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Degarelix Versus Goserelin Plus Bicalutamide in the Short‐Term Relief of Lower Urinary Tract Symptoms in Prostate Cancer Patients: Results of a Pooled Analysis
Author(s) -
MASON Malcolm,
RICHAUD Pierre,
BOSNYAK Zsolt,
MALMBERG Anders,
NEIJBER Anders
Publication year - 2017
Publication title -
luts: lower urinary tract symptoms
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.451
H-Index - 15
eISSN - 1757-5672
pISSN - 1757-5664
DOI - 10.1111/luts.12114
Subject(s) - medicine , goserelin , urology , bicalutamide , prostate cancer , lower urinary tract symptoms , adverse effect , clinical endpoint , prostate , international prostate symptom score , randomized controlled trial , cancer , androgen receptor
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 P hase 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.