Acute toxicity analysis of patients receiving surgery, Gliadel wafer implantation, and postoperative daily temozolomide with radiation therapy for primary high-grade glioma

Abstract

11504 Background: Treatment of patients with newly diagnosed malignant glioma using Gliadel wafer implantation at initial surgery has been shown to increase survival (Westphal et al 2003). Similarly, administration of temozolomide during and after radiotherapy has also been shown to increase survival in this patient population (Stupp et al 2005). Accordingly use of both Gliadel and temozolomide may be advantageous for these patients although it is possible that the toxicity of these two approaches used together might be prohibitive. Methods: The Preston Robert Tisch Brain Tumor Center at Duke has occasionally treated with this approach over the last several years, and we now present an analysis of the observed acute toxicity. We retrospectively reviewed the Duke patients treated with surgery plus Gliadel wafer placement followed by daily temozolomide (75 mg/m2-150 mg/m2) and radiation therapy. Results: Of 28 patients reviewed, four patients were diagnosed with AA (WHO grade III), two patients were diagnosed with AO (WHO grade III) and the remaining 22 patients were diagnosed with glioblastoma multiforme (WHO grade IV). Two of the 28 7.1%) patients experienced grade 3 or 4 hematologic toxicity during radiation and daily temozolomide therapy. This is similar to the 7% of patients found to have hematologic toxicity reported by Stupp et al (2005). Three patients (10.7%) had grade 3 or 4 seizure activity. Two patients (7.1%) had grade 4 pulmonary emboli. No events of cerebral edema or wound complications were noted in this review of patient events following Gliadel wafer placement. Conclusions: In summary, the addition of Gliadel wafer placement at the time of surgery followed by radiation therapy with concurrent daily low dose temozolomide does not appear to have significant acute toxicity over that observed with radiation therapy and daily temozolomide. Future formal trials combining these therapeutic strategies may allow evaluation of the possible survival advantage associated with this approach. [Table: see text]