Gliadel® Research: Safety
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Last Updated: 9/12/2013 - This page reviewed and approved by Virginia Stark-Vance, M.D.

Experience with Gliadel wafers: Ten-year retrospective review of implanting Gliadel wafers in 288 patients at Johns Hopkins University

PubMed citation
  • Attenello FJ, Mukherjee D, Datoo G, et al. Use of Gliadel (BCNU) wafer in the surgical treatment of malignant glioma: a 10-year institutional experience. Ann Surg Oncol. 2008;15(10):2887-2893.

Background: Gliadel (polifeprosan 20 with carmustine [BCNU] implant) is commonly used for local delivery of BCNU to high-grade gliomas after resection and is associated with increased survival. Various complications of Gliadel wafers have been reported but not consistently reproduced. We set out to characterize Gliadel-associated morbidity in our 10-year experience with Gliadel wafers for treatment of malignant glioma.

Methods: We retrospectively reviewed records of 1013 patients undergoing craniotomy for resection of malignant brain astrocytoma (World Health Organization grade III/IV disease). Perioperative morbidity occurring within 3 months of surgery was assessed for patients and compared between patients receiving versus not receiving Gliadel wafer. Overall survival was assessed for all patients.

Results: A total of 1013 craniotomies were performed for malignant brain astrocytoma. A total of 288 (28%) received Gliadel wafer (250 glioblastoma multiforme (GBM), 38 anaplastic astrocytoma/anaplastic oligodendroglioma (AA/AO), 166 primary resection, 122 revision resection). Compared with the non-Gliadel cohort, patients receiving Gliadel were older (55 ± 14 vs. 50 ± 17, p = 0.001) and more frequently underwent gross total resection (75% vs 36%, p 0.01) but otherwise similar. Patients in Gliadel versus non-Gliadel cohorts had similar incidences of perioperative surgical site infection (2.8% vs 1.8%, p = 0.33), cerebrospinal fluid leak (2.8% vs 1.8%, p = 0.33), meninigitis (0.3% vs 0.3%, p = 1.00), incisional wound healing difficulty (0.7% vs 0.4%, p = 0.63), symptomatic malignant edema (2.1% vs 2.3%, p = 1.00), 3-month seizure incidence (14.6% vs 15.7%, p = 0.65), deep-vein thrombosis (6.3% vs 5.2%, p = 0.53), and pulmonary embolism (PE) (4.9% vs 3.7%, p = 0.41). For patients receiving Gliadel for GBM, median survival was 13.5 months after primary resection (20% alive at 2 years) and 11.3 months after revision resection (13% alive at 2 years). For patients receiving Gliadel for AA/AO, median survival was 57 months after primary resection (66% alive at 2 years) and 23.6 months after revision resection (47% alive at 2 years).

Conclusion: In our experience, use of Gliadel wafer was not associated with an increase in perioperative morbidity after surgical treatment of malignant astrocytoma.

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