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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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