Dataset Information

Prostate-cancer mortality at 11 years of follow-up.

ABSTRACT: Several trials evaluating the effect of prostate-specific antigen (PSA) testing on prostate-cancer mortality have shown conflicting results. We updated prostate-cancer mortality in the European Randomized Study of Screening for Prostate Cancer with 2 additional years of follow-up.The study involved 182,160 men between the ages of 50 and 74 years at entry, with a predefined core age group of 162,388 men 55 to 69 years of age. The trial was conducted in eight European countries. Men who were randomly assigned to the screening group were offered PSA-based screening, whereas those in the control group were not offered such screening. The primary outcome was mortality from prostate cancer.After a median follow-up of 11 years in the core age group, the relative reduction in the risk of death from prostate cancer in the screening group was 21% (rate ratio, 0.79; 95% confidence interval [CI], 0.68 to 0.91; P=0.001), and 29% after adjustment for noncompliance. The absolute reduction in mortality in the screening group was 0.10 deaths per 1000 person-years or 1.07 deaths per 1000 men who underwent randomization. The rate ratio for death from prostate cancer during follow-up years 10 and 11 was 0.62 (95% CI, 0.45 to 0.85; P=0.003). To prevent one death from prostate cancer at 11 years of follow-up, 1055 men would need to be invited for screening and 37 cancers would need to be detected. There was no significant between-group difference in all-cause mortality.Analyses after 2 additional years of follow-up consolidated our previous finding that PSA-based screening significantly reduced mortality from prostate cancer but did not affect all-cause mortality. (Current Controlled Trials number, ISRCTN49127736.).

SUBMITTER: Schroder FH

PROVIDER: S-EPMC6027585 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature

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Prostate-cancer mortality at 11 years of follow-up.

Schröder Fritz H FH Hugosson Jonas J Roobol Monique J MJ Tammela Teuvo L J TL Ciatto Stefano S Nelen Vera V Kwiatkowski Maciej M Lujan Marcos M Lilja Hans H Zappa Marco M Denis Louis J LJ Recker Franz F Páez Alvaro A Määttänen Liisa L Bangma Chris H CH Aus Gunnar G Carlsson Sigrid S Villers Arnauld A Rebillard Xavier X van der Kwast Theodorus T Kujala Paula M PM Blijenberg Bert G BG Stenman Ulf-Hakan UH Huber Andreas A Taari Kimmo K Hakama Matti M Moss Sue M SM de Koning Harry J HJ Auvinen Anssi A

The New England journal of medicine 20120301 11

<h4>Background</h4>Several trials evaluating the effect of prostate-specific antigen (PSA) testing on prostate-cancer mortality have shown conflicting results. We updated prostate-cancer mortality in the European Randomized Study of Screening for Prostate Cancer with 2 additional years of follow-up.<h4>Methods</h4>The study involved 182,160 men between the ages of 50 and 74 years at entry, with a predefined core age group of 162,388 men 55 to 69 years of age. The trial was conducted in eight Eur ...[more]

PMID: 22417251

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Project description:BackgroundThe prostate component of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial was undertaken to determine whether there is a reduction in prostate cancer mortality from screening using serum prostate-specific antigen (PSA) testing and digital rectal examination (DRE). Mortality after 7-10 years of follow-up has been reported previously. We report extended follow-up to 13 years after the trial.MethodsA total of 76 685 men, aged 55-74 years, were enrolled at 10 screening centers between November 1993 and July 2001 and randomly assigned to the intervention (organized screening of annual PSA testing for 6 years and annual DRE for 4 years; 38 340 men) and control (usual care, which sometimes included opportunistic screening; 38 345 men) arms. Screening was completed in October 2006. All incident prostate cancers and deaths from prostate cancer through 13 years of follow-up or through December 31, 2009, were ascertained. Relative risks (RRs) were estimated as the ratio of observed rates in the intervention and control arms, and 95% confidence intervals (CIs) were calculated assuming a Poisson distribution for the number of events. Poisson regression modeling was used to examine the interactions with respect to prostate cancer mortality between trial arm and age, comorbidity status, and pretrial PSA testing. All statistical tests were two-sided.ResultsApproximately 92% of the study participants were followed to 10 years and 57% to 13 years. At 13 years, 4250 participants had been diagnosed with prostate cancer in the intervention arm compared with 3815 in the control arm. Cumulative incidence rates for prostate cancer in the intervention and control arms were 108.4 and 97.1 per 10 000 person-years, respectively, resulting in a relative increase of 12% in the intervention arm (RR = 1.12, 95% CI = 1.07 to 1.17). After 13 years of follow-up, the cumulative mortality rates from prostate cancer in the intervention and control arms were 3.7 and 3.4 deaths per 10 000 person-years, respectively, resulting in a non-statistically significant difference between the two arms (RR = 1.09, 95% CI = 0.87 to 1.36). No statistically significant interactions with respect to prostate cancer mortality were observed between trial arm and age (P(interaction) = .81), pretrial PSA testing (P(interaction) = .52), and comorbidity (P(interaction) = .68).ConclusionsAfter 13 years of follow-up, there was no evidence of a mortality benefit for organized annual screening in the PLCO trial compared with opportunistic screening, which forms part of usual care, and there was no apparent interaction with age, baseline comorbidity, or pretrial PSA testing.

