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Phase I/IIa Study of Cilengitide and Temozolomide With Concomitant Radiotherapy Followed by Cilengitide and Temozolomide Maintenance Therapy in Patients With Newly Diagnosed Glioblastoma.


Posted on: 05/06/2010

  J Clin Oncol. 2010 May 3. [Epub ahead of print]
 

Phase I/IIa Study of Cilengitide and Temozolomide With Concomitant Radiotherapy Followed by Cilengitide and Temozolomide Maintenance Therapy in Patients With Newly Diagnosed Glioblastoma.

 
Stupp R, Hegi ME, Neyns B, Goldbrunner R, Schlegel U, Clement PM, Grabenbauer GG, Ochsenbein AF, Simon M, Dietrich PY, Pietsch T, Hicking C, Tonn JC, Diserens AC, Pica A, Hermisson M, Krueger S, Picard M, Weller M.
Centre Pluridisciplinaire d'Oncologie, Department of Neurosurgery, Service de Radio-Oncologie, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne; Institute of Medical Oncology, University of Bern, Bern; Division d'Oncologie, Hôpitaux Universitaires de Genève, Geneva; Department of Neurology, University Hospital, Zurich, Switzerland; Department of Medical Oncology, Universitair Ziekenhuis Brussel, Brussels; Department of Clinical Oncology, Katholieke Universiteit Leuven, Leuven, Belgium; Department of Neurosurgery, University Hospital of Cologne, Cologne; Department of Neurosurgery, University of Munich, Munich; Neurologische Universitätsklinik des Knappschaftskrankenhauses Bochum-Langendreer, Ruhr University, Bochum; Friedrich Alexander University, Erlangen; Department of Neurosurgery, Institute of Neuropathology, University of Bonn, Bonn; Merck Serono, Darmstadt; and Department of General Neurology, University of Tübingen, Tübingen, Germany.
 
Abstract
PURPOSE Invasion and migration are key processes of glioblastoma and are tightly linked to tumor recurrence. Integrin inhibition using cilengitide has shown synergy with chemotherapy and radiotherapy in vitro and promising activity in recurrent glioblastoma. This multicenter, phase I/IIa study investigated the efficacy and safety of cilengitide in combination with standard chemoradiotherapy in newly diagnosed glioblastoma.
 
PATIENTS AND METHODS Patients (age >/= 18 to </= 70 years) were treated with cilengitide (500 mg) administered twice weekly intravenously in addition to standard radiotherapy with concomitant and adjuvant temozolomide. Treatment was continued until disease progression or for up to 35 weeks. The primary end point was progression-free survival (PFS) at 6 months.
 
Results Fifty-two patients (median age, 57 years; 62% male) were included. Six- and 12-month PFS rates were 69% (95% CI, 54% to 80%) and 33% (95% CI, 21% to 46%). Median PFS was 8 months (95% CI, 6.0 to 10.7 months). Twelve- and 24-month overall survival (OS) rates were 68% (95% CI, 53% to 79%) and 35% (95% CI, 22% to 48%). Median OS was 16.1 months (95% CI, 13.1 to 23.2 months). PFS and OS were longer in patients with tumors with O(6)-methylguanine-DNA methyltransferase (MGMT) promoter methylation (13.4 and 23.2 months) versus those without MGMT promoter methylation (3.4 and 13.1 months). The combination of cilengitide with temozolomide and radiotherapy was well tolerated, with no additional toxicity. No pharmacokinetic interactions between temozolomide and cilengitide were identified.
 
CONCLUSION Compared with historical controls, the addition of concomitant and adjuvant cilengitide to standard chemoradiotherapy demonstrated promising activity in patients with glioblastoma with MGMT promoter methylation.
 
 PMID: 20439646 [PubMed - as supplied by publisher] 
 

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