Results of the first randomized control trial conducted in the United States to help determine the success of surgery for ovarian cancer have been published in the New England Journal of Medicine. The research shows that a second additional surgical procedure does not significantly improve survival rates for patients with advanced ovarian cancer.
“To date, efforts to improve survival among women with advanced ovarian cancer have had only limited success,” said study leader Peter Rose, M.D., section head of gynecologic oncology at The Cleveland Clinic. “Standard treatment for this type of cancer includes surgery to remove as much as the tumor as possible plus subsequent chemotherapy. This study attempted to determine whether a second surgical procedure aimed at removing more of any remaining tumor combined with chemotherapy would prolong a patient’s life.”
A total of 550 patients with stage III or stage IV ovarian cancer were enrolled in the study from June 1994 through January 2001 six weeks after their initial cytoreduction surgery (surgery to remove as much of the tumor as possible). Of the number, 216 patients were randomly assigned to receive the second surgery followed by chemotherapy, and 208 were assigned to receive chemotherapy alone after the first surgery. Surgery was declined or medically contraindicated in 15 patients who were assigned to secondary surgery. At the completion of the study, 296 patients had died and 82 had progressive disease.
Analysis of the results showed that undergoing this second surgery did not improve patient survival compared to undergoing only one surgery and chemotherapy. These results contrast with previous a clinical trial of a similar design.