Society of Gynecologic Oncologists Release: New Study Reports Increased Response To Therapy With No Added Toxicity In Treatment Of Recurrent Ovarian Cancer

PALM SPRINGS, Calif., March 24 /PRNewswire/ -- In a study released today at the Society of Gynecologic Oncologists 37th Annual Meeting on Women's Cancer, researchers found the addition of thalidomide to topotecan for the treatment of recurrent ovarian cancer significantly increases the response to therapy and the duration of progression free survival without additional toxicity.

The study, "A Prospective Randomized Trial of Thalidomide with Topotecan Compared to Topotecan Alone in Women with Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma," was led by Levi S. Downs Jr., M.D., University of Minnesota Medical School and Cancer Center, Minneapolis, MN.

"This trial is among the first to combine a biologic agent with a conventional chemotherapy agent for the treatment of ovarian cancer," said the study's lead author, Dr. Levi S. Downs, Jr. "The statistically significant improvement in overall response rate demonstrated in this experimental treatment is promising as we continue to seek better therapies to fight ovarian cancer."

Thalidomide is a biologic therapy that may fight tumors in two ways: First by inhibiting the tumors ability to generate new blood vessels to feed a growing mass of cells and second by boosting the immune response to the abnormal tumor cells. Biologic therapies are intended to work with the body's natural defenses to help fight tumor cells without harming healthy cells -- these therapies hold promise for effectiveness without the extreme toxicities seen in conventional chemotherapy.

This randomized trial involved women from seven different research sites (although a majority were from one institution) who had recurrent or persistent epithelial ovarian carcinoma. The final analysis included 39 women in the topotecan/control arm and 30 women in the thalidomide/topotecan arm. The women in the thalidomide/topotecan arm:

-- Had a 47 percent overall response rate compared to 21 percent in the control arm; and -- Had a two month improvement in disease free survival compared to the control arm.

While there was a trend toward an improvement in overall survival (19 months compared to 15 months in the control arm) the results were not statistically significant in this trial.

"The results of this study suggest that new molecules under development that act as immune modulators and anti-angiogenic agents, like thalidomide, should be studied in women with ovarian cancer in combination with traditional cytotoxic chemotherapy," said Dr. Downs. "While the development of new chemotherapy options has improved survival for women diagnosed with this disease, there is clearly a need for new, effective chemotherapy options."

According to the American Cancer Society ovarian cancer is the leading cause of death from gynecologic malignancy and the fifth most common cause of cancer death in women in the United States.

The study, "A Prospective Randomized Trial of Thalidomide with Topotecan Compared to Topotecan Alone in Women with Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma," was partially funded by Celgene Corporation and conducted by Levi S. Downs Jr., M.D., University of Minnesota, Minneapolis, MN; Patricia L. Judson, M.D., University of Minnesota, Minneapolis, MN; Peter A. Argenta, M.D., University of Minnesota, Minneapolis, MN; Rahel Ghebre, M.D., University of Minnesota, MN; Matthew P. Boente, M.D., MN Oncology Hematology PA, Edina, MN; William A. Nahhas, M.D., Wright State University Miami Valley Hospital, Dayton, OH; Samir Z. Abu-Ghazaleh, M.D., Dakota Midwest Cancer Institute, Sioux Falls, SD; M. Dwight Chen, M.D., Center for Gynecologic Oncology and Pelvic Surgery, Los Gatos, CA; and Linda F. Carson, M.D., University of Minnesota, Minneapolis, MN.

The 2006 Annual Meeting on Women's Cancer is the premier educational and scientific event for physicians and health care professionals involved in the field of gynecologic oncology and is being held March 22-26 at the Palm Springs Convention Center in Palm Springs, California. For more information visit .

About SGO

The SGO is a national medical specialty organization of physicians who are trained in the comprehensive management of women with malignancies of the reproductive tract. Its purpose is to improve the care of women with gynecologic cancer by encouraging research, disseminating knowledge which will raise the standards of practice in the prevention and treatment of gynecologic malignancies and cooperating with other organizations interested in women's health care, oncology and related fields. The Society's membership is primarily comprised of gynecologic oncologists, as well as other related medical specialists such as, medical oncologists, radiation oncologists and pathologists. SGO members provide multidisciplinary cancer care including chemotherapy, radiation therapy, supportive care and surgery. More information on the SGO can be found at .

Contact: Jennifer Grunstad Cell: (312) 282-0627

On-site SGO Annual Meeting Newsroom: (760) 322-8469

Society of Gynecologic Oncologists

CONTACT: Jennifer Grunstad of SGO, Cell, +1-312-282-0627, or On-site SGOAnnual Meeting Newsroom, +1-760-322-8469

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