Bevacizumab (Avastin) effectively delayed the progression of advanced ovarian cancer, according to a new phase 3 clinical trial conducted by the Gynecologic Oncology Group. The research suggests the potential for an avenue of treatment for patients in addition to surgery and chemotherapy.
"This approach can be looked upon as a third major component of treatment for ovarian cancer and related malignancies," said Robert A. Burger, MD, lead investigator of the GOG study and director of the Women's Cancer Center at Fox Chase Cancer Center in Philadelphia. "We've had the combination of surgical management and cytotoxic chemotherapy for many years, but we haven't really seen anything else in terms of a fundamental class of treatment. This represents a new way for us to control the disease."
The placebo-controlled study, which was sponsored by the National Cancer Institute, enrolled 1,873 patients with previously untreated advanced disease from 336 sites, primarily in the United States and also in Canada, South Korea and Japan. The patients had either stage III ovarian cancer that could not be entirely removed with surgery or stage IV disease, and were randomly assigned to one of three groups.
For patients who received bevacizumab with chemotherapy followed by bevacizumab for up to an additional 10 months, the median time until their cancer progressed was 14.1 months, compared to 10.3 months for patients in the control group, who received chemotherapy with a placebo and then continued with a placebo. The net effect was a 28% reduction in the risk of disease of ovarian cancer progression over time. Patients who received bevacizumab only with chemotherapy, and not afterward, had a median progression-free survival of 11.2 months.
The National Cancer Institute estimates that nearly 22,000 women were diagnosed with ovarian cancer in 2011, and more than 15,000 died of the disease. For patients diagnosed before the cancer has spread, the 5-year relative survival rate is about 93% (relative survival measures survival of cancer only, independent of other causes of death).
But early symptoms such as bloating, abdominal pain and trouble eating are typical of many illnesses and easily dismissed as non-threatening, meaning women often do not learn they have the disease until it has spread. In 62% of new cases, the patient's cancer has metastasized to distant sites, and the 5-year survival rate is less than 27%.
Bevacizumab is already FDA-approved for use against some types of colon, lung, kidney and brain cancers. However, its accelerated approval for metastatic breast cancer was recently revoked by the FDA (see www.nurse.com/article/Avastin). The drug acts by binding with vascular endothelial growth factor, a protein produced by certain cancers that helps initiate the growth of new blood vessels that feed the tumor.
The results of the trial appear in the Dec. 29 issue of the New England Journal of Medicine. To read a study summary and access the study via subscription or purchase, visit http://bit.ly/uWrFuo.
"This approach can be looked upon as a third major component of treatment for ovarian cancer and related malignancies," said Robert A. Burger, MD, lead investigator of the GOG study and director of the Women's Cancer Center at Fox Chase Cancer Center in Philadelphia. "We've had the combination of surgical management and cytotoxic chemotherapy for many years, but we haven't really seen anything else in terms of a fundamental class of treatment. This represents a new way for us to control the disease."
The placebo-controlled study, which was sponsored by the National Cancer Institute, enrolled 1,873 patients with previously untreated advanced disease from 336 sites, primarily in the United States and also in Canada, South Korea and Japan. The patients had either stage III ovarian cancer that could not be entirely removed with surgery or stage IV disease, and were randomly assigned to one of three groups.
For patients who received bevacizumab with chemotherapy followed by bevacizumab for up to an additional 10 months, the median time until their cancer progressed was 14.1 months, compared to 10.3 months for patients in the control group, who received chemotherapy with a placebo and then continued with a placebo. The net effect was a 28% reduction in the risk of disease of ovarian cancer progression over time. Patients who received bevacizumab only with chemotherapy, and not afterward, had a median progression-free survival of 11.2 months.
The National Cancer Institute estimates that nearly 22,000 women were diagnosed with ovarian cancer in 2011, and more than 15,000 died of the disease. For patients diagnosed before the cancer has spread, the 5-year relative survival rate is about 93% (relative survival measures survival of cancer only, independent of other causes of death).
But early symptoms such as bloating, abdominal pain and trouble eating are typical of many illnesses and easily dismissed as non-threatening, meaning women often do not learn they have the disease until it has spread. In 62% of new cases, the patient's cancer has metastasized to distant sites, and the 5-year survival rate is less than 27%.
Bevacizumab is already FDA-approved for use against some types of colon, lung, kidney and brain cancers. However, its accelerated approval for metastatic breast cancer was recently revoked by the FDA (see www.nurse.com/article/Avastin). The drug acts by binding with vascular endothelial growth factor, a protein produced by certain cancers that helps initiate the growth of new blood vessels that feed the tumor.
The results of the trial appear in the Dec. 29 issue of the New England Journal of Medicine. To read a study summary and access the study via subscription or purchase, visit http://bit.ly/uWrFuo.
Send comments to editor@nurse.com or post comments below.
