Government scientists have created a potential
vaccine against a virus that causes cervical cancer, a promising
development against a cancer that each year kills 200,000
women worldwide, including 5,000 Americans.
The experimental vaccine just passed its first
human safety test but has years more testing ahead to prove
if it does protect women against cancer.
Still, "the prospects for this vaccine
are remarkably promising," said Dr. Harald zur Hausen,
a cervical cancer expert in Heidelberg, Germany. He reviewed
the research in Tuesday's Journal of the National Cancer Institute.
Until a vaccine becomes reality, a widely available
virus test is highly effective at telling which of some 2
million American women with inconclusive Pap smears each year
need further cancer exams - and who can relax, says a second
study in Tuesday's journal.
Digene Corp.'s Capture test is "a very
good option," NCI chief researcher Dr. Diane Solomon
said.
Not everyone needs virus testing, Solomon stressed.
Most American women with cervical cancer didn't get yearly
Pap smears, which are remarkably successful at catching precancerous
cells in time to prevent cancer.
"Women have to understand the importance
of regular Pap testing as the first step," she said.
But when that exam isn't conclusive, Digene's
test may help those women decide if they need a biopsy - or,
by ruling out viral infection, provide "excellent reassurance"
that they're healthy and should just continue regular Pap
testing.
Human papillomavirus, or HPV, is a sexually
transmitted virus that infects some 40 million Americans.
There are over 80 strains, the vast majority symptomless and
harmless. But some strains cause cervical cancer, including
HPV-16, considered the riskiest and the one the experimental
vaccine targets.
Cervical cancer strikes 400,000 women worldwide
every year, including almost 13,000 Americans. The global
toll is much higher because women in developing countries
cannot afford those $25 Pap smears, so doctors there are hoping
anxiously for a vaccine.
Paps aren't perfect - about 2 million of the
50 million performed each year in the United States are inconclusive.
The vast majority of those women prove to be healthy, but
doctors struggle over how to catch the precancer cases without
subjecting too many healthy women to unnecessary biopsies
or repeat Paps.
That's where HPV testing comes in. The government
approved Digene's $50 test in 1999 as an aid in the diagnosis
dilemma and about 15 percent of inconclusive Pap patients
get it, but should more?
Tuesday's studies shed light on both fronts:
NCI researcher Dr. Douglas Lowy and colleagues
created a vaccine against HPV-16 that proved so successful
at preventing infection in animals that they tested it in
72 healthy people. This Phase 1 safety testing found no serious
side effects; the main complaint was mild injection-site pain.
Better, most participants' blood developed
40 times more virus-fighting antibodies after vaccination
than do people naturally infected with HPV. Those are "sky-high
levels," and "the higher the immune response, the
more likely it is that you will get protection," Lowy
explained.
To prove if the vaccine prevents HPV-16 infection
and consequently reduces cancer, NCI researchers plan to begin
studying thousands of women next year in Costa Rica, where
cervical cancer is far more prevalent. The study will take
up to eight years - and even if it succeeds, doctors must
develop vaccines against other cancer-causing HPV strains,
too, Lowy cautioned.
For today, Solomon's study of 3,488 women shows
HPV testing is an option that can help women worried about
an inconclusive Pap. She compared how well Digene's HPV test
or a repeat Pap predicted which women needed a biopsy.
Among those ultimately diagnosed with precancer,
Digene's HPV test was 96 percent accurate, compared with a
repeat Pap's 85 percent accuracy.
More good news: Women who tested infection-free
had a 99.5 percent probability of being healthy, meaning the
45 percent of women studied who were HPV-negative safely avoided
a biopsy.
Still, "there's no one option that's best
in all circumstances for all women," cautioned Solomon,
who advises women to discuss the alternatives with their doctors.