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More Aggressive Treatment of Advanced Ovarian Cancer
Recommended
National Cancer Institute says IP therapy extends
life by a year
Jan. 5, 2006 - The National Cancer Institute (NCI),
part of the National Institutes of Health, yesterday issued an
announcement encouraging treatment with anticancer drugs via two
methods, after surgery, for women with advanced ovarian cancer. The
combined methods, which deliver drugs into a vein and directly into the
abdomen, extend overall survival for women with advanced ovarian cancer
by about a year.
The clinical announcement to surgeons and other
medical professionals who treat women with ovarian cancer was made with
the support of six professional societies and advocacy groups.
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The announcement coincides with publication in the
New England Journal of Medicine of the results of a large clinical trial
by Deborah Armstrong, M.D., medical oncologist and an associate
professor at Johns Hopkins Kimmel Cancer Center in Baltimore, Md., and
her colleagues in an NCI-supported research network known as the
Gynecologic Oncology Group (GOG).
This is the eighth trial evaluating the use of
chemotherapy delivered into the abdomen for ovarian cancer. Together,
these trials show a significant improvement in survival for women with
advanced ovarian cancer.
The two treatment methods are called intravenous,
or IV, for chemotherapy delivered into a vein and intraperitoneal, or
IP, for chemotherapy delivered into the abdominal, or peritoneal,
cavity.
The Armstrong trial involved 429 women with stage
III ovarian cancer who were given chemotherapy following the successful
surgical removal of tumors. It compared two treatment regimens:
1) IV paclitaxel followed by IV cisplatin, to
2) IV paclitaxel followed by IP cisplatin and the subsequent
administration of IP paclitaxel.
"Americans look to NCI--and to all of the
institutes that constitute the National Institutes of Health--for
unbiased research studies and sound counsel. This clinical announcement
is a demonstration of that commitment," said NIH Director Elias A.
Zerhouni, M.D.
"The National Cancer Institute wants to make
certain that the results of clinical research are rapidly disseminated
to both health care providers and patients, in order to ensure that
life-enhancing cancer treatments are widely available," said NCI
Director Andrew C. von Eschenbach, M.D.
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About
Ovarian Cancer |
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Information from
American Cancer Society
This is a cancer that
mainly develops in older women. Around two-thirds of women are
55 or older. It is slightly more common in white women that
African-American women.
Ovarian cancer is the
seventh most common cancer among women, excluding non-melanoma
skin cancers. The American Cancer Society estimates that about
22,220 new cases of ovarian cancer will be diagnosed in the
United States during 2005. Ovarian cancer accounts for about 3%
of all cancers in women.
A womans risk of
getting ovarian cancer during her lifetime is 1.7% or about 1 in
58. Her lifetime chance of dying from ovarian cancer is 1.0% or
1 in 98. The risk of developing and dying from ovarian cancer is
higher for white women than black women.
This is a cancer that
mainly develops in older women. Around two-thirds of women are
55 or older. It is slightly more common in white women that
African-American women.
The good news is that
the ovarian cancer incidence rate has decreased since 1991. The
incidence rate is a precise way for scientists to describe how
common or rare a disease is. The ovarian cancer incidence rate
is defined as the number of new cases diagnosed each year per
100,000 women.
Ovarian cancer ranks
fourth in cancer deaths among women, accounting for more deaths
than any other cancer of the female reproductive system. It is
estimated that there will be about 16,210 deaths from ovarian
cancer in the United States during 2005.
About 77% of women with
ovarian cancer survive 1 year after diagnosis, and 45% survive
longer than 5 years after diagnosis. Women younger than age 65
have better 5-year survival rates than older women. If diagnosed
and treated while the cancer has not spread outside the ovary,
the 5-year survival rate is 90-95%. However, only 19% of all
ovarian cancers are found at this early stage. |
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"IP therapy is not a new treatment approach, but it
has not been widely accepted as the gold standard for women with ovarian
cancer," said Armstrong.
"There has been a prejudice against IP therapy in
ovarian cancer because it's an old idea, it requires skill and
experience for the surgery and for the chemotherapy, and it's more
complicated than IV chemotherapy.
"But now we have firm data showing that we should
use a combination of IP and IV chemotherapy in most women with advanced
ovarian cancer who have had successful surgery to remove the bulk of
their tumor."
Standard treatment for women with stage III
ovarian cancer has been surgical removal of the tumor (debulking),
followed by six to eight courses of IV chemotherapy given every three
weeks with a platinum drug, such as cisplatin or carboplatin, and a
taxane drug, such as paclitaxel.
The new NCI clinical announcement recommends
that women with advanced ovarian cancer who undergo effective surgical
debulking receive a combination of IV and IP chemotherapy.
