Pegylated liposomal doxorubicin in recurrent high-grade glioma: Comparison of clinical trial results and compassionate use

2073 Background: Results from prospective clinical studies may not always be reproduced in clinical practice. Therefore it is important to compare data from clinical trials with data from compassionate use of the same treatment. Here, we present patients with relapsed high-grade glioma treated outside a clinical trial with liposomal pegylated doxorubin (PEG-DOX). Methods: This data was documented prospectively and compared to our earlier published study results. Forty-nine patients with recurrent high-grade glioma (WHO III: n=18; IV: n=31) were treated with PEG-DOX (days 1 and 14/28, 20 mg/m2) alone or in combination therapy with temozolomide (TMZ) (days 1 to 5/28, 200 mg/m2). The clinical response rate, time to progression, progression free survival and overall survival were evaluated. Results: The overall response rate including disease stabilization was 53% (WHO III: 61; IV: 48). PFS-6 was 27% (WHO III: 33%; IV: 23%). The median OS after initiation of PEG-DOX was 35 weeks (WHO III: 68; IV: 31). Compari...