BACKGROUND: Combining Gliadel wafers and radiochemotherapy with TMZ may carry 
the risk of increased adverse events (AE). We analyzed the efficacy and safety 
in patients with glioblastoma who underwent multimodal treatment with 
implantation of Gliadel wafers.
METHODS: One hundred sixty-five consecutive patients with newly diagnosed (77 
patients) or recurrent (88 patients) glioblastoma were studied. Forty-seven 
patients underwent surgery + Gliadel. The impact of age (≥65 vs. <65), resection 
extent (gross total vs. partial), use of Gliadel and adjuvant treatment (TMZ vs. 
other schemes/no adjuvant therapy) on overall survival (OS, for patients with 
newly diagnosed glioblastoma) and on recurrence-survival (for patients with 
recurrent glioblastoma) was analyzed with Cox regression. The impact of age, 
history (newly diagnosed vs. recurrent glioblastoma), number of Gliadel wafers 
implanted (0 vs. <8 vs. 8), resection extent (gross-total vs. partial) and 
adjuvant treatment (TMZ vs. other schemes/no adjuvant therapy) on the occurrence 
of AE and on the occurrence of implantation site-related AE (ISAE) was analyzed 
with the logistic regression model. Significance was set at p < 0.05.
RESULTS: Multivariate analysis showed the only factor associated with longer 
survival, both for newly diagnosed and for recurrent GBM, was resection extent. 
Both patients with a higher number of wafers implanted and patients with 
recurrent tumors were significantly at risk for AE and ISAE. Patients with eight 
Gliadel wafers implanted had a 3-fold increased risk of AE and a 5.6-fold 
increased risk of ISAE, and patients with recurrent tumor had a 2.8-fold 
increased risk of AE and a 9.3-fold increased risk of ISAE.
CONCLUSIONS: Adding Gliadel to standard treatment did not significantly improve 
the outcome. The toxicity after Gliadel use was significantly higher, both for 
patients with newly diagnosed and patients with recurrent glioblastoma.