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Nelen V.,Provinciaal Instituut voor Hygiene | Thys G.,Provinciaal Instituut voor Hygiene | Hermans A.,Oncological Center | D'Hooge K.,Provinciaal Instituut voor Hygiene | And 4 more authors.
European Journal of Cancer

Background: The European randomised study of screening for prostate cancer (ERSPC) was initiated to evaluate the effect of Prostate Specific Antigen (PSA) screening on prostate cancer mortality. Variations in screening modalities between participating centres, such as the interval between screening rounds are likely to affect the outcome of screening. Methods: The study describes the number and characteristics of interval cancers in men in the screening arm of the Antwerp ERSPC aged 55-65 years at the time of randomisation and participating in the screening rounds they were invited for. The interval between the first screening rounds was 6 years on average. Interval cancers were defined as cancers diagnosed during the screening interval but not detected by screening. Cases with a positive screening test were considered as interval cancers if diagnosis through biopsy occurred more than 1 year after screening. Interval cancer cases were identified through linkage with cancer registries. Aggressive interval cancer was defined as cancer with at least one of the following characteristics: stage M1 or N1, Gleason score higher than 7 or World Health Organisation (WHO) score of 3. Results: The 10 year cumulative incidence of interval cancers was 3.0% (n = 50) and the cumulative incidence of aggressive interval cancers was 0.5% (n = 8). During the first screening interval 36 interval cancers were detected. Of these 20 (55.6%) were detected more than 4 years after the initial screening and 5 (13.9%) were considered aggressive. All aggressive interval cancers emerged more than 4 years after initial screening. Conclusion: The occurrence of interval cancers in this study was higher than in the ERSPC centres that used a shorter screening interval. Aggressive interval cancers only started to emerge 4 years after initial screening. © 2010 Published by Elsevier Ltd. Source

Wemakor A.,University of Ulster | Wemakor A.,University for Development Studies | Casson K.,University of Ulster | Garne E.,Hospital Lillebaelt | And 15 more authors.
European Journal of Epidemiology

Evidence of an association between early pregnancy exposure to selective serotonin reuptake inhibitors (SSRI) and congenital heart defects (CHD) has contributed to recommendations to weigh benefits and risks carefully. The objective of this study was to determine the specificity of association between first trimester exposure to SSRIs and specific CHD and other congenital anomalies (CA) associated with SSRI exposure in the literature (signals). A population-based case-malformed control study was conducted in 12 EUROCAT CA registries covering 2.1 million births 1995–2009 including livebirths, fetal deaths from 20 weeks gestation and terminations of pregnancy for fetal anomaly. Babies/fetuses with specific CHD (n = 12,876) and non-CHD signal CA (n = 13,024), were compared with malformed controls whose diagnosed CA have not been associated with SSRI in the literature (n = 17,083). SSRI exposure in first trimester pregnancy was associated with CHD overall (OR adjusted for registry 1.41, 95 % CI 1.07–1.86, fluoxetine adjOR 1.43 95 % CI 0.85–2.40, paroxetine adjOR 1.53, 95 % CI 0.91–2.58) and with severe CHD (adjOR 1.56, 95 % CI 1.02–2.39), particularly Tetralogy of Fallot (adjOR 3.16, 95 % CI 1.52–6.58) and Ebstein’s anomaly (adjOR 8.23, 95 % CI 2.92–23.16). Significant associations with SSRI exposure were also found for ano-rectal atresia/stenosis (adjOR 2.46, 95 % CI 1.06–5.68), gastroschisis (adjOR 2.42, 95 % CI 1.10–5.29), renal dysplasia (adjOR 3.01, 95 % CI 1.61–5.61), and clubfoot (adjOR 2.41, 95 % CI 1.59–3.65). These data support a teratogenic effect of SSRIs specific to certain anomalies, but cannot exclude confounding by indication or associated factors. © 2015, Springer Science+Business Media Dordrecht. Source

Zappa M.,ISPO Cancer Research and Prevention Institute | Puliti D.,ISPO Cancer Research and Prevention Institute | Hugosson J.,Sahlgrenska University Hospital | Schroder F.H.,Erasmus University Rotterdam | And 11 more authors.
European Urology

The advantages and disadvantages of two different methods of analyzing the European Randomized Study of Screening for Prostate Cancer (ERSPC) trial with respect to the effect of prostate-specific antigen (PSA) screening on prostate cancer (PCa) mortality (ie, disease-specific mortality analysis and excess mortality analysis) are discussed in depth. The traditional disease-specific mortality is the best end point, but it could be biased by misclassification of causes of death, and it does not take into account the possible effect of the screening process on other causes of death. Excess mortality analysis overcomes these problems, but the results could be biased if the expected mortality is not corrected for attendance status. Both methods, when applied to the ERSPC trials, demonstrate that no increase in non-PCa mortality occurred in the screening group and confirm that PSA screening decreases PCa mortality. © 2013 European Association of Urology. Source

