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Artículo Tomo 71, Número. 3, Abril 2018

Archivos Españoles de Urología

Maximal androgen deprivation with abiraterone acetate in hormone sensitive prostate cancer.

Authors: Alfredo Rodríguez Antolín, Javier Romero Otero, José Duarte Ojeda, Lucía García González,Raquel Sopeña Sutil, Daniel González Padilla, Esther García Rojo, Juan Justo Quintas y Bernardino Miñana López.

Arch. Esp. Urol. 2018; 71 (3): 267-275

Vol. 71, Number. 3, April 2018

OBJECTIVES: The treatment of metastatic prostate cancer has remained unchanged for more than 70 years, based on androgen deprivation therapy (ADT). In 2015, following the CHAARTED and STAMPEDE trials, it was established that the addition of 6 cycles of docetaxel to ADT was associated with significantly increased survival. In June 2017, the LATITUDE trial and the G arm of the STAMPEDE trial showed that the addition of Abiraterone with Prednisone (5 mg/day) to ADT was also associated with a significant increase in survival in metastatic patients. The present study analyzes these two trials.

RESULTS: LATITUDE demonstrated a 38% reduction in the risk of death (HR=0.62, 95% CI, 0.61-0.76) in almost all sub-groups. Risk reduction for radiological progression was 53% (HR=0.47, 95% CI 0.39-0.55). Secondary objectives such as prostate specific antigen progression, time to chemotherapy or a new skeletal event are also significantly delayed. STAMPEDE also showed that the combination of Abiraterone and Prednisone is associated with a 37% increase in survival (HR=0.63, 95% CI, 0.52- 0.76, p<0.001) in metastatic patients, but not in nonmetastatic patients. Progression-free survival was greatly improved in this arm (HR=0.29, 95% CI 0.25-0.34, p<0.001). The side effects reported show the known pattern of mineral corticosteroid excess with increased blood pressure, hypokalemia, and of liver enzymes elevation.

CONCLUSIONS: The indirect comparison of docetaxel and abiraterone studies confirms that both populations and results are comparable. Two comparative indirect metanalysis (>6000 patients) gave marginal superiority to abiraterone. In favor of abiraterone we have that it is an oral, comfortable medication with a good tolerance profile and side effects that are easy to manage, useful in patients who are old and fragile, in whom chemotherapy may not be indicated; the downsides are prolonged exposure to the drug and its current price. Future trials, currently in progress, will determine the ideal patient profile, or a potential association of both therapies.

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