Chicago — Roche recently announced the results from OCEANS, a phase III study evaluating bevacizumab in combination with chemotherapy (gemcitabine and carboplatin) followed by the continued use of bevacizumab alone in women with previously treated (recurrent) platinum-sensitive ovarian cancer.
Women who received bevacizumab experienced a 52 percent reduction in the risk of their disease progressing compared to women who received chemotherapy alone.
Adverse events in OCEANS were consistent with those seen in previous pivotal trials of bevacizumab across tumor types. These results were featured in a press briefing at the 47th annual meeting of the American Society of Clinical Oncology in Chicago.
“Women with recurrent ovarian cancer need new treatment options, and it is therefore an important advance to halve the risk of disease progression in this incurable cancer,” said Dr. Hal Barron, chief medical officer and head of global product development.
“These data add to the growing body of evidence supporting bevacizumab’s potential role in this disease, which includes two previously presented phase III clinical trials in women with newly diagnosed ovarian cancer,” Barron said.
In OCEANS, women with recurrent, platinum-sensitive ovarian cancer, who received bevacizumab in combination with chemotherapy followed by the continued use of bevacizumab alone until disease progression, experienced the following results:
• A median progression-free survival (PFS; the time without the disease progressing) of 12.4 months compared to 8.4 months in women who received chemotherapy alone.
• Tumor shrinkage in 79 percent of women receiving the bevacizumab-based regimen compared to 57 percent of women who received chemotherapy alone.
Select adverse events that occurred more often in the bevacizumab arm compared to the chemotherapy alone arm were hypertension, proteinuria (an excess of protein in the urine), and bleeding that does not occur in the central nervous system.
Notably, there were no gastrointestinal perforations (a hole in the stomach or intestine) seen during the safety reporting period of this study.
OCEANS is a multicenter, randomized, double-blind, placebo-controlled phase III study in 484 women with platinum-sensitive recurrent ovarian, primary peritoneal or fallopian tube cancer.
Women in OCEANS had received no more than one treatment regimen prior to enrolment in the trial. The trial was designed to evaluate bevacizumab in combination with carboplatin and gemcitabine chemotherapy, followed by bevacizumab as a single agent until disease progression, or unacceptable toxicity, compared to placebo in combination with carboplatin and gemcitabine chemotherapy, followed by placebo alone.
The primary endpoint of the study was progression-free survival, while the secondary endpoints of the study included overall survival, objective response, duration of response and safety profile.
Ovarian cancer is the eighth most commonly diagnosed cancer in women and the seventh leading cause of cancer death among women worldwide.
Annually, over 220,000 women will be diagnosed with ovarian cancer around the world and approximately 140,000 will die from the disease.
Surgery to remove as much of the tumor as possible is a mainstay of treatment but unfortunately, the majority of patients are diagnosed with late stage disease (when the cancer has grown or spread) and they require further treatment.
Ovarian cancer is associated with high concentrations of vascular endothelial growth factor (VEGF), a protein associated with tumor growth and spread.
Studies have shown a correlation between a high concentration of VEGF and ascites development (excess fluid in the body cavity), disease worsening, and a poorer prognosis in women with ovarian cancer.
Bevacizumab is designed to specifically target VEGF.
With the initial approval in the United States for advanced colorectal cancer in 2004, bevacizumab became the first anti-angiogenic therapy made widely available for the treatment of patients with advanced cancer.