930P - What patient groups have special benefits using the GnRH-antagonist degarelix? Conclusions based on real life data from a German registry

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Prostate Cancer
Presenter Goetz Geiges
Authors G. Geiges1, M. Schulze2, M. Gedamke3
  • 1IQUO, 10719 - Berlin/DE
  • 2Uro-oncology, IQUO, 10719 - Berlin/DE
  • 3Urology/uro-oncology, Ferring Arzneimittel GmbH, 24103 - Kiel/DE

Abstract

Introduction and objective

The GnRH-antagonists, especially degarelix, are still relatively new substances in the treatment of prostate cancer. Data on advantages of this specific approach to ADT is accumulating. It is of interest to understand which patient groups have a special benefit in using degarelix. We have collected data on efficacy and safety of degarelix in daily practice in order to compare with data from clinical studies.

Methods

Data from 421 patients with prostate cancer treated with degarelix were collected by 93 office based urologists. Previous treatment, concomitant medication, tumour stage and grade as well as alkaline phosphatase (ALP), prostate volume, testosterone, PSA and side-effects were documented over a period of up to 2 years or until completion of therapy.

Results

Tumour stages were documented at baseline as T1 27.9%, T2 22.0%, T3 25.1%, T4 13.1% and Tx 11.5%. Median PSA at baseline was 12.4 ng/mL. Testosterone was above castration level (>0.5 ng/mL) in 41.7% of patients (pts) with previous hormone therapy and available testosterone value at inclusion (n = 48). In 14.5% of the pts degarelix was used intermittently. Prostate volume measured by transrectal ultrasound was reduced by 40.8% within 3 months compared to baseline. For pts in which ALP was measured (n = 61), ALP was suppressed from a median of 639.9 (IU/L) to 108.7 (IU/L) after 2 months and was still suppressed to 78.6 (IU/L) at month 12. Treatment of pts with prior hormone-therapy resulted in 53.8% in a stable PSA after 1 year. PSA-reduction to <4 ng/mL after 2 years was achieved in 88.9% of pts with baseline-PSA < 10ng/mL (incl. pts with previous hormonal therapy). The major side effects observed were hot flushes (8.8 %) and injection site erythema (7.9 %).

Conclusions

The efficacy of degarelix shown in routine practise is comparable to other androgen-deprivation-therapies. It is used in a wide range of tumour stages. Degarelix may be of special benefit in the following groups: - Pts. with insufficient testosterone suppression under LHRH-agonists - Intermittent androgen deprivation therapy - Pts. where prostate volume reduction is needed - Metastatic pts. (ALP-control) - Rising PSA under LHRH-agonists.

Disclosure

G. Geiges: Clinical trials, oral presentations, consultancy concerning health sercives research for: Amgen, Astellas, Bayer, Cephalon, CSG, EuMeCom, Ferring, GSK, Hexal, Johnson & Johnson, Lilly, Medconcept, Novartis and others.

All other authors have declared no conflicts of interest.