학술논문
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
Document Type
Article
Author
Climent, Miguel A.; Font, Albert; Durán, Ignacio; Puente, Javier; José Méndez-Vidal, María; Sáez, María Isabel; Santander Lobera, Carmen; Ángel Arranz Arija, Jóse; González-del-Alba, Aranzazu; Sánchez-Hernandez, Alfredo; Juan Fita, Maria Jose; Esteban, Emilio; Alonso-Gordoa, Teresa; Mellado Gonzalez, Begoña; Maroto, Pablo; Lázaro-Quintela, Martín; Cassinello-Espinosa, Javier; Pérez-Valderrama, Begoña; Garcias, Carmen; Castellano, Daniel
Source
Subject
*DISEASE progression
*CONFIDENCE intervals
*ORAL drug administration
*METASTASIS
*ABIRATERONE acetate
*ANTINEOPLASTIC agents
*TREATMENT effectiveness
*RANDOMIZED controlled trials
*COMPARATIVE studies
*DOCETAXEL
*DESCRIPTIVE statistics
*PREDNISONE
*PROGRESSION-free survival
*PATIENT safety
*PHARMACODYNAMICS
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Language
ISSN
0959-8049
Abstract
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. NCT02036060 https://clinicaltrials.gov/ct2/show/NCT02036060. • Docetaxel plus abiraterone acetate plus prednisone (AAP) versus docetaxel plus prednisone after progression to AAP in metastatic castration-resistant prostate cancer. • The 12-month radiographic progression-free survival rates did not differ (34.9% versus 33.9%). • No differences in the time to radiographic progression and overall survival. • Higher frequency of grade 3–5 and serious adverse events with the intervention. • Maintaining AAP added to docetaxel after progression to AAP is not an option. [ABSTRACT FROM AUTHOR]