Trastuzumab subcutáneo en el tratamiento del cáncer de mama HER2 positivo

Enrique Díaz-Cantón; Máximo de la Vega

doi:10.56969/oc.v21i1.94

Autores/as

Enrique Díaz-Cantón Sección Oncología, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (CEMIC), Ciudad Autónoma de Buenos Aires
Máximo de la Vega Sección Oncología, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (CEMIC), Ciudad Autónoma de Buenos Aires

DOI:

https://doi.org/10.56969/oc.v21i1.94

Palabras clave:

trastuzumab, subcutáneo, no inferioridad, subcutaneous, non-inferiority

Resumen

La sobreexpresión o amplificación del receptor HER2 se observa en el 20% de pacientes con cáncer de mama y se asocia con un pronóstico adverso. El agente anti HER2 más ampliamente utilizado en la clínica es el trastuzumab, anticuerpo monoclonal. El tratamiento adyuvante tiene una duración de 12 meses y en cáncer de mama metastásico se continúa más allá de la progresión. La mayoría de los pacientes recibirá trastuzumab durante 1 año, muchos recibirán 2 a 3 años, y algunos han recibido/recibirán más de 8 años. Surge así un interés creciente por la vía subcutánea (SC) de administración: menos invasiva, menos costosa y más cómoda. El estudio HannaH, ensayo de fase III, abierto y aleatorizado, utilizó una dosis fija subcutánea de 600 mg de trastuzumab en combinación con quimioterapia neoadyuvante y la comparó con la vía de administración endovenosa (EV) aprobada. Se incluyeron pacientes con cáncer de mama HER2 (+) operable, localmente avanzado e inflamatorio. Los objetivos primarios fueron: concentración sérica mínima predosis del ciclo 8 y respuesta patológica completa. Se aleatorizaron 299 pacientes a trastuzumab EV y 297 a trastuzumab SC. La concentración sérica mínima media fue 57.8 μ/ml en el grupo EV y 78.7 en el grupo SC. El 40.7% de los pacientes en el grupo EV y el 45.4% en el grupo SC logró respuesta patológica completa. Trastuzumab SC resultó no inferior para ambos objetivos primarios. La incidencia de eventos adversos grados 3 a 5 fue similar en ambos grupos. La demostración de no-inferioridad sugiere que el trastuzumab SC ofrece una válida y más conveniente alternativa al trastuzumab EV.

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