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Se ha observado un ligero incremento en los niveles sericos de LH y FSH que no es dependiente de la dosis, aun con dosis bajas; este efecto es, sin embargo, el esperado para la clase farmacologica, y es probablemente el resultado de la retroalimentacion a nivel de la pituitaria, debido a la reduccion en los niveles de estrogeno que estimulan la secrecion de gonadotropinas en la pituitaria en mujeres posmenopausicas. Tratamiento coadyuvante del cancer de mama en estadios iniciales: En un estudio multicentrico, aleatorizado, doble ciego, realizado en 4,724 pacientes posmenopausicas con cancer de mama y receptor estrogenico positivo o desconocido, que habian permanecido sin la enfermedad, despues de recibir tratamiento coadyuvante con tamoxifeno durante 2 o 3 anos, fueron aleatorizadas para recibir exemestano (25 mg/dia) o tamoxifeno (20 o 30 mg/dia) durante 2 a 3 anos, hasta completar un total de 5 anos de terapia hormonal. Seguimiento medio de 35 meses: Despues de una duracion media del tratamiento de unos 27 meses y un seguimiento medio de aproximadamente 35 meses, los resultados mostraron que el tratamiento secuencial con exemestano despues de 2 a 3 anos de tratamiento coadyuvante con tamoxifeno, se asocio con una mejoria clinica y estadisticamente significativa en la supervivencia sin enfermedad (DFS) en comparacion con la continuacion del tratamiento con tamoxifeno. El analisis mostro que durante el periodo de estudio, el exemestano redujo el riesgo recidivante del cancer de mama 31% en comparacion con el tamoxifeno (indice de riesgo 0. El efecto benefico del exemestano sobre el tamoxifeno respecto a la DFS fue claro, independientemente del estado ganglionar o de una quimioterapia previa. De igual forma, el exemestano produjo una reduccion significativa del riesgo de cancer de mama contralateral (indice de riesgo 0. Mediana de seguimiento a 52 meses: Despues de una mediana de duracion de tratamiento de 30 meses y una mediana de seguimiento de aproximadamente 52 meses, los resultados mostraron que el tratamiento secuencial con exemestano despues de 2 a 3 anos de tratamiento adyuvante con tamoxifeno, se asocio con una mejoria clinica y estadisticamente significativa de la supervivencia libre de enfermedad en comparacion con la continuacion del tratamiento con tamoxifeno. El analisis mostro que mas alla del periodo de estudio, el exemestano redujo el riesgo de recurrencia de cancer de mama 24% en comparacion con el tamoxifeno (indice de riesgo 0. El efecto benefico de exemestano sobre el tamoxifeno respecto a la supervivencia libre de enfermedad, fue aparentemente independiente del estado ganglionar o de una quimioterapia previa. De igual forma, el exemestano produjo una reduccion significativa del riesgo de cancer de mama contralateral (indice de riesgo 0. Resultados de un subestudio endometrial indicaron que despues de 2 anos de tratamiento hubo una mediana de reduccion en el grosor endometrial de 33% en los pacientes tratados con exemestano en comparacion con una no notable variacion en los pacientes tratados con tamoxifeno. El engrosamiento endometrial, reportado al inicio del tratamiento de estudio, revirtio a la normalidad en 54% de los pacientes tratados con exemestano. Tratamiento del cancer de mama avanzado: En un estudio clinico, fase 3 realizado por la EORTC (Organizacion Europea para la Investigacion y Tratamiento del Cancer), el exemestano se comparo con el tamoxifeno como tratamiento de primera linea del cancer de mama avanzado. Los resultados indicaron que los pacientes en el grupo de tratamiento del exemestano presentaron una media mayor del tiempo de Supervivencia Sin Progresion (PFS), en comparacion con el tamoxifeno (9. Asimismo, los pacientes tratados con exemestano presentaron un mayor indice de respuesta al tumor objetivo, en comparacion con el tamoxifeno (44 vs. En un estudio clinico, controlado, aleatorizado y revisado por expertos, se demostro que la dosis diaria de 25 mg de exemestano produce un aumento estadisticamente significativo en la supervivencia, del Tiempo hasta la Progresion (TTP) y del Tiempo hasta el Fracaso del Tratamiento (TFT), en comparacion con el tratamiento hormonal estandar con acetato de megestrol en pacientes posmenopausicas con cancer de mama avanzado, que ha progresado despues o durante el tratamiento con tamoxifeno, ya sea como terapia coadyuvante o como tratamiento de primera linea para la enfermedad avanzada.
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