Phase Ii Randomized Study Of Preradiation Treatment With Temozolomide (Tmz) And Bevacizumab (Bev) Previous To Tmz Plus Radiation Plus Bev Versus The Same Treatment Without Bev Therapy In Unresectable Glioblastoma (Gb): Genom 009

e12519 Background: Unressectable GB hardly benefits from standard treatment. Patients frequently deteriorate neurologically during radiotherapy. An effective pre-radiation treatment might improve their prognosis and allow them to complete concomitant radiotherapy and temozolomide treatment. Bevacizumab in recurrent HGG displays high objective responses. Methods: We are conducting a phase II, two arms, open label, randomized, multicentric study with 2 cycles of temozolomide before radiation therapy and concomitant temozolomide plus maintenance in patients with GB and ‘biopsy-only’ (Arm A). Bevacizumab is added to one arm during the neo-adjuvant and concomitant phase (Arm B). Ninety patients will be randomized Primary endpoints: response rate after neoadjuvant treatment (RANO criteria). Secondary endpoints: differences between arms in PFS, completion of radiotherapy, toxicity, maintenance of neurological status and overall survival We present here the previously planned results of a security analysis after the inclusion of the first 10 patients treated with bevacizumab. Results: After the inclusion of 22 patients: 2 patients were not evaluable and 10 patients were treated in each arm. Arm A: 3 adverse events: 1/10p hematological grade 4 toxicity in the neo-adjuvant phase, 2/10p lung embolism all solved with treatment. From these patients 6/10 completed neo-adjuvant and concomitant phase, 2/10 completed only neo-adjuvant phase and 2/10 progressed without completing neo-adjuvant phase. Arm B: 2 adverse events: 1 pneumonia grade 3 and 1 p with hypertensive crisis grade 2 all solved with treatment. From these patients, 7/10 p completed neo-adjuvant and concomitant treatment, 2/10 completed neo-adjuvant treatment and 1/10 progressed without completing neo-adjuvant phase Conclusions: The trial is ongoing as the security analysis was acceptable.