SURG-14. Gliadel for brain metastasis: Results from the VIGILANT prospective registry

Abstract INTRODUCTION Brain metastases effect approximately 30-40% of patients with solid tumor malignancies. Treatments include surgery, radiosurgery, whole brain radiotherapy, and CNS-penetrating systemic therapies. Despite expanding treatment options, overall survival (OS) remains poor. Patients with local recurrence after radiosurgery or tumors too large for radiosurgery are particularly challenging. GLIADEL implant, a biodegradable carmustine chemotherapy wafer that delivers high dose carmustine within a tumor, shows efficacy in malignant glioma treatment, while limited data exists in brain metastasis. The VIGILANT (Vigilant Observation of Gliadel Wafer Implant) registry examines use and efficacy of GLIADEL, including in patients with brain metastases. Here we present results of patients with brain metastasis from the VIGILANT registry. METHODS 48 patients underwent surgical resection of metastatic brain tumors with GLIADEL implantation at Wake Forest Baptist Medical Center starting in 2017. 33 were treated due to local recurrence despite radiosurgery. 15 had lesions deemed too large for successful radiosurgery. Patients were evaluated primarily for OS and progression free survival (PFS) from date of surgery, and secondarily for adverse events and local progression. RESULTS Median OS was 14.9 months (95% CI 8.3, 26.0). Of 25 deaths, 7 (28%) met criteria for neurological etiology. 27 (56%) patients had progression during follow up, 6 (12.5%) had local progression. 2 (4%) had local progression that required additional neurosurgical treatment. Median PFS when considering death censored was 4.9 months (95% CI 3.6, 11.4). Of 15 patients not previously treated with radiosurgery, 8 (53%) had no progression. 43 total patients had adverse events; two considered possibly GLIADEL related. CONCLUSIONS Placing GLIADEL wafers for treatment of brain metastases may favorably increase OS (14.9 months vs. 7.9-24 months) and decrease 1 year local progression rates (12% vs up to 39%) compared to the literature and was well tolerated in this population, the majority whom failed initial radiosurgical management.