Abstract

ABSTRACT Background Degarelix is a GnRH-antagonist, which is used in the treatment of prostate cancer since 2009. We performed a non-interventional study (NIS) with prostate cancer (PCA) patients treated routinely with degarelix. This NIS focused on pharmaco-economic data, health-related quality of life (HRQoL) as well as efficacy and safety in patients receiving degarelix as first or second line therapy. Materials In the interim analysis of this ongoing NIS, data from 279 out of 670 PCA-patients treated with degarelix were included. The included cohort reflects advanced PCA patients (age: 72 years, PSA: 15.8 ng/ml (median)).Testosterone and PSA values, health-related quality of life (HRQL) and pharmaco-economic data were collected at baseline, 1, 3, 6, 9 and 12 months. HRQL was assessed by EORTC QLQ-C30. Pharmaco-economic data included costs for physicians, drugs, hospital, emergency treatment and others. Results Treatment costs in hormone-naive patients treated with degarelix were lower than in the hormonally pre-treated patients. Costs for 12 months were € 3177 for hormone-naive patients treated with degarelix in contrast to € 3782 for hormonally pre-treated patients. As expected there was a marked difference in the PSA-decline between hormone-naive patients and hormonally pre-treated patients. Hormone-naive patients experienced a sharp median decrease in PSA by 80.7% (n = 116) at month 1. This decline remained stable in 98.7% of the patients after one year. Median PSA reduction was significantly different (p = 0.013) between hormone-naive and pre-treated patients. Furthermore treatment with degarelix improved HRQL by 16% at one year in metastatic patients. Safety results mirrored the results of previous clinical trials, with x, y and z being the most frequent ones. Conclusions First line treatment with degarelix was supported by a marked difference in health care costs between hormone-naive and pre-treated prostate cancer patients. As expected, a pronounced difference in the PSA-decrease for hormone-naive vs. pre-treated patients was seen. However a distinct health-related quality of life improvement was noted in all patients. Disclosure All authors have declared no conflicts of interest.

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