The U.S. Food and Drug Administration (FDA) has approved the use of Avastin® (bevacizumab), in combination with 5-fluorouracil (5-FU)-based chemotherapy, for the treatment of advanced colorectal cancer in patients who have received a prior therapeutic regimen. Avastin is already approved for use as initial treatment in combination with 5-FU-based chemotherapy in patients with advanced colorectal cancer.
Colorectal cancer is the second leading cause of cancer-related deaths in the U.S. Once the cancer has spread to distant sites in the body, it is referred to as metastatic cancer. At this stage, treatment is generally aimed at prolonging survival and improving quality of life.
Metastatic colorectal cancer remains virtually incurable. Treatment and current research is often aimed at improving duration of survival while maintaining quality of life for these patients.
Avastin belongs to a group of drugs called monoclonal antibodies. Avastin produces its anticancer effects by targeting and binding to vascular endothelial growth factor (VEGF) and preventing the interaction of VEGF with its receptors.
VEGF, a type of protein, is important in a process leading to cellular growth, replication and spread, and new blood vessel formation. Avastin binds to VEGF and inhibits its normal effects. It reduces the growth and spread of cancer cells by inhibiting the growth of new blood vessels, making it harder for the tumor to grow.
Previously, Avastin was approved for the initial treatment of advanced colorectal cancer in combination with 5-fluorouracil-based chemotherapy. Avastin continues to be evaluated with different chemotherapy combinations and targeted agents for the treatment of several different types of cancers.
The trial that prompted the new FDA indication for Avastin was called the E3200 trial. Avastin plus chemotherapy was directly compared to chemotherapy alone in patients with metastatic colorectal cancer who had received prior therapy. This trial included 829 patients who were treated with either Avastin plus the regimen referred to as FOLFOX4 (5-FU, Eloxatin® [xaliplatin], leucovorin), or FOLFOX4 only and were directly compared.
• Patients treated with Avastin/FOLFOX4 had a 33% improvement in overall survival compared to those treated with FOLFOX4 only.
• The median survival for patients treated with Avastin/FOLFOX4 was 13 months, compared to 10.8 months for those treated with FOLFOX4 only.
• The addition of Avastin was generally well tolerated.
Patients with metastatic colorectal cancer that has progressed or returned following previous treatment may wish to speak with their physicians regarding their individual risks and benefits of treatment with Avastin.
Related News:Addition of High Dose Avastin® to FOLFOX4 Improves Survival in Recurrent Colorectal Cancer (5/17/2005)
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