Clinical Alert:
NCI Issues Clinical Announcement for
Preferred Method of Treatment for Advanced Ovarian Cancer
The National Cancer Institute
(NCI), part of the National Institutes of Health, today 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. 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.
"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.
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For Questions and Answers about IP treatment for advanced ovarian cancer, after
5 p.m. EST on Jan. 4, 2006, please go to
http://www.cancer.gov/newscenter/pressreleases/IntraperitonealQandA. The
clinical announcement regarding treatment for advanced ovarian cancer will be
available online after 5 p.m. EST on Jan. 4, 2006, at
http://ctep.cancer.gov/highlights/ovarian.html. The article in the New
England Journal of Medicine can be viewed online after 5 p.m. EST on Jan. 4,
2006. To obtain accompanying video footage, please contact the NCI Media
Relations Branch at (301) 496-6641 or
ncipressofficers@mail.nih.gov.
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, please visit http://www.cancer.gov/clinicaltrials/developments/IPchemo-digest.
For more information about ovarian cancer, please
go to
http://www.cancer.gov/cancertopics/types/ovarian/. For more information
about clinical trials for ovarian cancer, please go to
http://www.cancer.gov/search/clinicaltrials/ and
http://www.cancer.gov/clinicaltrials/ovarian-cancer-updates. For more
information about cancer, please visit the NCI Web site at
http://www.cancer.gov or call NCI's Cancer
Information Service at 1-800-4 CANCER (1-800-422-6237).
Professional Societies and Advocacy Groups
Gynecologic Cancer Foundation:
http://www.thegcf.org
Contact: Marsha Wilson, (301)320-3342
Gynecologic Oncology Group: http://www.gog.org
Contact: Marsha Wilson, (301)320-3342
Oncology Nursing Society: http://www.ons.org
Contact: Karen Hochberg, (412) 859-4667
Ovarian Cancer National Alliance:
http://www.ovariancancer.org
Contact: Sharon Flynn, (202) 331-1332
Society of Gynecologic Nurse Oncologists:
www.sgno.org
Society of Gynecologic Oncologists: www.sgo.org
Contact: Marsha Wilson, (301)320-3342
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*Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland
LJ, Walker JL, Burger RA. Intraperitoneal cisplatin and paclitaxel in
ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43.
Last updated: 04 January 2006
First published: 03 January 2006
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