Project description:BACKGROUND:The European Randomised study of Screening for Prostate Cancer (ERSPC) has shown significant reductions in prostate cancer mortality after 9 years and 11 years of follow-up, but screening is controversial because of adverse events such as overdiagnosis. We provide updated results of mortality from prostate cancer with follow-up to 2010, with analyses truncated at 9, 11, and 13 years. METHODS:ERSPC is a multicentre, randomised trial with a predefined centralised database, analysis plan, and core age group (55-69 years), which assesses prostate-specific antigen (PSA) testing in eight European countries. Eligible men aged 50-74 years were identified from population registries and randomly assigned by computer generated random numbers to screening or no intervention (control). Investigators were masked to group allocation. The primary outcome was prostate cancer mortality in the core age group. Analysis was by intention to treat. We did a secondary analysis that corrected for selection bias due to non-participation. Only incidence and no mortality data at 9 years' follow-up are reported for the French centres. This study is registered with Current Controlled Trials, number ISRCTN49127736. FINDINGS:With data truncated at 13 years of follow-up, 7408 prostate cancer cases were diagnosed in the intervention group and 6107 cases in the control group. The rate ratio of prostate cancer incidence between the intervention and control groups was 1·91 (95% CI 1·83-1·99) after 9 years (1·64 [1·58-1·69] including France), 1·66 (1·60-1·73) after 11 years, and 1·57 (1·51-1·62) after 13 years. The rate ratio of prostate cancer mortality was 0·85 (0·70-1·03) after 9 years, 0·78 (0·66-0·91) after 11 years, and 0·79 (0·69-0·91) at 13 years. The absolute risk reduction of death from prostate cancer at 13 years was 0·11 per 1000 person-years or 1·28 per 1000 men randomised, which is equivalent to one prostate cancer death averted per 781 (95% CI 490-1929) men invited for screening or one per 27 (17-66) additional prostate cancer detected. After adjustment for non-participation, the rate ratio of prostate cancer mortality in men screened was 0·73 (95% CI 0·61-0·88). INTERPRETATION:In this update the ERSPC confirms a substantial reduction in prostate cancer mortality attributable to testing of PSA, with a substantially increased absolute effect at 13 years compared with findings after 9 and 11 years. Despite our findings, further quantification of harms and their reduction are still considered a prerequisite for the introduction of populated-based screening. FUNDING:Each centre had its own funding responsibility.

Project description:BACKGROUND: The estimation of healthy life years (HLY) by socio-economic status (SES) requires two types of data: the prevalence of activity limitation by SES generally extracted from surveys and mortality rates by SES generally derived from a linkage between the SES information in population databases (census, register) and mortality records. In some situations, no population-wide databases are available to produce mortality rates by SES, and therefore some alternatives must be explored. This paper assesses the validity of calculating HLY by SES using mortality rates derived from a linkage between surveys and mortality records. METHODS: TWO SURVEYS WERE CHOSEN TO EXPLORE THE VALIDITY OF THE PROPOSED APPROACH: The Belgian Health Interview Survey (HIS) and the Belgian Survey on Income and Living Conditions (SILC). The mortality follow-up of these surveys were used to calculate HLY by educational level at age 25. These HLY were compared with HLY estimates calculated using the mortality follow-up of the 2001 census. The validity of this approach was evaluated against two criteria. First, the HLY calculated using the census and those calculated using the surveys must not be significantly different. Second, survey-based HLY must show significant social inequalities since such inequalities have been consistently reported with census-based HLY. RESULTS: Both criteria were met. First, for each educational category, no statistically significant difference was found when comparing census-based and survey-based HLY estimates. For instance, men in the lowest educational category have shown a HLY of 34 years according to the HIS, and while this figure was 35.5 years according to the census, this difference was not statistically significant. Second, the survey-based HLY have shown a significant social gradient. For instance, men in the highest educational category are expected to live 9.5 more HLY than their counterparts in the lowest educational category based on the HIS estimates, compared with 7.3 HLY based on the census estimates. CONCLUSIONS: This article suggests that using the mortality follow-up of a nationally representative cross-sectional survey is a valid approach to monitor social inequalities in HLY in the absence of population-wide data.

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Prostate-cancer mortality at 11 years of follow-up.

Publications

Prostate-cancer mortality at 11 years of follow-up.

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