Desenlaces clínicos en hematoncología: diez años de investigaciones en Pubmed
Palabras clave:
Mieloma múltiple, Leucemias, Linfomas, Estudios clínicos aleatorizados;, Oncología, Desenlaces intermedios, Supervivencia globalResumen
Objetivo: Determinar cuáles son los desenlaces clínicos empleados en los estudios fase III de tratamiento de neoplasias hematoncológicas y qué proporción de ellos emplean supervivencia global como desenlace primario.
Método: Mediante una búsqueda en Pubmed, analizar todos los experimentos clínicos aleatorios publicados en los últimos 10 años, de tratamientos de novo, en población adulta.
Resultados: La búsqueda inicial arrojó 310 referencias, entre las que se seleccionaron 90 estudios clínicos. La enfermedad más estudiada fue mieloma múltiple, con 29 estudios, seguida de linfoma no Hodgkin, con 26. Las otras fueron: leucemia mieloide aguda (12), leucemia linfocítica crónica (10), leucemia mieloide crónica (8), síndromes mielodisplásicos (3) y linfoma de Hodgkin (2). En 20 estudios (22%) se empleó la supervivencia global como desenlace primario (en solo 3 de ellos alcanzó significación estadística), en 37 más (41%) se agrupó con otros desenlaces para conformar un desenlace compuesto. En 55 estudios (61%) la supervivencia global fue un desenlace secundario.
Conclusiones: Aunque la supervivencia global es el estándar de oro en terapia oncológica, los desenlaces agrupados u otros, como tiempo libre de enfermedad o indicadores paraclínicos de actividad de la enfermedad, son más empleados, quizá por ser buenos predictores y requerir muestras y seguimientos menores. Su capacidad para predecir supervivencia global (en algunos casos calidad de vida) debe ser validada. Solo en las formas más agresivas de cáncer se justifica usar de rutina la supervivencia global como el desenlace primario.
Biografía del autor/a
Diego Rosselli, Pontificia Universidad Javeriana
Departamento de Epidemiología Clínica y Bioestadística, Facultad de Medicina, Pontificia Universidad Javeriana, Bogotá D.C., Colombia
Carlos Eduardo Díaz, Pontificia Universidad Javeriana
Departamento de Epidemiología Clínica y Bioestadística, Facultad de Medicina, Pontificia Universidad Javeriana, Bogotá D.C., Colombia
Laura Gutiérrez, Pontificia Universidad Javeriana
Departamento de Epidemiología Clínica y Bioestadística, Facultad de Medicina, Pontificia Universidad Javeriana, Bogotá D.C., Colombia
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