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Prednisona más cabazitaxel o mitoxantrona para el cáncer de próstata metastásico resistente a la castración que
Johann Sebastian de Bono1, Stephane Oudard, Mustafa Ozguroglu
1Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton, UK. johann.de-bono@icr.ac.uk
Lancet (London, England)
|October 5, 2010
Resumen
Cabazitaxel más prednisona mejora significativamente la supervivencia general en hombres con cáncer de próstata metastásico resistente a la castración que progresa después del docetaxel. Esta terapia combinada demuestra una eficacia superior en comparación con la mitoxantrona más prednisona.
Área de la Ciencia:
- Oncología Oncología.
- Farmacología Farmacología.
- Los ensayos clínicos son ensayos clínicos.
Sus antecedentes:
- El cabazitaxel es un nuevo taxano con actividad antitumoral en cánceres resistentes al docetaxel.
- El cáncer de próstata metastásico resistente a la castración (mCRPC) a menudo progresa después del tratamiento con docetaxel.
- La evaluación de tratamientos alternativos para el mCRPC post-docetaxel es crucial.
Objetivo del estudio:
- Para comparar la eficacia y seguridad de cabazitaxel más prednisona frente a mitoxantrona más prednisona.
- Para evaluar los resultados del tratamiento en hombres con mCRPC progresivo después de la terapia basada en docetaxel.
Principales métodos:
- Un ensayo abierto, aleatorizado de fase 3 en el que participaron 755 hombres con mCRPC post-docetaxel.
- Los participantes recibieron prednisona diaria por vía oral más cabazitaxel intravenoso (25 mg/m2) o mitoxantrona (12 mg/m2) cada 3 semanas.
- El objetivo primario fue la supervivencia global; los objetivos secundarios incluyeron la supervivencia libre de progresión y la seguridad.
Principales resultados:
- La mediana de la supervivencia global fue de 15,1 meses con cabazitaxel frente a 12,7 meses con mitoxantrona (HR 0,70, p<0,0001).
- La mediana de la supervivencia libre de progresión fue de 2,8 meses con cabazitaxel frente a 1,4 meses con mitoxantrona (HR 0,74, p<0,0001).
- Los eventos adversos de grado 3 o superior incluyeron neutropenia (82% de cabazitaxel frente a 58% de mitoxantrona) y neutropenia febril (8% frente a 1%).
Conclusiones:
- Cabazitaxel más prednisona demuestra una actividad antitumoral clínica significativa en el mCRPC.
- Este régimen mejora la supervivencia general en pacientes con progresión de la enfermedad después de la terapia basada en docetaxel.
- El cabazitaxel ofrece una opción de tratamiento más efectiva en comparación con la mitoxantrona en esta población de pacientes.
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