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Radical Prostatectomy improves
prostate specific death rate in comparison to "watchful waiting".
Analysis of Swedish trial as reported the New England Journal of
Medicine, 2002. (November 2002)
A much quoted article, "A Randomized
Trial Comparing Radical Prostatectomy With Watchful Waiting In Early
Prostate Cancer" appeared in the September 12 issue of the N Eng J Med. It
reported that the overall mortality in 696 Swedish men at a median
follow-up of 6.2 years was not significantly different for the RP group
versus the observation group. The men's average was 64 years, PSA's <50 ng/mL,
expected future life 10 years or more, and bone scans negative. If nodes
were positive at RP the man was excluded from the study. Similar treatment
was given to the two groups when local or distant disease developed.
Important points for this discussion are: 1) Screening accounted for only
5.2% of diagnoses (the study period began in l987 at the very beginning of
the PSA period) and 40% of men were symptomatic at diagnosis; 2) 12% of
men presented with T1C and 12% T1B disease respectively, and 75% were T2,
and, 3) 46% of PSA's were >10 ng/mL, and, 4) 60% of Gleason score were
2-6, 23% 7, and 5% 8-10.
The outcome: at 6.2 year median F/U PCSD was 4.6% in the RP group and 8.9%
in the WW group. Early data at eight years showed a PCSD rate of 7.1% for
the RP group versus l3.6% for WW. HOWEVER, at 6.2 years of F/U, the
OVERALL mortality was not significantly different. (Editor: This is the
point that I fear most lay readers might take away from the study]
Interestingly, at only the five year point there was no difference between
PCSD in either group. It was only at 8 years that the full survival
advantage in PCSD was seen favoring the RP group, i.e. 7.1% versus 13.6%.
At 8 years there was a 6% absolute reduction in both overall and disease
specific death rate favoring the RP group but this was incomplete data. At
2 years there was no difference in metastatic disease, but by 8 years the
RP group showed a 14% comparative reduction. And by 8 years local
recurrence developed in 60% for the WW group versus 20% for RP.
Bottom Line: The question here is - Is this study really about EARLY
prostate cancer?
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