Neurocognitive function in patients with glioblastoma multiforme in first or second relapse treated with bevacizumab in the BRAIN study.
2056 Background: Patients with glioblastoma multiforme (GBM) suffer from neurocognitive decline due to both the disease and its treatment. We analyzed neurocognitive function of patients with recurrent GBM who participated in the BRAIN study, a phase II, multicenter, randomized, noncomparative clinical trial which assessed the efficacy and safety of bevacizumab alone or in combination with irinotecan. METHODS: Eighty-five patients who participated in the bevacizumab-only group of the BRAIN study were assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R), Trail Making Test parts A (TMTA) and B (TMTB), and the Controlled Oral Word Association (COWA) test. Assessments were conducted at baseline and then every 6 weeks while patients remained on study drug, up to 52 weeks. Change in neurocognitive function from baseline to Week 6 was categorized as improved, stable, or declined, using the reliable change index. Changes were confirmed at the next assessment, when available. Results were not adjusted for practice effects. RESULTS: Between 93 and 98% of patients completed each test at baseline and 73-78% completed each test at both baseline and Week 6. The majority of patients demonstrated stable performance on each test at Week 6, relative to baseline. With the exception of the COWA test, 18-25% of patients demonstrated improved performance on one or more tests at Week 6. CONCLUSIONS: Preliminary results suggest that the majority of patients with recurrent GBM who were treated with bevacizumab alone in the BRAIN study demonstrated stable or improved neurocognitive function during the first 6 weeks of treatment. Changes across tasks and associations with measures of clinical efficacy, patient characteristics, and concomitant medications will be explored. [Table: see text] [Table: see text].
Wefel, JS; Cloughesy, T; Zazzali, J; Yi, J; Friedman, HS; BRAIN Investigators,
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