Degarelix Therapy for Prostate Cancer in a Real-world Setting

Experience From the German IQUO (Association for Uro-Oncological Quality Assurance) Firmagon Registry

Götz Geiges; Thomas Harms; Gerald Rodemer; Ralf Eckert; Frank König; Rolf Eichenauer; Jörg Schroder

Disclosures

BMC Urol. 2015;15(122) 

In This Article

Methods

Data were analysed retrospectively from the IQUO (Association for uro-oncological quality assurance) patient registry records using the QuaSi-URO® documentation system, a live system based on data from IQUO members. Data from the Firmagon® Registry (The Electronic Therapy Documentation [ETD] Firmagon® – Urology) were prospectively collected from all consecutive patients with PCa treated with degarelix in 138 uro-oncology practices in Germany between 27 May 2009 and 10 December 2013. All patients with PCa receiving degarelix who were entered into ETD Firmagon® were documented and all patients with at least one fully documented entry in the registry were included. The only criterium for inclusion into the registry was prescription of degarelix, thus everyday usage should be mirrored by this register. The decision to treat patients with degarelix was taken by the treating physician before the decision for inclusion into the registry.

The underlying data collection for this publication was performed in accordance with the principles of the Declaration of Helsinki. The data collection did not take place in a study environment but utilized electronic data capture according to the documentation system and documentation guidelines of the IQUO. Within the electronic data capture there is no personal or patient identifying information; data were collected anonymously and pseudonymised. Identification of patients is possible only by the physician and the documentation staff. Therefore, according to three independent legal opinions there was no need for ethics committee approval or a patient consent form.

Study Variables

The data repository was reviewed for information on the following variables: tumour response to degarelix; overall survival (OS); PSA PFS; percentage change in median PSA and testosterone over time; percentage of patients with PSA ≤ 4 ng/ml over time; percentage change in median S-ALP over time; change in mean prostate volume. These variables were measured for patient subgroups as summarized in Table 1. Prior hormonal therapy (HT) included LHRH agonists, GnRH antagonists or antiandrogens. Prior LHRH analogue therapy included LHRH agonists or GnRH antagonists. Recording of the testosterone, S-ALP and prostate volume at the time of documentation was optional.

Tumour response (objective progression or stabilization, complete or partial remission) was assessed using the Response Evaluation Criteria In Solid Tumors [RECIST] guidelines[9] and measured at 6-month intervals up to a total duration of 3 years. Median time to PSA progression was defined according to Prostate Cancer Clinical Trials Working Group [PCWG2] criteria: a ≥25 % increase and an absolute increase of ≥2 ng/ml from the nadir, confirmed by a second value ≥3 weeks later.[10] At the time of PSA progression, patients were also required to have testosterone levels < 0.5 ng/ml [castration level]. The date of PSA progression was the date of the first PSA test value.

Percentage change in median PSA, testosterone and S-ALP, and mean prostate volume were measured monthly during the first year of treatment and thereafter in 3-monthly intervals for up to 39 months. Percentage change in median PSA and percentage of patients with PSA ≤ 4 ng/ml are presented for 3-month intervals for up to 36 and 24 months, respectively. Longer term data is not shown due to the smaller patient numbers towards the end of the evaluation period, especially in subgroups. Since collection of testosterone, ALP and prostate volume data was optional, patient numbers are smaller and therefore percentage change in median testosterone is presented for up to 2 years (1 year in metastatic disease subgroup), S-ALP for up to 1 year and mean prostate volume for up to 6 months.

The first data point in the registry refers to the time of the first administration of degarelix (baseline). In ongoing treatments, the last data point refers to the time of the last documented administration of a degarelix dose.

Statistics

Change in PSA, S-ALP, and prostate volume are summarized using descriptive statistics (percentage change, percentage change in median, mean). OS and PSA PFS were analysed using the Kaplan–Meier method. Survival was calculated from the date of first treatment until the date of any cause of death.

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