Thalidomide, a drug blamed in the 1950s for causing birth defects, is now showing promise as a safe and effective treatment for women with recurrent ovarian cancer, according to a study led by a University of Minnesota Cancer Center researcher.
Levi Downs, Jr., M.D., principal investigator for the multicenter, randomized Phase II clinical trial, has published the findings of this research study in the current issue of the journal Cancer. Downs is an assistant professor and a researcher of gynecologic oncology at the University of Minnesota Medical School and Cancer Center.
"For some women, ovarian cancer has become a chronic disease," Downs said. "The standard chemotherapy regimens can put recurrent cancer in remission, often more than once. However, when the cancer resists the standard treatments, we need new options for treatment."
The study compared the effectiveness and safety of the combination of thalidomide and topotecan, a chemotherapy often used for ovarian cancer, versus topotecan alone for treatment of recurrent epithelial ovarian cancer in patients who had received prior treatment. Epithelial ovarian cancer is a disease in which cancer cells form in the tissue that covers the ovary.
The study evaluated 75 women who were randomly assigned to receive either the combination of thalidomide and topotecan or only topotecan. This is the first randomized clinical trial to test thalidomide for recurrent ovarian cancer. Other clinical trials have shown thalidomide to be effective for treatment of multiple myeloma, a cancer of the bone marrow.
"We found that patients who received topotecan plus thalidomide showed an overall response rate of 47 percent compared to 21 percent response in patients who received only topotecan," Downs said. "In patients receiving topotecan plus thalidomide, 30 percent achieved a complete response, meaning the cancer went away, compared to 18 percent for patients only getting topotecan.
"Furthermore, patients getting topotecan plus thalidomide had a longer cancer-free period after treatment than those receiving topotecan alone," he said. "What all of this means is that while thalidomide may not cure ovarian cancer, it may broaden the treatment options available to physicians and provide more hope to women diagnosed with the cancer."
Ovarian cancer is the fifth most common cancer among women. This year in the United States, more than 25,000 women will be diagnosed with ovarian cancer, and about 16,000 will die from it. About 78 percent of women diagnosed with the cancer survive one year after diagnosis, and more than 50 percent survive five years after diagnosis.
The results of this study have led to the development of a new clinical trial at the University of Minnesota that will test the safety and effectiveness of a newer member of the class of drugs containing thalidomide properties for treatment of recurrent ovarian cancer.
This study was sponsored by Celgene Corporation, biopharmaceutical company and manufacturer of thalidomide. Cancer centers in Minnesota, Ohio, South Dakota, and California participated in this study.