Eficacia de lutecio-177 DOTA TATE/TOC en pacientes con tumores neuroendocrinos bien diferenciados en estado avanzado. Ensayo clínico fase II

  • Amelia De los Reyes
  • Augusto Llamas-Olier
  • Alejandro Martí
  • Felipe Fierro
  • Leonardo Rojas
  • María Cristina Martínez
  • Carlos Eduardo Granados
  • Humberto Varela
  • Álvaro Calderón
  • Nathaly Barbosa
  • Nidia Delgado
  • Javier Rada
  • Diana Isabel Cuéllar Instituto Nacional de Cancerología
  • Alfonso Lozano
  • Yeinnyer Muleth
Palabras clave: Tumores neuroendocrinos, Receptores de somatostatina, Lutecio/administración & dosificación, Somatostatina/análogos & derivados, Radiofármacos/uso terapéutico

Resumen

Introducción: En el año 2009, el Instituto Nacional de Cancerología elaboró el 177Lu-DOTATATE/TOC. El propósito del estudio fue demostrar la eficacia de estos radiopéptidos en el tratamiento paliativo de pacientes con tumores neuroendocrinos (TNE) avanzados inoperables (metastásicos o localmente avanzados) y en progresión. Métodos: ensayo clínico abierto fase II de un solo brazo en 13 pacientes adultos con TNE grado 1 o 2, con expresión de receptores de somatostatina en lesiones blanco demostrada por captación Krenning 3 o 4 en 99mTc-HYNIC TOC. Los pacientes fueron tratados con 177Lu-DOTATATE o 177Lu-DOTATOC (según disponibilidad) a una actividad acumulativa proyectada de 600-800 mCi dividida en 3-4 dosis cada 6-9 semanas comenzando siempre con una actividad fija de 200 mCi y dosimetría con la primera dosis. El desenlace primario fue la respuesta objetiva calculada 6 y 12 meses después de la última dosis del tratamiento. Resultados: Se incluyeron 13 pacientes (7 mujeres) de 63 ± 11,6 años con TNE avanzado inoperable y en progresión. La actividad final administrada fue de 800 mCi, 600 mCi, 400 mCi y 200 mCi en 4, 7, 1 y 1 pacientes, respectivamente. La tasa de respuesta objetiva a 6 y 12 meses fue de 69,2% y 45,5%, respectivamente, logrando únicamente enfermedad estable. Fallecieron 7 pacientes, 2 de ellos en los primeros 6 meses. La mediana de supervivencia global a partir de la última dosis del radiopéptido fue de 15,7 meses. Conclusiones: Se corroboró la eficacia y la seguridad del tratamiento con los radiopéptidos en NETs avanzados

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Publicado
2021-01-19
Cómo citar
[1]
De los Reyes, A., Llamas-Olier, A., Martí, A., Fierro, F., Rojas, L., Martínez, M.C., Granados, C.E., Varela, H., Calderón, Álvaro, Barbosa, N., Delgado, N., Rada, J., Cuéllar, D.I., Lozano, A. y Muleth, Y. 2021. Eficacia de lutecio-177 DOTA TATE/TOC en pacientes con tumores neuroendocrinos bien diferenciados en estado avanzado. Ensayo clínico fase II. Revista Colombiana de Cancerología. 25, 1 (ene. 2021). DOI:https://doi.org/10.35509/01239015.132.
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Artículos de investigación/originales