Objectives To assess the effect of screening in terms of excess mortality in the European Randomized Study of Screening for Prostate Cancer (ERSPC). Methods A total of 141,578 men aged 55-69 were randomized to systematic screening or usual care in ERSPC sections in Finland, Italy, the Netherlands and Sweden. The excess number of deaths was defined as the difference between the observed number of deaths in the prostate cancer (PC) patients and the expected number of deaths up to 31 December 2006. The expected number was derived from mortality of all study participants before a diagnosis with PC adjusted for study centre, study arm and study attendance. The excess mortality rates were compared between the two study arms. Results The PC incidence was 9.25 per 1000 person-years in the intervention arm and 5.49 per 1000 person-years in the control arm, relative risk (RR) 1.69 (95% confidence interval [CI] 1.62-1.76). The excess mortality among men with PC was 0.29 per 1000 person-years in the intervention arm and 0.37 per 1000 person-years in the control arm; the RR for excess mortality was 0.77 (95% CI 0.55-1.08). The absolute risk reduction in the excess mortality was 0.08 per 1000 person-years. The overall mortality was not significantly different between the intervention and the control arms of the study: RR 0.99 (95% CI 0.96-1.01). Conclusions Although the reduction in excess mortality was not statistically significant, the between-arm reduction in excess mortality rate was in line with the previously reported 20% reduction in the disease-specific mortality. This finding indicates that the reduction in PC mortality in the ERSPC trial cannot be due to a bias in cause of death adjudication.
Journal of medical screening. 2013 Mar [Epub]
Pim J van Leeuwen, Ries Kranse, Timo Hakulinen, Jonas Hugosson, Teuvo L Tammela, Stefano Ciatto, Monique J Roobol, Marco Zappa, Harry J de Koning, Chris H Bangma, Sue M Moss, Anssi Auvinen, Fritz H Schröder
MD, PhD., Erasmus University Medical Centre , Rotterdam , the Netherlands., Statistician , Comprehensive Cancer Center the Netherlands (IKNL) , Rotterdam , the Netherlands., Professor of Epidemiology and Biostatistics , Finnish Cancer Registry , Helsinki , Finland., Professor of Urology , Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg , Gothenburg , Sweden., Professor of Urology , Tampere University Hospital , Tampere , Finland., Professor of cancer screening , The Department of Diagnostic Medical Imaging , Florence , Italy., Associate professor of cancer screening , Erasmus University Medical Centre , Rotterdam , the Netherlands., MD, Unit of Epidemiology , Institute for Cancer Prevention , Florence , Italy., Professor of Epidemiology , Department of Public Health, Erasmus MC, University Medical Centre Rotterdam , the Netherlands., Professor of Urology , Erasmus University Medical Centre , Rotterdam , the Netherlands., MD, Cancer Screening Evaluation Unit , Surrey, London , UK., Professor of Epidemiology , Tampere School of Public Health , Tampere , Finland.