Abstract
BACKGROUND: Two multicenter phase III trials, RTOG0825 and AVAglio, evaluated the addition of BEV to radiation and temozolomide in newly diagnosed GBM and demonstrated a lack of statistically significant increased survival and discordant health-related quality of life results. We performed a retrospective chart review in newly diagnosed GBM to understand clinical benefit in BEV-treated patients in the community. METHODS: Newly diagnosed adult GBM pts treated at Duke were identified through our "Primary and Recurrent Glioblastoma Registry". We conducted a retrospective chart review of pts who initiated BEV between 1/1/2009 and 5/14/2012. Pts who participated in a clinical trial prior to receiving BEV were excluded. Pts alive on 5/15/2012 consented to the prospective collection of their data. Demographic and clinical data, including corticosteroid use and Karnofsky performance status (KPS), were analyzed. OS, PFS and time to KPS reduction were measured from BEV initiation. RESULTS: A total of 188 pts have been analyzed. At BEV initiation, median age was 57 years, 64% were male, 86% had KPS ≥80, and 46% were on corticosteroids. Median OS was 23.3 months (95% CI, 20.0-26.2 months). Median PFS was 14.8 months (95%CI, 12.2-17.9 months). Median time to KPS reduction ≥10-points and ≥20-points were 10.8 and 34.0 months, respectively. Of 86 pts on steroids pre-BEV, 78% discontinued steroids at a median of 64 days. Of 102 pts not on steroids pre-BEV, 57% did not initiate steroids, 31% initiated steroids while on BEV, and 12% initiated steroids while on another regimen. CONCLUSION: In newly diagnosed GBM pts treated on BEV in clinical practice, this retrospective review suggests a median OS and median PFS of 23.3 and 14.8 months, respectively. A majority of patients discontinued steroids, or remained off steroids during BEV treatment. Initial KPS levels were maintained by 86% of pts through the first year of follow-up.