Urologische Gemeinschaftspraxis, Pruener Gang, Kiel, Germany
Jan Lehmann , Markus Flesch , Sebastian Vosgerau , Michael Gedamke
Background: HDT with LHRH agonists (LHRH) or LHRH-antagonists (degarelix, D) is the standard of care in advanced mPCa. A correlation between leuprolide/goserelin and an increased risk of CV events as compared to D has been shown in a pooled analysis of 6 RCTs in 2013, therefore we aimed to evaluate potential changes in selection of HDTs in Germany. Methods: To evaluate changes in selection of HDT, we compared data from a retrospective (2013 - 2014) and prospective (FPFV in 09/2014) study on CV disease and selection of ADT that were collected from the same pool of study sites. In the ProComD, a two-arm, prospective non-interventional study (NIS), potential comorbidity dependent differences in the selection of D vs LHRH treatment were investigated. Preceding the ProComD we conducted the retrospective randomised analysis to determine baseline CV disease frequencies in ADT treated patients. Results: In the retrospective part, frequencies of CV-disease were skewed towards LHRH compared to D (59.8 vs. 49.0 %). In the prospective ProComD data on patients with a minimum follow-up period of one year (visit 5, n = 238, D = 149, LHRH = 89) up to two years (visit 7, n = 84, D = 51, LHRH = 33) were documented. Baseline criteria were generally similar except for disease T-stage (p = 0.0038). The average age of patients was 74.4 years. Stage distribution: D vs. LHRH, pT2 26.8/28.1 %, pT3 23.5/38.2 %, pT4 5.4/1.1 %, unkown. 44.3/32.6 %, cNX 51.0/44.9 %, cN0 32.2/42.7 %, cN+ 16.8/12.4 %, cMX 26.8/23.3 %, cM0 34.9/47.2 %, cM1 38.2/29.2 %. Comorbidities were reported in 184 patients (77.3 %). Most frequent comorb. were vascular and metabolic diseases (hypertension and diabetes mellitus; (n = 139/57; 75.5/31.0 %) followed by cardiac diseases (n = 74; 40.2 %). More patients with peripheral arterial disease (PAD) (17.9 vs 3.0 %) and cardiac diseases (41.9 vs 37.3 %) received D as compared to LHRH. Conclusions: Our results indicate that selection of ADT seems to have shifted following new data on CV-risk differences between leuprolide/goserelin and degarelix. Patients with cardiac and PAD comorbidities have received more often degarelix treatment as compared to LHRH treatment.
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