El pasado 6 de septiembre fue publicado en JAMA Oncology un estudio retrospectivo sobre el fenómeno de la enfermedad hiperprogresora asociada al tratamiento (HPD), dónde se observó los efectos perjudiciales que puede suponer la inmunoterapia en pacientes con cáncer de pulmón de células no pequeñas (CPNM) avanzado.
El HPD es un patrón de progresión en CPNM en el que el crecimiento del tumor, medido por TC, es más rápido después del inicio del tratamiento que antes del inicio del tratamiento. Para medirlo se requieren tres tomografías computarizadas: una inicial antes de la línea de base; se otra de referencia justo antes del inicio del tratamiento; y una tercera en el primer punto de evaluación. Para el estudio actual, el HPD se definió como un cambio en la tasa de crecimiento del tumor en la primera evaluación en exceso del 50% en comparación con la tomografía computarizada de referencia tomada justo antes del inicio del tratamiento.
El estudio, liderado por Benjamin Besse, MD, PhD, Instituto Gustave Roussy (Villejuif, Francia) incluyó a 406 pacientes con CPNMP en estadio III o IV que recibieron un inhibidor de PD-1/PD-L1, de los cuales 59 pacientes formaron parte de la cohorte de control y recibieron quimioterapia convencional con un solo agente:
- Entre la cohorte de inmunoterapia, el 13.8% de los pacientes fueron clasificados con HPD, y entre los pacientes del grupo de control, el 5,1%.
- Para aquellos pacientes que experimentaron HPD [dentro de las primeras 6 semanas del inicio del tratamiento con inhibidores de PD-1 / PD-L1], la supervivencia general fue de solo 3,4 meses en comparación con los pacientes sin HPD que progresaron bajo inmunoterapia, donde la supervivencia general fue de 6,2 meses (p = 0,003). Respecto a este resultado, Besse advierte que «Lo que esto significa es que tiene que evaluar a los pacientes para HPD en una etapa temprana a las 6 u 8 semanas después del inicio de la inmunoterapia, y en el caso de una rápida aceleración del crecimiento del tumor, debe cambiar a una nueva línea de quimioterapia. «
- La HPD era significativamente más probable que ocurriera en pacientes que tenían más de dos sitios de metástasis antes del inicio de la terapia con inhibidores de PD-1 / PD-L1 (62.5%) en comparación con los pacientes que no tenían HPD (42.6%; P = .006).
- En contraste, no se observaron diferencias significativas entre los pacientes que experimentaron HPD y aquellos que no lo hicieron en términos de la carga tumoral basal, el número de líneas de terapia anteriores o la edad.
Después de un año del tratamiento, los resultados obtenidos en los diversos grupos fueron los siguientes:
- En la cohorte de inmunoterapia, a una mediana de seguimiento de 12,1 meses, la tasa de respuesta objetiva fue del 18,9%, informan los autores del estudio.
- Para el 41,9% de estos pacientes, la enfermedad progresiva fue la mejor respuesta a la inmunoterapia.
- La mediana de supervivencia libre de progresión (SLP) fue de 2,1 meses; la mediana de SG fue de 13,4 meses.
- En la cohorte de quimioterapia, la mediana de seguimiento fue de 26,3 meses.
- La tasa de respuesta objetiva fue del 10,2%; Para el 30,5% del grupo, la mejor respuesta fue la enfermedad progresiva.
- La mediana de SSA fue de 3,9 meses; la tasa media de SG fue de 8,6 meses.
- Seis semanas después del inicio del tratamiento, entre los pacientes con HPD, la SG media fue de 4.5 meses, en comparación con los 3.9 meses entre los pacientes sin HPD pero que se encontró que tenían enfermedad progresiva en la primera evaluación (p = 0.60).
Besse observó que en muchos estudios de fase 3 que comparaban la inmunoterapia de agente único con la quimioterapia de agente único, los resultados favorecieron la inmunoterapia. Sin embargo, en el tratamiento de segunda línea del NSCLC avanzado, éste comentó que los hallazgos del estudio sugieren el hecho de considerar su uso debido a la deficiente OS asociada con el HPD.
Aunque la inmunoterapia es alabada como un cambio de juego, el fenómeno del HPD continúa sirviendo como una advertencia de que la nueva terapia es potencialmente dañina para algunos pacientes. Así pues, los investigadores concluyeron que para los pacientes con signos de HPD, «se debe considerar un cambio temprano a la quimioterapia de rescate».
Fuente: MedScape. Immunotherapy May Accelerate Some Lung Cancers. 11 September 2018.
Disponible en: https://www.medscape.com/viewarticle/901823#vp_2
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