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HOUSTON--Studies of a drug for adults with a fatal form of brain cancer reportedly prolongs life with few side effects, say researchers at The University of Texas M. D. Anderson Cancer Center.
The medical study showing the new drug prolonged life for individuals diagnosed with anaplastic astrocytoma on average by eight months is published in the current issue (September 1999) of the Journal of Clinical Oncology.
The findings led to accelerated approval of the drug, known chemically as temozolomide, by the U.S. Food and Drug Administration (FDA) Aug. 12. It was the first time in more than 20 years any new drug has been approved for adults with anaplastic astrocytoma who previously failed standard therapies, including radiation therapy and chemotherapy.
"This research represents an important new treatment option in recurrent anaplastic astrocytoma, one of the most serious and aggressive types of malignant brain tumors," said Dr. W.K. Alfred Yung, chairman of the Department of Neuro-Oncology at M. D. Anderson and lead investigator of the international study. "It is especially convenient because it is in the form of a capsule, enabling the patients to take the medication in the comfort of their homes instead of at doctors' offices or hospitals where intravenous chemotherapy treatments normally are administered."
The drug was tested among 111 patients at 32 medical institutions in the United States, Canada and Europe. The average life span for patients who fail traditional radiation therapy and chemotherapy treatment is about six months, Dr. Yung explained. But for the patients in the study, it was 14.5 months.
"This is quite significant, considering that it has been more than 20 years since we've found a drug that creates any response," he said. "For many patients, one more month, two more, or three more months of life means a lot. Future research will focus on using the drug in combination with other agents for possibly even better outcomes," he said.
Dr. Yung pointed out that more than 5,000 individuals in the United States, about 60 percent male, are expected to be diagnosed with anaplastic astrocytomas this year. The median survival rate for these individuals following diagnosis is 3.5 years.
All of the patients evaluated in the study had failed conventional therapies. All had previously received radiation therapy, and 60 percent also received chemotherapy. In addition, 18 percent of the patients had recurrent tumors surgically removed as part of their treatment.
In the study, the patients daily took one or more capsules of temozolomide five days a week for as long as their tumors were shrinking, or in regression, but no longer than two years. Dosage was determined by individual body weight. Tumor regression or progression was monitored with magnetic resonance imaging (MRI) technology.
Dr. Yung noted that patients on the medication had few side effects while on the drug. About half of the patients in the study experienced "mild to moderate" side effects, including nausea, constipation and vomiting.
The Schering-Plough pharmaceutical company produces the drug, known commercially as Temodar. The corporation also funded the study leading to accelerated FDA approval of Temodar, which will be commercially available beginning in September.
- 30 - 8/30/99
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