Dec 21 2004
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.
“Because the study showed the second surgery had little impact on patient survival, that places increased importance on the success of the first surgery,” Dr. Rose said. “This also highlights the value of an initial examination by a surgeon who is prepared to perform an aggressive surgery to remove the tumor.”
Dr. Rose also serves as director of gynecologic oncology at MetroHealth Medical Center and is a professor in the Department of Reproductive Biology and Oncology at the Case Western Reserve School of Medicine, both in Cleveland.
Ovarian cancer is the fifth most common cancer among women, affecting about one in 57 women in the United States. The American Cancer Society estimates that about 25,580 new cases of ovarian cancer will be diagnosed in the United States during 2004. Although it is one of the most deadly forms of gynecologic cancers, incidence in the United States has been decreasing since 1991.