Abstract
2029^ Background: The prognosis of unresectable glioblastoma (GBM) remains poor despite temozolomide- based chemoradiation with a median of 6 month progression-free survival (PFS). Activity of bevacizumab/irinotecan has been reported in patients with relapsed GBM (Vredenburgh, 2007). The objective of this randomized phase II trial was to evaluate the efficacy and safety of irinotecan (IRI) and bevacizumab (BVZ) as neo-adjuvant and adjuvant treatment to chemoradiation with temozolomide (TMZ) and BVZ for naive unresectable glioblastoma. Control arm was TMZ as concomitant and adjuvant treatment to radiation. Methods: Pts with de novo unresectable GBM, aged 18-70, and KPS > 50, and EORTC RPA class 5 were eligible. Experimental arm (A) consisted of neo-adjuvant BVZ 10 mg/kg and IRI 125 mg/m2, every 2 wk for 4 cycles before radiotherapy 60 Gy in 30 fractions with concurrent TMZ 75 mg/m2/day and BVZ every 2 wk. Adjuvant BVZ and IRI were given every 2 wk for 6 month. The control arm (B) consisted of concomitant T...
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