomas”. Stout hizo esta clasificación sobre la base de la presentación clínica y la patología. Hoy en día, según Dei Tos, morfología es menos relevante para el diagnóstico del GIST y es esencial hacer inmunohistoquímica (tinción) de las muestras de las proteínas KIT y DOG1, características de los GIST. Durante el período de preguntas, un médico le inquirió acerca de la relevancia de la distinción entre los GIST benignos y malignos. ¿Podemos hablar alguna vez de un GIST benigno? Dei Tos dijo que el 99% de los “microGISTs” no progresan; sin embargo, incluso un paciente con un pequeño GIST tiene un pequeño riesgo de metástasis. Por lo tanto, probablemente no debemos llamar ningún GIST “benigno”.

María Debiec-Rychter (Lovaina, Bélgica; un miembro del equipo de investigación del Life Raft Group) presentó “The molecular biology of GIST”. Ella comenzó señalando que el 75% de los tumores de los pacientes con GIST tienen una mutación en el gen KIT y el 15% tienen una mutación en el gen de PDGFRA. Dijo que en su registro en Lovaina, tienen 1.862 pacientes con GIST caracterizados por pruebas mutacionales. Ella cree que el análisis mutacional debería ser una práctica clínica estándar en GIST.

Ella discutió “GIST de tipo salvaje” y repasó los avances recientes en la clasificación de estos tumores, que no tienen mutaciones KIT o PDGFRA. Ella mostró el esquema de Boikos y Stratakis:

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El síndrome de Carney-Stratakis se asocia con mutaciones de la línea germinal (heredadas) en los genes de la SDH (succinato deshidrogenasa). En estos casos de GIST, se necesita el asesoramiento genético para la familia.

Dr. Heike Joensuu de Finlandia, uno de los pioneros de la terapia con imatinib para GIST, habló acerca de la terapia adyuvante. Repasó la historia de los ensayos aleatorios de imatinib adyuvante en GIST (ACOSOG Z9001; EORTC 62024, y SSG XVIII). Observó que los médicos tienden a subestimar el riesgo de recurrencia para muchos pacientes con GIST. Observó que dos ensayos clínicos en curso prueban si el consumo de imatinib adyuvante durante más de tres años es eficaz en la prevención de la recurrencia.

Con respecto a la dosis de imatinib, Joensuu dijo que titula la dosis hasta aquella que el paciente puede tolerar, tales como 500, 600, o 700 mg, en lugar de utilizar la misma dosis para todos los pacientes.

Dr. Peter Reichardt, Berlín, discutió la terapia enfocada del GIST metastásico. Dio un repaso de los primeros días de tratamiento con imatinib para GIST y también discutió alternativas para el tratamiento de GIST de tipo salvaje. En el período de preguntas, Dr. Mikael Eriksson (Suecia) le preguntó: “¿Cree que es ético utilizar un control con placebo en un ensayo de un nuevo fármaco?” Reichardt contestó que pensaba que podría ser justificado, ya que puede ayudar a conseguir la aprobación más rápida de un nuevo fármaco. Eriksson respondió: “No, no es ético, porque ya sabemos lo que va a pasar con los pacientes que toman el placebo.”

La conferencia principal comenzó el martes. Markus Wartenberg fue una de las personas invitadas al escenario para dar la bienvenida a los delegados, y habló elocuentemente en nombre de SPAEN (SPAEN Sarcoma Patients EuroNet; cheap accutane for sale ). Presentó un modelo en el que las asociaciones de pacientes pueden actuar como interfaz entre, por un lado, los pacientes y los cuidadores, y por el otro, los médicos, las organizaciones de investigación, las agencias reguladoras, y las compañías farmacéuticas. Yo estaba feliz de observar la forma muy positiva y respetuosa en la que la ESMO y la comunidad médica interactuaron con los defensores de los pacientes, durante toda la reunión.

El Dr. George Demetri (Dana Farber Cancer Institute, Boston), otro de los pioneros de la terapia con imatinib en GIST, discutió “el tratamiento médico del GIST”. Repasó los primeros días de tratamiento con imatinib para GIST. Curiosamente, destacó que “la paciente cero”, la paciente femenina tratada por primera vez con imatinib, quien fue el tema del informe en 2002 de la New England Journal of Medicine que anunció por primera vez la eficacia de imatinib en GIST, en realidad fue tratada de acuerdo con un protocolo escrito de ensayo clínico aprobado por un comité. No era sólo una especie de ocurrencia única, como unas personas pueden pensar. Hizo hincapié en que hay una tasa de 15% de sobrevivientes a largo plazo del primerísimo grupo tratado con imatinib alrededor del 2001. En relación con imatinib adyuvante, preguntó, provocativamente, “Con una persona joven que tiene un GIST de alto riesgo, ¿por qué dejaría de suministrar imatinib adyuvante?”

