BUFFALO, NY – A post-surgical combination chemotherapy method that uses two methods of administration extends overall survival for women with advanced ovarian cancer by approximately one year, according to an announcement by the National Cancer Institute (NCI). Shashikant Lele, MD, Chair of the Department of Gynecologic Oncology, Roswell Park Cancer Institute (RPCI), is the principal investigator at RPCI for the Gynecologic Oncology Group (GOG) and a major contributor to the clinical trial effort.

The announcement coincides with the publication by New England Journal of Medicine of the clinical trial results led by colleagues in the GOG, an NCI-supported research network. RPCI is a member of the GOG and houses the GOG Statistical Data Center, which provides the primary scientific infrastructure for the GOG in the areas of biostatistics, information management and study coordination.

            The study investigated the delivery of two standard chemotherapy drugs, paclitaxel and cisplatin, by two different treatment methods. The methods are called intravenous, or IV, for chemotherapy delivered into a vein, and intraperitoneal, or IP, for chemotherapy delivered into the abdominal cavity. The 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. Complications associated with the abdominal catheter used to deliver the IP chemotherapy were the primary reason 42 percent of women completed all IP treatments.

“Intraperitoneal chemotherapy has the advantage of delivering very high local concentrations of potentially effective chemotherapy directly to the tumor site in patients who had successful surgery with residual tumor less than one centimeter prior to adjuvant therapy,” noted Dr. Lele who also is co-author of the study. “This study is an important advance in the first-line treatment for ovarian cancer patients. Roswell Park is pleased to have contributed to the study which may change the way ovarian cancer is treated and thereby extend the lives of future patients diagnosed with this disease.”

“The GOG Statistical and Data Center at RPCI provided study design, data management and review, statistical analysis and manuscript editing of the clinical trial,” said Brian Bundy, PhD, co-author of the publication and Associate Biostatistician at RPCI. “We are grateful to the women that participated in this trial. They, as well as all participants in cancer clinical trials, should be honored and thanked. Without their willingness to be involved, determining the most effective therapies against cancer would be impossible.”

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 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, MD.

“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,” said Dr. Lele.

Ovarian cancer accounts for approximately 4 percent of all women’s cancers and is the fourth leading cause of cancer-related death among women in the United States. In 2005, an estimated 22,000 women were diagnosed with ovarian cancer, and more than 16,000 women died from the disease.

Roswell Park Cancer Institute, founded in 1898, is the nation’s first cancer research, treatment, and education center and is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. RPCI is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers. For more information, visit RPCI’s website at www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.