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. University of Louisville’s James Graham Brown Cancer Center participated in the NCI-supported clinical trials, which led to this clinical announcement.
“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.
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).
The two treatment methods are called: intravenous, or IV, for chemotherapy delivered into a vein and intraperitoneal; and 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: IV paclitaxel followed by IV cisplatin; and IV paclitaxel followed by IP cisplatin and the subsequent administration of IP paclitaxel.
"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."
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.
“Because the James Graham Brown Cancer Center has participated in these trials,” said Dr. Lynn Parker, director of gynecologic oncology at the Brown Cancer Center, “we have been using it as an option for treatment for our ovarian cancer patients for the past several years. This is just another example of the advantages we provide as one of the region's academic, research, and teaching medical centers. Our patients benefit from the latest medical advances, often long before they become available in non-teaching settings.”
Standard treatment for women with stage III ovarian cancer had just 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. Platinum and taxane are two classes of anticancer drugs. 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.
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.
The James Graham Brown Cancer is part of UofL Health Care, the region’s leading academic, research, and teaching medical center. The Brown Cancer Center is affiliated with the National Cancer Institute and the Kentucky Cancer Program. It is the only cancer center in the region to use a unified approach to cancer care, with multidisciplinary teams of physicians working together to guide patients through diagnosis, treatment and recovery.
For more information on ovarian cancer, women can call the Mint Jubilee Cancer Resource Center at (502) 562-4158.
To make an appointment with a doctor at the Brown Cancer Center’s Clinic of Gynecologic Oncology, please call (502) 561-7220.