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Gliadel® is FDA-approved for the treatment of patients with newly-diagnosed high-grade glioma as an adjunct to surgery and radiation. Gliadel® is also indicated for the treatment of patients with recurrent glioblastoma as an adjunct to surgery. (#1, #13)
Gliadel® wafers are biodegradable discs infused with carmustine (a.k.a BCNU) that are placed in the resection cavity site at the time of surgical tumor removal. The wafers are about dime-size in diameter. Usually, 7 or 8 wafers are placed in the area where the tumor was located. The number of wafers implanted depends on the size of the space left after the removal of the tumor. The advantage of this approach is that the drug gets released over time directly into the tumor site and does not need to cross the blood-brain barrier. (#1, #2)
In one study, at 12 months after surgery, 63% of the Gliadel patients were still alive, and 19% of those in the placebo group were still alive. However, some concern was expressed about the validity of these findings. (#3) Multiple subsequent studies and meta-analyses have concluded there is a modest, but often statistically significant, improvement in overall survival when the wafers are used as compared with placebo. (#4, #5, #10, #11, #12) Despite a survival benefit, one meta-analysis noted that widespread use of Gliadel® has been somewhat limited because its use may preclude enrollment in subsequent clinical trials. (#11)
Side effects of this treatment can include fever, urinary tract infections, and wound healing abnormalities. (#2, #3)
There have been instances of cerebral edema showing up later on in patients who have received the Gliadel® treatment. (#8) This swelling of the brain can increase pressure inside the skull.
There have also been some instances of Adverse Events occurring in patients who have been treated with Gliadel®, and then have later had to be operated on again, for recurrent tumors. (#9) In addition to cerebral edema, there have been cases of seizures and hydrocephalus.
A study reported Adverse Events including convulsions, confusion, brain edema and aphasia. But similar levels of Adverse Events were reported in at least one of the trials studied, for both the Gliadel® and placebo groups. (#10)
A 2022 long-term post-marketing surveillance study in Japan evaluated the overall survival (OS) and prognostic factors in patients with malignant glioma who received Gliadel 7.7 mg implants. The study found that Gliadel wafers prolonged OS in Japanese patients with malignant glioma. The median OS was 18.0 months overall, with OS rates of 39.8% and 31.5% at 2 and 3 years, respectively. (#6)
A 2023 study investigated the clinical significance of radiological changes associated with Gliadel wafer implantation in recurrent high-grade gliomas. The study found that certain radiological changes might be associated with improved survival outcomes. (#7)