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Inicio Actas Urológicas Españolas (English Edition) Efficacy of enzalutamide and apalutamide in the treatment of non-metastasic cast...
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Vol. 43. Issue 7.
Pages 355-363 (September 2019)
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Vol. 43. Issue 7.
Pages 355-363 (September 2019)
Original article
DOI: 10.1016/j.acuroe.2019.03.011
Efficacy of enzalutamide and apalutamide in the treatment of non-metastasic castration-resistant prostate cancer: Indirect comparison
Enzalutamida y apalutamida en el tratamiento del cáncer de próstata no metastásico resistente a la castración: comparación indirecta de la eficacia
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P. Nieto-Gómez
Corresponding author
pnietog90@gmail.com

Corresponding author.
, R. Ubago-Pérez, J. Cabeza-Barrera
Unidad de Gestión Clínica de Farmacia Hospitalaria, Hospital Universitario San Cecilio, Granada, Spain
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Tables (2)
Table 1. Main characteristics of the PROSPER and SPARTAN RCTs.
Table 2. Efficacy results.
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Abstract
Objectives

To perform an adjusted indirect comparison of the efficacy of enzalutamide and apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of progression to metastatic disease.

Material and methods

After carrying out a literature search, we performed an adjusted indirect comparison (Bucher et al.) of the relative efficacy of enzalutamide and apalutamide in patients with nmCRPC with a high risk of progression to metastatic disease. The outcomes included were metastasis-free survival (MFS) and PSA response rate (PSARR).

Results

There were no statistically significant differences between enzalutamide and apalutamide regarding the analysed outcomes. For the comparison enzalutamide+ADT vs. apalutamide+ADT: MFS a HR (95% CI)=1.036 (0.781–1.373) was obtained. For PSARR, a RR (95% CI)=0.81 (0.339–1.938) was obtained.

Conclusions

The adjusted indirect comparison performed in this study shows that there are no statistically significant differences in terms of efficacy regarding MFS and PSARR between enzalutamide+ADT and apalutamide+ADT in patients with nmCRPC with a high risk of progression to metastatic disease. However, in order to confirm these results, an independent trial with direct comparison between both drugs would be required.

Keywords:
Prostate cancer
Enzalutamide
Apalutamide
Metastasis-free survival
Indirect comparison
Resumen
Objetivos

Realizar una comparación indirecta ajustada de la eficacia relativa de enzalutamida y apalutamida en pacientes con cáncer de próstata no metastásico resistente a la castración (CPRCnm) con alto riesgo de progresión a enfermedad metastásica.

Material y métodos

Tras realizar una búsqueda bibliográfica se llevó a cabo una comparación indirecta ajustada de la eficacia relativa de enzalutamida y apalutamida en pacientes con CPRCnm con alto riesgo de progresión a enfermedad metastásica siguiendo el método de Bucher et al. Como variables se seleccionaron la supervivencia libre de metástasis (SLM) y la tasa de respuesta al PSA (TRPSA).

Resultados

No se observaron diferencias estadísticamente significativas para las variables evaluadas entre enzalutamida y apalutamida. Para la comparación enzalutamida+TDA vs. apalutamida+TDA: SLM obtuvo un HR (IC95%)=1,036 (0,781-1,373) y TRPSA obtuvo un RR (IC95%)=0,81 (0,339-1,938).

Conclusiones

La comparación indirecta ajustada realizada en este estudio muestra que no existen diferencias estadísticamente significativas en términos de eficacia, a nivel de SLM y TRPSA, entre enzalutamida+TDA y apalutamida+TDA en pacientes con CPRCnm con alto riesgo de progresión a enfermedad metastásica. Sin embargo, se debería diseñar un ensayo independiente en el que se comparasen directamente ambos fármacos para confirmar estos resultados.

Palabras clave:
Cáncer de próstata
Enzalutamida
Apalutamida
Supervivencia libre de metástasis
Comparación indirecta

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