IP chemotherapy allows higher doses and more
frequent administration of drugs, and it appears to be more effective in
killing cancer cells in the peritoneal cavity, where ovarian cancer is
likely to spread or recur first.
"In our trial, women who received part of their
chemotherapy via an IP route had a median survival time 16 months longer
than women who received only IV chemotherapy," said Armstrong.
The 205 women treated via the IP route fared
better, even though most of them received fewer than the six planned
treatments. Complications associated with the abdominal catheter used to
deliver the IP chemotherapy were the main reason only 86 of the women
completed all six IP treatments. Women who received IP chemotherapy had
more side effects than those treated with IV chemotherapy alone, but
most side effects were temporary and easily managed. One year after
treatment, women in both study groups had the same reported quality of
life.
"Randomized, multicenter clinical trials, including
this most recent study, clearly show the value of IP chemotherapy--an
extended life for women with advanced ovarian cancer," said Philip
DiSaia, M.D., chairman of the GOG.
"For most women who have had successful surgical
removal of tumors to less than one centimeter in size, we now know that
the longest survival may be achieved by giving their chemotherapy
directly into the abdomen," said Beth Karlan, M.D., president of the
Society of Gynecologic Oncologists and director of Gynecologic Oncology
and the Gilda Radner Ovarian Cancer Program at Cedars-Sinai Medical
Center in Los Angeles, Calif.
In response to this announcement, the Ovarian
Cancer National Alliance's outgoing president, Ginger Ackerman, and its
executive director, Sherry Salway Black, said the Alliance would widely
disseminate this information on IP therapy to their patient community.
"We welcome the results of the recent trial that demonstrates increased
survivorship," said Salway Black.
"It is important for women to have the facts about
when it is appropriate to consider IP chemotherapy," said Karl Podratz,
M.D., Ph.D., chairman of the board of the Gynecologic Cancer Foundation
(GCF) and professor of obstetrics and gynecology at the Mayo Clinic,
Rochester, Minn. "GCF looks forward to working with NCI and the ovarian
cancer community to educate women about the results of this very
important clinical trial, and what it means for women with advanced
ovarian cancer."
Karen Stanley, R.N., M.S.N, president of the
Oncology Nursing Society, and Susan Vogt Temple, R.N., president of the
Society of Gynecologic Nurse Oncologists, noted that their societies
have plans in place to teach oncology nurses and women with ovarian
cancer how IP chemotherapy can be given safely and reliably.
More studies are needed to determine the best IP
drug regimen and the optimal number of IP treatments. Future trials also
will address how to reduce toxicity associated with IP administration.
In addition to continued research to improve
ovarian cancer treatment, NCI is funding studies to identify disease
markers and develop improved screening techniques, enabling earlier
detection and treatment of the disease. An estimated 22,220 women in the
United States were diagnosed with ovarian cancer in 2005. It causes more
deaths in the United States than any other cancer of the female
reproductive system, with an estimated 16,210 women dying from the
disease in 2005. The most recent statistics show that only 45 percent of
women survive five years after being diagnosed with ovarian cancer; the
rate increases to 94 percent when the disease is diagnosed before it has
spread. However, women with ovarian cancer frequently have no symptoms
or only mild symptoms until the disease is advanced. As a result, only
19 percent of all cases are detected at that early, localized stage.
For more information and a Q&A on this
recommendation
click here.
For further information:
● Additional information on IP
chemotherapy, including administration, as well as other resources for
clinicians and patients can be obtained at
http://www.gog.org,
http://onsopcontent.ons.org/Toolkits/Chemotherapy/ and
http://www.ons.org/patientEd/Treatment/chemotherapy.shtml.
● For a digest of information on IP
chemotherapy, visit
http://www.cancer.gov/clinicaltrials/developments/IPchemo-digest.
● For more information about ovarian cancer, go
to
http://www.cancer.gov/cancertopics/types/ovarian/.
● For more information about clinical trials for
ovarian cancer, go to
http://www.cancer.gov/search/clinicaltrials/ and
http://www.cancer.gov/clinicaltrials/ovarian-cancer-updates.
● For more information about cancer, visit the
NCI Web site at
http://www.cancer.gov
Professional Societies and Advocacy Groups
● Gynecologic Cancer Foundation:
http://www.thegcf.org
● Gynecologic Oncology Group:
http://www.gog.org
● Oncology Nursing Society:
http://www.ons.org
● Ovarian Cancer National Alliance:
http://www.ovariancancer.org
● Society of Gynecologic Nurse Oncologists:
www.sgno.org
● Society of Gynecologic Oncologists:
http://www.sgo.org
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