Gliadel® Wafer Improves Survival in Aggressive Gliomas
According to a press release from MGI Pharma, Inc., the use of Gliadel® wafers improves long-term survival among patients diagnosed with aggressive gliomas.
Approximately 20,000 individuals are diagnosed annually in the U.S. with cancer that originates in the brain. There are several different types of brain cancer; they are distinguished by the cells in the brain where the cancer originates, the extent of spread, aggressiveness of the cancer, and characteristics of the cancer.
Initial therapy for brain cancer may include the surgical removal of the cancer, radiation to the brain, and/or chemotherapy. Unfortunately, a large portion of patients with brain cancer experience a recurrence or progression of their cancer following initial therapy. Survival for these patients remains poor, and researchers continue to evaluate new methods to improve survival.
Brain cancer often recurs at or near the area of the initial cancer; this demonstrates a need to kill additional cancer cells that may be undetectable near the site of cancer. The Gliadel wafer is a thin, coin-sized “wafer” that contains the chemotherapy agent carmustine (BiCNU®). It is implanted into the cavity of the brain from which the cancer was removed; chemotherapy may thus be delivered directly to the surrounding cells. The Gliadel wafer is approved for the treatment of high-grade (aggressive) gliomas and recurrent glioblastoma multiforme, two different types of cancer that originate in the brain.
These recent results are the products of long-term follow-up of previously reported results evaluating the Gliadel wafer in patients with high-grade glioma or recurrent glioblastoma. The trial included 240 patients; 59 were available for long-term follow-up. All patients underwent the surgical removal of their cancer plus radiation therapy. Approximately half were treated with Gliadel wafer, while the other half received a placebo wafer (inactive substitute).
Patients treated with the Gliadel wafer demonstrated improved survival compared to those who received placebo:
- At three years, survival was 9.2% for those treated with the Gliadel wafer, compared with only 1.7% for those who received placebo.
- Over the study period, the use of the Gliadel wafer reduced the risk of death by 27% in patients with high-grade gliomas.
- At nearly 5 years following treatment, 11 patients were still alive; nine of these 11 had been treated with the Gliadel wafer.
- Median overall survival for patients with high-grade glioma was nearly 14 months for those treated with the Gliadel wafer and 11.6 months for those who received placebo.
- Median overall survival for patients with recurrent glioblastoma increased from 4.6 months for those who received placebo to 6.4 months for those treated with the Gliadel wafer.
The researchers concluded that long-term follow-up continues to indicate that treatment with the Gliadel wafer improves survival for patients with high-grade gliomas or recurrent glioblastoma. Patients with cancer that originated in the brain may wish to speak with their physician regarding their individual risks and benefits of treatment with the Gliadel wafer or the participation in a clinical trial further evaluating new therapeutic approaches. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (www.cancer.gov) and www.cancerconsultants.com.
Related News:FDA Approves Gliadel Wafer® as Initial Therapy for Gliomas (2/28/03)
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