Jul 19, 2012 - 1:29 am
July 18, 2012
Preliminary results were released more than a year ago.
The newly published conclusion:
"Our findings support observation for men with localized prostate cancer, especially those who have a low PSA value and those who have low-risk disease. Up to two thirds of men who have received a diagnosis of prostate cancer have a low PSA value or low-risk disease, but nearly 90% receive early intervention — typically surgery or radiotherapy."
The findings appear in the latest issue of the New England Journal of Medicine.
IN 2011, Dr. Timothy Wilt, the lead author on the paper, presented findings from the study, called PIVOT for short, at a meeting of urologists in Washington. Thousands of doctors, many of whom routinely perform prostate surgery, sat silent as the evidence suggested that waiting was a reasonable choice for men whose cancer hadn't spread and appeared to be a low risk to their health.
The federally funded PIVOT study looked at the health of 731 men diagnosed with prostate cancer between 1994 and 2002. They were randomly assigned to have their prostates surgically removed or to be observed. After follow-up of about 10 years, a little fewer than half of the men in each group had died.
Now that the data have been subjected to peer review and have been published in an influential journal, they may get even more attention.
"Overtreatment of prostate cancer is a well-recognized phenomenon," Dr. Durado Brooks, of the American Cancer Society, said in a statement about the paper. "Observational management has been recommended for some men for over a decade, yet 9 out of 10 U.S. men diagnosed with prostate cancer continue to receive definitive therapy (usually surgery or radiation)."
Prostate surgery has risks and side effects, including incontinence and impotence.
The PIVOT results may help give doctors and patients more confidence that waiting can be OK, he said. "Some 30 to 40 percent of men diagnosed with prostate may be candidates for observation, many men have never heard of observational management and are never informed that this may be a reasonable option for them."
Some doctors have already gotten the message. "For my practice it's not going to change much," urologist Benjamin Davies, a cancer specialist at the University of Pittsburgh med school, told Shots. The PIVOT results "confirm our su****ions that treating low-risk prostate cancer in older men is not helpful."
In his reading of the study, there is a survival benefit for patients with high-risk cancers. For men whose PSA results were greater than 10 and who had surgery, the rate of death from any cause was lower than for men with similar PSAs who didn't have surgery.
An accompanying editorial pointed out some shortcomings in the study, including the fact that about one-fifth of men didn't stay in their assigned group. But it notes that the results from PIVOT and some other trials show "that a national focus on PSA screening and treatment for prostate cancer may have a marginal benefit on the lifespan of men but at a considerable cost."
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