Tag: Carmustine wafers

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Safety and efficacy of Gliadel wafers for newly diagnosed and recurrent glioblastoma

Acta Neurochir (2012) 154:1371–1378

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.

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Prognostic factors and survival in a prospective cohort of patients with high-grade glioma treated with carmustine wafers or temozolomide on an intention-to-treat basis

Acta Neurochir (2012) 154:211–222.DOI 10.1007/s00701-011-1199-7

Patients with high-grade glioma can be treated with carmustine wafers or following the Stupp protocol. As far as we are aware, no scientific evidence has been published comparing the two treatments. The primary objective of this study was to analyse the survival of groups of patients with each of these treatment modalities. The secondary objective was to assess the influence of the usual prognostic factors on the patients in our hospital.

Methods A prospective cohort of 110 patients with single, supratentorial high-grade glioma treated by craniotomy and tumour resection was retrospectively studied. Half of the patients had carmustine wafers placed during this operation while the others (55) did not, the latter group receiving firstline systemic chemotherapy on an intention-to-treat basis.

Findings Patients treated with carmustine wafers had a median survival of 13.414 months compared with 11.047 in the group without implants (p=0.856). For the overall cohort of patients, the following factors were found to influence survival: age (p<0.0001), postoperative KPS score (p=0.001), histological grade (p=0.004), RPA class (p=0.001), extent of resection (p=0.002) and salvage surgery (p=0.028).

Conclusions In this prospective cohort of patients, analysed on the basis of intention-to-treat at the time of the first surgery, no statistically significant differences in survival were found between the two treatment modalities (carmustine wafers vs. first-line systemic chemotherapy). On the other hand, age, preoperative KPS, histological grade, and RPA class were confirmed to be prognostic factors in this cohort. Finally, the extent of resection was also found to influence survival.

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