Treatment > Temozolomide Clinical Trials · Thalidomide

Meeting Abstract

Combined thalidomide and temozolomide treatment in patients with glioblastoma multiforme

M. Bjeljac, F. Baumann and R. Bernays

University Hospital Zurich, Zurich, Switzerland

Purpose. This is a preliminary report of a non-randomised open-label phase II study of the use of the antiangiogenic agent thalidomide alone and in combination with the chemotherapeutic agent temozolomide for patients with Glioblastoma multiforme.
The objectives are to determine whether these strategies can improve the median survival of patients with Glioblastoma multiforme and to evaluate toxicity.
Microsurgical tumor extirpation and radiotherapy precede thalidomide and temozolomide therapy.
Combination drug therapy is continued until disease progression, unacceptable toxicity, or for a maximum of one year.
Patients are evaluated by magnetic resonance imaging and neurologically status for response and toxicity every 3 months.

Patients and Methods. Forty-four patients with Glioblastoma multiforme were evaluated for survival, time to tumor progression ( TTP ) and side effects.
Nineteen patients ( 43% ) received thalidomide only ( T ), and 25 patients ( 57% ) had a combined therapy of thalidomide and temozolomide ( TT ).
Median thalidomide dosage was 200 mg/day.
Median temozolomide dosage was 200 mg/m2/day for five days, in monthly cycles.
Neuroradiological outcomes were assessed using a semiquantitative grading system.

Results. Median survival was 103 weeks for TT-patients and 63 weeks for T-patients ( P< 0,01 ).
Median TTP for the TT-group was 36 weeks and 17 weeks for the T-group ( P< 0,06 ).
Neuroradiologically, 20 of 44 patients ( 45% ) showed stable disease, 22 ( 50% ) progressive disease, and two ( 5% ) tumor regression.
Thalidomide and concurrent temozolomide were safe and well tolerated with mild to moderate toxicities.

Conclusion. This is the study investigating the tolerability and efficacy of continuous thalidomide treatment, alone and in combination with temozolomide, in patients with Glioblastoma multiforme.
Thalidomide as a single agent did not show prolonged patient survival, whereas the combination of thalidomide and temozolomide appears to confer a survival advantage to selected patients.

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