Degarelix versus Goserelin plus Bicalutamide in the short-term relief of lower urinary tract symptoms in prostate cancer patients: results of a pooled analysis

Mason, Malcolm ORCID: https://orcid.org/0000-0003-1505-2869, Richaud, Pierre, Bosnyak, Zsolt, Malmberg, Anders and Neijber, Anders 2017. Degarelix versus Goserelin plus Bicalutamide in the short-term relief of lower urinary tract symptoms in prostate cancer patients: results of a pooled analysis. LUTS: Lower Urinary Tract Symptoms 9 (2) , pp. 82-88. 10.1111/luts.12114

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Abstract

Objective In patients with prostate cancer (PCa), prostate enlargement may give rise to lower urinary tract symptoms (LUTS); many patients suffer from moderate-to-severe symptoms. We compare the efficacy of degarelix and goserelin plus bicalutamide in improving LUTS in PCa patients. Methods Data were pooled from three Phase 3, randomized clinical trials of once-monthly treatment for 12 weeks with degarelix (240/80 mg; n = 289) or goserelin (3.6 mg) plus bicalutamide (50 mg; n = 174) for initial flare protection. LUTS at weeks 4, 8, and 12 were compared to baseline. Clinically relevant LUTS relief was a ≥3-point International Prostate Symptom Score (IPSS) decrease. Adverse events were assessed throughout the trials. Results Patients receiving degarelix had significantly greater decreases in IPSS vs. goserelin at week 12 (adjusted difference: −1.24; 95% CI −2.33 to −0.14, P = 0.03). Clinically relevant LUTS relief with degarelix was especially pronounced in patients with moderate-to-severe LUTS (baseline IPSS ≥13) (odds ratio; OR 2.31; 95% CI 1.19–4.47, P = 0.01) and advanced PCa (OR 2.36; 95% CI 1.10–5.04, P = 0.03). A twofold higher OR for early (week 4) LUTS relief was seen with degarelix vs. goserelin (OR 2.03; 95% CI 1.14–3.60, P = 0.02). No difference in total prostate volume or urinary tract infection-related adverse events (2%) was seen between treatment groups. Conclusion An early, significant and clinically more pronounced improvement of LUTS, especially in patients with moderate-to-severe LUTS or advanced PCa, was seen with degarelix vs. goserelin plus bicalutamide.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Schools > Medicine
Uncontrolled Keywords:	bicalutamide; degarelix; goserelin; lower urinary tract symptoms
Publisher:	Wiley
ISSN:	1757-5664
Date of First Compliant Deposit:	16 January 2018
Date of Acceptance:	13 July 2015
Last Modified:	25 Nov 2024 17:15
URI:	https://orca.cardiff.ac.uk/id/eprint/102594

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