Published: Jan. 5, 2006
Updated: Jan. 5, 2006
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By Duke Medicine News and Communications
DURHAM, N.C. -- A national study of women with advanced ovarian cancer has demonstrated that physicians can significantly extend their survival by giving them anti-cancer drugs directly into their abdominal cavity in addition to the standard intravenous (IV) chemotherapy.
The team of oncologists from the Gynecologic Oncology Group (GOG) showed that women who received part of their chemotherapy abdominally -- called "intraperitoneally" (IP) -- survived an average of 16 months longer than women who received IV chemotherapy alone (66 months versus 50 months).
Results of the study, funded by the National Cancer Institute, will be published in the Jan. 5, 2006, issue of the New England Journal of Medicine. The Division of Gynecologic Oncology at Duke University was a major contributor to the trial but the team was not listed among the study's authors, who included clinical trial coordinators and principal investigators at the largest accrual sites. Duke is one of more than 40 cancer centers that participated in the GOG trial and has conducted previous studies demonstrating IP therapy's benefits in treating ovarian cancer.
"Infusing chemotherapy directly into the abdomen more effectively targets the region where ovarian cancer cells remain after most of the tumor is surgically removed," said Angeles Alvarez Secord, M.D., a gynecologic oncologist and the lead investigator for the GOG study at Duke. The GOG is a national consortium that studies cancers of the reproductive system.
"Moreover, direct infusion of drugs via IP therapy allows much higher concentrations of chemotherapy to bathe residual tumors than can be safely achieved with traditional intravenous chemotherapy," she said.
The Duke researchers said a 16-month survival extension is notable because 5-year survival among women with advanced ovarian cancer is just 45 percent. Advanced ovarian cancer refers to tumors that have spread to the surfaces of organs in the abdominal or "peritoneal" cavity, including the abdominal wall, liver or spleen.
IP has shown survival benefits in several previous ovarian cancer studies, but it has not gained widespread acceptance because it is more complicated than traditional IV chemotherapy, said Secord. Not all patients are candidates for the therapy, and the surgery that precedes IP therapy requires expertise not widely available.
"The success of IP chemotherapy is dependent upon appropriate patient selection, surgical resection of the tumor, and training of the physicians and nurses," said Dr. Andrew Berchuck, M.D., director of the Duke Division of Gynecologic Oncology. "At Duke we have embraced intraperitoneal chemotherapy and believe that this can be translated into an improvement in overall survival and quality of life for women with ovarian cancer." Berchuck said the Duke team has acquired extensive experience administering IP chemotherapy over the past two decades.
Based on the current findings, the NCI and the National Institutes of Health have issued an announcement to surgeons and other medical professionals encouraging them to use the combination IP and IV therapy for women with advanced ovarian cancer.
IP therapy extended survival even among women who did not complete their six planned treatments due to the higher rate of side effects, the study showed. Common side effects included varying degrees of abdominal pain, nausea, bone marrow suppression, infection at the site where the catheter enters the abdomen, leaking or blocked catheters, but most effects were temporary and manageable, the researchers said.. Moreover, quality of life one year after the treatments was no different in the two groups of patients. Secord said these side effects illuminate the need to optimize techniques for IP chemotherapy administration.
The study included 429 women who received two drugs, paclitaxel and cisplatin, either intravenously or in a combination of intravenous and intra-peritoneal delivery. IP chemotherapy is delivered through a catheter that is placed in the upper abdomen, just below the ribs. Physicians pump chemotherapy through the catheter and into the abdominal cavity, where it washes over the affected organs.
Women were eligible for the study only if they had undergone surgery resulting in optimal removal or "resection" of their cancers such that the largest residual tumor nodules were less than 1 cm in diameter prior to beginning chemotherapy. A procedure called "segmental bowel resection" was required to remove large tumors in 32 percent of the women before they were treated with IP chemotherapy.
"This finding highlights the importance of referral of women with known or suspected ovarian cancer to physicians with special expertise and training in the surgical management of ovarian cancer," said Berchuck.