Abstract
1583 Background: GBM is a highly malignant tumor with a median survival of less than 15 months. Dysregulated signalling of platelet derived growth factor receptors (PDGF-Rs) is implicated in pathogenesis. Imatinib (I) plus Hydroxyurea (HU) is effective in patients (pts) with recurrent progressing GBM. In a pilot series of 30 pts with recurrent GBM progression free survival (PFS) at 6 and 24 months was 32 % and 16 % respectively. 37 % of pts achieved disease stabilisation (SD). Despite the aggressive course of GBM, short periods without progression after primary treatment or effective treatment of relapse is common. The current Phase II study is designed to analyse the efficacy of I plus HU treatment in GBM pts with SD as sequential treatment. Methods: From Dec 2003 up to June 2005 30 pts were included. No enzyme-inducing anticonvulsive drugs were allowed. I at the dose of 600 mg and 1000 mg of HU were given as a continuous daily treatment, follow up included blood cell count weekly and magnetic resonance imaging (MRI) every 6 weeks. The primary endpoint is 12 months PFS. Results: All pts are eligible for safety and 28 pts of them for 6 months PFS and 6 months overall survival (OS) so far; 25 pts were male, 5 pts female, median age was 44 years (32 to 71). All 30 pts had prior irradiation, 21 pts had temozolomid containing and 9 pts non-temozolomid containing regimens. Eight pts were free from relapse, 17 pts after first and 5 pts after second relapse. 25 pts had measurable disease in MRI scan, 5 pts had no evidance of disease. The median follow up was 14 months. The best response was partial remission in 4 pts. SD for more than 3 months in 20 pts. 6 months PFS was 64% (18/28) and 6 months OS was 93 % (26/28). Hematotoxicity grade 2 and 3 occurred in 11 out of 30 pts (anemia grade 3: 2 pt; anemia grade 2: 4 pts; leucopenia grade 3:2 pts; grade 2: 7 pts; thrombopenia grade 2: 4 pts) and required dose reduction of HU in 8 pts, dose reduction of I in 1 patient and G-CSF subcutaniously in 8 pts. Conclusions: I (600 mg/d) and HU (1000 mg/d) showed significant efficacy as sequential treatment. Hematotoxicity was higher compared to I (400 mg/d) and HU (1000mg/d). Six months PFS and OS data are promising so far. Complete analysis according to the primary endpoint will be presented at the 2006 ASCO meeting. [Table: see text]
Published Version
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