The National Cancer Institute (NCI), part of the National Institutes of Health, 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 Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital participated in the NCI-supported clinical trial which led to this clinical announcement.
The announcement coincides with publication in the New England Journal of Medicine of the results of a large clinical trial 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.
“There are pros and cons to this type of treatment,” says David G. Mutch, M.D., director of the Division of Gynecologic Oncology at Washington University School of Medicine. “The benefits and risks should be discussed with the treating physician, but this modality offers significant benefits in a select group of patients.”
The two treatment methods are called intravenous (IV) chemotherapy delivered into a vein and intraperitoneal (IP) chemotherapy delivered into the abdominal, or peritoneal, cavity. The 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.
“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 lead author Deborah Armstrong, M.D., medical oncologist and associate professor at Johns Hopkins Kimmel Cancer Center. “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. 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.
“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.
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 NCI’s 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, including the Society of Gynecological Oncologists, the Ovarian Cancer National Alliance, the Gynecological Cancer Foundation, the Oncology Nursing Society and the Society of Gynecologic Nurse Oncologists.
- 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.
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.
Washington University School of Medicine’s full-time and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.
Siteman Cancer Center is the only NCI-designated Comprehensive Cancer Center within a 200-mile radius of St. Louis. Siteman Cancer Center is composed of the combined cancer research and treatment programs of Barnes-Jewish Hospital and Washington University School of Medicine.