2 juli 2010: Bron The Lancet

Preventief screenen op prostaatkanker door middel van regelmatige PSA metingen blijft de gemoederen bezig houden. De ene studie toont een groot verschil aan . Andere studies weer niet. zie verderop in dit bericht. Gisteren publiceerde The Lancet een Zweedse 14 jarige bevolkingsstudie die heeft aangetoond dat preventief screenen van mannen tussen 50 en 65 jaar de sterfte aan prostaatkanker met bijna de helft kan verminderen.  Hier het abstract zoals dat door de Lancet is gepubliceerd. daaronder twee andere publicaties waarvan 1 studie dit resultaat bevestigt en een andere studie geen verschil aantoont.

The Lancet Oncology, Early Online Publication, 1 July 2010
doi:10.1016/S1470-2045(10)70146-7Cite or Link Using DOI

Mortality results from the Göteborg randomised population-based prostate-cancer screening trial

Summary

Background

Prostate cancer is one of the leading causes of death from malignant disease among men in the developed world. One strategy to decrease the risk of death from this disease is screening with prostate-specific antigen (PSA); however, the extent of benefit and harm with such screening is under continuous debate.

Methods

In December, 1994, 20 000 men born between 1930 and 1944, randomly sampled from the population register, were randomised by computer in a 1:1 ratio to either a screening group invited for PSA testing every 2 years (n=10 000) or to a control group not invited (n=10 000). Men in the screening group were invited up to the upper age limit (median 69, range 67—71 years) and only men with raised PSA concentrations were offered additional tests such as digital rectal examination and prostate biopsies. The primary endpoint was prostate-cancer specific mortality, analysed according to the intention-to-screen principle. The study is ongoing, with men who have not reached the upper age limit invited for PSA testing. This is the first planned report on cumulative prostate-cancer incidence and mortality calculated up to Dec 31, 2008. This study is registered as an International Standard Randomised Controlled TrialISRCTN54449243.

Findings

In each group, 48 men were excluded from the analysis because of death or emigration before the randomisation date, or prevalent prostate cancer. In men randomised to screening, 7578 (76%) of 9952 attended at least once. During a median follow-up of 14 years, 1138 men in the screening group and 718 in the control group were diagnosed with prostate cancer, resulting in a cumulative prostate-cancer incidence of 12·7% in the screening group and 8·2% in the control group (hazard ratio 1·64; 95% CI 1·50—1·80; p<0·0001). The absolute cumulative risk reduction of death from prostate cancer at 14 years was 0·40% (95% CI 0·17—0·64), from 0·90% in the control group to 0·50% in the screening group. The rate ratio for death from prostate cancer was 0·56 (95% CI 0·39—0·82; p=0·002) in the screening compared with the control group. The rate ratio of death from prostate cancer for attendees compared with the control group was 0·44 (95% CI 0·28—0·68; p=0·0002). Overall, 293 (95% CI 177—799) men needed to be invited for screening and 12 to be diagnosed to prevent one prostate cancer death.

Interpretation

This study shows that prostate cancer mortality was reduced almost by half over 14 years. However, the risk of over-diagnosis is substantial and the number needed to treat is at least as high as in breast-cancer screening programmes. The benefit of prostate-cancer screening compares favourably to other cancer screening programs.

Funding

The Swedish Cancer Society, the Swedish Research Council, and the National Cancer Institute.

19 maart 2009: Bron: http://content.nejm.org/cgi/content/abstract/NEJMoa0810696v1

Preventief screenen van mannen op prostaatkanker zou volgens grote Europese studie 21% minder sterfgevallen aan prostaatkanker betekenen. Een grote Amerikaanse studie met zelfde opzet geeft daarentegen aan dat preventief screenen weinig tot geen verschil in sterven aan prostaatkanker zou betekenen. Beide studies benadrukken dat overdiagnose van prostaatkanker het grote gevaar is van voortijdig screenen omdat veel prostaatkanker, vooral bij oudere mannen zelden tot overlijden leidt en zelfs zonder behandelingen kunnen mannen met prostaatkanker oud worden. Hieronder de twee abstracten maar interessanter voor artsen is om de volledige studieverslagen te lezen. Daarin staat utivoerig beschreven de voor- en nadelen en ook waarom er zulke grote verschillen optreden in resultaat tussen Amerikaanse en Europese studie. Zie daarvoor: http://content.nejm.org/

ABSTRACT

Background The European Randomized Study of Screening for Prostate Cancer was initiated in the early 1990s to evaluate the effect of screening with prostate-specific–antigen (PSA) testing on death rates from prostate cancer.

