Efficacy of Lutetium-177 DOTATATE/TOC in Advanced Neuroendocrine Tumors

Revista Colombiana de Cancerología

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Title Efficacy of Lutetium-177 DOTATATE/TOC in Advanced Neuroendocrine Tumors
Eficacia de lutecio-177 DOTA TATE/TOC en pacientes con tumores neuroendocrinos bien diferenciados en estado avanzado. Ensayo clínico fase II
 
Creator De los Reyes, Amelia
Llamas-Olier, Augusto
Martí, Alejandro
Fierro, Felipe
Rojas, Leonardo
Martínez, María Cristina
Granados, Carlos Eduardo
Varela, Humberto
Calderón, Álvaro
Barbosa, Nathaly
Delgado, Nidia
Rada, Javier
Cuéllar, Diana Isabel
Lozano, Alfonso
Muleth, Yeinnyer
 
Subject Neuroendocrine tumors
Receptors,somatostatin
Lutetium-177
Somatostatin/analogs and derivates
Radiopharmaceuticals/therapeutic use
Tumores neuroendocrinos
Receptores de somatostatina
Lutecio/administración & dosificación
Somatostatina/análogos & derivados
Radiofármacos/uso terapéutico
 
Description ABSTRACT
Objectives: The National Cancer Institute first developed the 177Lu-DOTATATE/TOC in 2009. The purpose of this study was to prove the efficacy of these radiopeptides in the palliative treatment of patients with progressive advanced inoperable neuroendocrine tumors (NETs). Methods: A single-arm phase II open-label clinical trial was conducted in 13 adult patients with Grade 1 or 2 NETs, with somatostatin receptor expression in target lesions proven by Krenning Score 3 or 4 uptake at 99mTc-HYNIC TOC. Patients were treated with 177Lu-DOTATATE or 177Lu-DOTATOC (depending on availability) at a projected cumulative activity of 600-800 mCi divided into 3-4 doses every 6-9 weeks, always beginning with a fixed activity of 200 mCi and dosimetry with the first dose. The primary outcome was an objective response to therapy. Results: 13 patients (7 women) aged 63 ± 11.6 years with inoperable advanced NETs were included. The final therapeutic activity administered was 800 mCi, 600 mCi, 400 mCi, and 200 mCi in 4, 7, 1 and 1 patients, respectively. The disease control rate at 6 and 12 months was 69.2% and 45.5%, respectively, achievieng only a stable disease. Seven patients died, 2 of them within the first 6 months. The median overall survival rate was 15.7 months from the last treatment dose. Conclusions: The efficacy of the treatment with 177Lu-DOTATATE or 177Lu-DOTATOC radiopeptides developed in-house was confirmed, becoming a management alternative for patients with advanced NETs.
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
 
Publisher Instituto Nacional de Cancerología
 
Date 2021-01-19
 
Type info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
 
Format application/pdf
 
Identifier https://www.revistacancercol.org/index.php/cancer/article/view/132
10.35509/01239015.132
 
Source Revista Colombiana de Cancerología; Vol. 25 No. 1 (2021)
Revista Colombiana de Cancerología; Vol. 25 Núm. 1 (2021)
Revista Colombiana de Cancerología; v. 25 n. 1 (2021)
2346-0199
0123-9015
 
Language spa
 
Relation https://www.revistacancercol.org/index.php/cancer/article/view/132/516
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