Safety analysis of bevacizumab plus NovoTTF-100A in patients with recurrent malignant gliomas.

Abstract

2082 Background: Both bevacizumab and the NovoTTF-100A device are treatments approved by the FDA for recurrent glioblastoma. We examined our single-institution experience in using this combination for patients with recurrent malignant gliomas. Methods: We identified retrospectively the side effects experienced by patients while on both bevacizumab and NovoTTF-100A. Overall survival was also tabulated from initiation of this combined modality treatment. Results: There were 14 men and 6 women. Their median age was 54 (range 29-76). All had Karnofsky Performance Status of 60 or above. Fourteen patients received NovoTTF-100A after failure of bevacizumab treatment while the other 6 received both treatments concurrently. The median duration of bevacizumab plus NovoTTF-100A treatments was 2.3 (95% CI 1.8-4.7) months. There were 2 patients who experienced electric shock sensation on the scalp from a poorly-applied transducer array that resulted in minor scalp burns, 3 patients developed scalp rashes (2 moderate and 1 severe), 4 patients experienced liquefied hydrogel from the arrays as a result of high ambient temperature during summer months, 2 experienced vivid dreams of applying the arrays and 3 removed the arrays while periods of sleep or confusion. Only one patient required NovoTTF-100A treatment interruption because of severe scalp rash. No hemorrhage into the malignant glioma or thromboembolism was seen in this cohort. From the time of initiation of bevacizumab plus NovoTTF-100A treatments, the Kaplan-Meier median overall survival was 5.6 (95% CI 4.2-N/A) months. Conclusions: No additive or synergistic side effects were observed when patients were treated with both bevacizumab and NovoTTF-100A. Further evaluation in a prospective manner would be needed to evaluate both side effects and efficacy of this treatment combination.