Safety results from a prospective study of concurrent radiosurgery and bevacizumab for recurrent malignant glioma.
2082 Background: Most patients with a malignant glioma recur after primary chemoradiation. Bevacizumab (BVZ) has been shown in phase II trials to improve disease-free survival in patients with recurrent glioma. Retrospective studies of stereotactic radiosurgery (SRS) for recurrent glioma have also suggested improved outcomes, particularly when BVZ is administered after SRS. METHODS: Patients with a recurrent unifocal malignant glioma who were treated with chemoradiation at diagnosis and failed salvage chemotherapy were eligible for this IRB-approved study. MRI and CT imaging were used for SRS planning. The contrast-enhancing lesion on the T1-weighted MRI was expanded by 1 mm for the planning target volume. Lesions <2 cm and 2-2.9 cm in size were prescribed 24 and 18 Gy in a single fraction, respectively. Lesions measuring 3-5 cm were prescribed 25 Gy in 5 fractions. Subjects received BVZ 10 mg/kg the day of SRS and 14 days later. The primary endpoint of the study was toxicity. Secondary endpoints included survival, cognitive function, and quality of life. Adverse events were scored using the NCI Common Terminology Criteria. Patients underwent baseline cognitive testing which was repeated 1 week and 2 months after SRS using the Mini-Mental State Exam and Trail Making Test. RESULTS: 15 subjects were enrolled between 1/2010 and 1/2011. Median age and KPS were 53 years (range 25-66) and 90 (range 80-100). Median time from primary diagnosis to salvage SRS was 19.6 months. There were 5 treatment-related grade 2 adverse events including neuropathy, cognitive disturbance, dizziness, and fatigue. One patient experienced grade 3 headache requiring hospitalization. No patient experienced a cerebrovascular accident or thrombotic event. No grade 4/5 adverse events were seen. Cognitive testing scores did not significantly decrease 1 week or 2 months following SRS compared to baseline. After a median follow up of 5.7 months 14 of the 15 patients are alive. CONCLUSIONS: Treatment with concurrent SRS and BVZ in heavily pre-treated patients with a recurrent malignant glioma appears well tolerated. Further follow up in this and a larger patient cohort is needed to test the efficacy of this approach.
Cuneo, KC; Cabrera, AR; Sampson, JH; Allen, KJ; Vredenburgh, JJ; Peters, K; Chang, Z; Herndon, JE; Desjardins, A; Reardon, DA; Kirkpatrick, J
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