Key Findings From ERSPC
In the ERSPC, 182,000 men between the ages of 50 and 74 years who resided in 7 different European countries were randomized to either PSA screening, at an average of once every 4 years, or to a control group. The predefined core age group for the study consisted of 162,243 men aged 55 to 69 years, and the primary outcome for the study was rate of death from prostate cancer. Mortality follow-up was completed on December 31, 2006.
The average and median follow-up times were 8.8 and 9 years, respectively. These are the key findings of the ERSPC:
• There were 214 prostate-cancer-related deaths in the screening group and 326 deaths in the control group in the core age group.
• The cumulative incidence of prostate cancer was 8.2% in the screening group and 4.8% in the control group.
• PSA screening was associated with a significant absolute reduction of 0.71 prostate cancer deaths per 1000 men after an average of 9 years.
• To prevent 1 prostate cancer death, 1410 men would have to be screened and an additional 48 men would require treatment.
• An analysis of participants who actually underwent screening during the first round provided a rate ratio for prostate-cancer-related mortality of 0.73 (95% confidence interval, 0.56 to 0.90).
This study has a number of limitations that deserve serious consideration, according to Mary McNaughton-Collins, MD, a general medicine internist and health services researcher at Massachusetts General Hospital and Harvard Medical School, in Boston, who participated in the round-table discussion but was not involved in the study.
One of the limitations is that the trial pulled together studies conducted in different countries, and since protocols were different, it wasn't a uniform study design, Dr. McNaughton-Collins noted.
In addition, this is the third interim analysis, she pointed out. So the "20% mortality reduction is only marginally statistically significant at 0.04, raising the question: Why stop now?"
The numbers needed to treat and screen are high, and this is problematic, she said. "For right now, we should probably maintain a healthy skepticism about this type of screening program," she commented. "Any effective screening program, we know, requires more than just effectiveness. We have to find out more about quality of life or cost-effectiveness."