Picard, M; Weller, M (2010). Phase I/IIa study of cilengitide and temozolomide with concomitant radiotherapy followed by cilengitide and temozolomide maintenance therapy in patients with newly diagnosed glioblastoma. Patients and MethodsPatients (≥18 to ≤70 years) were treated with cilengitide (500 mg) administered twice weekly i.v. in addition to standard radiotherapy with comcomitant and adjuvant temozolomide. Treatment was continued until disease progression or for a maximum of 35 weeks. The primary endpoint was progression-free survival (PFS) at 6 months. ResultsFifty-two patients (median age 57 years; 62% male) were included. Six-and 12-month PFS rates were 69% (95% confidence interval [CI], 54-80%) and 33% (95% CI, 21-46%). Median PFS was 8 months (95% CI, 6.0-10.7). Twelve-and 24-month overall survival (OS) rates were 68% (95% CI, 53-79%) and 35% (95% CI, 22-48%). Median ConclusionCompared with historical controls, the addition of concomitant and adjuvant cilengitide to standard chemoradiation demonstrated promising activity in patients with glioblastoma with MGMT promoter methylation.5

Continuous daily temozolomide and concomitant radiation is safe. This regimen of concomitant chemoradiotherapy followed by adjuvant chemotherapy may prolong the survival of patients with glioblastoma. Further investigation is warranted, and a randomized trial is ongoing.

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