 


Measurement of serum prostate-specific antigen (PSA), a biomarker for prostate cancer,1 is useful for the detection of early prostate cancer.2 Nevertheless, the effect of PSA-based screening on prostate-cancer mortality remains unclear.3 The European Randomized Study of Screening for Prostate Cancer (ERSPC) was initiated in the early 1990s to determine whether a reduction of 25% in prostate-cancer mortality could be achieved by PSA-based screening.4 Preliminary data from this study have been published and can be accessed at www.erspc.org. Another randomized screening trial in the United States, the Prostate, Lung, Colon, and Ovarian (PLCO) Cancer Screening Trial, was initiated around the same time, and interim results are also reported in this issue of the Journal.5

 Published at www.nejm.org March 18, 2009 (10.1056/NEJMoa0810696)

 

Mortality Results from a Randomized Prostate-Cancer Screening Trial
 

Gerald L. Andriole, M.D., Robert L. Grubb, III, M.D., Saundra S. Buys, M.D., David Chia, Ph.D., Timothy R. Church, Ph.D., Mona N. Fouad, M.D., Edward P. Gelmann, M.D., Paul A. Kvale, M.D., Douglas J. Reding, M.D., Joel L. Weissfeld, M.D., Lance A. Yokochi, M.D., E. David Crawford, M.D., Barbara O'Brien, M.P.H., Jonathan D. Clapp, B.S., Joshua M. Rathmell, M.S., Thomas L. Riley, B.S., Richard B. Hayes, Ph.D., Barnett S. Kramer, M.D., Grant Izmirlian, Ph.D., Anthony B. Miller, M.B., Paul F. Pinsky, Ph.D., Philip C. Prorok, Ph.D., John K. Gohagan, Ph.D., Christine D. Berg, M.D., for the PLCO Project Team

 ABSTRACT

Background The effect of screening with prostate-specific–antigen (PSA) testing and digital rectal examination on the rate of death from prostate cancer is unknown. This is the first report from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial on prostate-cancer mortality.

Methods From 1993 through 2001, we randomly assigned 76,693 men at 10 U.S. study centers to receive either annual screening (38,343 subjects) or usual care as the control (38,350 subjects). Men in the screening group were offered annual PSA testing for 6 years and digital rectal examination for 4 years. The subjects and health care providers received the results and decided on the type of follow-up evaluation. Usual care sometimes included screening, as some organizations have recommended. The numbers of all cancers and deaths and causes of death were ascertained.

Results In the screening group, rates of compliance were 85% for PSA testing and 86% for digital rectal examination. Rates of screening in the control group increased from 40% in the first year to 52% in the sixth year for PSA testing and ranged from 41 to 46% for digital rectal examination. After 7 years of follow-up, the incidence of prostate cancer per 10,000 person-years was 116 (2820 cancers) in the screening group and 95 (2322 cancers) in the control group (rate ratio, 1.22; 95% confidence interval , 1.16 to 1.29). The incidence of death per 10,000 person-years was 2.0 (50 deaths) in the screening group and 1.7 (44 deaths) in the control group (rate ratio, 1.13; 95% CI, 0.75 to 1.70). The data at 10 years were 67% complete and consistent with these overall findings.

Conclusions After 7 to 10 years of follow-up, the rate of death from prostate cancer was very low and did not differ significantly between the two study groups. (ClinicalTrials.gov number, NCT00002540 [ClinicalTrials.gov] .)

