Enzalutamide (MDV3100, Xtandi, Medivation\Astellas) is an oral inhibitor of androgen receptor signaling that blocks androgen receptor interaction, inhibits translocation of the androgen receptor to the nucleus, impairs androgen receptor binding to DNA, and inhibits coactivator recruitment and receptormediated DNA transcription. In a phase III randomized study comparing enzalutamide with placebo in men with progressive castration-resistant prostate cancer (CRPC) who were previously treated with docetaxel, enzalutamide showed an improvement in overall survival (18.4 vs. 13.6 months, HR, 0.63; P < 0.001). In addition, all secondary endpoints including proportion of patients with prostate-specific antigen (PSA) decline, soft-tissue response, quality-of-life response, time to PSA progression, radiographic progressionfree survival, and the time to the first radiographic skeletal event all significantly favored patients treated with enzalutamide. Fatigue, diarrhea, and hot flashes were common in patients treated with enzalutamide, with seizures reported in 5 (0.6%) of the patients. Enzalutamide is a novel therapy that very potently blocks the androgen signaling pathway, which is unregulated during the development of CRPC. The preclinical studies along with the pivotal trials that led to its approval by the U.S. Food and Drug Administration (FDA) in September 2012 will be reviewed.
in 29 (91%), 2 (6%) and 1 (3%) patients, respectively. Median EBL, OT and LOS were 250 ml, 330 min and 10 days, respectively. A total of 31 (97%) patients received ileal conduit as urinary diversion. Clavien-Dindo !3a complications rate at 90-day was 28%, whereas late (>90 days) complication rate was 46%. As shown in Figure 1, 90-day cumulative incidence complication rate estimates ranged from 32% to 70%. At a median (IQR) follow-up of 30 (15-40) months, all patients were alive. At univariate analyses, ACCI was the only parameter associated with risk of early complications (OR: 1.75; 95% confidence interval[CI]: 1.05-2.9; p[0.03).CONCLUSIONS: RAC for UAEs in patients with history of pelvic irradiation is a feasible option in high-volume centres. The use of new technologies can help to overcome some technical difficulties and to reduce the risk of perioperative and late complications.
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