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Phase I/II study of cetuximab plus temozolomide as radiochemotherapy for primary glioblastoma (GERT)


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Website: http://www.asco.org/ASCO/Abstracts+%26+Virtual+Meeting/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=32491

Posted on: 10/04/2008

Phase I/II study of cetuximab plus temozolomide as radiochemotherapy for primary glioblastoma (GERT)--Eudract number 2005-003911-63; NCT00311857.

Sub-category:

Central Nervous System Tumors

Category:

Central Nervous System Tumors

Meeting:

2008 ASCO Annual Meeting

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Abstract No:

2077

Citation:

J Clin Oncol 26: 2008 (May 20 suppl; abstr 2077)

Author(s):

S. E. Combs, D. Schulz-Ertner, C. Hartmann, T. Welzel, C. Timke, K. Herfarth, A. von Deimling, L. Edler, M. Platten, W. Wick, J. Debus

Abstract:

Background: Glioblastomas (GB) are known to express high levels of EGFR; targeting of EGFR using cetuximab has proven to be a successful treatment. This phase I/II trial of radiochemotherapy (RCHT) with TMZ and cetuximab in patients with primary GB evaluates feasibility and toxicity. Methods: Seventeen patients with pathologically confirmed GB were included into this analysis. Radiotherapy (RT) is delivered with a median dose of 60 Gy, 5*2Gy/week. TMZ is prescribed concomitantly at a dose of 75mg/m2, followed by 6 cycles of adjuvant TMZ. Cetuximab is applied as weekly infusions (loading dose 400 mg/m2 on day 1, and concomitant with RT on days 8, 15, 22, 29, 36, 43 at 250 mg/m2). Fourteen patients were male and 3 patients were female. Median age at diagnosis was 48 years. Neurosurgical resections had been complete in 7, subtotal in 7, and a biopsy in 3 patients. O(6)-methylguanine DNA methyltransferase (MGMT) gene promoter methylation was investigated in the tumor tissue: 33% of the patients were MGMT-positive, and 66% were MGMT-negative. EGFR-analysis is currently being conducted. Treatment was initiated after a median of 15 days after primary diagnosis. Median follow-up time at the time of this analysis was 13 months. Results: RCHT with cetuximab is safe and well tolerated. Cetuximab-related side effects included acneiform rash. In one patient cetuximab infusions were discontinued after occurrence of bilateral pulmonary embolism in treatment week 7. One patient died in treatment week 4 after tumor progression and massive brain edema which could not be controlled by medication including high-dose steroids. In all other patients the scheduled 7 cycles of cetuximab could be applied. Overall survival (OS) was 87% at 12 months. No prognostic factors could be determined until now. Methylated MGMT was not associated with longer OS (p=0.22). Progression-free survival (PFS) was 81% at 6 months and 37% at 12 months. Methylated MGMT was not associated with longer PFS (p=0.59). No prognostic factors of PFS could be identified. Conclusions: Early data from trimodal therapy in GB patients with RT, TMZ and cetuximab indicate feasibility without an increased toxicity profile. PFS as well as OS appear to be very promising.

 

 

 

Abstract Disclosures

 




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