Comparative impact of treatment on clinical benefit in patients with glioblastoma (GBM) enrolled in the phase II trial of ICT-107.

2036 Background: This study was a randomized double blind placebo-controlled phase 2 trial of dendritic cell(DC) Vaccine ICT-107 following standard treatment in newly diagnosed patients with GBM. Although OS was not different, PFS was longer in those receiving the vaccine. To evaluate the clinical benefit of this prolonged PFS, Karnofsky Performance Status (KPS) and steroid dosing, as well as patient reported QOL using the Functional Assessment of Cancer Therapy –Brain (FACT-BR) were evaluated during the progression free period. Methods: The FACT-BR was completed by patients at baseline, and longitudinally during the maintenance phase after four induction vaccinations and at the end of study visit. Corticosteroid dosing and KPS were evaluated throughout the progression free period at monthly timepoints for 12 months and every 6 months thereafter. Between arm differences were evaluated using Fisher test or ANOVA statistics. A p-value of 0.05 was considered significant when comparing the two treatment group...