From: Reuters
Published April 16, 2008 05:33 PM

Cediranib shows promise for recurrent glioblastoma

By Megan Rauscher

NEW YORK (Reuters Health) - The results of a mid-development stage clinical trial suggest that an experimental pan-VEGF inhibitor called cediranib may help shrink tumors and prolong survival in patients with recurrent glioblastoma.

"Glioblastoma has a poor prognosis, with less than 5 percent alive at 5 years, so there is a significant need for new therapeutics in this disease," lead investigator Dr. Tracy T. Batchelor of Massachusetts General Hospital Cancer Center noted at the American Association of Cancer Research annual meeting in San Diego.

He reported the 6-month results of daily oral cediranib treatment in 31 patients with glioblastoma who had failed prior therapy with surgery, radiation and chemotherapy. Cediranib is a drug that binds to and inhibits several vascular endothelial growth factor (VEGF) receptors


needed to form new blood vessels. Interruption of this process prevents the flow of oxygen-rich blood required by the tumor to grow.

At 6 months, "25.8 percent of patients were alive with no disease progression," Batchelor reported. This compares favorably to the 15 percent average survival rate at 6 months, he noted.

The average progression-free survival period was 117 days and average overall survival was 221 days, which also compares favorably with other rates.

"Over half of the patients saw a reduction in tumor mass and edema," much higher than seen with conventional chemotherapy drugs, Batchelor said.

"Cediranib normalized tumor blood vessels and relieved swelling, "which is a major cause of illness in this patient population and which often requires glioblastoma patients to remain on steroids for prolonged periods of time," he added. The majority of patients who were on steroids at the start of the study were able to reduce the dose or discontinue steroids.

Cediranib-associated toxicity was "manageable," Batchelor said. The most common side effects were fatigue, high blood pressure and diarrhea. Two patients stopped the drug due to fatigue and 15 patients required at least one dose reduction.

"There has been some concern about hemorrhage with this class of agents," Batchelor reported. However, they saw no hemorrhaging around the tumor or in the brain, and there were no deaths associated with treatment, Batchelor reported.

Another, larger study is planned and should begin this year in the United States, Canada and Europe. Batchelor said his team also has a grant from the National Cancer Institute to combine cediranib with radiation and chemotherapy and study the effects in newly diagnosed glioblastoma patients.

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