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Researchers
are reporting that they have taken the first step toward developing a
reliable blood test for ovarian cancer, including cases that are still
early enough to be curable. A
means of early detection is much needed, doctors say, because ovarian
cancer is usually diagnosed late, and as a result is often fatal. In
a preliminary study in 116 women, 50 with ovarian cancer and 66 without,
the new test looked promising. It missed none of the cancers, although it
gave false-positive results - mistakenly diagnosing cancer in healthy
women - in 5 percent of the cases. The
test, developed by scientists at the National Cancer Institute, the Food
and Drug Administration, or FDA, and Correlogic Systems, a company in
Bethesda, Maryland, requires only a drop of blood and gives results in 30
minutes. It is described in a report posted Friday on the Web site of the
British medical journal The Lancet (www.thelancet.com). The
test is still experimental, and not available to the public outside of
clinical trials. Its developers say it needs further study in many more
women to determine whether the early findings hold up. If it does come to
market, it will not be for several years, and its use might initially be
limited to women at high risk. Emanuel
Petricoin, who helped create the test, said, "I'm all too aware as an
FDA scientist of promising early results that start to fail as you go into
the real world." Ovarian
cancer is not common, but it is often deadly. More than 80 percent of
cases are advanced by the time of detection, and only about 25 percent of
those patients survive five years or more. But when the cancer is found
early, more than 90 percent of women live five years or more, and most are
cured. In 2001, 23,400 American women developed the disease; 13,900 died
of it. Unlike
most blood tests, which measure levels of single substances, the new test
looks for patterns of proteins that set cancer patients apart. The blood
is first analyzed with a technique called mass spectroscopy, which is used
to sort proteins by their weight and electrical charge. The technique
creates a spectrum, or graph, full of spiky-looking peaks and valleys that
represent hundreds of proteins. The
spectrum is then analyzed by a computer program, known as an artificial
intelligence algorithm, that is designed to recognize patterns. Initially,
the researchers had the computer analyze spectrums from 50 women who had
ovarian cancer and 50 who did not. The program found a pattern of five
unidentified proteins that existed only in the cancer patients. Next,
using the pattern information from the first 100 patients, the researchers
analyzed 116 more spectra, from 50 women with cancer and 66 without it.
The 66 women were known to be free of ovarian cancer because their blood
had been drawn and frozen five years before, and their health monitored
ever since. The diagnoses were concealed from the researchers until after
the computer analysis was done. The
program correctly selected all 50 cases of cancer, including 18 that were
Stage 1 and therefore highly curable. It also recognized that 63 of the 66
other women did not have cancer; in three of the healthy women, 5 percent,
the computer mistakenly diagnosed cancer. Dr.
Lance Liotta, chief of pathology at the National Cancer Institute, who
helped develop the test, said, "We were able to see a pattern in the
blood of patients that reflected something going on in an internal body
organ." Most
important, Dr. Liotta added, was that the pattern could be picked out even
in early cancers - that is, those that were still limited to the ovaries
and had not begun to spread. He said he and his colleagues expected to
apply the same technique to other cancers. Dr.
Martee Hensley of Memorial Sloan-Kettering Cancer Center in Manhattan, who
runs a clinic for women at high risk of ovarian cancer and who was not
involved in the study, called the findings exciting and said, "I
found it encouraging that the computer algorithm could find the
early-stage cancers." A
blood test now used in high-risk women, for a substance called CA125, is
much less reliable, Dr. Hensley said, giving high readings in only about
half of patients with early ovarian cancers, and 80 percent with advanced
disease. But
regarding the new test, she added: "There are certain caveats. The
data are somewhat preliminary, and we don't know how this computer
algorithm might work in a larger population." A
great concern with any screening test is the rate of false-positive
results, because, in addition to frightening patients, mistaken findings
can lead to unnecessary surgery. The
study on the new test was conducted in women who were at high risk for
ovarian cancer because they had genetic mutations or a family history of
the disease. In a general population with an average risk of ovarian
cancer, the false-positive rate could be different. The only way to find
out, the researchers said, is to study the test in larger groups,
including those with different levels of risk.
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