|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
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
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
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 email@example.com.
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.
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: http://www.sgno.org
Society of Gynecologic Oncologists: http://www.sgo.org
Contact: Marsha Wilson, (301)320-3342
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).
The National Institutes of Health (NIH) — The Nation's Medical Research
Agency — includes 27 Institutes and Centers and is a component of
the U. S. Department of Health and Human Services. It is the primary Federal
agency for conducting and supporting basic, clinical, and translational medical
research, and it investigates the causes, treatments, and cures for both common
and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.