surgery and radiation therapy, the six-month survival rate after repeat surgery increased from 47% (53/112) for patients receiving placebo to 60% (66/110) for patients treated with Gliadel® Wafer. Median survival increased by 33%, from 24 weeks (5.5 months) with placebo to 32 weeks (7.4 months) with Gliadel® Wafer treatment. In patients with GBM, the six-month survival rate increased from 36% (26/73) with placebo to 56% (40/72) with Gliadel® Wafer treatment. Median survival of GBM patients increased by 41% from 20 weeks (4.6 months) with placebo to 28 weeks (6.4 months) with Gliadel® Wafer treatment. In patients with pathologic diagnoses other than GBM at the time of surgery for tumor recurrence, Gliadel® Wafer produced no survival prolongation.
6-MONTH KAPLAN-MEIER SURVIVAL CURVES FOR PATIENTS UNDERGOING SURGERY FOR RECURRENT GBM
KAPLAN-MEIER OVERALL SURVIVAL CURVES FOR PATIENTS UNDERGOING SURGERY FOR RECURRENT GBM
INDICATIONS AND USAGE
Gliadel® Wafer is indicated in newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. Gliadel® Wafer is indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery.
CONTRAINDICATIONS
Gliadel® Wafer contains carmustine. Gliadel® Wafer should not be given to individuals who have demonstrated a previous hypersensitivity to carmustine or any of the components of Gliadel® Wafer.
WARNINGS
Patients undergoing craniotomy for malignant glioma and implantation of Gliadel® Wafer should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with Gliadel® Wafer, including one case leading to brain herniation.
Pregnancy: There are no studies assessing the reproductive toxicity of Gliadel® Wafer. Carmustine, the active component of Gliadel® Wafer, can cause fetal harm when administered to a pregnant woman. Carmustine has been shown to be embryotoxic and teratogenic in rats at i.p. doses of 0.5, 1, 2, 4, or 8 mg/kg/day when given on gestation days 6 through 15. Carmustine caused fetal malformations (anophthalmia, micrognathia, omphalocele) at 1.0 mg/kg/day (about 1/6 the recommended human dose (eight wafers of 7.7 mg carmustine/wafer) on a mg/m2 basis). Carmustine was embryotoxic in rabbits at i.v. doses of 4.0 mg/kg/day (about 1.2 times the recommended human dose on a mg/m2 basis). Embryotoxicity was characterized by increased embryo-fetal deaths, reduced numbers of litters, and reduced litter sizes.
There are no studies of Gliadel® Wafer in pregnant women. If Gliadel® Wafer is used during pregnancy, or if the patient becomes pregnant after Gliadel® Wafer implantation, the patient must be warned of the potential hazard to the fetus.
PRECAUTIONS
General
Communication between the surgical resection cavity and the ventricular system should be avoided to prevent the wafers from migrating into the ventricular system and causing obstructive hydrocephalus. If a communication larger than the diameter of a wafer exists, it should be closed prior to wafer implantation.
Computed tomography and magnetic resonance imaging of the head may demonstrate enhancement in the brain tissue surrounding the resection cavity after implantation of Gliadel® Wafers |
