Degarelix Versus Goserelin Plus Bicalutamide in the Short-Term Relief of Lower Urinary Tract Symptoms in Prostate Cancer Patients: Results of a Pooled Analysis

作者：Mason Malcolm^*; Richaud Pierre; Bosnyak Zsolt; Malmberg Anders; Neijber Anders

来源：Lower Urinary Tract Symptoms, 2017, 9(2): 82-88.

DOI：10.1111/luts.12114

• bicalutamide
• degarelix
• goserelin
• lower urinary tract symptoms

ObjectiveIn 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.
MethodsData were pooled from three Phase 3, randomized clinical trials of once-monthly treatment for 12weeks with degarelix (240/80mg; n=289) or goserelin (3.6mg) plus bicalutamide (50mg; 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.
ResultsPatients 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.
ConclusionAn 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.

• 出版日期2017-5