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ERSPC: PSA-Screeningsstudie |
| Allgemeines |
In 8 europäischen Ländern wurden 182.160 Männer randomiert zu PSA-Sceening oder Beobachtung. |
| Alter |
162.388 waren zwischen 50 und 74 Jahre alt. |
| Screening |
Screening - Interval: 4 Jahre (2 in Schweden). PSA > 3.0: Sextant Biopsie. |
| Biopsie |
Bei PSA > 3.0 erfolgte eine Sextant Biopsie. |
| Prostata - Ca - Mortalität (2) |
In der Screening Gruppe war die Sterblichkeit an Prostata - Ca um 21% geringer (RR = 0,79, p < 0,001).
Absolute Reduktion der Sterblichkeit: Screening 0,1 Tote /1000 Mannjahre - kein Screening: 1,07 Sterbefälle / 1000 Mannjahr |
| Prostata - Ca - Mortalität (3) |
In der Screening Gruppe war die Sterblichkeit an Prostata - Ca um 17% geringer (RR = 0,83, p < 0,001).
55-69 Jahre: 21% Reduktion, RR 0,79. Nach 9 Jahren 15% reduktion, nach 11 Jahren 22%, nach 13 Jahren 21%.
Gesamt-Sterblichkeit durch PSA-Screening nicht verändert. |
| Ergebnisse 2012 (2) |
| Gruppe |
Screening | kein Screening |
| Anzahl |
72,891 | 89,352 |
| Prostata - Ca |
6963 |
5396 |
| low risk |
4198 (60.3%) | 2249 (41.7%) |
| intermediate risk |
1495 (21.5%) | 1442 (26.7%) |
| high risk |
515 (7.4%) | 673 (12.5%) |
| M1 or PSA >100 ng/ml |
180 (2.6%) | 424 (7.9%) |
| Sterbefälle insgesamt |
13.917 |
17.256 |
| Prostata - Ca - Sterbefälle |
299 (0.4%) |
462 (0.5%) | |
Ergebnisse 2014 (3) |
| Gruppe |
Screening |
kein Screening |
| Prostata - Ca |
6107 |
7408 |
| Sterbefälle insgesamt |
18251 |
21.992 |
| Prostata - Ca - Sterbefälle |
299 (0.4%) |
462 (0.5%) |
|
Quellen |
1.) 1.) Schröder FH, et al.:
Screening and prostate-cancer mortality in a randomized European study.
N Engl J Med 360(2009):1320-8
2.) Schröder FH, et al.:
Prostate-cancer mortality at 11 years of follow-up.
N Engl J Med 2012;366:981-90
3.) Schröder FH, Hugosson J, Roobol M, et al.:
Screening and prostate cancer mortality: results of the European Randomised
Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up.
Lancet 2014; 384: 2027–34.
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1.Schroder FH, Hugosson J, Roobol MJ, et al. Screening and prostate-cancer
mortality in a randomized European study. N Engl J Med. 2009;360:1320–1328
View In ArticleCrossRef 2.Andriole GL, Crawford ED, Grubb RL, et al.
Mortality results from a randomized prostate-cancer screening trial. N Engl
J Med. 2009;360:1310–1319 Ciezki JP, Reddy CA, Kupelian PA, et al. Effect of
prostate-specific antigen screening on metastatic disease burden 10 years
after diagnosis. Urology. 2012;80:367–372 Loeb S, Zhu X, Schroder FH, et al.
Long-term radical prostatectomy outcomes among participants from the
European Randomized Study of Screening for Prostate Cancer (ERSPC)
Rotterdam. BJU Int. 2012;110:1678–1683 Loeb et al. Long-term radical
prostatectomy outcomes among participants from the European Randomized Study
of Screening for Prostate Cancer (ERSPC) Rotterdam. BJU Int 2012. (5)
Summary: Loeb et al (5) focused on the Rotterdam section of ERSPC and
examined the effect of treatment with radical prostatectomy on outcome
depending on the arm of the trial (eg, screening vs control) to which the
patient was randomized. During the study period examined (1993-1999), there
were a total of 42,376 men randomized. Prostate cancer diagnoses were made
in 1151 men in the screening arm and in 210 men in the control arm; 420 men
in the screening arm and 54 men in the control arm subsequently underwent a
radical prostatectomy. With a median follow-up of 9.9 years, the
investigators reported that patients in the screening arm had improved
progression-free, metastases-free, and cancer-specific survival versus
patients in the control arm. In multivariable modeling, the men in the
screening arm had a higher biochemical progression-free survival (hazard
ratio [HR] = 0.43; 95% CI = 0.23-0.83; P=.011) and a higher metastases-free
survival (HR = 0.18; 95% CI = 0.06-0.59; P=.005). The authors also noted
that the patients in the screened arm had a lower pre-prostatectomy PSA and
more favorable pathology, most notably lower tumor volume, after
prostatectomy, which they attributed to lead-time bias. Comment: Using some
of the data that generated the problematic US Preventive Services Task
Force’s recommendation, the authors have provided evidence that PSA
screening is associated with significant benefits, clearly arguing for its
continued use. The reduction in the development of metastatic disease
associated with screening is intuitively an extremely important finding when
the burden that metastatic disease imposes on the health care delivery
system is considered. The treatment of metastatic prostate cancer not only
involves the costly end-of-life care associated with most long-term
illnesses, it is also often preceded by a protracted course of
pharmacologic, radiotherapeutic, and surgical interventions. In their
discussion, the authors state that the lead-time bias imparted by screening
has been estimated at approximately 11 years from previous examinations of
the ERSPC data. Other authors using different data sets have estimated the
lead-time bias associated with PSA screening at approximately 5 years (6).
Regardless of the actual length of lead time that PSA screening yields, it
seems to be associated with a reduction of the rate of metastatic disease
after treatment. Traditionally, lead-time bias has been viewed as a
confounder with negative connotations when examining the outcome of prostate
cancer treatment. If a reduction in metastatic disease is associated with
lead-time bias and lead-time bias is associated with PSA screening, then the
lead-time bias resulting from PSA screening that decreases the metastatic
burden of the population should be viewed positively. The same positive view
may be taken of PSA screening when one considers the global impact: mild
decrease in prostate cancer-specific mortality coupled with a significant
decrease in metastatic disease. Of course, the harsh reality of medical care
delivery demands an assessment of the financial cost associated with
screening. Investigators have used the European screening trial data to
extrapolate cost-effectiveness in the United States, but they addressed only
the cost relative to prostate cancer-specific survival (7). They performed a
number-needed-to-screen analysis from which they concluded that 48 patients
must be screened to prevent 1 prostate cancer death. Because the number of
men living with metastatic prostate cancer is about 3 times as great as
those who die of it in any given year (8), one may adjust their
number-needed-to-screen analysis to focus on metastatic disease by
increasing the event rate by a factor of 3. This gives a new result of 16 as
the number of patients one must screen to prevent 1 metastatic failure
because an increase in the event rate by a factor of 3 decreases the
number-needed-to-screen by two-thirds. The authors stated that PSA screening
in the United States would not be cost-effective because a
number-needed-to-screen of 48 exceeds their cost-effectiveness threshold of
21. This new calculation of 16 drops the number needed to screen below 21,
which one assumes would be cost-effective. Loeb et al (5) offer us an
alternative way to view PSA screening in which PSA screening decreases
metastatic disease in the screened population in a potentially
cost-effective manner.
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