THE GLIOBLASTOMA GROUP

Abstract No:

12502

Citation:

Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 12502

Author(s):

A. Fabi, A. Felici, M. A. Mirri, G. Metro, A. Vidiri, A. Pace, M. A. Carosi, F. Cognetti, E. Occhipinti, C. M. Carapella

Abstract:

Background: In a previous phase I study (ASCO 2006), where FDR Gemcitabine at 10/mg/m²/min was tested in association with radiotherapy (RT) for the treatment of newly diagnosed GBM, a maximum tolerated dose of 175 mg/m²/wk was identified. Methods: After surgery for GBM (either citoreduction or sterebiopsy), patients were treated with fractionated focal RT at a daily dose of 2.0 Gy per fraction, five days per week for six weeks (total dose of 60 Gy). FDR Gemcitabine at 175 mg/m²/wk was given concomitantly starting 24-72 hours prior to RT and then for the whole duration of RT. An MRI performed at 7 and 40 days from the end of chemo-radiotherapy was used for activity assessment. Standard oral temozolamide 150-200 mg/m² was administrated following the combined treatment. Results: From 07/2004 16 patients (9 male, 7 female) have been enrolled. Characteristics of patients were: median age 57 years (42-72), median KPS at baseline 90 (70-100), surgery/stereobiopsy 14/2. Median time from diagnosis to initiation of Gemcitabine was 45 days (28-54). Among the 14 evaluable patients 3 (21.4%) partial responses, 7 (50%) stable disease and 4 (28.5%) progressive diseases were recorded. At a median follow up of 18 months (2-33) time to progression was 6 months (1.5-24). Toxicity was manageable with only one G3 neutropenia and hypertransaminasemia in two patients respectively. Grade 1 hypertransaminasemia was registered in 6 patients (43%). Conclusions: These preliminary results show that in patients with newly diagnosed GBM, radiosensitizing FDR Gemcitabine at 175 mg/m²/wk is a well tolerated regimen with an interesting activity. Accrual is ongoing and final results will be presented at the meeting.