 

11 januari 2006: Bron: Arch Intern Med 2006;166:38-43 en Medscape

Voortijdige screening op PSA en/of digitale rectum screening voor opsporen van prostaatkanker heeft geen enkel positief effect op de uiteindelijke overlevingscijfers van de mannen die prostaatkanker bleken te hebben. Dit toont een grote cohort studie aan van vier jaar, van 1991 tot 1995 onder 70.000 mannen in de regio New England in Amerika waarvan er uiteindelijk 1425 mannen werden gediagnosteerd met prostaatkanker. De onderzoekers en betrokken artsen merken op dat ze dit nu tegen hun patienten zeggen: "De PSA test is onbetrouwbaar, en screening kan leiden tot mogelijke schade als wel tot mogelijk profijt. Het profijt kan betekenen een grotere potentie voor een verbeterde kans op overleving bij sommige mannen. De schade kan betekenen dat sommige mannen onnodige behandelingsgerelateerde schade oplopen in de vorm van incontinentie en impotentie veroorzaakt door ook nog eens ineffectieve en onnodige behandelingen."

Prostate Cancer Screening May Not Reduce Mortality
By Anthony J. Brown, MD

NEW YORK (Reuters Health) Jan 09 - In the latest study to question the value of prostate cancer screening, researchers have shown that evaluation with PSA testing or digital rectal examination (DRE) does not reduce mortality.

"Among studies of the effectiveness of prostate cancer screening, our study is important in focusing on mortality as the outcome and in using rigorous methods to identify screening tests," lead author Dr. John Concato, from the VA Connecticut Healthcare System in West Haven, told Reuters Health. "We also have a large sample size and selected cases and controls from a community-based sample of participants."

The unclear benefits of prostate cancer screening are reflected in the different recommendations put forth by medical organizations. For example, the American Cancer Society and American Urological Association both recommend PSA and DRE screening for men older than 50 years, whereas the US Prevention Services Task Force believes that evidence is lacking to advocate screening.

The new findings, which appear in the Archives of Internal Medicine for January 9, are based on an assessment of 1425 men diagnosed with prostate cancer between 1991 and 1995, identified from among more than 70,000 patients who received ambulatory care at one of ten VA medical centers in New England.

Among the group with prostate cancer, 501 men died between 1991 and 1999. These cases were matched to 501 controls selected from the prostate cancer cohort who were alive at the time the corresponding case patient died. "Definite screening with PSA occurred in 70 cases (14%) and 65 controls (13%)," the researchers report. They point out that if screening were beneficial, the rate would be lower among the fatal cases than the controls.

The team's analysis shows that screening with PSA and DRE, either alone or in combination, did not reduce all-cause or cause-specific mortality. As to why such screening may not improve survival, Dr. Concato noted that "men will benefit from screening only if a tumor with the potential to cause harm is detected and treated before it becomes metastatic; and this may not happen often enough for screening of healthy men to 'work'."

Dr. Concato said that while the present study provides useful information on this topic, the issue of whether prostate cancer screening is worthwhile is by no means settled. The results of ongoing studies, released in the next few years, "will hopefully provide more clarity," he added. In the meantime, Dr. Concato said clinicians should counsel their patients that "the PSA test isn't perfect, and that screening may lead to possible harm as well as potential benefit. The benefits include the potential for improved survival in some men. The harms include possible treatment-related side effects, including incontinence and impotence, for therapies that may be unnecessary or ineffective." There is also the stress and anxiety associated with false-positive results, he added.

Arch Intern Med 2006;166:38-43.

 

 

 

Screening and Prostate-Cancer Mortality in a Randomized European Study
 

Fritz H. Schröder, M.D., Jonas Hugosson, M.D., Monique J. Roobol, Ph.D., Teuvo L.J. Tammela, M.D., Stefano Ciatto, M.D., Vera Nelen, M.D., Maciej Kwiatkowski, M.D., Marcos Lujan, M.D., Hans Lilja, M.D., Marco Zappa, Ph.D., Louis J. Denis, M.D., Franz Recker, M.D., Antonio Berenguer, M.D., Liisa Määttänen, Ph.D., Chris H. Bangma, M.D., Gunnar Aus, M.D., Arnauld Villers, M.D., Xavier Rebillard, M.D., Theodorus van der Kwast, M.D., Bert G. Blijenberg, Ph.D., Sue M. Moss, Ph.D., Harry J. de Koning, M.D., Anssi Auvinen, M.D., for the ERSPC Investigators


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