A phase II multicentric study of sunitinib administered as upfront therapy in glioblastoma: A study by the GEINO group.

2045 Background: Sunitinib is a multitargeted tyrosine kinase inhibitor that has direct antitumor and antiangiogenesis activity through targeting VEGFR 1-2, PDGFR α-β, c-kit, bFGF, (CSF-1), FLT3 and RET. Experimental studies in GB mice showed angiogenic activity, prolonged survival and synergy with irradiation Methods: Eligible pts were ≤75 years with GB not amenable to resection, PS≥2, MMS ≥25. Treatment was sunitinib 37.5mg daily for 8 w before radiotherapy, during radiotherapy (60Gy, 6 w) and after radiotherapy until disease progression. Primary endpoint was overall response (OR) (RANO criteria) after 8 w of sunitinib treatment before radiotherapy. Secondary endpoints were % pts free of neurological deterioration before radiotherapy, % pts who completed radiotherapy, PFS, OS and 1-year survival. We used a Simon 2-stage design (12 →20) based on OR to calculate the number of patients needed to detect at least 10% of responses with α error of 0.05 and β error of 0.10. Twelve patients were included in the ...