Investigadores han demostrado que el uso combinado del inhibidor CDK4/6 abemaciclib (Verzenio) junto con la endocrinoterapia tiene beneficios significativos a largo plazo en pacientes con cáncer de mama temprano de alto riesgo. Esta combinación ha mostrado mejoras en la sobrevida libre de enfermedad invasiva y de recaída a distancia en comparación con la endocrinoterapia sola.
El estudio monarchE, que siguió a las pacientes durante cinco años, reveló que la adición de abemaciclib a la endocrinoterapia resultó en una mejora absoluta del 7,6% en la sobrevida libre de enfermedad invasiva y del 6,7% en la de recaída a distancia. Estos resultados son clínicamente significativos y respaldan la inclusión de abemaciclib como parte del tratamiento adyuvante para el cáncer de mama temprano de alto riesgo con receptores hormonales positivos y sin expresión de HER2.
El cáncer de mama HR+, HER2- es el subtipo más común, pero las pacientes con enfermedad temprana y ganglios afectados corren un alto riesgo de recidiva y requieren un tratamiento más intensivo. El ensayo monarchE incluyó a pacientes consideradas de alto riesgo en función de características clínico-patológicas, como el número de ganglios axilares afectados, la enfermedad de grado 3 y los tumores de 5 cm o más.
En el estudio, más de 5.600 pacientes fueron asignadas aleatoriamente para recibir abemaciclib más endocrinoterapia durante dos años, o solo endocrinoterapia seguida de endocrinoterapia adicional según la indicación clínica (150 mg dos veces al día). Después de un seguimiento de cinco años, se observó una reducción significativa en el riesgo de recurrencia y metástasis en el grupo que recibió la combinación de abemaciclib y endocrinoterapia.
Beneficios del adyuvante con abemaciclib
Es importante destacar que los beneficios de esta combinación fueron consistentes en varios subgrupos de pacientes, incluyendo diferentes edades, estados menopáusicos, tamaños tumorales y el número de ganglios linfáticos afectados. Esto sugiere que este combo puede ser beneficioso para una amplia gama de pacientes con cáncer de mama temprano de alto riesgo.
Además de los beneficios en la sobrevida libre de enfermedad invasiva, el estudio también encontró una mejora en la sobrevida libre de recaída a distancia. Esto significa que las pacientes que recibieron el tratamiento tuvieron menos probabilidades de experimentar una recaída a distancia, lo que implica una mejor calidad de vida y mayores posibilidades de curación.
Aunque hubo una mayor proporción de efectos adversos en el grupo que recibió la combinación, estos fueron similares en ambos grupos después de finalizar el tratamiento. Lo que sugiere que el combo adyuvante con abemaciclib es generalmente seguro y bien tolerado por las pacientes.
La Dra. Harbeck del Centro de Mama del Hospital Universitario Ludwing Maximilianas de Múnich, Alemania comentó sobre los resultados del análisis actual, afirmando que es tranquilizador observar que los efectos adversos graves reportados durante el período de seguimiento, una vez finalizado el tratamiento del estudio, son bastante similares tanto en el grupo que recibió endocrinoterapia sola como en el grupo que recibió abemaciclib más endocrinoterapia.
Cambios en los protocolos
Los inhibidores de CDK4/6, como abemaciclib, han demostrado cambiar el protocolo de tratamiento para el cáncer de mama HR+, HER2- comentó el Dr. Kevin Kalinsky del Winship Cancer Institute de la Emory University en Atlanta, Estados Unidos. Estos medicamentos actúan bloqueando ciertas enzimas que promueven el crecimiento de las células cancerosas, lo que ayuda a detener la progresión de la enfermedad. Los resultados del estudio monarchE respaldan la inclusión de abemaciclib como parte del tratamiento estándar para el cáncer de mama temprano de alto riesgo.
El Dr. Kalinsky enfatizó la importancia del seguimiento a largo plazo, ya que aproximadamente el 50% de las recidivas ocurren después de los primeros 5 años en este subtipo de cáncer de mama. Aunque los inhibidores de CDK4/6 son considerados fármacos citostáticos, se ha observado un efecto de arrastre en el que abemaciclib durante 2 años mejora los resultados a lo largo de 5 años. Se requieren investigaciones adicionales para comprender mejor estos aspectos y determinar la mejor estrategia de tratamiento a largo plazo.
**A la fecha Abemaciclib no cuenta con la aprobación del INVIMA sobre la ampliación de su
indicación en cáncer de mama temprano en Colombia
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