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Análisis de datos para la integración de datos del mundo real en pacientes con CPNM tratados con TKI utilizando
L Mazzeo1,2, F Corso1, P Baili3
1Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
ESMO real world data and digital oncology
|February 6, 2026
Resumen
El análisis de datos del mundo real muestra que osimertinib mejora significativamente la duración del tratamiento y la supervivencia general en pacientes con cáncer de pulmón no microcítico avanzado en comparación con otros inhibidores de la tirosina quinasa.
Área de la Ciencia:
- Oncología; Ciencia de Datos; Farmacovigilancia
Sus antecedentes:
- Los datos del mundo real (RWD) de los registros electrónicos de salud (EHR) son cruciales para analizar la efectividad de los medicamentos contra el cáncer.
- Se desarrolló un marco analítico para generar evidencia del mundo real (RWE) a partir de RWD.
- Este marco se aplicó a pacientes con cáncer de pulmón no microcítico avanzado (CPNM avanzado) tratados con inhibidores de la tirosina quinasa (TKI).
Objetivo del estudio:
- Investigar los patrones de tratamiento y los resultados clínicos en el mundo real de pacientes con CPNM avanzado tratados con TKI.
- Comparar la eficacia del osimertinib de primera línea frente a otros TKI en CPNM avanzado con mutación EGFR.
- Demostrar la utilidad del análisis de datos del mundo real en la investigación del cáncer.
Principales métodos:
- Recopilación de datos retrospectivos de 190 pacientes con CPNM avanzado y mutación EGFR (2014-2022).
- Análisis del tratamiento de primera línea con osimertinib u otros TKI no osimertinib utilizando un algoritmo de minería de textos en EHR.
- Los puntos finales de supervivencia (mTTD, mOS) se estimaron con curvas de Kaplan-Meier y se analizaron con regresión de Cox dependiente del tiempo.
Principales resultados:
- El osimertinib de primera línea (38% de los pacientes) mostró un mayor tiempo medio hasta la interrupción del tratamiento (15 meses frente a 10 meses).
- Osimertinib fue un factor protector independiente contra los eventos adversos.
- La mediana de supervivencia general fue mayor con osimertinib (27 meses frente a 20,2 meses).
Conclusiones:
- Los marcos de análisis de datos integran eficazmente la RWE para la investigación del cáncer.
- Los patrones de tratamiento y los resultados del mundo real para los TKI son comparables a los datos de ensayos clínicos.
- Los estudios de RWE respaldan la toma de decisiones clínicas y el desarrollo de políticas de salud para las terapias contra el cáncer.
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