El Dr. Demetri dio una lista de nuevas opciones que puedan estar disponibles para GIST metastásico:

  • Inhibidores que se enfocan a la mutación PDGFRA D842V
  • Medicamentos BRAF-específicos (en pacientes con mutaciones en ese gen)
  • Enfocamiento metabólico para GIST DSH-deficiente
  • Anticuerpos monoclonales anti-KIT
  • Combinaciones de fármacos TKI (inhibidores de la tirosina quinasa)
  • Inhibidores MEK y FGFR
  • Inmuno-oncología

El Dr. Reichardt habló sobre “El reto clínico de la resistencia secundaria en GIST”. Hizo una lista de las posibles causas de la resistencia secundaria a imatinib en GIST como mutaciones de resistencia secundaria (la causa principal), y otros posibles factores, incluyendo que una cantidad insuficiente de droga llegue al tumor; la sobre-expresión de la meta de KIT, y la pérdida de la expresión de KIT resultante de “de-diferenciación” de las células tumorales.

Una estrategia que estudian ahora en ensayos clínicos es alternar entre dos fármacos, como el imatinib/ regorafenib o sunitinib/ regorafenib.

El Dr. Reichardt discutió la situación en la que un paciente deja el imatinib adyuvante (por ejemplo, después de tres años de tratamiento), y dijo que los pacientes deben ser monitoreados de cerca después de la suspensión, escaneados cada 3 meses. Algunas de las preguntas pendientes que necesitan ser contestadas, en relación con imatinib adyuvante, incluyen

  • ¿Si el tratamiento debe extenderse más de 3 años?
  • ¿Si los pacientes del exón 9 deben recibir 800 mg por día?
  • ¿Si los pacientes PDGFRA D842V deben recibir algún tratamiento adyuvante?

No parece haber consenso sobre la conveniencia de utilizar 800 mg para el tratamiento adyuvante de los pacientes del exón 9. Después de esta charla, el Dr. Trent pidió una votación de la audiencia a mano alzada, en cuanto a si los médicos  prescriben 800 mg, y la respuesta fue mixta.

El miércoles, el Dr. Robert Maki (Sloan-Kettering, Nueva York) habló sobre “La Terapia Inmune en STS: ¿Dónde estamos?”. Se refirió a las muchas nuevas estrategias para la modulación inmune que se desarrollan, incluyendo nuevas vacunas, anticuerpos monoclonales, “células T” activadas, fármacos que pueden provocar la estimulación de las células T, y las drogas “inhibidores de puesto de control inmunológico” que pueden liberar una respuesta inmune pre-existente pero reprimida. Su conclusión general es que espera ver una plétora de nuevas opciones para la inmunoterapia en GIST.

Por último, el Dr. Ron De Matteo (Memorial Sloan-Kettering Cancer Center, Nueva York) discutió “La inmunidad en el GIST”, y consideraba el desafío de alto nivel, ¿cómo vamos a curar el GIST? Sus sugerencias incluyeron la terapia adyuvante mejor; mejor cirugía para la enfermedad residual; nueva y mejores fármacos TKI, y la inmunoterapia.

Hubiera sido maravilloso haber escuchado un anuncio importante del éxito de un nuevo fármaco o inmunoterapia, en ESMO/ GIST/ STS 2016. Eso no sucedió. Sin embargo, es alentador ver el rápido progreso que se está realizando sobre la clasificación y caracterización de los GIST– ciertamente ya no puede ser considerado como una sola enfermedad, sino más bien un grupo de varias enfermedades relacionadas– y que muchos de los nuevos desarrollos se realizan con respecto a la terapia con medicamentos y terapias biológicas tales como la inmunoterapia. También tuve la sensación de satisfacción que toda la comunidad GIST tiene un espíritu de cooperación y dedicación al reto de tratar la enfermedad, lista para compartir sus nuevas ideas (y sistemas experimentales, como líneas de células GIST) y mantener sus canales de comunicación abiertos.

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Fuente: The Life Raft Group – [cheap accutane canada]

Autor:  – David Josephy – The Life Raft Group Canada

Traducción: Michael Josephy – Alianza GIST

 

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