Heijnsdijk E.A.M.,Erasmus Medical Center | Wever E.M.,Erasmus Medical Center | Auvinen A.,University of Tampere | Auvinen A.,International Agency for Research on Cancer | And 20 more authors.
New England Journal of Medicine

Background: After 11 years of follow-up, the European Randomized Study of Screening for Prostate Cancer (ERSPC) reported a 29% reduction in prostate-cancer mortality among men who underwent screening for prostate-specific antigen (PSA) levels. However, the extent to which harms to quality of life resulting from overdiagnosis and treatment counterbalance this benefit is uncertain. Methods: On the basis of ERSPC follow-up data, we used Microsimulation Screening Analysis (MISCAN) to predict the number of prostate cancers, treatments, deaths, and quality-adjusted life-years (QALYs) gained after the introduction of PSA screening. Various screening strategies, efficacies, and quality-of-life assumptions were modeled. Results: Per 1000 men of all ages who were followed for their entire life span, we predicted that annual screening of men between the ages of 55 and 69 years would result in nine fewer deaths from prostate cancer (28% reduction), 14 fewer men receiving palliative therapy (35% reduction), and a total of 73 life-years gained (average, 8.4 years per prostate-cancer death avoided). The number of QALYs that were gained was 56 (range, -21 to 97), a reduction of 23% from unadjusted life-years gained. To prevent one prostate-cancer death, 98 men would need to be screened and 5 cancers would need to be detected. Screening of all men between the ages of 55 and 74 would result in more life-years gained (82) but the same number of QALYs (56). Conclusions: The benefit of PSA screening was diminished by loss of QALYs owing to postdiagnosis long-term effects. Longer follow-up data from both the ERSPC and quality-of-life analyses are essential before universal recommendations regarding screening can be made. (Funded by the Netherlands Organization for Health Research and Development and others.) Copyright © 2012 Massachusetts Medical Society. Source

Buzzoni C.,ISPO Cancer Research and Prevention Institute | Auvinen A.,University of Tampere | Roobol M.J.,Erasmus Medical Center | Carlsson S.,Gothenburg University | And 17 more authors.
European Urology

Background The European Randomized Study of Screening for Prostate Cancer (ERSPC) has shown a 21% reduction in prostate cancer (PCa) mortality and a 1.6-fold increase in PCa incidence with prostate-specific antigen (PSA)-based screening (at 13 yr of follow-up). We evaluated PCa incidence by risk category at diagnosis across the study arms to assess the potential impact on PCa mortality. Design, setting, and participants Information on arm, centre, T and M stage, Gleason score, serum PSA at diagnosis, age at randomisation, follow-up time, and vital status were extracted from the ERSPC database. Four risk categories at diagnosis were defined: 1, low; 2, intermediate; 3, high; 4, metastatic disease. PSA (≤100 or >100 ng/ml) was used as the indicator of metastasis. Outcome measurements and statistical analysis Incidence rate ratios (IRRs) for screening versus control arm by risk category at diagnosis and follow-up time were calculated using Poisson regression analysis for seven centres. Follow-up was truncated at 13 yr. Missing data were imputed using chained equations. The analyses were carried out on an intention-to-treat basis. Results and limitations In the screening arm, 7408 PCa cases were diagnosed and 6107 in the control arm. The proportion of missing stage, Gleason score, or PSA value was comparable in the two arms (8% vs 10%), but differed among centres. The IRRs were elevated in the screening arm for the low-risk (IRR: 2.14; 95% CI, 2.03-2.25) and intermediate-risk (IRR: 1.24; 95% CI, 1.16-1.34) categories at diagnosis, equal to unity for the high-risk category at diagnosis (IRR: 1.00; 95% CI, 0.89-1.13), and reduced for metastatic disease at diagnosis (IRR: 0.60; 95% CI, 0.52-0.70). The IRR of metastatic disease had temporal pattern similar to mortality, shifted forwards an average of almost 3 yr, although the mortality reduction was smaller. Conclusions The results confirm a reduction in metastatic disease at diagnosis in the screening arm, preceding mortality reduction by almost 3 yr. Patient summary The findings of this study indicate that the decrease in metastatic disease at diagnosis is the major determinant of the prostate cancer mortality reduction in the European Randomized study of Screening for Prostate Cancer. © 2015 European Association of Urology. Source

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