Læknablaðið : fylgirit - 01.06.2009, Blaðsíða 13

27TH CONGR SCAND ASSOC UROL
F Y L G I R I T 6 1
therapy trial ever conducted in men with localised or locally
advanced prostate cancer. The aim of the program is to
evaluate the benefits of bicalutamide 150 mg/day when added
to standard care (prostatectomy, radiotherapy, or watchful
waiting). We now report data from the 4th and final analysis of
the program (median 9.7 years' follow-up).
Materials and methods: The program consists of 3 prospective,
placebo-controlled trials, and includes 8113 men with Tl-4,
M0, any N prostate cancer. Primary endpoints were objective
progression-free survival (PFS) and overall survival (OS).
Results and discussion: Across the whole program, 31% of
patients have died of any cause; 6.3% of patients with localised
disease died of prostate cancer compared with 16.2% of
those with locally advanced disease. Bicalutamide continues
to significantly improve PFS (HR 0.85; p<0.00001), while
no significant difference in OS was seen (HR 1.01; p=0.76).
Overall results are consistent with previous analyses, with PFS
improvements driven by locally advanced subgroups and the
previously observed trends regarding OS in watchful waiting
patients continuing to be seen.
Conclusions: In localised disease, the risks of hormonal
therapy with bicalutamide outweigh the benefits in delaying
progression. However, in locally advanced disease there are
benefits: conversion to metastatic disease can be delayed and
survival can be improved in certain groups.
14 Efficacy and safety of degarelix vs leuprolide in a 12-
month, randomised, phase III study
P Iversen1, TK Olesen2, B-E Persson3
^Rigshospitalet, Copenhagen, Denmark; 2Ferring Pharmaceuticals
Inc., Parsippany, United States, 3Ferring Pharmaceuticals, Saint-Prex,
Switzerland
pigi@dadlnet.dk
Aim: To compare the efficacy and safety of degarelix, a new
GnRH receptor blocker, with leuprolide in a 12-month, open-
label study in patients with prostate cancer.
Materials and methods: 610 patients with adenocarcinoma
of the prostate for whom androgen deprivation therapy was
indicated, were randomised to: degarelix starting dose 240 mg
s.c. for 1 month followed by monthly maintenance doses of 80
mg s.c. (n=207), 160 mg s.c. (n=202) or monthly i.m. injections
of leuprolide depot 7.5 mg (n=201). Here we report data for
degarelix 240/80 mg (approved dose) vs. leuprolide.
Results and discussion: Baseline characteristics were similar
across groups (mean age 72 yrs; median T 3.93 ng/mL; median
prostate-specific antigen [PSA] 19.0 ng/mL). LH and FSH levels
decreased rapidly during degarelix treatment; at study end,
mean FSH had decreased from baseline by 88.5% and 54.8%,
in the degarelix and leuprolide groups, respectively. Degarelix
demonstrated non-inferiority vs. leuprolide at achieving
the primary endpoint (serum T levels s0.5 ng/mL from Day
28 through Day 364). Safety profiles were mainly related to
hormonal effects of treatment and the underlying disease.
Degarelix 240/80 mg (n=207) Leuprolide 7.5 mg (n=201)
Patients with testosterone s0.5 ng/mL, %
Day 3 96.1 0
Day 14 100.0 18.2
Days 28-364 97.2 96.4
Patients with testosterone surge, n (%) 0 80.1
Patients with testosterone escape.a n (%) 2.4 3.5
Median reduction in PSA from baseline, %
Day 14 64* 18
Day 28 85* 68
aTestosterone (T) escape = at least one T value >0.5 ng/mL between Day 28 and Day 364.
*p<0.001 vs leuprolide
Conclusion: Degarelix reduces serum FSH, LH, testosterone and
PSA levels faster than leuprolide; without a testosterone surge.
Testosterone was reduced to very low levels and degarelix was
at least as effective as leuprolide in maintaining serum T levels
s0.5 ng/mL for the duration of the study.
15 PVP with 120W Greenlight laser in the treatment of
patients with BPH on anticoagulants
G Piotrowicz, H Zielinski, R Jedynak
Urology Department, Militnry lnstitute ofMedicine, Warsaiu, Poland
gppiotr@poczta.onet.pl
Aim: The aim of the study is to evaluate the results of
photoselective vaporization of the prostate (PVP) with 120W
Greenlight laser in the treatment of patients with BPH on
anticoagulants.
Material and methods: 77 patients underwent PVP in
our department from 2006 to 2008. 65 patients were on
anticoagulants.
We evaluated objective and subjective parameters before and
1, 6 and 12 months after PVP. Duration of the procedure, time
of catheterization and hospitalization as well as morphological
and biochemical parameters and intra - and postoperative
complications were assessed.
Results: The mean catheterization time was 18.5 hours. The
mean hospitalization time after PVP was 1.4 days. The mean
maximum urinary flow rate improved from 9.8 before to 21.8,
22.8 and 21.9 ml/s; PVR decreased from 118.2 to 35.6, 32.9 and
34.1 ml; IPSS decreased from 24.7 to 11.2, 7.3 and 7.1; QoL score
decreased from 4.85 to 2.3, 1.74 and 1.71 at 1, 6 and 12 months,
respectively.
There was no major complication during PVP. No significant
change in morphological and biochemical parameters was
observed and no blood transfusion was necessary. Main
postoperative complications included mild transient dysuria
and hematuria. 2 patients required recatheterization due
to urine retention. 10 out of 26 sexually active patients had
retrograde ejaculation. 1 patient required re-TURP and 2 had
urethral stricture.
Conclusion: PVP with 120W Greenlight laser appears to be safe
and effective method of treatment for patients with BPH on
anticoagulants.
LÆKNAblaðið 2007/93 13