Alan Sandler, M.D.
New treatment for advanced lung cancer approved
Promising results from a multi-center clinical trial led by Alan Sandler, M.D., of the Vanderbilt-Ingram Cancer Center, helped win approval this week of a new treatment for advanced lung cancer.
The U.S. Food and Drug Administration this week approved the use of bevacizumab (Avastin) in patients with advanced non-small cell lung cancer.
Avastin previously was approved to treat metastatic colorectal cancer, which has spread to other parts of the body.
The trial led by Sandler, medical director of Thoracic Oncology at Vanderbilt-Ingram, was conducted by the Eastern Cooperative Oncology Group (ECOG), one of the nation's largest clinical cancer research organizations.
Nearly 900 patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC), who had not received any prior chemotherapy, participated in the trial.
The patients were randomized and half received Avastin in addition to chemotherapy, while the other half received chemotherapy alone.
Patients who received Avastin combined with chemotherapy lived, on average, about two months longer than the group who only received chemotherapy, the researchers reported in May 2005 at the annual meeting of the American Society of Clinical Oncology in Orlando, Fla.
In an interview, Sandler said two months might not sound like much, but for patients with this advanced, and often deadly, form of lung cancer, it is a major advancement.
“Patients overwhelmingly want to live longer. It is important to note, these numbers represent an 'average.’ Some patients may not achieve any benefit, while some may receive a survival benefit far beyond the two-month average.”
In addition, some patients who received the drug plus chemotherapy saw their tumors shrink or go away altogether.
“This is the first time in more than 10 years that we've seen an increase in survival in patients with metastatic non-small cell lung cancer,” said Sandler, who also is medical director of Hematology/Oncology at Vanderbilt-Ingram.
“More specifically, bevacizumab represents the first targeted agent that, when combined with chemotherapy (in patients who had not previously received chemotherapy) revealed an improvement in overall survival,” he continued. “ECOG is now planning a large, international, randomized trial of chemotherapy with/without bevacizumab in patients with resected NSCLC. If this study proves positive this would translate into more patients being cured of their disease.”
Each year in the United States, about 175,000 new cases of non-small cell lung cancer are diagnosed and about 160,000 people die from the disease, more than the deaths caused by the second, third, fourth and fifth most common cancers combined.
Avastin prevents the development of new blood vessels that allow a tumor to continue to grow.
The humanized monoclonal antibody binds to and blocks a protein called vascular endothelial growth factor (VEGF), “which appears to be extremely important in new blood vessel development,” explained Sandler.
Because Avastin is directed against a specific target, Sandler said it spares normal, healthy cells, and side effects are not as severe as those caused by standard chemotherapy.
However, there are some unique side effects, the most serious of which is bleeding from the primary lung tumor.
“It is a drug that works on blood vessels,” Sandler said, “and that is something that we need to pay close attention to.”
For more information, call the Vanderbilt-Ingram Information Program at (800) 811-8480, or visit www.vicc.org.
Bill Snyder contributed to this story