on Saturday, June 4, 2011
Bevacizumab (Avastin®) in combination with chemotherapy resulted in a clinical benefit for patients with recurrent ovarian cancer, according to a new study. Results from the phase III “OCEANS” trial were presented today by the lead author, Carol Aghajanian, MD, of Memorial Sloan Kettering Cancer Center, at the 2011 annual meeting of the American Society of Clinical Oncology.
Progression-free survival, the length of time that a patient doesn’t experience any cancer growth, was significantly improved in the women who received the new drug combination compared to those who received a standard treatment. A 52 percent reduction in the risk of cancer progression was seen.
“This is good news for women with ovarian cancer, as we are increasingly able to treat ovarian cancer as a chronic disease,” said Dr. Aghajanian, Chief of the Gynecologic Medical Oncology Service at Memorial Sloan Kettering. “This is the first phase III trial to show a strong benefit for these patients using an antiangiogenic such as bevacizumab in combination with chemotherapy for recurrent disease.”
This study was a randomized, double-blind trial of patients with platinum-sensitive recurrent ovarian cancer - which means that the women have experienced a disease progression of greater than six months after completing their first-line chemotherapy.
“Ovarian cancer tends to present at late stage and about 80 percent of women recur after initially being treated with surgery and chemotherapy, so our ability to offer women a new treatment option is very important,” says Dr. Aghajanian.
The study included 484 patients - 242 who received chemotherapy and bevacizumab and 242 who received chemotherapy and a placebo. All patients received chemotherapy in addition to either bevacizumab or the placebo and continued to receive bevacizumab or the placebo as “maintenance therapy,” designed to maximize the benefit to patients, until they showed signs of disease progression. Disease progression was measured by CT scans that were taken every nine weeks throughout the study. The study was unblinded in February 2011 after demonstrating a positive treatment effect.
The women who received bevacizumab in addition to chemotherapy showed a 52 percent improvement in progression-free survival. Of the women who received bevacizumab and chemotherapy, 79 percent exhibited significant tumor shrinkage compared to 57 percent of the women who received the placebo and chemotherapy. In addition to the decrease in tumor size for those receiving bevacizumab and chemotherapy, researchers also found that the tumor shrinkage lasted for a longer time for those women.
“This study is extremely important because it demonstrates a clear, clinically meaningful response from bevacizumab in these cancers,” said Dr. Aghajanian.
According to the National Cancer Institute, ovarian cancer accounts for approximately 3 percent of all cancers in women and is the fifth leading cause of cancer-related death among women in the United States. Ovarian cancer is the term that is typically used to encompass the group of diseases including epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), and fallopian tube (FTC) cancer.
The study was funded by Genentech (a member of the Roche Group).