January 4, 2006

Birmingham, Ala. - UAB specialists concur that flooding the abdominal cavity with conventional chemotherapy, a new regimen for treating certain patients with advanced ovarian cancer, provides a "significant" survival extension and will likely become a component of standard treatment in the near future.

The University of Alabama at Birmingham enrolled participants in a series of successful clinical trials reported in tomorrow's issue of The New England Journal of Medicine (NEJM, Jan. 5, Vol. 354, No. 1, pgs. 34-43). The new delivery method, called intraperitoneal (IP) chemotherapy, also is the subject of a rare clinical announcement from the National Cancer Institute (NCI) being issued concurrently with the NEJM publication. It recommends the procedure's use by physicians nationwide.

The NEJM study, "Intraperitoneal Cisplatin and Paclitaxel in Ovarian Cancer," is by Deborah K. Armstrong of the Johns Hopkins Kimmel Cancer Center, Baltimore, and others in the nationwide Gynecologic Oncology Group (GOG), a clinical trial consortium.

Mack N. Barnes, M.D., UAB principal investigator for GOG's contribution to this week's report, said that he and his colleagues, impressed by the 17-month average extension of life provided by the regimen, have been offering a combination of IP and intravenous chemotherapy to appropriate patients for the past year. He estimates that approximately 75 percent of women with advanced ovarian cancer may be eligible to receive IP chemotherapy. About 300 new cases of this kind come to UAB every year, among an estimated 24,000 nationally.

Barnes, an associate professor, is a scientist at the UAB Comprehensive Cancer Center. He says IP chemo attacks malignancy in two ways, by bathing the tumor with a higher concentration of drugs and by providing increased absorption by blood vessels serving the tumors.

The NCI clinical announcement states that, in order to receive benefit from IP chemotherapy, patients must receive very aggressive initial surgery to reduce the tumor to less than one centimeter in size, and then be counseled about the clinical benefit associated with combined IP and IV chemotherapy. Based on data presented in the NEJM this week, "strong consideration should be given" to a regimen containing IP-delivered cisplatin plus another chemotherapeutic agent, taxane, given by either route. The IP drugs are delivered via a catheter that is put in place at the same time the patient's tumor is surgically removed.

Barnes said that six overnight hospital stays are required over the course of the treatment regimen, "although at some point this may become an outpatient procedure." As recently as 20 years ago, women with advanced ovarian cancer of this type were considered to have only a six-month survival rate, and usually were not even offered surgery. Improved prognoses arrived in the mid-1970s, when it was determined that patients would benefit from extensive surgical removal of the tumor mass. Incorporation of drugs like cisplatin and taxol in the late 1980s and early 1990s provided survival benefits of about 30 additional months. "Now, with those drugs and the new delivery method, we can expect these patients to enjoy a survival benefit of four to five years."

UAB's gynecologic oncology program is one of the most comprehensive in the Southeast, and has been involved in the development of innovative treatments for decades, Barnes added. "We are cited in the NCI announcement for two important studies conducted here at UAB. Dr. Shamila Makhija was lead author on a survey of IP-chemo complications that was specifically mentioned in the announcement."