RT Journal Article
T1 A phase II randomised trial of abiraterone acetate plus prednisone in combination with docetaxel or docetaxel plus prednisone after disease progression to abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer: The ABIDO-SOGUG trial.
A1 Climent, Miguel A
A1 Font, Albert
A1 Duran, Ignacio
A1 Puente, Javier
A1 Mendez-Vidal, Maria Jose
A1 Saez, Maria Isabel
A1 Santander-Lobera, Carmen
A1 Angel-Arranz-Arija, Jose
A1 Gonzalez-Del-Alba, Aranzazu
A1 Sanchez-Hernandez, Alfredo
A1 Juan-Fita, Maria Jose
A1 Esteban, Emilio
A1 Alonso-Gordoa, Teresa
A1 Mellado-Gonzalez, Begoña
A1 Maroto, Pablo
A1 Lazaro-Quintela, Martin
A1 Cassinello-Espinosa, Javier
A1 Perez-Valderrama, Begoña
A1 Garcias, Carmen
A1 Castellano, Daniel
K1 Abiraterone acetate
K1 Combination
K1 Docetaxel
K1 Metastatic castration-resistant prostate cancer
K1 Phase II
AB We aimed to compare the efficacy and safety of maintaining or withdrawing abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer who had experienced cancer progression to this treatment and were beginning a docetaxel-based therapy. Phase II, randomised, open-label study conducted in patients with metastatic castration-resistant prostate cancer who were asymptomatic or mildly symptomatic. After open-label treatment with AAP, patients who had experienced cancer progression to AAP were randomised to 75 mg/m2 of docetaxel plus AAP or to receive 75 mg/m2 of docetaxel plus 10 mg of prednisone orally daily. The primary outcome was the radiographic progression-free survival rate at 12 months as evaluated by the investigators in all randomised patients. A total of 148 patients were included in open-label treatment with AAP, and of them, 94 patients were randomised to receive either docetaxel plus AAP (intervention group; n = 47) or docetaxel plus prednisone (control group; n = 47). The 12-month radiographic progression-free survival rates did not differ between the intervention group (34.9%; 95% CI 20.7-49.2) and the control group (33.9%; 95% CI 19.5-48.3). There were no significant differences in the time to radiographic progression and the overall survival between the intervention and control groups. Grade 3-5 neutropenia with the combination of docetaxel plus prednisone and AA was more frequent than with docetaxel plus prednisone (59.6% versus 27.7%). Our results indicate that the therapeutic strategy of maintaining AAP added to docetaxel in chemotherapy-naïve patients who have experienced cancer progression to AAP treatment should not be further evaluated and should be avoided in clinical practice. 
PB Elsevier
YR 2022
FD 2022-08-04
LK http://hdl.handle.net/10668/22179
UL http://hdl.handle.net/10668/22179
LA en
NO Climent MA, Font A, Durán I, Puente J, José Méndez-Vidal M, Sáez MI, et al. A phase II randomised trial of abiraterone acetate plus prednisone in combination with docetaxel or docetaxel plus prednisone after disease progression to abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer: The ABIDO-SOGUG trial. Eur J Cancer. 2022 Nov;175:110-119
DS RISalud
RD Apr 6, 2025