A retrospective safety and efficacy analysis of combination therapy using Gliadel wafers plus external beam radiation therapy with concurrent temozolomide in newly diagnosed glioblastoma multiforme patients

Abstract

12510 Background: Safety and efficacy of malignant glioma treatment with carmustine-containing biodegradable implants (Gliadel® Wafers) followed by conventional radiotherapy (RT) and treatment with RT and concomitant temozolomide have both been well established. Multimodal therapy combining Gliadel® Wafers, RT, and temozolomide has recently demonstrated significant improvements in clinical outcomes of newly-diagnosed glioblastoma multiforme (GBM) patients. However, Gliadel® Wafer implantation in newly-diagnosed GBM patients is limited by the suspected risk of toxicities associated with multimodal therapy. Thus, the safety of multimodal therapy with Gliadel® Wafers, RT, and temozolomide needs to be determined. Methods: We conducted a retrospective analysis of medical records of 21 Florida Hospital Neuro- Oncology Center patients who were newly diagnosed with GBM from January 2003 to December 2005 and initially received multimodal therapy. All systemic and local toxicities were graded according to CTC AE v.3.0. Results were compared to historical data. Results: Our study population did not differ significantly from prior study populations with regard to patient demographics. 4 of 21 (19%) patients had grade 3 toxicities, which may have been related to multimodal therapy. None of the 21 patients had grade 4 toxicities. Median time to progression from initial surgery was 12.8 months (range 2–24 months). Median overall survival was 17 months (95% CI of 15–25 months). Conclusion: The addition of Gliadel® Wafers to concurrent RT and temozolomide did not result in a notable increase in grade 3 and 4 toxicities but did produce clinical outcomes comparable with those found in prior studies. The small sample size does not allow for definitive conclusions regarding efficacy. However, the addition of Gliadel® Wafers to concurrent RT and temozolomide appears to be safe in newly-diagnosed GBM patients. [Table: see text] No significant financial relationships to disclose.

Advanced Temporally‐Spatially Precise Technologies for On‐Demand Neurological Disorder Intervention

“…In 1986, Gliadel, a biodegradable round wafer loaded with carmustine, was first approved by Food and Drug Administration (FDA) as the adjuvant for glioblastoma therapy via intracranial implantation. [ 19 ] The spatially‐focused release of chemotherapeutics at surgical sites kills the residual tumor cell, efficaciously obviating the post‐operation metastasis or recurrence, consequently prolonging the overall survival of patients. [ 20 ] Nevertheless, this controlled‐release mechanism simply depends on the natural degradation of polymers, resulting in unstable pharmacokinetics.…”