Degarelix monotherapy compared with luteinizing hormone-releasing hormone (LHRH) agonists plus anti-androgen flare protection in advanced prostate cancer : an analysis of two randomized controlled trials
| Autor: | Anders Malmberg, Laurence Klotz, Jan-Erik Damber, Peter Iversen, Bo-Eric Persson |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Agonist
medicine.medical_specialty anti-androgen Bicalutamide medicine.drug_class Urology 030232 urology & nephrology degarelix lcsh:RC870-923 Antiandrogen Hormone antagonist 03 medical and health sciences Prostate cancer chemistry.chemical_compound 0302 clinical medicine Internal medicine Urologi och njurmedicin Medicine Urology and Nephrology Degarelix Original Research luteinizing hormone-releasing hormone agonist business.industry Hazard ratio lcsh:Diseases of the genitourinary system. Urology medicine.disease prostate cancer Endocrinology chemistry 030220 oncology & carcinogenesis business Luteinizing hormone testosterone flare medicine.drug |
| Zdroj: | Therapeutic Advances in Urology, Vol 8 (2016) |
| Popis: | Objectives: The objective of this study was to assess differences in efficacy outcomes between luteinizing hormone-releasing hormone (LHRH) agonist plus antiandrogen (AA) flare protection and monotherapy with the gonadotrophin-releasing hormone antagonist degarelix in patients with prostate cancer. Methods: Data from 1455 patients were pooled from two prospective, phase III randomized 1-year clinical trials of degarelix versus LHRH agonist with or without AA. The AA bicalutamide was administered at the investigator’s discretion. Adjusted hazard ratios (HRs) were calculated using a Cox proportional hazards regression model and a conditional logistic regression model was used for a case-control analysis of odds ratios (ORs). Results: Patients received degarelix monotherapy ( n = 972) or LHRH agonist ( n = 483) of whom 57 also received AA. Overall, prostate-specific antigen progression-free survival (PSA PFS) was improved with degarelix versus LHRH agonist + AA (Cox proportional hazards regression model-adjusted HR for PSA PFS failure was 0.56 [95% confidence interval (CI) 0.33–0.97, p = 0.038]). To compensate for a higher proportion of patients with metastases, Gleason score 7–10, and PSA >20 ng/ml in the LHRH agonist + AA group, a case-control analysis using a conditional logistic regression model was utilized. This resulted in an OR for PSA PFS of 0.42 (95% CI 0.20–0.89; p = 0.023) in the overall population, and 0.35 (95% CI 0.13–0.96; p = 0.042) in patients with PSA >50 ng/ml at baseline, when treated with degarelix versus LHRH agonists + AA. There were a small number of deaths, 1.9% with degarelix and 7% with LHRH agonists + AA (case-control analysis OR = 0.37; p = 0.085). Conclusions: Degarelix monotherapy produced a more favorable effect on PSA PFS outcomes than a LHRH agonist + AA flare protection therapy in patients with prostate cancer when a case-control analysis was used to compensate for differences between treatment groups. |
| Databáze: | OpenAIRE |
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