First trial to combine a biologic agent with a conventional chemotherapy agent for the treatment of ovarian cancer

In a study released 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.