Radical prostatectomy versus watchful waiting in early
prostate cancer. Bill-Axelson A, Holmberg L, Ruutu M
et al. N Engl J Med 2005; 352: 1977-1984.
Radical prostatectomy is becoming one of the post common major surgical
procedures in many Western countries. However, there have been few
randomised trials quantifying the benefit of this surgical procedure.
The aim of this study was to assess whether the relative reduction in the
risk of death due to prostate cancer after surgery increases with time and
to assess whether radical surgery significantly improves survival.
Between 1989 and 1999, 695 men with early prostate cancer (mean age = 65
years) were randomly assigned to radical prostatectomy (n=347) or watchful
waiting (n=348). The follow-up was complete through 2003, with
blinded evaluation of the causes of death. The primary endpoint was
death due to prostate cancer. The secondary end points were death
from any cause, metastasis and local progression. During a median
follow-up of 8.2 years, 83 men in the surgery group and 106 men in the
watchful waiting group died (p=0.04). In 30 of the 347 men assigned
to surgery (8.6%) and 50 of the 348 men assigned to watchful weighting
(14.4%) death was due to prostate cancer. The difference in the
cumulative incidence of death due to prostate cancer increased from 2.0%
after 5 years to 5.3% after 10 years, for a relative risk of 0.56 (95% CI
0.36-0.88. p=0.01). For distant metastasis the corresponding
increase was from 1.7% to 10.2% for a relative risk in the surgery group
of 0.60 (95% CI 0.42-0.86. p=0.004). For local tumour
progression the corresponding increase was from 19.1% to 25.1% for a
relative risk in the surgery group of 0.33 (95% CI 0.25-0.44. p<0.001).
It was concluded that radical prostatectomy reduces disease-specific
mortality, overall mortality and the risks of metastasis and local
progression. The absolute reduction in the risk of death after 10
years is small, but the reduction in risk of metastasis and local tumour
progression are substantial.
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