Last Updated:9/12/2013 - This page reviewed and approved by Virginia Stark-Vance, M.D.
Overview Of Gliadel®
- Gliadel wafers consist of biodegradable polymer (polifeprosan 20) impregnated with the drug carmustine (bis-chloroethylnitrosourea [BCNU]), an alkylating agent used for chemotherapy.
- Gliadel is one of only two drugs approved by the United States Food and Drug Administration (FDA) for the treatment of newly diagnosed malignant high-grade glioma in the last 40 years. (Systemic carmustine (BCNU), for intravenous injection, and lomustine (CCNU), oral capsules, were approved by the FDA in the 1970s.)
- Gliadel was approved by the FDA in 2002 for newly diagnosed high-grade glioma.
- Temodar (temozolomide) was approved by the FDA in 2005 for newly diagnosed high-grade glioma.
- Gliadel is also one of only two drugs approved by the FDA for treatment of recurrent glioblastoma.
- Gliadel was approved by the FDA in 1995 for treatment of recurrent glioblastoma.
- Avastin (bevacizumab) was approved by the FDA in 2009 for treatment of recurrent glioblastoma.
- Gliadel wafers are implanted by neurosurgeons within the tumor cavity at the time the tumor is removed. The wafers are placed by neurosurgeons up against the walls of the tumor cavity before the membrane, skull, and scalp are closed. The wafers slowly dissolve over several days, releasing the drug carmustine. Carmustine penetrates into the surrounding brain tissue to treat microscopic tumor cells left behind after surgery, in order to prevent and delay regrowth of the tumor. Gliadel wafers are the only high-grade glioma treatment that delivers a chemotherapeutic drug directly at the brain tumor site without needing to cross the blood-brain barrier.
- The safety and effectiveness of Gliadel wafers, as an adjunct to surgery and radiation, for the treatment of newly diagnosed high-grade glioma have been demonstrated in a double-blind, randomized, placebo-controlled trial of 240 patients. Compared with placebo, implantation of Gliadel wafers statistically significantly increased median time of survival in newly diagnosed high-grade glioma patients by 2.3 months (p = 0.03).
- The safety and effectiveness of Gliadel wafers, as an adjunct to surgery, for the treatment of recurrent glioblastoma have been demonstrated in a double-blind, randomized, placebo-controlled trial of 222 patients. Compared with placebo, implantation of Gliadel wafers statistically significantly increased median time of survival in recurrent glioblastoma patients by 8 weeks (p = 0.0006).
- There are side effects possible from implantation of Gliadel wafer. Because Gliadel can increase the risk of seizures within the first few days after surgery, an anticonvulsant medication is preventively administered at the time of the Gliadel implantation. Patients receiving Gliadel wafers can also experience more swelling of the surrounding brain and more difficulty with wound healing at the site of the tumor resection and Gliadel implantation.
- The use of Gliadel wafers for treatment of patients with newly diagnosed high-grade glioma and for patients with recurrent glioblastoma has been included in the 2013 guideline recommendations of the National Comprehensive Cancer Network, an alliance of 21 cancer centers in the United States. The use of Gliadel wafers for treatment of patients with newly diagnosed high-grade glioma has also been included in 2008 guideline recommendations of the American Academy of Neurological Surgeons and the Congress of Neurological Surgeons (Fadul CE, Wen PY, Kim L, Olson JJ. Cytotoxic chemotherapeutic management of newly diagnosed glioblastoma multiforme. J Neurooncol. 2008;89(3):339-357).
- The use of Gliadel wafers combined with systemic temozolomide for treatment of newly diagnosed high-grade glioma has been evaluated in a number of studies. Combination therapy of Gliadel wafers and temozolomide (administered according to the Stupp protocol) has not been evaluated in a double-blind, randomized, placebo-controlled trial. However, in most but not all of the studies to date of combination therapy, there appears to be an additive benefit of the combination on patient outcomes, in comparison with either Gliadel alone or temozolomide as part of the Stupp protocol alone. Median overall survival time is extended, median progression-free survival time is extended, and a larger percentage of patients survive to 2 years.
- Contemporary use of Gliadel alone and in combination therapy with temozolomide has been summarized in several detailed medical reviews.
- Gliadel wafers have also been experimentally investigated for the treatment of brain metastasis.
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