OBJECT: Gliadel (BCNU) wafer and concomitant temozolomide (TMZ) therapy, when 
used individually as adjuvant therapies, extend survival from that achieved by 
resection and radiation therapy (XRT) for glioblastoma multiforme (GBM). It 
remains unstudied whether combining Gliadel and TMZ therapy is safe or further 
improves survival in patients with newly diagnosed GBM. The authors reviewed 
their initial experience utilizing combined Gliadel, TMZ, and radiation therapy 
for the treatment of GBM.
METHODS: All cases involving patients undergoing primary resection of GBM with 
or without Gliadel wafer (3.85% BCNU) implantation and adjuvant XRT over a 
10-year period (1997-2006) were retrospectively reviewed. Beginning in 2004, 
concomitant TMZ became the standard of care at the authors' institution and all 
patients with Gliadel implantation also received concomitant TMZ (Stupp 
protocol). Overall survival and treatment-related morbidity were assessed for 
all patients treated with Gliadel plus concomitant TMZ (XRT + Gliadel + TMZ). 
Age-matched (<or= 70 years) comparison of survival and morbidity was performed 
between the XRT + Gliadel + TMZ (post-2003) and XRT + Gliadel (pre-2004) 
cohorts.
RESULTS: Thirty-three patients were treated with XRT + Gliadel + TMZ. The median 
survival in this group was 20.7 months, with a 2-year survival rate of 36%. 
Six-month morbidity included surgical site infection in 1 case (3%), 
perioperative seizures in 2 cases (6%), deep-vein thrombus in 1 (3%), pulmonary 
embolism in 3 (9%), and cerebral edema requiring admission for intravenous 
dexamethasone in 1 case (3%). Myelosuppression required premature termination of 
TMZ in 7 patients (21%) (thrombocytopenia in 5, neutropenia in 2 cases). In 
patients <or= 70 years of age, XRT + Gliadel + TMZ (30 patients, post-2003) was 
independently associated with improved median survival (21.3 vs 12.4 months, p = 
0.005) versus XRT + Gliadel (78 patients, pre-2004), with 2-year survival of 39 
versus 18%, respectively. In these patients, XRT + Gliadel + TMZ was not 
associated with an increase in perioperative morbidity in comparison with XRT + 
Gliadel.
CONCLUSIONS: In this experience, concomitant TMZ therapy in addition to Gliadel 
wafer implantation was associated with a median survival of nearly 21 months 
without increased perioperative morbidity. Temozolomide can be safely 
administered to patients receiving Gliadel wafers after resection of GBM.