Authors: Nicholas Butowski Kathleen R Lamborn Mitchel S Berger Michael D Prados Susan M Chang
Publish Date: 2007/04/25
Volume: 85, Issue: 1, Pages: 87-94
Abstract
New treatments for patients with glioblastoma multiforme GBM are frequently tested in phase II surgically based clinical trials that require gross total resection GTR In order to determine efficacy in such singlearm phase II clinical trials the results are often compared to those from a historical control group that is not limited to patients with GTR Recursive partitioning analysis RPA can define risk groups within historical control groups however RPA analyses to date included patients irrespective of whether a patient had a GTR or not To provide a more appropriate historical control group for surgically based trials requiring a GTR we sought to determine survival for a group of patients with newly diagnosed GBM all of who underwent GTR and were treated on prospective clinical trials GTR was defined as removal of 90 of the enhancing mass determined by postoperative magnetic resonance imaging Of 893 patients with GBM treated during these trials 153 underwent GTR The median survival for the GTR group was 71 weeks 95 CI 65–76 which was better than those who did not have a GTR Within the GTR group the median age was 54 years range 25–77 years and median Karnofsky Performance Score was 90 range 60–100 Considering only patients with GTR age at diagnosis continued to be a statistically significant prognostic factor Patients treated during surgically based phase II studies should be matched with a historical control group restricted to patients with similar pretreatment variables including GTR
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