研究人员于4月14日举行的欧洲泌尿外科协会年会上表示，地加瑞克对前列腺癌患者的下尿路症状改善要好于戈舍瑞林与比卡鲁胺合并用药。
晚期前列腺癌患者的初级处理是使用促性腺激素释放(GnRH)拮抗剂或激动剂。这可能有助于减少前列腺体积，在放疗之前降低疾病进程。然而，由于前列腺癌也与下尿路症状有关，所以这些患者的治疗可以通过改善下尿路症状的治疗效果而进行辅助治疗。
英国卡迪夫癌症及遗传研究所、卡迪夫大学医学院的医学博士Malcolm Mason与同行对比了GnRH拮抗剂地加瑞克与GnRH激动剂戈舍瑞林加比卡鲁胺的效果。
在试验中，治疗12周时地加瑞克用药组与戈舍瑞林+比卡鲁胺用药组相比，国际前列腺症状评分(IPSS)显著降低，再次证实了目前的分析。
在这里，下尿路症状的临床相关缓解被定义为12周治疗期间，IPSS评分下降≥3。“这被认为是一个临床有意义的结果，” Mason博士称。对混淆因素调整之后，与戈舍瑞林+比卡鲁胺用药组相比，明显更大比例的地加瑞克用药患者获得下尿路症状的临床缓解。
两种治疗方法在降低总前列腺体积及睾丸激素，或在尿路感染相关紧急治疗诱发不良事件方面未发现有显著性差异。这似乎证明，在缓解下尿路症状方面，地加瑞克比戈舍瑞林与比卡鲁胺合并用药更加有效。
Degarelix Superior to Goserelin/Bicalutamide for Urinary Tract Symptoms in Prostate Cancer: Presented at EAU
STOCKHOLM, Sweden -- April 16, 2014 -- Degarelix improves lower urinary tract symptoms better than goserelin plus bicalutamide in patients with prostate cancer, researchers said here on April 14 at the 29th Annual European Association of Urology (EAU) Congress.
The primary treatment for patients with advanced prostate cancer is a gonadotropin-releasing hormone (GnRH) antagonist or agonist. These can serve to reduce prostate volume and to downstage the disease prior to radiotherapy.
However, as prostate cancer is also associated with lower urinary tract symptoms, the treatment of these patients can be aided by a treatment that has improved efficacy against lower urinary tract symptoms.
Malcolm Mason, MD, Cardiff University School of Medicine, Institute of Cancer and Genetics, Cardiff, United Kingdom, and colleagues compared the efficacy of the GnRH antagonist degarelix with that of the GnRH agonist goserelin in combination with the anti-androgen bicalutamide.
The pooled individual patient data from these 3 trials included 463 patients who had been randomised to either degarelix 240/60 mg (n = 289) or goserelin 3.6 mg plus bicalutamide 50 mg initially for 17 to 28 days (n = 174).
In the individual trials, there were significantly greater reductions at week 12 for International Prostate Symptom Score (IPSS) for degarelix over goserelin plus bicalutamide, which was again confirmed in the present analysis.
Here, clinically relevant relief of lower urinary tract symptoms was defined as ≥3 point decrease in IPSS during the 12 weeks treatment. “This was taken as being a clinically meaningful result,” said Dr. Mason.
With adjustments for confounders, a significantly greater proportion of patients on degarelix compared with goserelin/bicalutamide experienced clinically relevant relief of lower urinary tract symptoms (odds ratio [OR], 1.62; P =. 0.03).
This benefit of degarelix was particularly pronounced in patients with moderate to severe lower urinary tract symptoms (IPSS ≥13 at baseline; OR, 2.35; P< .01), as well as in patients with dominance of voiding at baseline (P< .017) and those with baseline total prostate volume ≥40 mL (P< .020).
However, “in patients defined as having localised disease, we did not see the same degree of benefit,” said Dr. Mason.
No differences between these treatments were seen for the reductions in total prostate volume (37.0% vs 38.4%) and testosterone (98.8% vs 97.3%), or for urinary tract infection-related treatment-emergent adverse events (2% vs 2%).
“This appears to show evidence that degarelix is more efficacious than the goserelin plus bicalutamide combination in the relief of lower urinary tract symptoms,” Dr. Mason concluded.
Funding for the trials included in this analysis was provided by Ferring Pharmaceuticals.
[Presentation title: Greater Short-Term Relief of Lower Urinary Tract Symptoms in Prostate Cancer Patients Treated With Degarelix Compared to Goserelin Plus Bicalutamide: Results of a Pooled Analysis. Abstract 975]
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