430PGEINOFOTE: SAFETY AND ACTIVITY ANALYSIS OF THE USE OF FOTEMUSTINE (FT) IN DIFFERENT SCHEDULES IN PROGRESSIVE GLIOBLASTOMA (GB) IN SPAIN

Abstract Aim: Previous studies showed that FT may be useful as treatment in recurrent GB. The present study evaluate the activity and toxicity of FT in recurrent malignant GB patients in the clinical setting in Spain. Methods: Patients (age >18 years) with GB that was progressive (first or second recurrence) after prior standard radiotherapy plus temozolomide (TMZ) chemotherapy were eligible for the study. Patients were scheduled to receive FT in different schedules (Addeo vs others). Tumor response was assessed by MRI every 8-12 weeks. The primary end point was safety; secondary points included progression free survival (PFS), overall survival (OS). We analyze the differences between Addeo schedule (A) vs others (O) and 1° recurrence (1°R) vs 2° recurrence (2°R) in terms of safety and activity. Results: 84 patients were assessed; all of them began FT previously Nov 31, 2012. There were 46 males, and the median age was 56 years (ranged from 30 to 73). The median KPS was 70 (40-100). A schedule was used in 60 pts (71.4%). FT in first recurrence was used in 39 pts (46.2%) and 45 pts (51.2%) in second recurrence. The median PFS was (A 1°R / O 1°R/ A 2°R / O 2°R) 3.11/2.41/3.04/2.84 months, the median OS was (A 1°R / O1°R/ A 2° R / O 2°R) 6.15/5.29/4.36/3.87 months . The most common toxicities include thrombocytopenia and neutropenia. There were no statistical differences in Grade III or IV toxicities in relation with the type of schedule (A vs O) nor the 1° or 2° R (17%-7%). The patients received more frequent A schedule than O in 1°R or 2° R. No differences between A vs O in terms of clinical benefit, PS improve or less dexametasone use. Time to response: patients in A schedule spent less time to get the better response than patients with O schedules, whenever we use FT (no significant differences). Conclusions: FT has modest activity for recurrent GB with acceptable toxicity, regardeless the type of schedule. Probably, A get better response in less time than O schedules. Disclosure: All authors have declared no conflicts of interest.