Contact: Donna Breckenridge,
New Treatment Method for Advanced Ovarian Cancer
Designed by
The
The NCI today issued a clinical announcement encouraging
treatment with anticancer drugs via two methods, after surgery, for women with
advanced ovarian cancer. The combined treatment methods are called
intraperitoneal, or IP, for chemotherapy delivered into the abdominal, or
peritoneal, cavity, and intravenous, or IV, for chemotherapy delivered into a
vein. The IP experimental therapy was designed in large part by David S.
Alberts, M.D., director of the
“It has taken 25 years of
careful research development to prove that the direct administration of our most
active drugs into the intraperitoneal space of newly diagnosed women with
surgically removed, advanced ovarian cancer can dramatically improve their
survival,” said Dr. Alberts.
The results of the current
Gynecologic Oncology Group (GOG) trial, to be published in the Jan. 5, 2006,
issue of the New England Journal of
Medicine, document an 18-month survival advantage for IP therapy with
the median survival being well over five years (67 months).
“This
study will lead to a revolutionary change in the way ovarian cancer is treated
from now on, ” Dr. Alberts said. “But we still have a long way to go before we
can declare victory over this devastating disease.”
The research of
Dr. Alberts and colleagues is summarized below:
• Dr. Alberts led a
team of
• Dr.
Alberts and colleagues in the Southwest Oncology Group (SWOG) published the
positive results of the first definitive trial of IP therapy in 1996 in the
New England Journal of Medicine,
documenting an eight-month survival advantage, as well as less blood
count and hearing toxicity associated with the IP treatment.
• Dr.
Alberts helped design a follow-up phase III trial of IP versus IV therapy in the
SWOG and GOG groups in the late 1990s and served as the third author on a
publication in the Journal of Clinical
Oncology in 2001. That trial documented an 11-month survival
advantage associated with the IP treatment.
• Dr. Alberts and
colleagues designed the IP experimental arm of the current phase III trial and
published their results in Gynecologic
Oncology in 2002. This trial documented the longest progression-free
survival ever recorded for a front-line treatment of Stage III ovarian
cancer.
• Dr. Alberts and colleagues published an editorial in the
Journal of Clinical Oncology in
2003, calling for the use of the IP route as standard therapy for advanced
ovarian cancer and stating, “Our patients deserve no less!”
The
The full text of the press
release from the NCI is copied
below.
###
Department of Health and Human
Services
National Institutes of Health
National Cancer
Institute
EMBARGOED FOR RELEASE
Wednesday,
January 4, 2006
5:00
p.m. EST
CONTACT:
NCI
Media Relations Branch
(301) 496-6641
ncipressofficers@mail.nih.go
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
“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
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
###
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.
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.
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
Contact:
Sharon Flynn, (202) 331-1332
Society of Gynecologic Nurse
Oncologists: 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).
* 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. NEJM, January 5, 2006, Vol. 354,
No. 1, pgs. 34-43.
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