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Tres o 6 ciclos de quimioterapia para el retinoblastoma de alto riesgo: un ensayo clínico aleatorizado
Huijing Ye1, Kang Xue2, Ping Zhang1
1State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.
JAMA
|October 21, 2024
Resumen
Tres ciclos de quimioterapia con CEV (carboplatino, etoposida y vincristina) no son inferiores a los seis ciclos para el retinoblastoma de alto riesgo. Este hallazgo apoya un régimen de tratamiento menos intensivo, reduciendo los eventos adversos y los costos.
Área de la Ciencia:
- Oncología pediátrica
- Oftalmología
- Ensayos clínicos
Sus antecedentes:
- La quimioterapia adyuvante es crucial para el tratamiento del retinoblastoma.
- Los ensayos comparativos limitados comparan diferentes conteos de ciclos de quimioterapia con VEC para los casos de alto riesgo.
Objetivo del estudio:
- Determinar si 3 ciclos de quimioterapia con CEV no son inferiores a 6 ciclos para el retinoblastoma unilateral enucleado con características patológicas de alto riesgo.
Principales métodos:
- Un ensayo aleatorizado, abierto, de no inferioridad en el que participaron 187 pacientes con retinoblastoma unilateral enucleado.
- Los pacientes recibieron 3 o 6 ciclos de quimioterapia con VEC después de la enucleación.
- El objetivo primario fue la supervivencia libre de enfermedad a los 5 años.
Principales resultados:
- La supervivencia libre de enfermedad a cinco años fue del 90,4% para 3 ciclos frente al 89,2% para 6 ciclos, cumpliendo el criterio de no inferioridad.
- El grupo de 3 ciclos mostró menos eventos adversos, mejor calidad de vida y menores costos.
- La mediana de seguimiento fue de 79 meses.
Conclusiones:
- Tres ciclos de quimioterapia con CEV son una alternativa viable y no inferior a los seis ciclos para el retinoblastoma de alto riesgo.
- Esto apoya un enfoque de quimioterapia reducido, mejorando los resultados de los pacientes y reduciendo la carga de atención médica.
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