PIVOT study results -- New York Times (July 19, 2012?)

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JULY 18, 2012, 5:39 PM

Questioning Surgery for Early Prostate Cancer

By TARA PARKER-POPE

A new study shows that prostate cancer surgery, which often leaves men impotent

or incontinent, does not appear to save the lives of men with early-stage

disease, who account for most cases, and many of these men would do just as well

to choose no treatment at all.

The findings were based on the largest-ever clinical trial comparing surgical

removal of the prostate with a strategy known as " watchful waiting. " They add to

growing concerns that prostate cancer detection and treatment efforts over the

past 25 years, particularly in the United States, have been woefully misguided,

rendering millions of men impotent, incontinent and saddled with fear about a

disease that was unlikely ever to kill them in the first place. About 100,000 to

120,000 radical prostatectomy surgeries are performed in the United States each

year.

" I think this is game-changing, " said Dr. Leonard Marks, a professor of urology

at the University of California, Los Angeles, who was not involved in the study.

" What this study does is call attention to the fact that there are a lot of

prostate cancers that are diagnosed today that are not dangerous. "

Even so, the research, published Wednesday in The New England Journal of

Medicine and paid for by the Department of Veterans Affairs, the National Cancer

Institute and the Agency for Healthcare Research and Quality, is unlikely to

settle the debate about the best course of care for men with prostate cancer.

An editorial accompanying the report argued that the study of 731 men, while

important, is still too small to draw definitive conclusions about the relative

benefits of radical prostatectomy. In addition, slightly more men who did not

undergo surgery developed bone metastases over the course of the 15-year study.

There was no statistical difference in risk of death from prostate cancer or any

cause among men who were randomly assigned to surgery or to an observation

group. There was also a suggestion that men with very high scores on a prostate

cancer screening test were more likely to benefit from surgery.

The study included only men with early-stage disease, about half of whom learned

of their cancer as a result of the prostate specific antigen, or P.S.A.,

screening blood test. About 81 percent of men with prostate cancer have

early-stage or localized cancer, which means it has not spread beyond the

prostate. But the findings are not relevant to men with more advanced disease,

who may benefit from aggressive treatment, said Dr. Ian , director of

the cancer therapy and research center at the University of Texas Health Science

Center in San .

" The real point is that we shouldn't focus on finding every prostate cancer

because, as this study and all the screening studies show, the majority that you

find don't need to be found,'' said Dr. , an author of the editorial.

" What we should focus our screening on and our testing on are patients who are

likely to have more aggressive tumors in which treatment seems to make a

difference. "

This year, about 242,000 men will receive a diagnosis of prostate cancer,

largely because of screening for high levels of P.S.A. in the blood. About

28,000 men die of prostate cancer each year, making it the second-biggest cancer

killer of men, second only to lung cancer. Even so, large studies now show that

early detection by P.S.A. screening makes little, if any, difference in whether

a man dies from prostate cancer.

In May, the United States Preventive Services Task Force issued a controversial

recommendation against regular P.S.A. screening. The task force concluded that

the test offers little, if any benefit, yet subjects men to anxiety and painful

biopsies and often puts them on the course of invasive and risky treatment. But

several medical groups have criticized the finding, and P.S.A. testing remains

an entrenched part of men's health care at middle age.

The latest research, called the Prostate Cancer Intervention Versus Observation

Trial, or Pivot, focuses on what happens after a man receives a diagnosis of

early-stage cancer, often as a result of a P.S.A. test. The men in the study

were randomly assigned either to surgical removal of the prostate or to an

observation group, where a man's cancer was monitored but not treated unless it

showed signs of progressing. Although the study originally set out to recruit

2,000 men, the researchers could not reach that goal and revised the research

plan to include 731 men.

By the end of the 15-year study, 354 men had died, but most of them had died of

from a cause other than prostate cancer. There was no statistical difference in

overall mortality rates in the surgical group, which had 171 deaths, compared

with the observation group, which had 183 deaths.

During the study, only 52 men, or about 7 percent of the study subjects, died of

prostate cancer, but again there was no statistical difference in the prostate

cancer mortality rate between the groups.

But in a secondary analysis, the researchers did find an important difference

between the groups, suggesting that surgery may benefit men with early-stage

disease who have a high P.S.A. score. Among men with a P.S.A. value higher than

10 nanograms per milliliter of blood, surgery lowered a man's risk of dying by

33 percent compared with the observation group. Overall, among men with high

P.S.A. scores, there were 13 percent fewer deaths in the surgery group compared

with the observation group. No difference was seen among men with a P.S.A. value

of 10 or less.

Dr. J. Wilt, the study's lead author and professor of medicine at

Minneapolis Veterans Affairs Center for Chronic Disease Outcomes Research, said

he hoped the results would give patients with early-stage disease more

confidence to choose watchful waiting as an option.

About 90 percent of men with early-stage disease choose immediate treatment with

surgery or radiation, he said.

" Many men, when they hear about a diagnosis of prostate cancer, become fearful, "

Dr. Wilt said. " They think if they aren't treated they will die from it. Our

results clearly demonstrate that's not true. The overwhelming majority will not

die of their disease if it's left untreated. "