Prostate Cancer Surgery Fails to Cut Death Rate in Study

Surgery for prostate cancer was no
better in saving lives than observation over a 10-year period,
according to one of the first rigorous studies to compare the
two approaches in American men with early-stage disease.

The U.S.-funded study assigned 731 men across the country
with early prostate cancer to have the gland surgically removed
or be observed without any attempt at curative treatment. Ten
years later, 47 percent of men in the surgery group had died,
mostly from other diseases, versus 49.9 percent who were just
watched, results published in the New England Journal of
Medicine found. The difference wasn't statistically meaningful.

The study is certain to fuel the debate over whether
doctors are aggressively treating prostate cancer in men who
aren't likely to die from it, causing side effects such as
incontinence and impotence.

"There is no question in my mind that what we have been
doing in the United States for the last 20 years has hurt a lot
of men needlessly," said Otis Brawley, chief medical officer
for the American Cancer Society. "We need to be telling men
that there is tremendous evidence that a large number of men
with prostate cancer could be watched and don't need to be
treated."

The study, while too small to rule out a modest life-saving
benefit from surgery, is relevant to the debate over excess
prostate cancer screening and treatment because it included
patients whose cancer was detected through PSA testing. In May,
the U.S. Preventive Services Task Force recommended against
using the prostate-specific antigen blood test to spot the
disease, saying the screening leads to overtreatment and
unnecessary side effects.

241,000 Diagnosed

More than 241,000 American men are diagnosed with prostate
cancer each year, and more than 28,000 die from it, making it
the second-leading cause of cancer death in men, according to
data from the American Cancer Society. The vast majority of
cases are discovered in the local and regional stages, where the
survival over five years is almost 100 percent.

Currently, only 10 percent of American men with prostate
cancer who are eligible for observation choose observation,
according to a National Institutes of Health report last year.
The vast majority elect surgery or various forms of radiation in
an attempt to cure their cancer. Both forms of treatment have
side effects, including impotence.

"When men hear cancer they want something done," said
Durado Brooks, director of prostate and colorectal cancers for
the cancer society. The idea that some prostate cancers aren't
life-threatening is "very difficult for people to accept
because they are accustomed to thinking of cancer as this
ravaging, always-lethal condition."

Difficult Enrollment

While the study originally intended to include 2,000
patients, the size was reduced to 731 men because of the
difficulty in getting men to enroll, researchers said. This
limited the study's ability to parse out small differences in
death rates, said Brawley of the cancer society. Nonetheless,
the result indicates that prostate surgery for localized cancer
detected through PSA tests saves very few lives, he said.

After a median of 10 years, 171 of 364 men assigned surgery
had died, while 183 of 367 assigned to observation died. In the
surgery group, 5.8 percent of the men died from prostate cancer
compared with 8.4 percent of the men in the observation group.
Neither difference was statistically significant.

Surgery Complications

More than 1 in 5 patients in the surgery group had
complications within 30 days of the operation. Urinary
incontinence and erectile dysfunction were much more common in
men who got the surgery, while men who got observation had a
higher rate of developing bone metastases.

"The results are consistent with emerging science
suggesting that for the vast majority of men observation can be
a wise and preferred treatment choice" if they have localized
prostate cancer, said Timothy Wilt, a researcher at the Center
for Chronic Disease Outcomes Research at the Minneapolis
Veterans Affairs Health Care System, and the study's lead
author.

The results supporting observation were most robust in men
with whose PSA levels were 10 nanograms per milliliter or less
when cancer was detected, Wilt said. This was about two-thirds
of the patients in the study.

Doctors used to consider a PSA above 4 as high and a cutoff
for further evaluation.

Death Rate

The death rate from prostate cancer among the patients with
lower PSA levels was the same regardless of whether patients got
surgery or observation, the study found. In patients with higher
PSA levels, surgery significantly reduced all deaths and
prostate cancer deaths, the study found.

The new results contrast with a Scandanavian study of
surgery versus observation. After 12.8 years, the trial of 695
men from Sweden, Finland and Iceland, found that surgery
prevented 1 prostate cancer death for every 15 patients who got
surgery, according to the most recent research update published
in 2011. The benefit from the surgery was confined to men
younger than age 65.

While the reason for the divergent results are unclear, one
difference between the studies is that the Scandanavian study
was conducted before PSA testing became common, and thus
included more people with larger tumors that were only detected
on a digital rectal exam, Wilt said.

The study led by Wilt was sponsored by the U.S. Department
of Veterans Affairs, the National Cancer Institute, and the
Agency for Healthcare Research and Quality.

To contact the reporter on this story:
Robert Langreth in New York at
rlangreth@bloomberg.net

To contact the editor responsible for this story:
Reg Gale at
rgale5@bloomberg.net