Gliadel Wafers continued….
Gliadel Wafers, which destroy the immune system,
passed the FDA for use in newly diagnosed GBM patients in 2003, but only increased overall survival by 9 weeks, and have all these side effects:
Side effects that have been reported in patients receiving Gliadel Wafer include seizures, intracranial infections, abnormal wound healing, and brain edema (swelling). Although these events may result as a consequence of brain surgery (craniotomy) without Gliadel Wafer, the above side effects are much more likely when Gliadel Wafer is used.
The rate of postcraniotomy surgical infection after Glidel wafer placement was reported to be as high as 28%. Extensive cerebral edema was also reported after Gliadel® placement, and led to severe neurologic compromise and death (Weber and Goebel 2005). Another cause of severe toxicity and death with Gliadel® wafers recently reported is obstructing hydrocephalus, and the authors of the case-report concluded that a large opening of the ventricle during surgery might be considered a contraindication for wafer placement (Gallego et al 2007).
Local treatment effects, such as pericavity necrosis are also commonly seen, affecting 11% of all patients, and 33% of the patients undergoing re-operation for radiological progression, which it makes difficult to differentiate between tumor recurrence and treatment effect based on non-invasive studies (Kleinberg et al 2004). Other observations following Gliadel® implantation include the formation of tumor bed cysts with new neurologic symptoms secondary to mass effect.
Gliadel Wafer is approved by the FDA for treatment of patients with newly-diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. The 2003 FDA approval was based on clinical trial results showing the median survival of patients with high-grade malignant gliomas increased to 13.9 months from 11.6 months, and the median survival of patients with recurrent GBM increased to 6.4 months from 4.6 months.
