|Register Today for This Free Webinar: Strategic Use
of BCNU Wafers in Contemporary Care
Lynn Stuart Ashby, MD
Assistant Director, Neuro Oncology Program
Barrow Neurological Institute (BNI)
Eyas M. Hattab, MD, MBA
AJ Miller Professor and Chair
Pathology and Laboratory Medicine
Timothy C. Ryken, MD, MS, FACS, FAANS
Professor and Chief
Section of Neurosurgery
Dartmouth-Hitchcock Medical Center
In this one-hour webinar, participants will receive an overview on the practical use of BCNU Wafers for the treatment of newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation and recurrent glioblastoma multiforme as an adjunct to surgery. Neurooncology, neuropathology and neurosurgery perspectives will be presented in the discussion covering peri-operative considerations for BCNU Wafer implantation as part of a multimodal treatment plan.
- Review historical changes in incidence and survival over recent decades for high grade malignant glioma (HGG) and summarize current FDA approved treatments.
- Evaluate pivotal evidence for the use of BCNU wafers and indications for newly diagnosed and recurrent HGG setting.
- Develop strategic approach for integrating BCNU wafers into multimodal standard treatment for patients at diagnosis and relapse of HGG.
- Discuss prerequisites for successful intraoperative consultation (IOC) outcomes and overcoming challenges in surgical neuropathology.
- Learn how to bridge the intraoperative gap between pathology and neurosurgery.
- Identify the best operative and post-operative approaches toward optimizing outcomes following BCNU wafer implantation.
IMPORTANT SAFETY INFORMATION
GLIADEL Wafer can cause fetal harm when administered to a pregnant woman. It is recommended that patients receiving GLIADEL Wafer discontinue nursing. Female patients of reproductive potential should receive counseling on pregnancy planning and prevention. Advise male patients of the potential risk of infertility and to seek counseling on fertility and family planning options prior to implantation of GLIADEL Wafer.
WARNINGS AND PRECAUTIONS
Seizures: Seizures occurred in 37% of patients treated with GLIADEL Wafers in the recurrent disease trial. New or worsening (treatment emergent) seizures occurred in 20% of patients; 54% of treatment-emergent seizures occurred within the first 5 post-operative days. The median time to onset of the first new or worsened post-operative seizure was 4 days. Institute optimal anti-seizure therapy prior to surgery. Monitor patients for seizures postoperatively.
Intracranial Hypertension: Brain edema occurred in 23% of patients treated with GLIADEL Wafers in the initial surgery trial. Additionally, one GLIADEL-treated patient experienced intracerebral mass effect unresponsive to corticosteroids which led to brain herniation. Monitor patients closely for intracranial hypertension related to brain edema, inflammation, or necrosis of the brain tissue surrounding the resection. In refractory cases, consider re-operation and removal of GLIADEL Wafers or Wafer remnants.
Impaired Neurosurgical Wound Healing: Impaired neurosurgical wound healing including wound dehiscence, delayed wound healing, and subdural, subgleal, or wound effusions occur with GLIADEL Wafer treatment. In the initial disease trial, 16% of GLIADEL Wafer-treated patients experienced impaired intracranial wound healing and 5% had cerebrospinal fluid leaks. In the recurrent disease trial, 14% of GLIADEL Wafer-treated patients experienced wound healing abnormalities. Monitor patients post-operatively for impaired neurosurgical wound healing.
Meningitis: Meningitis occurred in 4% of patients receiving GLIADEL Wafers in the recurrent disease trial. Two cases of meningitis were bacterial; one patient required removal of the Wafers four days after implantation; the other developed meningitis following reoperation for recurrent tumor. One case was diagnosed as chemical meningitis and resolved following steroid treatment. In one case the cause was unspecified, but meningitis resolved following antibiotic treatment. Monitor postoperatively for signs of meningitis and central nervous system infection.
Wafer Migration: GLIADEL Wafer migration can occur. To reduce the risk of obstructive hydrocephalus due to wafer migration into the ventricular system, close any communication larger than the diameter of a Wafer between the surgical resection cavity and the ventricular system prior to Wafer implantation. Monitor patients for signs of obstructive hydrocephalus.
The most common adverse reactions in Newly-Diagnosed High Grade Malignant Glioma patients (incidence >10% and between arm difference ≥4%) are cerebral edema, asthenia, nausea, vomiting, constipation, wound healing abnormalities and depression.
The most common adverse reactions in Recurrent Glioblastoma Multiforme patients (incidence >10% and between arm difference ≥4%) are urinary tract infection, wound healing abnormalities and fever.
Please click here for full Prescribing Information.
Gliadel® is manufactured by Eisai Inc. for Arbor Pharmaceuticals, LLC.
Gliadel® is a registered trademark of Eisai Inc.