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.
RCT Entities:
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.
Authors: Carlotta Buzzoni; Anssi Auvinen; Monique J Roobol; Sigrid Carlsson; Sue M Moss; Donella Puliti; Harry J de Koning; Chris H Bangma; Louis J Denis; Maciej Kwiatkowski; Marcos Lujan; Vera Nelen; Alvaro Paez; Marco Randazzo; Xavier Rebillard; Teuvo L J Tammela; Arnauld Villers; Jonas Hugosson; Fritz H Schröder; Marco Zappa Journal: Eur Urol Date: 2015-03-16 Impact factor: 20.096
Authors: J Pitkäniemi; K Seppä; M Hakama; O Malminiemi; T Palva; M-S Vuoristo; H Järvinen; H Paimela; P Pikkarainen; A Anttila; L Elovainio; T Hakulinen; S Karjalainen; L Pylkkänen; M Rautalahti; T Sarkeala; H Vertio; N Malila Journal: BMJ Open Gastroenterol Date: 2015-06-08
Authors: Stephen D Walter; Harry J de Koning; Jonas Hugosson; Kirsi Talala; Monique J Roobol; Sigrid Carlsson; Marco Zappa; Vera Nelen; Maciej Kwiatkowski; Álvaro Páez; Sue Moss; Anssi Auvinen Journal: Br J Cancer Date: 2016-11-17 Impact factor: 7.640
Authors: Ulla-Sisko Lehto; Markku Ojanen; Anna Väkevä; Tadeusz Dyba; Arpo Aromaa; Pirkko Kellokumpu-Lehtinen Journal: Qual Life Res Date: 2018-12-03 Impact factor: 4.147