Introduction & Objectives
Collection of data in daily clinical practice on the efficacy and safety of Degarelix in the treatment of patients with prostate cancer (PCa).
Material & Methods
Data of 1,010 Degarelix patients were collected. During the assessment, previous treatment, concomitant medication, stage and grade of tumour as well as alkaline phosphatase, testosterone and PSA-value, side-effects, and overall survival were documented. At the time of this assessment the maximum follow-up was 48 months.
The median overall survival was not yet reached. The 75% threshold for overall survival was reached for all patients after 149 weeks (176 vs. 132 weeks in the sub-groups of hormone-naive patients and patients with previous hormone treatment, respectively, Fig. 1).
In the sub-group of patients with previous LHRH agonist therapy, the median time to PSA progression was shorter (30 weeks, 75% threshold) than in the group without previous LHRH therapy (88 weeks, 75% threshold, Fig. 2). A higher proportion of patients with previous LHRH therapy experienced PSA progression (25%, n=114) as compared to patients without previous LHRH therapy (15%, n=86).
In the sub-group of metastatic patients, the median progression-free survival was 141 weeks. The median follow-up of the whole patient population was 128 weeks (32 months).
The mean prostate volume decreased from 37 ml at the beginning (n=85) to 30 ml after 3 months (19% decrease, n=25) and 26 ml after 6 months (30% decrease, n=16).
The most frequent side-effects were hot flushes (12.87%), erythema at the injection site (8.5%) and fatigue (5.25%).
Efficacy and safety of Degarelix were confirmed in routine daily practice. The median survival was not yet reached. The 75% threshold for the overall survival was reached after 37 months. Thus, these values are already above those reported in scientific literature for LHRH agonists at 25-31 months.