BY MARK SCHOLZ, MD
Between in 1994 and 2002, 731 men with an average PSA of 7.8 and age 67 volunteered to have either immediate surgery or observation based on a coin flip. The New England Journal of Medicine reported the 10-year survival statistics this week. What follows is a summary of the statistical outcome of the study. I think the raw numbers speak for themselves.
Of the 364 who had surgery, 21 men died of prostate cancer. Of the 367 assigned to observation 31 men died of prostate cancer. So with observation, the risk of dying was less than 9%. However, there was still a 6% chance of dying even with immediate surgery. The net difference between observation and immediate surgery was 3%.
During the first 30 days after surgery there were a number of very serious side effects including one death. Additionally, there were two men with blood clots in their legs, one stroke, 2 with blood clots in the lungs, 3 heart attacks, 1 man with renal failure requiring dialysis, 10 who required additional corrective surgery, 6 who required additional blood transfusions and 6 who still had urinary catheters more than 30 days after surgery.
Forty-nine men (17%) who had surgery compared to 18 men (6%) who underwent observation “have a lot of problems with urinary dribbling,” some losing larger amounts of urine than dribbling but not all day,” others who “have no control over urine,” and the remainder who “have an indwelling catheter.”
Two hundred thirty one men (81%) who had surgery compared to 124 men (44%) who underwent observation had erectile dysfunction defined as the inability to attain an erection sufficient for vaginal penetration.
Further statistical analysis of a subgroup of men with High-Risk prostate cancer indicated an 8% improved chance of not dying of prostate cancer compared to observation. Also, men who had surgery who were in the Intermediate-Risk or High-Risk category were 10% less likely to develop bone metastases within 10 years compared to the men on observation.
There was no difference in the incidence of mortality or metastases between surgery and observation in the men in the Low-Risk category.
This high-quality study, published in the most prestigious medical journal in the world evaluating the risks and benefits of surgery, required 18 years to perform. It shows a barely discernible benefit resulting from immediate surgery for men with High-Risk prostate cancer. These findings are quite similar to another large randomized trial of surgery versus watchful waiting that reported 15-year results in the New England Journal of Medicine in May 2011.
The bottom line is very clear: For men with Low-Risk disease, where surgery is concerned, the treatment is definitely worse than the disease. Even more striking, is the relatively small survival benefit for surgery in men with High-Risk disease. One can’t help but wonder if the substantial risks of immediate treatment-related side effects outweigh the small benefit in survival.