WASHINGTON
(May 4) BW HEALTHWIRE -- Findings of the largest study of its
kind ever conducted indicate that the two million U.S. women who
each year have borderline abnormal Pap tests may benefit from
a newly approved DNA test for human papillomavirus (HPV), according
to a Kaiser Permanente study published in the May 5 issue of The
Journal of the American Medical Association (JAMA).
HPV is recognized as the primary cause of cervical cancer.
M.
Michele Manos, PhD, MPH, of Kaiser Permanente's Division of Research
in Northern California and lead author of the study, told an American
Medical Association media briefing today that the new test offers
"accuracy, convenience, cost-effectiveness, and, in many cases,
quick reassurance for women facing abnormal Pap results."
The most common abnormal Pap result is called atypical squamous
cells of undetermined significance, or ASCUS. Some 5% to 10% of
women with ASCUS Pap results are thought to harbor underlying
pre-cancer. Current guidelines include three options for women
with ASCUS Pap results. These women may be referred for a follow-up
procedure called colposcopy, in which a special magnifying instrument
is used to examine the cervix for pre-cancerous lesions. Another
option is making a second office visit for a repeat Pap test,
followed by a colposcopy if indicated. The third option is the
new HPV DNA test, followed by colposcopy, if indicated.
Manos
and her colleagues studied routine Pap test screening results
for 46,009 women, ages 14-92. All women with ASCUS Pap results
were asked to participate in the study. For the nearly 1,000 women
who elected to participate, specimens collected at the initial
Pap exam were then subjected to the new HPV DNA test. For the
purpose of the study, all participants were then examined by colposcopy
and given a repeat Pap test. The HPV test was then compared with
the other options in terms of its ability to predict what was
found in the colposcopy examinations.
The
study found that the sensitivity of the HPV DNA test was "equivalent
to, if not greater than, that of the repeat Pap test." Moreover,
the HPV test eliminated unnecessary follow-up for those at lower
risk, and immediately identified almost all of the cases that
required more intensive examination.
The research also confirmed that a new liquid-based Pap test can
effectively obtain specimens at the time of the initial Pap screening
which can later be used for HPV DNA testing following an ASCUS
Pap result.
Further,
researchers also asserted that the savings from decreased visits
and procedures would offset the costs of implementing liquid-based
Pap testing for all routine screening and HPV testing for all
ASCUS results.
"It's
gratifying to play a role in a study that can save lives and offer
reassurance to women with abnormal Pap results," said Manos. "I
look forward to the day when all women in this country are screened
and treated appropriately so there are no deaths from cervical
cancer. I consider it a completely preventable disease."
Since
the introduction of the Pap test over 45 years ago, the incidence
of cervical cancer has been dramatically reduced by nearly 70%
in the U.S. Yet despite this success, each year approximately
15,000 women are diagnosed with cervical cancer and nearly 5,000
women die from the disease. Outside the United States, in countries
where preventive care is less available, cervical cancer death
rates are much higher.
Based
on earlier studies by Manos and others, HPV is now recognized
as the primary cause of cervical cancer. HPV is one of the most
common sexually transmitted diseases (STDs) in the United States.
It has been estimated that the majority of adults in the United
States have been infected with HPV at some time in their lives.
Despite the high incidence of HPV infection, only a very small
percentage of infected women will ever develop serious complications
or cervical cancer, due to a combination of factors including
genetics, number of births, smoking, specific type of the HPV
infection, and widespread preventive screening for cervical cancer.
Kaiser
Permanente is America's leading integrated health care organization.
Founded in 1945, it is a non-profit, group-practice prepayment
program with headquarters in Oakland, Calif. Kaiser Permanente
serves the health care needs of 8.6 million members in 17 states
and the District of Columbia. In addition, it conducts clinical
research in many health areas, which benefits its members and
the health of the public nationally.
Today,
Kaiser Permanente encompasses Kaiser Foundation Health Plan Inc.,
Kaiser Foundation Hospitals, and the Permanente Medical Groups,
as well as an affiliation with Group Health Cooperative, based
in Seattle. Nationwide, Kaiser Permanente includes about 90,000
technical, administrative and clerical employees and about 10,000
physicians representing all specialties.
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