An Audit to Evaluate the Clinical Safety and PSA Response of Firmagon® (Degarelix) in Patients with Advanced Metastatic Prostate Cancer -

Abstract

 Objectives: To evaluate the clinical safety and PSA response in patients with metastatic prostate cancer being treated with Firmagon^® (Degarelix) and to assess the drug's safety profile.

Patients and Methods: This was an audit of 35 patients with PSA levels >50 and advanced metastatic prostate cancer at presentation who received Firmagon^® (Degarelix) as per our North East & Cumbria Cancer Drug Approvals Group (NECDAG), UK guidelines. The audit was conducted using results from three hospitals in North East England with an aim to evaluate the safety profile, clinical and PSA response with this new drug. Baseline symptoms at diagnosis, presenting PSA and post treatment parameters on the commencement of with Firmagon^® (Degarelix) were recorded. All patients in our cohort were homogenous having had not received any previous treatment including any form of LHRH analogue therapy. PSA levels were measured at 6 weekly intervals initially followed by 3 monthly intervals to evaluate initial and long term response to treatment withFirmagon^® (Degarelix).

Results: There was no incidence of anaphylaxis or injection site complications on immediate administration ofFirmagon^® (Degarelix). No of our patients had renal or liver toxicity in our series. There was no incidence of tumour flare in any patient. A total of 23% of patients who presented primarily with severe bone pain described a complete resolution of Firmagon^® (Degarelix) and required no adjuvant treatment such as bisphosphonates or palliative radiotherapy. A significant reduction in PSA levels were noted immediately at 6 weeks and 3 months following treatment with Firmagon^® (Degarelix) (p=0.0038).

Conclusions: Firmagon^® (Degarelix) is a safe drug is well tolerated in patients with advanced metastatic prostate cancer. The reason of how bone pain completely resolves in some patients with extensive bone metastasis on the commencement of Firmagon^® (Degarelix) needs to be evaluated.