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Tivozanib más nivolumab versus la monoterapia con tivozanib en pacientes con carcinoma de células renales después de
Toni K Choueiri1, Laurence Albiges2, Philippe Barthélémy3
1Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Lancet (London, England)
|September 16, 2024
Resumen
En el carcinoma de células renales avanzado, la combinación de tivozanib con nivolumab no mejoró la supervivencia libre de progresión en comparación con el uso de solo tivozanib después de tomar inhibidores previos del punto de control inmunológico. La monoterapia con tivozanib muestra eficacia en el contexto post-ICI.
Área de la Ciencia:
- En el campo de la oncología
- La inmunoterapia
- Tratamiento del carcinoma de células renales
Sus antecedentes:
- El tratamiento del carcinoma de células renales avanzado (CCR) se basa en inhibidores del punto de control inmune (ICI) e inhibidores de la tirosina quinasa (TKI).
- La secuencia óptima de las terapias después de la progresión en el CCR avanzado sigue sin estar clara.
- Este estudio investiga el uso de tivozanib más nivolumab frente a la monoterapia con tivozanib en pacientes que progresan después de las terapias iniciales.
Objetivo del estudio:
- Evaluar los resultados clínicos de la terapia combinada con tivozanib y nivolumab frente a la monoterapia con tivozanib.
- Evaluar la eficacia del tratamiento en pacientes con carcinoma renal metastásico que ha progresado después de una o dos líneas de tratamiento previas, incluido el tratamiento con ICI.
- Determinar la estrategia de tratamiento óptima en el entorno post-ICI para el CCR avanzado.
Principales métodos:
- Un ensayo multicéntrico, aleatorizado y abierto de fase 3 (TiNivo-2) en el que participaron 343 pacientes con CCR avanzado.
- Los pacientes fueron asignados al azar 1:1 para recibir tivozanib más nivolumab o tivozanib en monoterapia.
- El criterio de valoración primario fue la supervivencia libre de progresión (SFP), evaluada mediante una revisión radiológica independiente.
Principales resultados:
- La mediana de la SFP fue de 5,7 meses para el grupo tivozanib-nivolumab frente a 7,4 meses para el grupo tivozanib en monoterapia (HR 1,10; p=0,49).
- En pacientes con tratamiento previo con ICI, la mediana de la SFP fue de 7,4 meses para el tivozanib-nivolumab y de 9,2 meses para el tivozanib en monoterapia.
- No se observaron diferencias significativas en la SFP entre los grupos, y las reacciones adversas graves fueron comparables.
Conclusiones:
- La combinación Tivozanib-nivolumab no demostró una SFP superior en comparación con la monoterapia con Tivozanib en esta población de pacientes.
- ICI rechallenge no está respaldado por estos hallazgos en RCC avanzado.
- La monoterapia con tivozanib muestra eficacia en el contexto post-ICI para el carcinoma de células renales avanzado.
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